Medical Device Industry Expert to Spearhead European Sales of the Carillon Mitral Contour System

KIRKLAND, Wash.–(BUSINESS WIRE)–Cardiac Dimensions^®, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the appointment of Carmelo Mastrandrea as the company’s Vice President of Sales.

“Cardiac Dimensions has an opportunity to make an enormous impact by offering physicians a safe, effective, and easy-to-use option to treat patients earlier in their disease diagnosis when treatment can have the biggest impact on disease progression and quality of life.”

Mastrandrea is an accomplished medical device veteran, having held diverse leadership positions in sales and management over the past 20 years. Prior to joining Cardiac Dimensions, Mastrandrea most recently served as Vice President of Sales for REVA Medical, a leader in bioresorbable polymer technologies for vascular applications. Previously, Mastrandrea held global sales management positions at Biosensors International, Biotronik, Guidant, and Avintos.

“Cardiac Dimensions is strongly positioned to be a leader in the mitral valve repair sector, with exceptional clinical data supporting the use of our minimally invasive heart failure treatment, our newly approved German DRG reimbursement in place, and growth expected in other European regions,” said Gregory D. Casciaro, Cardiac Dimension’s President and CEO. “We are thrilled to welcome Carmelo to the Cardiac Dimensions team at this important time for our company. His wealth of global sales leadership experience will be tremendously valuable to our team and the customers they serve.”

In October 2018, Cardiac Dimensions announced that InEK, the German Institute for the Hospital Remuneration System, has granted a permanent DRG (Diagnosis Related Group) code covering reimbursement for the company’s Carillon^® Mitral Contour System to treat patients with Functional Mitral Regurgitation (FMR) in Germany. The new reimbursement became effective on January 1, 2019.

“I am excited to join Cardiac Dimensions’ exceptional team to execute on the company’s vision of reshaping the course of heart failure,” said Mastrandrea. “Cardiac Dimensions has an opportunity to make an enormous impact by offering physicians a safe, effective, and easy-to-use option to treat patients earlier in their disease diagnosis, when treatment can have the biggest impact on disease progression and quality of life.”

The Carillon Mitral Contour System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. FMR occurs when the left ventricle of the heart is enlarged, dilating the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent the worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. The Carillon System is a minimally invasive approach that offers patients annular reduction while keeping adjunctive therapy options open.

To date, over 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, Italy, and The Netherlands. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for the CE Mark demonstrating safety and performance. The recently released REDUCE FMR data is expected to assist with expanding reimbursement and usage in additional geographies such as Poland, France, the United Kingdom, and Australia. Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany.

Cardiac Dimensions and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

Related Article: Cardiac Dimensions Announces $39 Million Series B Financing for Innovative Device to Treat Patients with Heart Failure

• AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitor
• Best-in-class efficacy and safety potential by selectively targeting principal oncogenic TGF-beta isoforms
• Reverses immunosuppression and renders tumors sensitive to checkpoint blockade in pre-clinical models

Jan. 7, 2019 – Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, announced today that the first patient was dosed in a Phase 1 clinical trial with AVID200. The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200 in patients with solid tumors.

“Our goal is to significantly expand the number of cancer patients who benefit from checkpoint blockade and other immunotherapies. AVID200 was designed to have the potency and isoform selectivity to effectively counteract the highly immunosuppressive effects of TGF-beta in the tumor microenvironment and reverse resistance to immunotherapy,” commented Dr. Maureen O’Connor-McCourt, CSO of Forbius.

AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity was also designed to circumvent cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action focuses on the reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune cell infiltration, and increased efficacy of immune checkpoint agents.

About Forbius

Forbius is a clinical-stage protein engineering company that designs, develops, and commercializes biotherapeutics for the treatment of fibrosis and cancer. Our current focus is the development of agents targeting the transforming growth factor-beta (TGF-beta) and epidermal growth factor receptor (EGFR) pathways.

Our lead program targeting the TGF-beta pathway is AVID200. AVID200 is a rationally designed and highly potent TGF-beta 1 & 3 inhibitor. This TGF-beta isoform selectivity was chosen in order to achieve an optimal therapeutic index. The AVID200 program has been cleared by the FDA for two Phase 1b clinical trials in fibrotic indications, as well as a Phase 1 clinical trial in solid tumors. Additional clinical trials in fibrotic indications are planned for 2019.

Forbius’ lead program targeting the EGFR pathway is AVID100. AVID100 is an anti-EGFR antibody-drug conjugate. This program has completed a Phase 1 clinical trial and has commenced Phase 2a clinical trials in EGFR overexpressing solid tumors.

Media Relations

Claudia Resch, info@forbius.com

Veteran Life Sciences Executive Brings Proven Experience Developing CNS Therapeutics

MONTREAL and TORONTO, Jan. 4, 2019 /CNW/ – KalGene Pharmaceuticals Inc., a biotechnology company developing therapeutics to slow the progression of Alzheimer’s disease, today announced the appointment of James Callaway, Ph.D. as chief executive officer, effective immediately.

“This has been a very important transition year as we have confirmed our initial thesis with respect to validating the company’s lead KG207, which in pre-clinical studies was shown to successfully cross the blood brain barrier and safely reduce plaque load.  The company has successfully completed early toxicology studies and has carried out all the requisite steps to manufacture product,” said Dr. Jacki Jenuth, Chairperson of the Kalgene’s board of directors.  “We are very pleased to have executed on the next key step of our strategy in attracting an accomplished new CEO to the company as we leverage this foundation and address significant inbound interest for the company and its lead program.  Jim brings an ideal set of leadership skills and domain expertise to guide the team through the transition from a pre-clinical to a clinical stage company.”

“KG207 has shown exceptional potential in pre-clinical studies, and I am excited about the prospect of bringing such a promising compound into the clinic,” Dr. Callaway commented. “I look forward to working with the savvy and talented team at KalGene as we strive to make a difference in the lives of individuals affected by Alzheimer’s disease.”

Dr. Callaway has over three decades of biopharmaceutical development experience, primarily targeting CNS therapeutics, and has served most recently as CEO for two privately-held biotech companies.  As the CEO of ArmaGen, he brought its products from the laboratory to the clinic, helping the company emerge as the first to demonstrate the ability of engineered biologics to cross the blood-brain barrier.  In addition, Dr. Callaway led the Alzheimer’s immunotherapy program at Elan Pharmaceuticals, which became the first company to introduce disease-modifying biologics (e.g., AN1792, bapinuzumab, ACC001) into clinical studies.  Dr. Callaway has filed and defended numerous NDAs and INDs during his career, including shepherding the approval of MyoBloc^® and the production of Tysabri^®.  He previously served in senior development roles at Bayer Pharmaceuticals, SmithKline Beecham (GSK), and InGene (since acquired by Xoma Corporation).  He holds a Ph.D. in Biological Chemistry from UCLA, with a focus on peptide chemistry.

About KalGene Pharmaceuticals Inc.
KalGene Pharmaceuticals Inc. is a pre-clinical-stage company focussed on the development of precision medicine therapeutics to slow the progression of Alzheimer’s disease both safely and effectively.  The company’s lead therapeutic candidate, KG207, targets toxic amyloid beta oligomers, and has been shown in animal models of Alzheimer’s disease to cross the blood-brain barrier, significantly reducing the plaque burden and leading to improved cognition and neuronal connectivity.  The molecule is a bifunctional agent that is a synthesis of two novel innovations licensed from the National Research Council of Canada (NRC).

LISLE, Ill., Jan. 3, 2019 –  Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced that industry veteran Jim Yearick has joined the executive leadership team as Senior Vice President of Sales and Marketing. Mr. Yearick will oversee Endotronix’s worldwide sales and marketing efforts for the Cordella™ Heart Failure System (Cordella System).

“Jim is a respected sales and marketing leader in heart failure with both early-stage and established company experience. He is commercially savvy, with a solid track record of building and developing high-performing teams,” commented Harry Rowland, CEO and co-founder of Endotronix. “His strong background across cardiology will be invaluable as we accelerate the Cordella System commercialization and initiate our landmark, PROACTIVE-HF pivotal study of the Cordella PA Sensor.”

Mr. Yearick joins Endotronix after leading market development and global expansion for HeartWare, an innovator of minimally invasive, miniaturized, left ventricular assist devices (LVADs) that provide mechanical circulatory support for patients with advanced heart failure. Following HeartWare’s acquisition by Medtronic in August 2016, Mr. Yearick helped lead the integration efforts for Medtronic’s newly formed Heart Failure Mechanical Circulatory Support (MCS) Division. Prior to his tenure at HeartWare/Medtronic, Mr. Yearick has held senior-level positions in sales and marketing in the medical device and consumer goods industries, including Global Vice President roles at CHF Solutions and Medtronic’s Cardiac Rhythm Management division.

“It is an exciting time at Endotronix. The Cordella System is on the cusp of transforming heart failure treatment with a proactive patient management solution that improves the experience for the implanting physician, managing clinician, and patient,” Yearick said. “We’re entering a pivotal phase for the company that will produce commercial success and clinical data that accelerates our market adoption. I look forward to working with the team and executing on our strategy.”

The Cordella System is a comprehensive heart failure management solution that enables proactive management and early detection of worsening heart failure. The platform consists of a comprehensive remote patient management system coupled with a seamlessly integrated, next-generation implantable pulmonary artery (PA) pressure sensor to streamline heart failure care management, reduce heart-failure-related hospitalizations, and support reimbursement for care delivery activities.

The Cordella System, without the sensor, is available for commercial use in the U.S. and currently in centers across the U.S. In parallel, the company will initiate an investigation device exemption (IDE) study, PROACTIVE-HF, in early 2019 to demonstrate the safety and effectiveness of the Cordella PA Sensor.

About Endotronix
Endotronix, Inc., a medical technology company, delivers an integrated platform that provides comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. Their solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. 

 Related Article: Endotronix Hires Seasoned Life Sciences Executive John Flavin as CFO

Trial evaluating safety and efficacy of Staccato Alprazolam in subjects with epilepsy and a predictable seizure pattern

Results from the open label portion of the study will be presented at a major medical meeting in 2019

NEW ORLEANS, Dec. 03, 2018 (GLOBE NEWSWIRE) — Engage Therapeutics today announced from the American Epilepsy Society’s Annual Meeting the successful completion of the open label portion of the StATES (Staccato Alprazolam Terminates Epileptic Seizures) study. Enrollment will now commence in the double blind, placebo-controlled portion of the study. Results from the open label portion of the study will be presented at a major medical meeting in the first half of 2019.

“We are very pleased to be moving one step closer in our research toward validating what could ultimately become an ultra-rapid option for acute seizure rescue treatment,” said Dr. Jaqueline French, the study’s principal investigator and professor in the Department of Neurology at NYU Langone Health, in the Comprehensive Epilepsy Center, and founder/director of the Epilepsy Study Consortium. French currently serves as the Epilepsy Foundation Chief Scientific Officer.  “Many patients with epilepsy live with the fear that a seizure may occur at any moment, highlighting the need for a rescue medication that could give patients the confidence that a seizure could be rapidly aborted.”

The StATES study is investigating the safety and efficacy of Staccato Alprazolam in subjects with epilepsy who have a predictable seizure pattern. The therapy combines the FDA-approved Staccato delivery technology with alprazolam, an FDA-approved benzodiazepine.

“We are grateful for the contributions of those who participated in the open label portion of the Phase 2b study and want to encourage people to visit www.epilepsyhealthstudy.com to determine whether they, or someone they know, may be a good candidate to join the double-blind placebo-controlled portion of the trial, and help us to more quickly make this therapy’s promise a reality,” said Greg Mayes, president, CEO and founder of Engage.

Engage Therapeutics has lined up 50 U.S.-based clinical trial sites for the StATES study, in addition to sites in Australia, Canada and Jamaica as part of an effort to increase accessibility for participants. One hundred subjects are needed for the double blind, placebo-controlled portion of the trial which should be completed in the second half of 2019. A map of U.S. site locations can be found online at www.engagetherapeutics.com/study-locations.

About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam, for the immediate cessation of active and acute epileptic seizures. The investigational product is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting delivery system already used in an FDA-approved product with FDA-approved alprazolam. Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The product has now proceeded into a Phase 2b study known as the StATES study. Engage Therapeutics is based in Summit, N.J. For additional information please see www.EngageTherapeutics.com.

International Group of Investors from Canada, the U.S. and China Support Former Senior Executives from Pharmasset and Idenix in New Venture

ATLANTA, Nov. 27, 2018 /PRNewswire/ — Antios Therapeutics, Inc. (“Antios”) today announced the completion of a US$25 million oversubscribed Series A financing led by Lumira Ventures and Domain Associates, two prominent life science venture capital firms.  Other investors participating in the financing include CAM Capital, Delos Capital, Quantum Vista Capital, Fonds de solidarité FTQ and Georgia Research Alliance Venture Fund.  The proceeds from this financing will be used to develop ATI-2173, Antios’ lead oral drug candidate for treating patients infected with Hepatitis B virus (HBV) and potentially Hepatitis D virus (HDV).

Antios is a biopharmaceutical company focused on the development of novel antiviral therapies for unmet medical needs.  The company’s lead program is aimed at developing a curative regimen for chronic HBV, a major unmet global health problem affecting over 250 million people worldwide, and a leading cause of chronic hepatitis, liver cirrhosis and liver cancer.  The company’s founders include former senior executives from Pharmasset (acquired by Gilead Sciences) and Idenix (acquired by Merck), with decades of experience in the successful discovery, development and commercialization of transformative therapies and technologies to treat and cure viral infections.

“The next frontier in virology is to cure Hepatitis B. At Antios, we are committed to this pursuit,” said co-founder and Chief Executive Officer, Abel De La Rosa, Ph.D. “The strong financial support from our investors along with their extensive experience in clinical development and success building innovative companies in the infectious disease field will enable us to accelerate the development of ATI-2173 as a potential backbone of therapy to cure HBV.”

“The unique mechanism of action combined with liver targeting and the potential for a one pill, once-a-day combination regimen makes ATI-2173 an exciting candidate for development to treat HBV,” added Douglas Mayers, M.D., co-founder and Chief Medical Officer.

“We believe ATI-2173 has demonstrated highly unique properties and could be part of a paradigm shift in the treatment of HBV,” said Beni Rovinski, Ph.D., Managing Director at Lumira Ventures.  “We are excited to work again with Dr. De La Rosa and the team at Antios to advance this promising therapy.”

Following the completion of the financing round, Dr. Beni Rovinski (Lumira Ventures), Nicole Vitullo (Domain Associates), Scott Morenstein (CAM Capital), Henry Chen (Delos Capital) and Dr. Abel De La Rosa, have joined Antios’ Board of Directors.

About Antios Therapeutics

Antios Therapeutics is a biopharmaceutical company devoted to developing innovative therapies for viral diseases. With an experienced and proven leadership team, the company is focused on the development of its lead oral drug candidate for a potentially curative treatment of HBV infections.

Exact Imaging’s Novel ExactVu™ Micro-Ultrasound System is Helping Urologists Worldwide Revolutionize Prostate Cancer Detection

TORONTO, Nov. 22, 2018 /PRNewswire/ – Exact Imaging, the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, proudly announces this it has been chosen as Life Science Ontario (LSO)’s 2019 Life Science Company of the Year.

“Exact Imaging is redefining the diagnosis of prostate cancer by driving significant benefits for patients, clinicians and the healthcare system globally”, says LSO President and CEO Dr. Jason Field. “They are an excellent example of how Ontario-based innovation, coupled with manufacturing and commercialization expertise is fostering world-class medical device companies. We are proud to have chosen Exact Imaging as our 2019 Life Science Company of the Year and look forward to watching their continued growth in the global marketplace”.

“We are honored to have been selected as LSO’s 2019 Life Science Company of the Year and I’m especially pleased for our 54-person team who have worked tirelessly to create and commercialize a technology that is changing lives and, through our customers, changing outcomes,” says Randy AuCoin, Exact Imaging’s President and CEO. “We are incredibly proud to be a Canadian-based company and are appreciative of the amazing ecosystem of medical device suppliers, partners and experts in Ontario who make up our extended family”.

The LSO awards will be presented to Exact Imaging during LSO’s Celebration of Success Awards Dinner at Toronto’s Liberty Grand, February 27, 2019.

About Life Sciences Ontario:

Life Sciences Ontario (LSO) is a member-driven organization that represents and promotes the province’s vibrant and diverse life sciences sector. LSO collaborates with governments, academia, industry, and other life science organizations in Ontario and across Canada to promote and encourage commercial success throughout the sector. Membership in Life Sciences Ontario includes individuals, students, emerging companies, investors, service providers, and companies with marketed products. The organization provides a wide range of networking and educational events and operates a mentorship program that is helping to develop highly-skilled talent and build new business opportunities for the life sciences sector. LSO is an effective conduit for delivering policy options to governments and is dedicated to promoting Ontario’s life sciences sector internationally.

About Exact Imaging:

Exact Imaging is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow. Using the Exact Imaging platform, urologists are able to visualize areas of interest in the prostate and specifically target biopsies at those areas. For those cases where MRI might assist (i.e., prior negative biopsies), the FusionVu™ micro-US/MRI fusion application operates on the ExactVu™ micro-ultrasound platform and facilitates MRI fusion-based targeting. The ExactVu™ micro-ultrasound system including the FusionVu application have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license).

Related Article: Exact Imaging Becomes UroGPO Imaging Partner By Providing Micro-Ultrasound Based Targeting Solution for Prostate Biopsies

Individuals Treated with TPS lost 3-fold More Weight Than Those in Sham-Controlled Placebo Arm

SAN CARLOS, Calif., Nov. 15, 2018 /PRNewswire/ — BAROnova, Inc., a clinical stage medical device company focused on the development of non-surgical solutions for the treatment of obesity, announced today the presentation of primary results of its pivotal trial, the ENDObesity II study, as a late-breaking clinical trial, at the scientific sessions of the 2018 Obesity Week conference.

The ENDObesity II study was a randomized, double-blinded, sham-controlled study that assessed the safety and effectiveness of the TransPyloric Shuttle Device for the treatment of obesity in patients with a body mass index of 30-40 kg/m². Primary endpoints were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of people in the treatment group who achieved 5% TBL or more after 12 months.

Individuals treated with the investigational TPS device on average lost three times (3x) more weight when compared to the sham-control group (9.5% for the TPS group and 2.8% for the Control, p<0.0001) at the 12-month follow up. Approximately 67% of people treated with TPS lost 5% or more of their body weight, exceeding the pre-specified performance target of 50% (p<0.0001). Forty percent (40%) of people treated with TPS lost 10% or more weight (vs. 14% in sham-treated controls). A weight loss of 5% or more is considered clinically meaningful for achieving health benefit. People in the TPS group also demonstrated greater improvement in their blood pressure and other cardiometabolic risk factors as well as a significant improvement in their quality of life when compared to those in the control group.

“Obesity is a worldwide epidemic with up to 40% of adult Americans suffering from obesity and its associated co-morbidities. We need effective solutions that are safe and acceptable by physicians and by people who live with this chronic condition. The TransPyloric Shuttle represents the next generation of intragastric devices that was designed to address some of the undesirable side effects with the first-generation devices and offer longer treatment duration.  Based on the successful results from this study, this treatment will likely find a very meaningful role in clinical practice, if approved by the FDA,” said Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair of Medicine for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study who presented the results.

The ENDObesity II study enrolled 302 patients from nine investigational centers across the United States. In the trial, the most common adverse events among people treated with the TPS device were gastrointestinal events, such as stomach pain, nausea, vomiting, and dyspepsia, as expected with an intragastric device designed to treat obesity through delay gastric emptying.

“We are pleased to see the magnitude of weight loss and significant clinical benefit demonstrated in the study.  Based on the positive pivotal study results, we have submitted the PMA application to the FDA,” said Lian Cunningham, M.D, PhD, Senior Vice President of Clinical Affairs and Regulatory Affairs of BAROnova Inc.. “We would like to thank all our clinical investigators and their staff for their contribution to the success of this trial. We look forward to bringing this new technology to patients and physicians if approved by the FDA.”

About Obesity
Obesity is defined as a Body Mass Index (BMI) >30 kg/m². Individuals with obesity are at increased risk of developing over 70 comorbid conditions including hypertension, hyperlipidemia, and type 2 diabetes. Obesity is a worldwide epidemic that has placed a major burden on healthcare systems globally.  There are currently over 75 million adults in the United States with a BMI between 30-40 kg/m² and over 600 million adults worldwide who are candidates for a safe and effective non-surgical therapy.

About the TransPyloric Shuttle
The TransPyloric Shuttle is a novel investigational device that is designed to be inserted and removed trans-orally using standard endoscopic techniques. It is mechanically constructed using solid silicone components and is not subject to inflation or deflation risks. The device is intended to reside in the stomach for 12 months.  The TransPyloric Shuttle’s primary mechanism of action is delayed gastric emptying which is a known mechanism of weight loss.  If approved by the FDA, the TPS will be the first and only intragastric device with a 12-month treatment duration available in the United States.

About BAROnova, Inc.
BAROnova is a Silicon Valley, venture-backed company that has developed a first-in-class non-surgical solution for obesity. BAROnova is headquartered in San Carlos, CA. For more information about the company, please visit www.BAROnova.com.

QUEBEC CITY, Nov. 1, 2018 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSX: OPS) (OTCQX: OPSSF) has reached an important milestone with more than 50,000 patients assessed with the OptoWire™, a pressure guidewire used to measure Fractional Flow Reserve (“FFR”) to diagnose and treat cardio vascular disease.

The use of pressure guidewires to measure FFR for the evaluation of coronary blockages has grown over the years and is now considered the gold standard. Clinical data have shown a reduction in mortality in patients assessed using this technique.

As Societies of Cardiology are recommending expanding the use of pressure guidewires and physiology assessments, Opsens has scaled up manufacturing to respond to the growing demand for the OptoWire in its main markets, namely Japan, the United States, Europe and Canada, and to expand its reach to new geographies.

“This milestone is a testament to the quality of our product, of our team and of our vision to take on the challenge to bring a second-generation fiber optic technology pressure guidewire to the market,” said Louis Laflamme, President and CEO. “Our customers are delighted by the benefits brought on by the OptoWire and we are encouraged by their excellent feedback in terms of diagnostic accuracy as well as the time-saving and cost-effectiveness it can provide to the procedure.”

Opsens differentiates from the competition by the performance of the OptoWire in terms of vessel accessibility, as well as for the reliability and the accuracy of its second-generation fiber optic sensor.

Market adoption of the OptoWire has grown at a rapid pace and Opsens is now commercializing the OptoWire in more than 30 countries, with especially robust growth in the United States and Japan.

Laflamme concluded by sharing the unique passion that lives at Opsens: “Passing the 50,000 units sold, especially when more than half of these sales were completed in the last 12 months is a tremendous achievement. More than a number of units sold, our team gets pride in supporting physicians to provide accurate diagnostic and proper treatment to their patients.”

With Reimbursement in Place and Positive Late-Breaking Data, Company Expects Continued Growth in Germany

Kirkland, Wash. – October 18, 2018 – Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced that InEK, the German Institute for the Hospital Remuneration System, has granted a permanent DRG (Diagnosis Related Group) code covering reimbursement for the company’s Carillon Mitral Contour System to treat patients with functional mitral regurgitation (FMR) in Germany. The new reimbursement becomes effective January 1, 2019.

Previously, the Carillon System had been available in limited volumes under the Neue Untersuchungs- und Behandlungsmethoden (NUB) program. The DRG approval will allow every eligible patient in Germany to have access to the Carillon procedure.

“With this reimbursement in place and following the positive late-breaking clinical data from REDUCE FMR presented last month at TCT, we expect to see significant growth in Germany, the largest market in which the Carillon Mitral Contour System is currently available,” said Gregory D. Casciaro, President and CEO of Cardiac Dimensions. “We are pleased that this decision means many more people will now benefit from Carillon therapy.”

Data presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Diego last month showed that the REDUCE FMR clinical trial met its primary endpoint, demonstrating a statistically significant reduction in regurgitant volume at one year in patients who received the Carillon Mitral Contour System versus the control cohort, consisting of patients under guideline-directed medical therapy who underwent a sham procedure. The reduction represented a 22% reduction in regurgitation in the treatment group, compared to an overall increase of 8% in regurgitation in the control group (p=0.03). Study patients, the imaging core lab, and the clinical assessors were blinded as to the patients’ randomization group through the one-year follow-up period of the study.

“This positive decision is good news for patients in need of mitral valve repair due to FMR,” said Prof. Michael Haude, M.D., Director of the Department of Internal Medicine I, Cardiology, Lukas Krankenhaus Neuss, who has been treating patients with the Carillon System since the Amadeus study in 2007. “The Carillon System provides an important option for patients that is easy to use and that can be used to treat patients earlier in the progression of their disease to prevent worsening quality of life.”

The company announced last month that it had enrolled its first patient in the pivotal CARILLON Trial, a multi-center, double-blinded, randomized controlled trial expected to randomize 450 patients at up to 75 centers in North America and Europe.

Functional mitral regurgitation occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. The Carillon System is a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

To date, approximately 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, Italy and The Netherlands. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for the CE Mark demonstrating safety and performance. The recently released REDUCE FMR data is expected to assist with expanding reimbursement and usage in additional geographies such as Poland, France, United Kingdom and Australia.  Additionally, the CARILLON Trial, the randomized sham-controlled U.S. pivotal IDE study, continues to enroll patients at centers in the U.S. and Europe.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.

The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.

Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

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Media Contact:

Rick Wypych

rwypych@cardiacdimensions.com

(425) 605-5910

-Target enrollment has been exceeded and completed ahead of schedule

-Company anticipates primary data analysis in Q4 2019

In Randomized Blinded Study, the Carillon Mitral Contour System Catheter-Based Treatment Meets Endpoint for Reduction in Regurgitant Volume

September 19, 2018 06:45 AM Eastern Daylight Time

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today announced it has named Anthony (Tony) Polverino, Ph.D., Executive Vice President of Early Development and Chief Scientific Officer. In his new role, Dr. Polverino will be instrumental in setting and driving the Zymeworks R&D strategy. He will also manage the advancement of product candidates from discovery research through translational research/early development, thereby creating a seamless link with clinical development. In this newly created position, Dr. Polverino will report to Ali Tehrani, Ph.D., President & CEO of Zymeworks.

“Having had the opportunity to assess Zymeworks’ technologies and pipeline, I believe they are extremely well positioned to deliver novel treatments for a number of serious diseases, and I am delighted to be joining the company.” – Ali Tehrani, Ph.D., President & CEO, Zymeworks

“Tony joins us with an extensive and productive background in drug discovery and development,” said Dr. Tehrani. “His career includes a number of successes identifying and advancing programs from discovery through to clinical development and beyond. With expertise in biologics, antibodies, and small molecule therapeutics, as well as a broad background in immunotherapy and cancer biology, he is well suited to lead and contribute on many fronts as Zymeworks enters the next phase of its growth in building a diversified pipeline of first and best-in-class preclinical and clinical therapeutic programs.”

From 2016 until 2018, Dr. Polverino was at Kite Pharma, Inc., which was acquired by Gilead Sciences, Inc. in 2017. While at Kite he served as the interim Chief Scientific Officer and before that as Vice President of Research. During his tenure, Yescarta®, Kite’s lead chimeric antigen receptor (CAR)-T cell therapy, was approved for relapsed or refractory B cell lymphoma, and multiple programs were advanced to the clinic. Dr. Polverino also assembled an innovative chimeric antigen receptor discovery and development team. Prior to Kite, he was at Amgen Inc. from 1994 to 2014, serving in a number of research leadership roles of increasing responsibility. While at Amgen he managed and advanced numerous research programs utilizing multiple therapeutic modalities, including immunotherapy, oncolytic viruses, bispecific antibodies, antibody-drug conjugates, and small molecules. He also played a key role in the development of over 12 novel antigens for antibody therapeutics.

“Having had the opportunity to assess Zymeworks’ technologies and pipeline, I believe they are extremely well-positioned to deliver novel treatments for a number of serious diseases, and I am delighted to be joining the company,” said Dr. Polverino. “Zymeworks’ multiple platforms will provide abundant opportunities to apply my scientific curiosity and passion for creating new medicines for patients.”

Dr. Polverino earned his undergraduate degree in pharmacology from Adelaide University and his Ph.D. in biochemistry from Flinders University, both in Adelaide, Australia. Subsequently, he was a post-doctoral scientist at Cold Spring Harbor Laboratory located in Cold Spring Harbor, New York. Dr. Polverino has authored dozens of scientific publications and is a named inventor on multiple patents. He serves as a board member for BrainStorm Cell Therapeutics, a biotechnology company developing adult stem cell therapeutics for neurodegenerative diseases.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to future contributions by the new Chief Scientific Officer, Zymeworks’ technology and potential future growth, the success of Zymeworks’ drug discovery and development, Zymeworks’ ability to deliver novel treatments or develop new medicines, and other information that is not historical information. When used herein, words and phrases such as “will,” “believe,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D., 604-678-1388
ir@zymeworks.com
or
Media Inquiries:
Angela Bitting, 925-202-6211
a.bitting@comcast.net

Related Article: Zymeworks Adds Experienced Executives to Management Team to Support Expanding Clinical Development

KIRKLAND, Wash.- Cardiac Dimensions, Inc. a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions, today announced the company has randomized its first patient in the CARILLON Pivotal Trial.

The CARILLON Trial is evaluating the Carillon^® Mitral Contour System^® for the treatment of functional mitral regurgitation (FMR) associated with heart failure (HF) as compared to a randomized control group treated with optimal medical management according to established heart failure guidelines. The multi-center, double-blinded, randomized controlled trial is expected to randomize 450 patients at up to 75 centers in North America and Europe. The trial has primary safety and efficacy endpoints at 12 months and will follow the randomized patients out to five years to document long-term safety and clinical status. The CARILLON Trial also includes a cross-over feature that allows patients originally randomized to the control group to receive the Carillon System after their one year follow-up visit.

“Current treatments to improve the quality of life for patients with FMR fall short and many heart failure patients are too frail for open-heart surgery,” said Samir Kapadia, M.D., interventional cardiologist and Cath Lab director at the Heart & Vascular Institute, Cleveland Clinic, and one of the principal investigators of the CARILLON Trial. “Transcatheter treatments have been shown to be safe and effective in the treatment of valve diseases, but there is no minimally invasive intervention yet approved in the U.S. for these patients. Today, most FMR patients are treated with medical therapy only for decreasing symptoms but this does not address the underlying anatomical problem leading to mitral regurgitation. The CARILLON Trial should provide us a better understanding of the benefits of the Carillon System as an option for heart failure patients with FMR.”

Functional mitral regurgitation occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery.

Prof. Tomasz Siminiak, professor of cardiology at Poznan University of Medical Sciences in Poznań, Poland, randomized the first patient in the CARILLON Trial.

“We are very excited to participate in this landmark trial to study the Carillon System for patients with FMR,” said Prof. Siminiak. “These patients need access to less invasive treatment options, and to be able to contribute to advancements that have the potential to slow the progression of this chronic disease, is very important to us.”

An estimated 26 million people suffer from heart failure worldwide¹ and, of those, approximately 70 percent have FMR. In the U.S., an estimated two million people are affected by symptomatic FMR associated with HF.^2,3 Overall, HF is a significant clinical and economic burden with direct and indirect costs expected to grow to $70 billion by 2030.⁴

“The initiation of the CARILLON Trial is the pinnacle of our clinical program, which includes positive data from three previous clinical trials, and is the final step on our path to bringing the Carillon System to patients in the United States,” said Gregory D. Casciaro, president and CEO of Cardiac Dimensions. “Our vision is to have a significant impact on the treatment of patients with FMR, offering physicians a safe and easy-to-use option that can treat a broader range of patients with the goal of slowing disease progression and preventing worsening quality of life.”

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression and prevent worsening quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

To date, approximately 900 patients have been treated with the Carillon System throughout the world. Commercially, the Carillon System has its CE Mark and is available in certain European markets as well as other key geographies including Turkey. Clinical data from three completed studies of the Carillon System (AMADEUS, TITAN, and TITAN II) were the basis for CE marking demonstrating safety and performance. In addition, the company will announce the results of its landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR at the Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference September 23, 2018. Additionally, the CARILLON Trial, continues to enroll patients.

About Cardiac Dimensions

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Washington; Sydney, Australia and Frankfurt, Germany.

The Carillon Mitral Contour System is an investigational device in the U.S. For more information, please visit www.cardiacdimensions.com.

Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

¹ Ponikowski P, Anker SD, AlHabib KF et al. Heart failure: preventing disease and death worldwide. ESC Heart Failure. 2014;1:4–25. doi: 10.1002/ehf2.12005.

² Nkomo VT, Gardin JM, Skelton TN, et al. Burden of valvular heart diseases: a population-based study. Lancet. 2006;368(9540):1005-11.

³ Patel JB, Borgeson DD, Barnes ME, el at. Mitral regurgitation in patients with advanced systolic heart failure. J Card Fail. 2004;10(4):285-91.

⁴ Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the Impact of Heart Failure in the United States. Circ Heart Fail. 2013;6(3):606-19.

Contacts

Cardiac Dimensions
Rick Wypych, 425-605-5910
rwypych@cardiacdimensions.com

G1 Therapeutics (Nasdaq: GTHX), a clinical-stage oncology company, today announced that it is expediting analyses of myelopreservation data from its randomized Phase 2 trial of trilaciclib in combination with chemotherapy and Tecentriq^® (atezolizumab) in first-line small cell lung cancer (SCLC). Myelopreservation results from the trial will be reported in the fourth quarter of 2018.

“We elected to make myelopreservation the primary outcome of the randomized trilaciclib/chemotherapy/Tecentriq trial based on the strength of the first-line small cell lung cancer myelopreservation results from our randomized Phase 2 trilaciclib/chemotherapy trial, which we reported in March,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, Research and Development. “This protocol amendment, which we have discussed with U.S. and European regulatory authorities, enables us to accelerate analyses of mature myelopreservation data collected from the trilaciclib/chemotherapy/Tecentriq trial. The trial will remain blinded to investigators and participants, with no impact on our timeline to report overall survival data.”

This randomized, double-blind Phase 2 trial enrolled 107 patients to receive trilaciclib or placebo in combination with chemotherapy (carboplatin + etoposide) and Tecentriq as first-line treatment for SCLC. The trial is evaluating the myelopreservation potential of trilaciclib. Myelopreservation is the ability to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Anti-tumor efficacy measures including overall response rate, progression-free survival and overall survival are also being evaluated. Under the revised protocol, myelopreservation results are now the primary outcome and overall survival is being assessed as a secondary outcome. The trial completed enrollment in February 2018.

“Data from the trilaciclib/chemotherapy/Tecentriq trial have the potential to confirm the myelopreservation results observed in our randomized Phase 2 trial of trilaciclib in combination with chemotherapy. Both trials evaluated trilaciclib in first-line small cell lung cancer using the same chemotherapy backbone,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “By the end of the year we will have myelopreservation data from all four randomized Phase 2 trials of trilaciclib, including three in small cell lung cancer and one in triple negative breast cancer. In these trials, trilaciclib was used in first-, second- and third-line settings in combination with a variety of chemotherapy regimens. We plan to discuss the totality of the data, which includes approximately three hundred participants who received trilaciclib, with U.S. and European regulatory authorities in the first half of 2019.”

Webcast and Conference Call 
The G1 management team will host a webcast and conference call at 8:30 a.m. ET today to discuss the trilaciclib clinical development program. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code: 3892548. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com.

About Trilaciclib
Trilaciclib is a first-in-class myelopreservation therapy designed to preserve hematopoietic stem and progenitor cell function, as well as immune system function, during chemotherapy. Trilaciclib is a short-acting intravenous CDK4/6 inhibitor administered prior to chemotherapy and has the potential to significantly improve treatment outcomes.

Trilaciclib is being evaluated in four randomized Phase 2 clinical trials. In March 2018, G1 announced positive Phase 2 data showing myelopreservation benefits in newly diagnosed, treatment-naive small cell lung cancer (SCLC) patients (NCT02499770). Additional results from this trial will be reported at the European Society for Medical Oncology (ESMO) 2018 Congress being held October 19-23. The company plans to report data from three other randomized Phase 2 trials in 2018: a trial in combination with chemotherapy and Tecentriq^® in first-line SCLC, (NCT03041311), a trial in combination with chemotherapy in previously treated SCLC (NCT02514447), and a trial in combination with chemotherapy in triple-negative breast cancer (NCT02978716).

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; G1 Therapeutics’ development of a CDK4/6 inhibitor to reduce chemotherapy-induced myelosuppression is novel, unproven and rapidly evolving and may never lead to a marketable product; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Jeff Macdonald
Head of Investor and Public Relations
919-213-9835
jmacdonald@g1therapeutics.com

Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced the close of a Series D financing round totaling $45 million. The round was led by LSP, investing from its LSP Health Economics Fund 2, and included Aperture Venture Partners, BioVentures Investors, Lumira Ventures, OSF Ventures, Seroba Life Sciences, SV Health Investors, Wanxiang Healthcare Investments, and an unnamed corporate strategic investor. Endotronix will expand the board of directors to include Fouad Azzam Ph.D., General Partner at LSP.

This financing supports the commercialization of the Cordella™ Heart Failure System (Cordella System) and clinical development of the Cordella™ Pulmonary Artery Sensor (Cordella Sensor) through CE Marking and FDA Premarket Approval (PMA). The product platform consists of a comprehensive remote patient management software solution coupled with a seamlessly integrated, next-generation implantable pulmonary artery sensor to streamline heart failure care management and provide early detection of worsening heart failure.

“We are thrilled with the world-class leadership and support of LSP and our existing investor group as we launch into the next phase of our company,” commented Harry Rowland, CEO of Endotronix. “This financing accelerates our U.S. and E.U. launch of the Cordella System and supports our upcoming landmark randomized, controlled clinical study, PROACTIVE-HF, to demonstrate the safety and effectiveness of proactive heart failure management.”

The Cordella System is designed to address inefficiencies in heart failure management and promote guideline-based therapy so physicians can improve patient care and reduce re-hospitalizations with effective and scalable remote patient management. Over 26 million people worldwide suffer from heart failure and it is a leading cause of re-hospitalization for people over 65^1,2. With U.S. treatment costs reaching $31B per year, heart failure management remains a pressing unmet clinical need³.

“Endotronix is on the cusp of transforming heart failure management,” stated Fouad Azzam. “Their scalable Cordella System enables streamlined and timely flow of clinical-level information that can improve patient outcomes and supports sustainable care delivery revenue for healthcare providers. We’re excited to be part of the team to drive this transformation in the heart failure market.”

This announcement builds on the earlier news of successful first-in-human use of the Cordella Sensor in Europe and first commercial use of the Cordella System at select U.S. sites.

About the Cordella™ Heart Failure System

The Cordella™ Heart Failure System is a proactive heart failure management solution that brings patient management into the digital age and allows physicians to treat more patients with guideline-based therapy. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient data and insights to the heart failure clinician to guide therapy and optimal dosing. In the U.S. market, the system drives care delivery revenue using Medicare’s existing Chronic Care Management Services to support proactive, high-quality heart failure care. For suitable patients, the system seamlessly integrates pulmonary artery pressure data with a next-generation wireless, implantable sensor. Clinical studies have demonstrated that pulmonary artery pressure-guided management can reduce heart failure-related hospitalizations and reduce mortality.

About Endotronix

Endotronix, Inc., a digital health, medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure. 

About LSP

LSP (Life Sciences Partners) is an independent European investment firm, providing financing for private and public life sciences companies. LSP’s mission is to connect investors to inventors, focusing on unmet medical needs. Since the late 1980s, the LSP team has invested in about 100 innovative enterprises, many of which have grown to become leaders of the global life sciences industry. With over €1.7 billion ($2.0 billion) of investment capital raised to date and offices in Amsterdam, Munich and Boston, LSP is Europe’s leading life sciences investor. The LSP Health Economics Fund 2 invests in innovative products that can increase the quality of health care, while reducing the cost of care.

Related Article: Endotronix Closes $32 Million in Financing to Address Heart Failure Management

G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that Garry Nicholson has been appointed to its board of directors, effective September 12, 2018.

“We are pleased to welcome Garry as an independent director to our board. He has a breadth of experience in oncology development and commercialization, including leading the global regulatory and launch strategy for the first CDK4/6 inhibitor approved in the U.S. and Europe. We look forward to his contributions as we advance our pipeline of innovative therapies to improve the lives of those affected by cancer,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

“I am excited to be joining the G1 board of directors as the company moves toward commercialization of its lead program. Trilaciclib is a first-in-class therapy that could benefit millions of people living with cancer,” added Mr. Nicholson.

Mr. Nicholson has more than 30 years of pharmaceutical and biotech oncology experience. He led the global oncology franchise at Pfizer in the role of President, Pfizer Oncology. His responsibilities included global commercialization and sales, clinical development and regulatory strategy, and business development. Mr. Nicholson also served on the board of directors of the Pfizer Foundation. Earlier in his career, he held various leadership positions in the oncology division of Eli Lilly and Company. Most recently, Mr. Nicholson served as President and Chief Executive Officer of XTuit Pharmaceuticals.

Mr. Nicholson currently serves on the board of directors of Five Prime Therapeutics, Inc., TESARO, Inc., and SQZ Biotechnologies.

About G1 Therapeutics
G1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs, trilaciclib, lerociclib and G1T48, that are designed to enable more effective combination treatment strategies and improve patient outcomes across multiple oncology indications.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, lerociclib and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, G1 Therapeutics’ ability to recruit and enroll patients in its studies; G1 Therapeutics’ initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; competition in the industry in which G1 Therapeutics operates; and market conditions, including future legislation that may increase the difficulty and cost for G1 Therapeutics to obtain marketing approval of and commercialize its product candidates. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
917-371-0940
jmacdonald@g1therapeutics.com

ExactVu™ micro-ultrasound platform – now with FusionVu – enables the highest real-time resolution for targeted prostate imaging and biopsy

Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced one-year follow-up data from the REDUCE LAP-HF I clinical study of its Interatrial Shunt Device (IASD^®). The IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. Data was presented in the late-breaking scientific session at the European Society of Cardiology meeting. Dr. Ted Feldman from Evanston Hospital in Illinois presented the results on behalf of the investigators and research staff.

REDUCE LAP- HF I is a prospective, double-blind, mechanistic study of 44 patients randomized to IASD or sham control. Primary study endpoints at 30 days included effectiveness of the IASD as measured by exercise pulmonary capillary wedge pressure (PCWP) reduction compared to sham control, and procedural safety as assessed by major adverse cardiovascular, cerebral, or renal events (MACCRE). The study met its primary endpoint.

The one-year results demonstrate shunt patency (blood flow from the left to right atrium) for all participants who received the implant. Results further showed the IASD is safe, improved quality of life and is associated with favorable trends in heart failure hospitalization and reduction in New York Heart Association (NYHA) heart class. Results are published today in JAMA Cardiology.

“The REDUCE LAP-HF I clinical study is of tremendous interest to me because HFpEF is a clinical problem for which there is no effective therapy,” commented Ted Feldman, M.D., Evanston Hospital in Illinois and co-principal investigator. “We’ve now studied the IASD in several consecutive trials. The early single-arm studies demonstrated that people felt better and their exercise capacity improved. Now, a sham-controlled randomized study conclusively proves the mechanism of action and again suggests clinical efficacy in midterm follow-up.”

Sanjiv Shah, M.D., Northwestern Memorial Hospital’s Center for Heart Failure at the Bluhm Cardiovascular Institute in Chicago, and co-principal investigator, commented “I am pleased with the results of the REDUCE LAP-HF trials so far. By leading and taking part in these studies, we hope to make a significant difference for patients who suffer from the devastating effects of this type of heart failure.”

“The data presented today by Dr. Feldman once again demonstrate the potential benefit of IASD therapy for the large underserved heart failure population,” said Jan Komtebedde, Senior Vice President and Chief Medical Officer at Corvia Medical. “While this particular study was focused on demonstrating a mechanistic effect and by design, underpowered for other outcome measures, the clinical results are consistent with prior trials confirming the IASD provided symptom relief, improved quality of life, and reduced heart failure events. We now are focused on demonstrating, in the ongoing REDUCE LAP-HF II study, that these positive clinical outcomes are robust enough, in a larger patient population, to carry this new technology into clinical practice.”

REDUCE LAP-HF II is a large multi-national prospective, double-blind, sham-controlled trial randomizing 608 HFpEF and HFmrEF patients. Recruitment is ongoing.

About the InterAtrial Shunt Device (IASD^®)

The Interatrial Shunt Device is the world’s first transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. For more information, please visit http://treatmyheartfailure.com/. The IASD is an investigational device and not available for commercial distribution in the United States

About Corvia Medical, Inc.

Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures and an undisclosed strategic investor. For more information, please visit http://corviamedical.com/.

MEDIA CONTACT: 
Jennifer Fitzgerald
+1-484-678-5018
jen@sprigconsulting.com

SOURCE Corvia Medical, Inc.

Related Links

http://corviamedical.com

Forbius announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for AVID200, an isoform-selective TGF-β inhibitor. This enables the company to begin a Phase 1 clinical study to evaluate AVID200 as a potential treatment for diffuse cutaneous systemic sclerosis (SSc), a life-threatening fibrotic disease.

SSc is a rare, severe, and progressively debilitating fibrotic disease, affecting predominately women in mid-life. The 10-year survival rate of SSc patients is approximately 55%. No therapeutic is currently approved for the treatment of SSc, which affects an estimated 50,000 people in the U.S. alone.

TGF-β is now widely accepted as being the primary driver of SSc pathogenesis (Lafyatis, R.Nat. Rev. Rheumatol. 10, 706–719 (2014)). Gene expression data demonstrate the increased expression of TGF-β regulated genes in SSc skin. Moreover, the extent of upregulation of expression of two of the three TGF-β isoforms (-β1 &-β3), which are the isoforms blocked by AVID200, correlates with the severity of SSc (O’Connoret al, JSRD, 2018, CO.22 Vol 3(1S):22-25)

“I am keen to investigate the potential of AVID200 to reverse this life-threatening condition. A substantial body of preclinical and clinical data demonstrate that the basic defect in SSc is diffusely increased TGF-β activity and that inhibition of TGF-β could reverse this disease. AVID200 appears to have the right profile to be the first disease modifying agent in SSc,” commented Coordinating Principal Investigator, Robert Lafyatis, M.D., Professor of Medicine, Medsger Professor and Director of the University of Pittsburgh Scleroderma Center at the University of Pittsburgh Medical Center.

The Phase 1 dose-escalation study will be conducted in multiple study centers throughout the United States. The trial will evaluate safety and pharmacokinetics, as well as pharmacodynamics and preliminary evidence of efficacy of AVID200 as a potential treatment of SSc.

About AVID200

The AVID200 program was recently featured in an oral presentation at the 5th Systemic Sclerosis World Congress and received an award from the World Scleroderma Foundation as “One of the Most Original Works Presented at the Congress”.

AVID200 is designed to be a highly potent and isoform-selective TGF-β inhibitor. AVID200 is unique since it selectively neutralizes TGF-β1 and -β3 with pM potency, while at the same time being minimally active against TGF-β2. Inhibiting the TGF-β1 and -β3 isoforms is advantageous since overexpression of these isoforms is closely associated with the progression of fibrosis and cancer. Conversely, blockage of TGF-β2 is undesirable because of the potential impact on normal cardiac function and dissemination of metastasis. AVID200 is therefore positioned to be an effective and well-tolerated therapeutic in a variety of clinical settings. AVID200 is undergoing development for the treatment of fibrotic diseases and immune oncology.

About Forbius (Formation Biologics)

Forbius is a clinical stage company that designs and develops biotherapeutics for the treatment of cancer and fibrotic diseases. Forbius’ medicines are designed to radically transform patients’ lives. We use our strength in biological understanding and diverse protein engineering technologies to design superior inhibitors of validated pathways.We have particularly deep expertise in targeting the transforming growth factor-beta (TGF-β) and epidermal growth factor receptor (EGFR) pathways. For both of these pathways, there is a significant body of evidence validating their role as drivers of multiple life-threatening conditions, including cancer and fibrosis. However, in the case of the EGFR pathway, the majority of patients do not benefit from currently marketed EGFR inhibitors; in the case of the TGF-β pathway, no agent targeting this pathway has yet been approved. By using multiple complementary platform technologies, Forbius’ team overcame barriers that prevented the development of effective therapeutics targeting these pathways. For more information, please visit www.forbius.com.

Contacts

Forbius (Formation Biologics)
Ilia A. Tikhomirov
info@forbius.com

Forbius (Formation Biologics) announced today that it has been awarded a Product Development grant totaling $18.75 million from the Cancer Prevention and Research Institute of Texas (CPRIT). The grant will support operations and Phase 2a development of AVID100, a highly potent anti-EGFR antibody-drug conjugate, in three cancer indications with significant unmet medical need.

The new CPRIT grant award follows a successful completion of an AVID100 Phase 1 clinical trial. The CPRIT review for this grant included an in-depth evaluation of AVID100 preclinical, manufacturing, and clinical data by a panel of scientific, medical, commercialization, and financial experts. The evaluation also included rigorous regulatory, product development, and intellectual property due diligence. Acceptance of the award is subject to completion of contract negotiations.

This grant will support additional preclinical and translational research, manufacturing, personnel costs, and clinical development of AVID100 in patients with confirmed EGFR overexpression in three Phase 2a clinical trials: breast cancer, squamous cell carcinoma of the head and neck (SCCHN), and non-small cell lung cancer (NSCLC). Currently, no therapy is approved for treatment of patients whose tumor overexpresses EGFR.

“AVID100 demonstrated a compelling profile in preclinical and Phase 1 clinical studies, and this significant CPRIT grant supports and accelerates development of this agent for several cancers with unmet medical needs. We are especially pleased to receive this award after the in-depth evaluation by CPRIT’s highly experienced panel of experts. We will commence dosing of patients with AVID100 in Phase 2a trials later this year,” commented Ilia A. Tikhomirov, CEO of Forbius.

About Forbius (Formation Biologics)

Forbius is a clinical stage company that designs and develops biotherapeutics for treatment of cancer and fibrotic diseases. Forbius’ medicines are designed to radically transform patients’ lives. We use our strength in biology and diverse protein engineering technologies to design superior inhibitors of validated biological pathways.

We have particularly deep expertise in targeting the transforming growth factor-beta (TGF-β) and epidermal growth factor receptor (EGFR) pathways. For both of these pathways, there is a significant body of evidence validating their role as drivers of multiple life-threatening conditions, including cancer and fibrosis. However, in the case of the EGFR pathway, the majority of patients do not benefit from currently marketed EGFR inhibitors; and in the case of the TGF-β pathway, no agent targeting this pathway has yet been approved. By using multiple complementary platform technologies, Forbius’ team overcame barriers that prevented the development of effective therapeutics targeting these pathways.  For more information, please visit www.forbius.com.

Contacts

Forbius (Formation Biologics)
Ilia A. Tikhomirov
info@forbius.com

August 16, 2018

External Link

• Acebilustat is the first novel anti-inflammatory molecule evidencing the potential to reduce frequency of pulmonary exacerbations and prolong time to first exacerbation in CF patients 
• Celtaxsys, with continued support from the CF Foundation, has commenced preparations for designing and executing the acebilustat Phase 3 clinical program

ATLANTA – Celtaxsys, Inc., a clinical stage pharmaceutical development company focused on advancing treatments for patients with rare inflammatory diseases, today announced top line results of its Phase 2 EMPIRE-CF trial evaluating oral, once daily anti-inflammatory molecule, acebilustat, for the treatment of cystic fibrosis (CF), irrespective of the causative genotype. In the 200 patient, double-blind, placebo controlled study, acebilustat demonstrated clinically meaningful improvements in pulmonary exacerbations, both reducing the frequency of pulmonary exacerbations (PEx) and increasing time to next exacerbation over 48 weeks of therapy. Full results from the trial will be presented this fall at the North American Cystic Fibrosis Foundation annual meeting.

“The trial data provide credible evidence to advance the development of this novel anti-inflammatory molecule,” said Steven M. Rowe, M.D. MSPH, professor of medicine and director of the Gregory Fleming James Cystic Fibrosis Research Center at the University of Alabama at Birmingham. “Patients in key prospectively-identified sub-groups, including those with mild obstruction at baseline or taking CFTR modulator therapy, derived the most benefit in pulmonary exacerbations. That benefit, when used in combination with a CFTR modulator, is an important consideration given the likelihood of an increase in the number of CF patients who are eligible to be treated with new CFTR modulators over the coming years.  This supports the unmet need to address lung inflammation adequately for the optimal treatment of patients with cystic fibrosis.”

On a per protocol assessment, acebilustat-treated patients exhibited an 19% reduction in PEx and a 22% reduced risk in progressing to first PEx versus placebo. Additionally, over 40% of patients treated with acebilustat completed the study without experiencing a PEx, an increase of 32% as compared with patients treated with placebo.  The benefits of acebilustat on pulmonary exacerbations were apparent as early as four months after start of treatment and persisted throughout the 48 weeks of the study. No difference in lung function, as measured by the primary endpoint of FEV1 percent predicted (FEV1pp), was observed in acebilustat-treated patients compared to placebo-treated patients over 48 weeks of treatment.  Additionally, FEV1pp response did not correlate with PEx rates.

Patients with less severe impairment of lung function (FEV1pp >75) achieved the largest benefit from acebilustat treatment, achieving a 34% reduction in PEx rate, a 43% reduction in risk of experiencing their first exacerbation and a 96% increased likelihood of being exacerbation free after 48 weeks of treatment. Furthermore, patients concomitantly treated with CFTR modulator therapy exhibited a clinically meaningful 20% reduction in PEx, a 29% increased time to first exacerbation and a 47% higher likelihood of no exacerbations compared to patients treated with CFTR modulators and placebo.

Acebilustat was well tolerated with no increased risk of infection, a key attribute for any anti-inflammatory development candidate to treat CF patients who have an increased risk of infection. The majority of adverse events were mild or moderate in severity with the most common adverse events regardless of treatment group, were infective pulmonary exacerbation, cough, nasopharyngitis, nasal congestion, headache, sputum increased, hemoptysis and fatigue. There was a low discontinuation rate from adverse events among patients treated with acebilustat, in line with patients treated with placebo.

Stuart Elborn, M.D., professor of respiratory medicine at Imperial College, director of the Adult CF Centre, Royal Brompton Hospital London and professor of respiratory medicine at Queen’s University Belfast, said, “I am encouraged by the data from this trial showing that acebilustat-treated patients had reduced frequency of pulmonary exacerbations, particularly as we recruited patients who had exacerbations in the year prior to study entry and therefore at high risk of new exacerbations. It was also interesting to see that a higher proportion of acebilustat-treated patients remained exacerbation free during the study compared to placebo. These data suggest that anti-inflammatory therapy effectiveness may be better assessed using clinical events such as pulmonary exacerbations. Pulmonary exacerbations, which are a clinical marker of unbridled lung inflammation, are significant events leading to acute decompensation and chronic decline of lung function and are strongly related to reduced survival.  Given this, acebilustat has the potential to help protect patients from the progressive and irreversible damage that is associated with CF.”

Sanjeev Ahuja, M.D., chief medical officer of Celtaxsys, said, “Acebilustat is notably the first novel anti-inflammatory molecule to prospectively demonstrate benefits in both reducing the frequency of pulmonary exacerbations and prolonging time to first exacerbation, when added to a CF patient’s existing treatment regimen in a clinical trial.  We would like to thank all the patients who participated in this trial and their families who supported them. We are grateful to the study investigators and coordinators and our advisors who helped us design and execute the program. We also appreciate the scientific insights and financial support of the CF Foundation that were essential in enabling us to conduct this important study.”

About acebilustat: Acebilustat is a once-daily oral drug candidate progressing to Phase 3 development. It is a novel small molecule inhibitor of Leukotriene A4 Hydrolase (LTA4H), the key enzyme in the production of the potent inflammatory mediator Leukotriene B4 (LTB4). LTB4 can create an over activation of neutrophil mediated immune response and inflammation and has been strongly implicated in the pathogenesis of many diseases involving excessive inflammation, including cystic fibrosis (CF). More specifically, an overactive immune response driven by neutrophils results in excessive inflammation in the CF lung. This leads to irreversible damage resulting in excessive morbidity and mortality in CF patients. Acebilustat is designed to modulate the neutrophil driven immune response bringing the inflammation to homeostasis, preventing overactive inflammation from occurring, and thus could be potentially helpful in CF patients. By contrast, pro-resolving agents theoretically tone down inflammation once it is overactive and already contributing to lung damage in patients. Furthermore, unlike immunosuppressive treatments, such as corticosteroids, acebilustat has not demonstrated any evidence of immunosuppression in preclinical studies or in clinical trials in humans, including healthy volunteers and CF patients. Acebilustat is the most advanced therapy in development in the CF anti-inflammatory pipeline.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system of 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, which causes excessively high levels of thick mucus to accumulate in the lungs, pancreas, and GI tract. Thickened mucus clogs the lungs and serves as a perfect environment to catalyze persistent bacterial infection and inflammation of the lungs. Chronic infection of the lungs in turn elicits an excessive neutrophil driven inflammatory immune response, with the overabundance of neutrophils clogging the lungs, thereby further compromising a patient’s breathing capacity. Excessive production of a neutrophil byproduct, neutrophil elastase, has been shown to be the best predictor of lung damage and dysfunction over the life of a CF patient. Excessive production of neutrophil elastase can also lead to reduced bacterial clearance. Over time, the amplification of this synergistic cycle of infection and inflammation leads to lung function decline and an increase in life-threatening pulmonary exacerbations. Lung inflammation is still the leading cause of morbidity and mortality associated with CF, leading the CF Foundation to identify development of safe and effective anti-inflammatory therapies as a key research priority.  Learn more about CF.

About Celtaxsys: Celtaxsys is a privately-held drug discovery and development company focused on advancing treatments for serious inflammatory diseases. The company is building a sustainable pipeline of first-in-class immuno-modulators, the most advanced of which is acebilustat. For more information, visit www.celtaxsys.com.

Media Contact: Angela Walsh
awalsh@celtaxsys.com
470-206-0153 ext. 124

(Reuters) – Privately held Celtaxsys Inc said on Thursday a mid-stage trial testing its experimental cystic fibrosis treatment was successful in reducing a key symptom of the genetic lung disease, but did not improve lung function.

There are few treatment options for the 70,000 cystic fibrosis patients worldwide, who rarely live beyond 40 and possess a defective gene that leads to the build-up of thick mucus which clogs the lungs and other organs, often triggering inflammation.

The company is considering private financing, a public offering and possible financial support from the Cystic Fibrosis Foundation ahead of a late-stage study set for the second half of 2019, Chief Executive Officer Greg Duncan told Reuters.

The drug, acebilustat, reduced pulmonary exacerbations, or an acute worsening of symptoms, by 34 percent in patients with a mild form of the disease, which represent an estimated three-quarters of the total affected population, Celtaxsys said.

However, after 48 weeks, patients on the anti-inflammation treatment did not show a difference in lung function versus those on placebo.

A regulatory approval is contingent on proving the treatment’s effectiveness in either reducing pulmonary exacerbations or improving lung function and the next trial is likely to focus on the former, the Atlanta-based biotech company said.

The Cystic Fibrosis Foundation contributed $8 million to Celtaxsys’ mid-stage study, which tested two doses of the once-a-day oral medicine in 200 patients.

Currently, Vertex Pharmaceuticals Inc is considered the leader in developing treatments for cystic fibrosis and has three approved drugs on the market.

____________________

Reporting by Tamara Mathias in Bengaluru; Editing by Bernard Orr

This article was originally published by Reuters here.

VICTORIA, British Columbia– Aurinia Pharmaceuticals Inc. today announced that it will release its second quarter 2018 financial results on Thursday, August 9, 2018, after the market closes. Aurinia’s management will host a conference call to discuss the company’s second quarter 2018 financial results and provide a general business update.

The conference call and webcast is scheduled for August 9, 2018 at 4:30pm EDT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under “News/Events” through the “Investors” section of the Aurinia corporate website. A replay of the webcast will be available on Aurinia’s website.

About Aurinia

Aurinia is a clinical stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are suffering from serious diseases with a high unmet medical need. The company is currently developing voclosporin, an investigational drug, for the treatment of LN, FSGS and DES. The company is headquartered in Victoria, BC and focuses its development efforts globally.

Aurinia Pharmaceuticals
Investor Contact:
Celia Economides
VP, Corporate & Public Affairs
IR@auriniapharma.com
or
Media:
Christopher Hippolyte, 212-364-0458
Christopher.hippolyte@inventivhealth.com

Related Article: Aurinia Named Company of the Year by LifeSciences BC

SAN CARLOS, Calif., /PRNewswire/ — BAROnova, Inc., announced today that it has submitted a Pre-Market Approval (PMA) application for the TransPyloric Shuttle device intended for the treatment of obesity to the Food and Drug Administration (FDA).

Obesity is a worldwide epidemic with over 40% of adult Americans suffering from obesity and its attendant co-morbidities.  The investigational TransPyloric Shuttle device is a novel, non-surgical, weight-loss solution intended for patients with a BMI between 30-40 kg/m².   Based upon best-in-class pivotal trial outcomes, the company has filed a PMA submission with the FDA.

The TPS is trans-orally placed in the stomach during a standard endoscopic procedure and is intended to reside in the stomach for 12 months after which it is endoscopically removed.  The TransPyloric Shuttle’s primary mechanism of action is delaying gastric emptying which is a known mechanism of weight loss.  If approved by the FDA, the TPS will be the first and only intragastric implant with a 12-month duration of action available in the United States.

The PMA submission includes clinical data from its pivotal trial, the ENDObesity II study.  The ENDObesity II study was a randomized, double-blinded, sham-controlled study which enrolled 302 patients from 9 sites across the United States. Primary outcomes were percent total body weight loss (%TBL) at twelve months follow up after the procedure and the proportion of subjects in the treatment group who achieved 5% TBL or more after 12 months. The trial successfully met its endpoints in a highly statistically significant fashion.  Results from the ENDObesity II Study are expected to be presented at the Obesity Week conference during November 11th-15th.

Dr. Richard Rothstein, the Joseph M. Huber Professor and Chair for the Dartmouth Geisel School of Medicine, and the lead investigator for the ENDObesity II study said, “Obesity is on the rise in the United States and the world.  Patients and physicians are searching for effective solutions for this condition and its accompanying co-morbidities.  Based on the results I have seen with this device, I believe it will find a very meaningful role in clinical practice if approved by the FDA”.

David Thrower, Chief Executive Officer of BAROnova, added, “The PMA submission represents a major milestone for the company. We are pleased by the outcome of the ENDObesity II study and believe we have demonstrated best-in-class results for the TPS device. If approved, we will bring a new medical device option to physicians who treat patients with obesity and to patients who are motivated to lose significant weight and improve their health.”

About Obesity

The obesity epidemic has placed a major burden on healthcare systems globally.  Obesity is defined as a Body Mass Index (BMI) >30 and is strongly associated with multiple comorbidities including hypertension, hyperlipidemia, and type 2 diabetes. There are currently over 75 million adults in the United States with a BMI between 30-40 and over 600Madults worldwide who are strong candidates for a safe, efficacious, non-surgical therapy.

About the TransPyloric Shuttle

BAROnova’s novel weight-loss investigational device, the TransPyloric Shuttle, is inserted and removed trans-orally using standard endoscopic techniques. If approved, the TransPyloric shuttle will be the first intra-gastric device utilizing delayed gastric emptying as the primary mechanism of action and the first intra-gastric device with a twelve-month dwell time in the stomach in the United States.

About BAROnova, Inc. 

BAROnova is a Silicon Valley, venture-backed company that has developed a best-in-class non-surgical solution for obesity. BAROnova is headquartered in San Carlos, CA. For more information about the company, please visit www.BAROnova.com.

BAROnova, Inc., Contact:

David Thrower, CEO

+1-650-638-9796 x33

dthrower@baronova.com

SOURCE BAROnova, Inc.

MONTRÉAL and BOSTON, /CNW/ – enGene Inc., a biotechnology company developing novel non-viral vector gene therapies to provide oral delivery of a wide range of protein drugs, including the Gene Pill™ , today announced the appointment of Jason D. Hanson as President, Chief Executive Officer and Director.  Mr. Hanson will succeed enGene co-founder Anthony Cheung, Ph.D., who will assume the role of Chief Technology Officer at the company.

SOUTH SAN FRANCISCO, California, /PRNewswire/ — Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of pre-cancerous lesions caused by human papilloma virus (HPV) infection, has raised $15 million in Series C-1 financing led by Hillhouse Capital Management. Sirona Capital, along with existing investors Canaan Partners, Sofinnova Ventures, Brace Pharma Capital, Osage University Partners and Lumira Capital also participated in the round. In conjunction with the financing, Hillhouse will appoint a representative to Antiva’s board of directors.

Antiva is currently assessing the safety and efficacy of its lead compound, ABI-1968, in two Phase 1b clinical studies. One study involves intravaginal delivery of topical ABI-1968 to women with high grade cervical intraepithelial neoplasia (CIN 2,3). CIN is a precancerous condition caused by HPV in which abnormal cell growth occurs on the surface of the cervix. The second study is assessing the use of topical ABI-1968 in high grade anal intraepithelial neoplasia (AIN 2,3). There are currently no FDA-approved drugs for either of these indications.

“We are seeing encouraging results in our ongoing clinical trials,” said Gail Maderis, president and CEO of Antiva. “This funding will support additional clinical studies in both indications over the next year, positioning us for strong Phase 2 studies in the second half of 2019.  We welcome Hillhouse to our board and look forward to benefiting from their expertise and relationships in the Chinese pharmaceutical industry. China is a strategic market for Antiva, given the high incidence and death rate from cervical cancer in China.”

HPV is an oncogenic virus responsible for 5% of all cancers worldwide and for almost all cases of cervical cancer. Globally, over 250,000 women die of cervical cancer each year; in some countries, cervical cancer is the number one cancer in women in both incidence and death. The World Health Organization (WHO) has designated screening and treatment of precancerous lesions to prevent cervical cancer a “Best Buy” intervention, prompting many countries to implement national screening and treatment programs.  ABI-1968 has the potential to fit the WHO’s “Screen and Treat” strategy:  a self-administered product capable of treating all stages of CIN and effective against all strains of HPV.

Hillhouse’s healthcare team expressed, “We are eager to leverage our global experience to assist Antiva in developing a topical therapy that has the potential to help millions of men and women across the world.  We believe in Antiva’s mission and are excited to partner with a talented team.”

About Antiva Biosciences

Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in South San Francisco, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego.

About Hillhouse Capital 

Founded in 2005, Hillhouse Capital is a firm of investment professionals and operating executives who are focused on building and investing in high quality business franchises that achieve sustainable growth. Independent proprietary research and industry expertise, in conjunction with world-class operating and management capabilities, are key to its investment approach. Hillhouse Capital partners with exceptional entrepreneurs and management teams to create value, often with a focus on Asia. Hillhouse Capital invests in the healthcare, consumer, TMT, advanced manufacturing, financial and business services sectors in companies across all equity stages. Hillhouse Capital and its group members manage more than US$50 billion in assets on behalf of institutional clients such as university endowments, foundations, sovereign wealth funds, and family offices.

Contact:
Gail Maderis
Antiva Biosciences, Inc.
650-822-1401

William Nevius
Canaan Partners
202-577-7929
wnevius@canaan.com

SOURCE Antiva Biosciences

RESEARCH TRIANGLE PARK, N.C., July 09, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced appointments for two newly created executive leadership roles to support the company’s continued growth. John Demaree joins the company as Chief Commercial Officer and Stillman Hanson has been named General Counsel.

“We are excited to welcome John and Stillman to G1, and look forward to their contributions as we build out our commercial capabilities and expand our business development, legal and regulatory efforts,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer. “John’s experience building a world-class commercial oncology organization will be invaluable as our three clinical-stage programs move toward key clinical and regulatory milestones. Moreover, Stillman’s extensive life sciences corporate legal experience will be critical as the company continues to grow and evolve from research and development to commercialization.”

Mr. Demaree has more than 20 years of oncology experience, building commercial capabilities and leading multiple successful product launches. Prior to joining G1, Mr. Demaree served as Vice President, Oncology Marketing at Astellas Pharma, where he was responsible for establishing and leading the oncology marketing function, including the successful launch of Xtandi^® (enzalutamide). Mr. Demaree oversaw commercial strategy and execution for two approved products and three compounds in development, as well as market access and reimbursement strategy, product lifecycle management and external commercial collaborations. Previously, Mr. Demaree led oncology business development and alliance management at Abbott. He has also held marketing leadership positions at Novartis and Eli Lilly.

Mr. Hanson recently served as Associate General Counsel and Vice President at IQVIA, where he led the Quintiles legal team in the $20 billion merger of Quintiles and IMS Health to create QuintilesIMS (now IQVIA). In prior positions at Quintiles, he negotiated strategic contracts, represented Quintiles in its initial public offering and was responsible for its public company securities reporting. Before joining Quintiles in 2010, Mr. Hanson practiced corporate law, including merger and acquisitions, commercial contracting, securities reporting and corporate governance.

About G1 Therapeutics, Inc. 
G1 Therapeutics, Inc. (G1) is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for the treatment of cancer. Two of the company’s pipeline assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a short-acting IV CDK4/6 inhibitor designed to preserve hematopoietic stem cell and immune system function (myelopreservation) during chemotherapy. G1T38 is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1’s ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1’s ability to recruit and enroll patients in its studies; competition in the industry in which G1 operates; and market conditions. Except as required by law, G1 assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
917-371-0940
jmacdonald@g1therapeutics.com

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine
Follow Me On Twitter @WayneKoberstein

The Enterprisers: Life Science Leadership In Action

External Link

IN 2016, AN ESTIMATED 564,000 CANADIANS SUFFERED FROM DEMENTIA. By 2031, says the Alzheimer’s Society of Canada, that figure will rise to 937,000. In the US it is estimated that the Alzheimer’s burden will triple from 5.3 million people today to 16 million by 2050. Worldwide, nearly 44 million people have or are living with an Alzheimer’s related disease. In 2016, the cost to Canada’s health care system, and to those who live with dementia, was estimated at $10.4 billion. By 2031, that total will likely reach $16.6 billion. In 2014, the direct costs of caring for people living with the disease was estimated to total well over $210 billion in the US.

Clearly, the need to act, to improve treatment and to pursue the eventual prevention of Alzheimer’s disease, is great. Fortunately, while the need is great, so is the response. In the US alone, approximately $991 million was spent on Alzheimer’s disease and dementia-related research in 2016. The Alzheimer’s disease therapeutics and diagnostics market alone reached more $6.7 billion. Among those leading the way is KalGene Pharmaceuticals, a privately held Canadian company working in partnership with leading clinician-scientists and academic institutions. One of the key reasons KalGene believes it is on the road to success, says its president and chief scientific officer, is because the road it has chosen to take accounts for the multiple failures of the past: It must attack the true pathological target, efficiently deliver the drug to the brain and select the patient group by utilizing novel AI technology which can best benefit from the drug treatment.

“It’s true, we have taken a novel approach to slowing down the progression of Alzheimer’s disease,” says Dr. T. Nathan Yoganathan. “A major obstacle to treating neurodegenerative diseases like Alzheimer’s is delivering therapeutics past the blood-brain barrier. Using technology licensed from the National Research Council of Canada, we’re overcoming that obstacle. As a result, our development candidate is able to pass through the blood-brain barrier, rapidly inducing brain and CSF-amyloid-beta clearance. Studies to date have indicated dramatic plaque removal.”

“The treatment we developed at the NRC and licensed to Kalgene is one of the first in the field to effectively deliver Alzheimer’s medicine to the target site inside the brain, using our revolutionary blood-brain barrier carriers, says Dr. Balu Chakravarthy, Team Leader, Central Nervous System Pharmacology at the NRC’s Human Health Therapeutics Research Centre.

KalGene’s work – and its success – has not gone unnoticed. Late last year, the firm received significant financial support from a syndicated investment led by Lumira Capital. Also participating in the transaction were Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices. François Gilbert, CEO of Anges Québec and Anges Québec Capital, explained the decision to support KalGene this way: “We were impressed by the quality of the science behind KalGene and their approach to Alzheimer’s treatments. We know that important challenges lie ahead in this race to tackle Alzheimer’s disease, but we are confident that the KalGene team has what it takes to succeed.”

If Dr. Yoganathan shares that optimism – and he does – he says it’s largely because of KalGene’s ability to attract and work with key partners, including the National Research Council of Canada and McGill University, where a number of the lead clinicians and researchers are located. “The scientists there deserve a lot of credit for what we’ve accomplished,” he says. “No doubt, their contributions have helped us move forward with confidence. The Douglas Hospital is at the forefront of AD clinical research. We will be employing brain imaging and are developing an innovative AI-based approach for patient monitoring which will allow us to progress rapidly, once the therapeutic enters the clinic.”

Dr. John Gillard, KalGene VP, Product Development, is a seasoned researcher and drug developer, he expresses his enthusiasm for the project as a “remarkable example of a collaborative venture, combining the best of Canadian drug design ingenuity with world-leading clinical insight to create a molecule with a real promise, and which I am proud to move forward.” The drug product is being bio-manufactured in Canada using a process developed by the team at the National Research Council Human Health Division in Montreal.

And forward is definitely the direction KalGene is heading. Dr. Yoganathan expects the company to hold the first clinical trial of its Alzheimer’s therapeutic candidate at McGill University in 2019. The company has worked closely with the McGill Centre for Aging over the past 2 years to characterise the molecule in a battery of tests resembling the proposed clinical study. Dr. Pedro Rosa Neto is the Assoc. Director at the Centre for Aging, who will also oversee the clinical trial. He says “We have had contributions from Canada’s leading Brain Research Foundations, Weston Brain Foundation, Ontario Brain Institute (OBI), Brain Canada and CQDM so we understand the workings of this molecule so well now. We have seen success in all the studies to date and we are now actively recruiting patients with the best chance of demonstrating a clinical effect”, He says the safety studies are expected to last about three months, the initial efficacy study a little less than a year.

In the meanwhile, KalGene will continue to pursue the development path it has chosen, confident that its approach towards Alzheimer’s Disease modification is the right one. Not only are we confident that we are headed in the direction, we’re carrying out our studies with the right partners … With the commitment of talented scientists, drug developers and clinicians; and the financial support from our investors, foundations, public agencies and granting sources we’ve created a dynamic biotechnology collaborative program well suited to develop a breakthrough therapy for this terrible disease.

____________________

This article was originally published in the Spring 2018 edition of the BIOTECanada Magazine. You can find a copy of the article here: KalGene.BIOTEC

As life expectancies around the globe continue to go up, the accompanying steady rise in senior populations has given way to a newly intensified global focus on dementia in recent years. Dr. Marga­ret Chan, director-general of the World Health Organization, underscored the ur­gency of current and future needs in her 2015 address to the first WHO Ministe­rial Conference on Global Action Against Dementia, warning of the “tidal wave of dementia coming our way”. Adding, “I can think of no other disease where innovation, including breakthrough dis­coveries, is so badly needed.”

A year earlier, public research agencies in the UK had pledged more than £200 million to the cause and last November Bill Gates personally invested $50 million in the Dementia Discovery Fund express­ing on his blog, “Of all the disorders that plague us later in life, one stands out as a particularly big threat to society: Alzheimer’s.”

A big part of that threat is the associ­ated costs of caring for afflicted patients. Until we discover a way to prevent the disease, the health system costs to care for and support patients bear the brunt of the impact. In 2017, the US spent $259 billion on hospital, hospice and long-term care for dementia patients. This is ex­pected to increase to $1 trillion by 2050.

An estimated 46 million people world­wide suffer from dementia. According to the Alzheimer’s Society of Canada some 564,000 Canadians suffered from demen­tia in 2016 and by 2031 that number will nearly double to 937,000. The associated costs to the health care system for treat­ment, care and support is estimated at $10.4 billion and will grow to $16.6 billion by 2031.

Clearly the need to improve treatment and to pursue the eventual prevention of Alzheimer’s disease is immense—both from an economic and social perspective. Industry response has been to step up research efforts to accelerate the develop­ment process. In the US, National Institute of Health funding has increased in the past five years from $503 million per year to $1.391 billion per year.

While Canada’s public research agencies are working to increase current research funding levels of just under $50 million, the private sector is stepping up to bridge the gaps and support promising new tech­nologies with the potential to change the way we treat the disease.

One such company is KalGene Phar­maceuticals, a privately held company working in partnership with leading clinician-scientists and academic institu­tions. The company has taken the road-less-travelled approach to its clinical program, looking to slow down disease progression by developing a treatment that can penetrate the blood-brain bar­rier. This breakthrough puts KalGene on the road to success according to president and chief scientific officer Dr. T. Nathan Yoganathan.

“A major obstacle to treating neurode­generative diseases like Alzheimer’s is de­livering therapeutics past the blood-brain barrier,” says Dr. Yoganathan. “Using technology licensed from the National Re­search Council of Canada, we’re overcom­ing that obstacle. As a result, our develop­ment candidate is able to pass through the blood-brain barrier, rapidly inducing CSF-amyloid-beta clearance. Studies to date have indicated dramatic plaque removal.”

KalGene has worked closely with the McGill center for Ageing over the past 2 years to characterise the therapeutic molecule in a battery of test resembling the proposed clinical study. They have received contributions from Weston Brain Foundation, Ontario Brain Institute, Brain Canada and CQDM for this study.

KalGene’s preclinical success has not gone unnoticed. Late last year, the firm received significant financial support from a syndicated investment led by Lumira Capital. Also participating in the transaction were Anges Québec, Anges Québec Capital, Accel-Rx Health Sciences Accelerator and a number of Canadian family offices.

“We know so much more now about this terrible disease than we did just a few years back,” says Jacki Jenuth, partner at Lumira Capital. “Kalgene will benefit tremendously from these new insights es­pecially as it relates to patient recruitment with their partners at McGill.”

For François Gilbert, CEO of Anges Qué­bec and Anges Québec Capital, KalGene’s novel approach was key to their decision. “We were impressed by the quality of the science behind KalGene and their approach to Alzheimer’s treatments,” he says. “We know that important challenges lie ahead in this race to tackle Alzheimer’s disease, but we are confident that the Kal­Gene team has what it takes to succeed.”

Dr. Yoganathan shares that optimism largely because of KalGene’s ability to attract and work with key partners, in­cluding the National Research Council of Canada and McGill University, where a number of the lead clinicians and re­searchers are located. “The scientists there deserve a lot of credit for what we’ve accomplished,” he says. “No doubt, their contributions have allowed us to move forward.”

Accel-Rx sees the work that KalGene is doing as exemplary of the potential of Canada’s health sciences environment to nurture and grow a vibrant sector. “When our ecosystem aligns—scientific exper­tise, industry-led strategy, private capi­tal—it provides a catalyst for companies like KalGene to drive hard to deliver on tremendous promise,” says Natalie Dak­ers, president & CEO, Accel-Rx. “When promising therapies are commercialized, ultimately it’s the patient who wins.”

“We are extremely confident with our approach—and that we are carrying out our work in the right place,” says Dr. Yoganathan. “The national ecosystem in which we conduct our research, with its government support, with the par­ticipation of talented scientists from other institutions, with the financial support of private and public foundations, is an ecosystem ideal for the breakthroughs we need to confront and eventually over­whelm this terrible disease.”

The company expects to conduct the first clinical trial of its Alzheimer’s thera­peutic candidate at McGill University in 2019. Safety studies are expected to last about three months and the efficacy studies a little less than a year.

Public-Private Partnerships Prove Promising

As researchers continue to grapple with the Alzheimer’s puzzle, countries around the world are increasingly looking towards public-private partnerships as the most effective strategy to stave off a health tsunami that will surpass cancer and heart disease as the population ages. Recalling the model to battle polio in the mid-20th century, nations are combining the funding strength of the public sector, research breakthroughs of academia and the developmental/commercial acumen of the biopharmaceutical industry to accelerate the path to treatment and care.

Anthony Boone is a writer and commu­nications professional with experience in the health sciences and clean tech sectors.

____________________

This article was originally published in the Summer 2018 edition of the Biotechnology Focus Magazine. You can find a copy of the article here: KaIGene.BIOFOCUS

LISLE, Ill., June 28, 2018 /PRNewswire/ — Endotronix, Inc., a digital health, medtech company dedicated to advancing the treatment of heart failure, today announced they have joined the American Heart Association’s Center for Health Technology & Innovation’s (CHTI) Innovators Network. The collaboration allows Endotronix to integrate the Association’s digital resources into the Cordella™ Heart Failure System to support guideline-based care. The system is currently in commercial use in the U.S.

In the US, nearly 6 million people suffer from heart failure and it is the leading cause of hospitalization in people over the age of 65¹. With high mortality rates, frequent hospital readmissions and annual treatment costs over $31B in the U.S., there is a need for better proactive management and coordination of care for patients with chronic heart failure^1,2.

The collaboration between Endotronix and the Association aims to shift the heart failure care paradigm and improve at-home care management by coupling Endotronix’s Cordella System with the Association’s patient education materials and content.

Endotronix joins the Association’s Center for Health Technology & Innovation Innovators Network with a comprehensive heart failure management system, designed to streamline clinical workflow. The Cordella System allows physicians to effectively scale HF management with the Association’s comprehensive CarePlans and education materials to improve patient outcomes. The easy-to-use system extends clinical care into the home by collecting and securely transmitting daily patient clinical data and insights to the clinician, which enable guideline-directed medical therapy. For suitable patients, the system seamlessly integrates pulmonary artery (PA) pressure data with a proprietary wireless, an implantable sensor that is currently in late-stage clinical development. Clinical studies have demonstrated that PA pressure-guided management can reduce HF-related hospitalizations by 37% and provide a mortality benefit^3,4.

“This collaboration with the American Heart Association is essential as we strive to extend high-quality care into the home to improve the standard of care for chronic heart failure patients,” said Harry Rowland, Chief Executive Officer and co-Founder of Endotronix. “As we begin commercialization, it is exciting to see the impact this integration is having on strengthening the communication between heart failure patients and their clinicians, enhancing coordinated care that improves outcomes and ultimately allowing patients to enjoy life again.”

The Cordella System is currently in commercial use in the U.S. The targeted launch is expected to accelerate in anticipation of the U.S. Pivotal Study for the Cordella Pulmonary Artery Pressure Sensor, which is planned for the near future. Endotronix’s goal to advance the treatment of heart failure took a leap forward this January when they announced their successful First-in-Human (FIH) implantation of the Cordella PA Pressure Sensor and initiation of the SIRONA FIH clinical trial.

About Endotronix:
Endotronix, Inc., a digital health, medtech company, is developing an integrated platform to provide comprehensive, reimbursable health management tools for patients suffering from chronic heart failure. The company’s comprehensive solution includes a cloud-based disease management data system and outpatient hemodynamic management with a breakthrough implantable wireless pulmonary artery sensor for early detection of worsening heart failure.

1 Mozzafarian D, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016
2 Heidenreich PA, et al. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011;123(8):933–44.
3 Abraham WT et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomized control study. Lancet. 2011 Feb 19;377(9766):658-66.
4 Abraham WT et al. Pulmonary artery pressure management in heart failure patients with reduced ejection fraction significantly reduces heart failure hospitalizations and mortality above and beyond background guideline-directed medical therapy. Abstract 902-04, ACC2015, San Diego.

MEDIA CONTACT:
Carla Benigni
SPRIG Consulting LLC
(847) 951-7430
Carla@sprigconsulting.com

Related Article: Endotronix Receives ISO 13485:2016 Certification

RESEARCH TRIANGLE PARK, N.C., June 08, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced that Cynthia Schwalm and Willie Deese have been appointed to its board of directors, effective June 7, 2018.

“We are pleased to welcome Cynthia and Willie as new independent directors to our board. Cynthia’s expertise in commercialization and Willie’s experience in operations broadens the board’s knowledge base and will enhance our efforts to develop and commercialize novel therapeutics that may benefit people living with cancer,” said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

Ms. Schwalm most recently served as President and Chief Executive Officer of Ipsen North America. Prior to joining Ipsen, she held several senior commercial leadership positions at Eisai Pharmaceuticals, Amgen and Johnson & Johnson.

Mr. Deese previously served as President of the Merck Manufacturing Division and a member of the Merck Executive Committee before retiring in 2016. Prior to his roles at Merck, Mr. Deese held operational leadership roles at GlaxoSmithKline, SmithKline Beecham and Kaiser Permanente.

Ms. Schwalm and Mr. Deese will fill board seats previously held by Christy Schaffer, Ph.D. and Tyrell Rivers, Ph.D., who have stepped down from the board following the expiration of their respective terms in June of this year.

“Christy and Tyrell provided invaluable counsel as we matured from a small, venture-backed startup with promising preclinical research to a publicly traded company that is now advancing multiple clinical-stage programs,” said Dr. Velleca. “We thank them for their contributions to our growth.”

About G1 Therapeutics
G1 Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for the treatment of cancer. Two of the company’s pipeline assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of oncology therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as backbone therapy of multiple combination regimens. Trilaciclib is a short-acting IV CDK4/6 inhibitor designed to preserve hematopoietic stem cell and immune system function (myelopreservation) during chemotherapy. G1T38 is a potential best-in-class oral CDK4/6 inhibitor for use in combination with other targeted therapies. G1 is also advancing G1T48, a potential best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer.

G1 is based in Research Triangle Park, NC. For additional information, please visit www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics’ ability to recruit and enroll patients in its studies; competition in the industry in which G1 Therapeutics operates; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
917-371-0940
jmacdonald@g1therapeutics.com

Vancouver, Canada, Tokyo, Japan and Basking Ridge, NJ (May 14, 2018)– Zymeworks Inc. (NYSE/TSX: ZYME), aclinical-stage biopharmaceutical company developing multifunctional therapeutics, and Daiichi Sankyo Company, Limited (Daiichi Sankyo) announced today that they entered into a new license agreement, building upon their 2016 cross-licensing and collaboration agreement.

“With a successful track record and our first bispecific antibody incorporating the Azymetric and EFECT technology having achieved a key research milestone in 2017, we look forward to adding two more bispecific compounds to our pipeline,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “We are exceptionally impressed with the robust impact that Zymeworks’ technology brings to antibody development.”

Under the terms of the second agreement, Daiichi Sankyo will acquire licenses to Zymeworks’ Azymetric™ and EFECT™ technology platforms to develop two additional bispecific antibody therapeutics. In exchange, Zymeworks will receive an upfront technology access fee of US$18 million and may receive up to US$466.7 million in potential clinical, regulatory and commercial milestone payments. In addition, Zymeworks will receive up to double-digit tiered royalties on global product sales.

“Expanding our relationship with a leading global pharmaceutical partner like Daiichi Sankyo is extremely satisfying as it underscores the power, versatility, and attractiveness of our technology platforms,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “Having already used our platforms to discover one bispecific antibody, Daiichi Sankyo now has increased access to our technology to create additional therapeutic candidates. We are pleased to be working with a healthcare pioneer with a proven track record of over 100 years of innovation leading to major breakthroughs in patient care.”

Zymeworks and Daiichi Sankyo began working together in September 2016 through an agreement to develop one bispecific antibody therapeutic for which Zymeworks is eligible to receive preclinical, clinical, and commercial milestones payments, as well as up to double-digit tiered royalties on global product sales. Additionally, Zymeworks obtained a license to certain immuno-oncology antibodies from Daiichi Sankyo, with the right to research, develop, and commercialize multiple bispecific products globally in exchange for royalties on global product sales.

About the Azymetric™ Platform
The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving them the ability to simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering and degradation, and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of naturally occurring antibodies, including low immunogenicity, long half-life and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, with the potential to significantly reduce drug development costs and timelines.

About the EFECT™ Platform
The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity of the antibody-mediated immune response, which includes both the up- and down-regulation of effector functions. This platform, which is compatible with traditional monoclonal as well as Azymetric bispecific antibodies, further enables the customization of therapeutic responses for different diseases.

About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks’ second product candidate, ZW49, capitalizes on the unique design and antibody framework of ZW25 and is a bispecific antibody-drug conjugate, or ADC, armed with its proprietary ZymeLink™cytotoxic payload. Zymeworks is also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through multiple strategic partnerships with global biopharmaceutical companies.

About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address diversified, unmet medical needs of patients in both mature and emerging markets. With over 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases. For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.

Cautionary Note Regarding Forward Looking Statements
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include statements that relate to Zymeworks’ technology, potential future milestones and royalties and other information that is not historical information. When used herein, words such as “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “potential”, “intend”, “expect” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions, Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for the three months ended March 31, 2018 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. You should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.

Contacts:

Zymeworks Inc.
Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

Daiichi Sankyo
Jennifer Brennan
Daiichi Sankyo, Inc.
+1 908 992 6631 (office)
+1 201 709 9309 (mobile)
jbrennan2@dsi.com

Topline Data Expected H2-2019

Peachtree BioResearch Solutions to Execute Multi-Center Trial

SUMMIT, N.J., May 03, 2018 (GLOBE NEWSWIRE) — Engage Therapeutics, Inc., today announced dosing of the first patient in its multi-center, double-blind, randomized Phase 2b StATES (Seizures) trial to investigate the safety and efficacy of Staccato alprazolam in subjects with epilepsy that have a predictable seizure pattern.

The StATES trial (NCT03478982) will enroll 108 patients across 40 U.S.-based clinical sites. The primary endpoint is the cessation of seizure activity. Seizure episode severity, as well as the incidence of adverse events, will also be evaluated. Topline data is expected in the second half of 2019. Staccato alprazolam, a single use, investigational epileptic seizure rescue therapy, combines the Staccato delivery technology, which is currently used in a U.S. Food and Drug Administration (FDA)-approved product, with alprazolam, an FDA-approved benzodiazepine. Together, this combination is novel for an epilepsy application in a patient population in need of innovative rescue options.

Greg Mayes, president, CEO and founder of Engage Therapeutics, said, “For individuals with epilepsy that have a predictable seizure pattern, currently available rescue treatments can only address the prevention of seizure activity once the first seizure ends, but Staccato alprazolam has the potential to be the first and only product that can abort an active seizure. We are excited by the enthusiastic response that this study has received from the epilepsy community and how quickly we have been able to advance this promising candidate to this point in development.”

Kristy Nichols, president and co-founder of Peachtree Bioresearch Solutions, a growing clinical research organization in the U.S., added, “Engage is the type of client we seek – an emerging CNS focused company with a novel therapy that addresses a significant unmet medical need. We are confident that our deep clinical trial management experience for CNS disorders and our demonstrated passion for partnership will result in a mutually successful outcome.”

About Engage Therapeutics, Inc.
Engage Therapeutics is developing Staccato alprazolam, for the cessation of active and acute epileptic seizures. The investigational product is a small, easy-to-use hand-held drug-device combination that leverages a fast-acting delivery system already used in an FDA-approved product with FDA-approved alprazolam. Staccato alprazolam demonstrated reduction of seizure-like activity in a photosensitivity model in a Phase 2a proof of concept study. The product has now proceeded into a Phase 2b study known as the StATES trial. Engage Therapeutics is a private company based in Summit, N.J. For additional information please see www.EngageTherapeutics.com.

About Peachtree
Entering its 10^th year, Peachtree BioResearch Solutions, Inc. is a Clinical Research Organization that specializes in providing clinical development services for emerging to mid-sized biotechnology, pharmaceutical, and medical device companies. With a highly-experienced clinical development team, Peachtree offers Clinical Project Management, Clinical Monitoring, Medical Monitoring, Biometrics (data management and statistical analysis), Technical Report Writing, Quality Assurance, and Clinical Staff Resourcing. Starting with one client at inception, Peachtree has grown its portfolio to over 65 clients providing services ranging from niche projects to full support. For additional information, visit www.peachtreebrs.com.

Media Contact
Greg Mayes
Engage Therapeutics
gmayes@engagetherapeutics.com

John Durkee
Vice President, Marketing & Business Development
john.durkee@peachtreebrs.com

KIRKLAND, Wash.–(BUSINESS WIRE)– Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for patients with heart failure, today announced the company has closed a $39 million Series B financing. The round includes new investor, Australia-based Hostplus, venture debt from Oxford Finance LLC, as well as support from existing investors M. H. Carnegie & Co., Arboretum Ventures, Lumira Capital, LSP Health Economics Fund and Aperture Venture Partners.

The financing will be used to continue to build clinical evidence for Cardiac Dimensions’ Carillon^® Mitral Contour System^® for the treatment of functional mitral regurgitation (FMR) in patients with heart failure, including continuing The CARILLON Trial U.S. pivotal study and completing the follow-up and publication of the landmark randomized, double-blinded REDUCE FMR global study.

The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life.

“Our clinical data and commercial experience suggest that the Carillon System offers a viable treatment option that addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. This funding will provide the resources to complete and publish the landmark REDUCE FMR trial, continue to support enrollment in The CARILLON pivotal trial here in the U.S., and enhance our presence throughout world markets,” said Gregory D. Casciaro, president and CEO of Cardiac Dimensions. “We welcome our newest investors to the team and are grateful to our returning investors for their continued support.”

Functional mitral regurgitation affects approximately seven million people in the United States, and occurs when the left ventricle of the heart is enlarged, dilating (stretching) the valve opening (annulus) and causing a backward flow of blood into the atrium. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The primary therapy for patients with this disease is to treat them with medical management.

“Hundreds of thousands of people around the world, and an estimated 50,000 Australians, have heart failure and FMR, and could benefit from treatment with the Carillon System,” said David Elia, chief executive officer of Hostplus. “We are excited to work with Cardiac Dimensions to expand access to the Carillon System to patients in need, not only here in Australia, but across the globe.”

About Hostplus

Hostplus is the national superannuation fund for those that live and love Australian hospitality, tourism, recreation and sport. The Australian Hotels Association and United Voice jointly established the fund in 1987. Hostplus is one of the largest in the country with over one million members, 170,000 employers and $30 billion in funds under management.

About Oxford Finance LLC

Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to its clients, enabling these companies to maximize their equity by leveraging their assets. In recent years, Oxford has originated over $4 billion in loans, with lines of credit ranging from $5 million to $100 million. Oxford is headquartered in Alexandria, Virginia, with additional offices in San Diego, California; Palo Alto, California; and the greater Boston and New York City areas.

About the Carillon Mitral Contour System

The Carillon Mitral Contour System is an innovative minimally invasive treatment for people diagnosed with FMR. The Carillon System is designed to offer physicians a safe and easy-to-use option to treat patients earlier in their disease diagnosis, including those with lesser degrees of FMR (2+ MR grade), to slow disease progression, and stabilize or improve quality of life. The Carillon System treats the dilated mitral annulus, the underlying mechanical problem of FMR, with a catheter-based alternative to medications and invasive surgery. Unlike other mitral regurgitation therapies, the Carillon System replicates traditional surgical standards through a simple, minimally invasive approach that offers patients annular reduction, while keeping adjunctive therapy options open.

To date, more than 850 patients worldwide have been treated with the Carillon System. The Carillon System has CE Mark and is available in certain European markets as well as other key geographies including Turkey, the Netherlands and Italy. Clinical data from three completed international studies of the Carillon System (AMADEUS, TITAN, and TITAN II) have demonstrated the performance of the device. In addition, the company is completing the follow up period of the landmark REDUCE FMR Trial – the first randomized, blinded evaluation of a therapy for FMR. The results of the REDUCE FMR Trial are expected before the end of 2018. Additionally, The CARILLON Trial, the company‘s U.S. pivotal study, is currently enrolling participants.

About Cardiac Dimensions

Cardiac Dimensions is the leader in innovative, minimally invasive treatment modalities addressing the heart failure patient population. Left untreated, FMR contributes to heart failure – a chronic, progressive condition that weakens the heart and makes everyday activities difficult. The Carillon System addresses the underlying mechanical problem of FMR with a catheter-based alternative to medications and invasive surgery. Cardiac Dimensions has operations in Kirkland, Sydney, and Frankfurt, Germany.

The Carillon Mitral Contour System is limited to investigational use in the U.S. Cardiac Dimensions, Carillon and Mitral Contour System are registered trademarks of Cardiac Dimensions.

Contacts

Rick Wypych, 425-605-5910
rwypych@cardiacdimensions.com

Related Article: New Data Confirms Cardiac Dimensions’ Carillon^® System Provides Acute Hemodynamic Efficacy in Patients with Functional Mitral Regurgitation

Quebec City, Quebec, April 24, 2018 – Opsens Inc. (“Opsens” or the “Company”) (TSX:OPS)(OTCQX:OPSSF) applauds Japan’s Ministry of Health, Labor and Welfare (“MHLW”) on its new regulation requiring the evaluation of any coronary stenosis prior to its treatment, specifically mentioning Fractional Flow Reserve (“FFR”) as a preferred assessment method.

The MHLW recently revised medical fees and established a requirement that functional ischemia (blockage of arteries) be evaluated before treatment for stable coronary artery disease.

This new review regulation is consistent with the results of multiple studies, such as the FAME study, which demonstrate that, when a patient’s lesion is assessed with FFR prior to treatment selection, clinical outcome is improved significantly.

The MHLW regulation is expected to have a positive impact on FFR penetration in the Japanese market, which currently represents the largest user of Opsens’ FFR products. Opsens’ revenues may be positively impacted as soon as the fourth quarter of fiscal year 2018.

About Opsens Inc. (www.opsens.com or www.opsensmedical.com)

Opsens focuses mainly on the measure of FFR in interventional cardiology. Opsens offers an advanced optical-based pressure guidewire (OptoWire) that aims at improving the clinical outcome of patients with coronary artery disease. Opsens is also involved in industrial activities in developing, manufacturing and installing innovative fibre optic sensing solutions for critical applications.

Forward-looking statements contained in this press release involve known and unknown risks, uncertainties and other factors that may cause actual results, performance and achievements of Opsens to be materially different from any future results, performance or achievements expressed or implied by the said forward-looking statements.

Neither TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) accepts responsibility for the adequacy or accuracy of this release.

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For further information, please contact:

Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

Robin Villeneuve, CPA, CA, Chief Financial Officer, 418.781.0333

LISLE, IL – APRIL 12, 2017- Endotronix, Inc., a medical technology company providing device and digital health solutions for heart failure management, today announced the appointment of seasoned life sciences executive and entrepreneur John Flavin as Chief Financial Officer. He joins the team as the company prepares to scale business operations in preparation of clinical trials and commercialization of the Cordella™ Heart Failure  (HF) System.

The Cordella System is a comprehensive HF management solution that extends care into the home by collecting and securely transmitting daily patient health data and insights to the clinician to guide treatment. The easy-to-use system is designed to create more time for patient care and strengthen the patient-clinician relationship. For patients with challenging disease management, the system includes a wireless, implantable pulmonary artery (PA) pressure sensor that enables proactive HF management.  PA pressure-guided HF management has demonstrated a mortality benefit and a reduction in HF-related hospitalizations.

The company implanted it’s first PA pressure sensor in a patient suffering from heart failure in Belgium in late 2017 and the Cordella System without the sensor has been in clinical use for over a year in the U.S.

“John has a rich background in life science technology commercialization, both from doing it directly in a hands-on operating role as well as creating an environment in which it can flourish,” said Harry Rowland, CEO and Co-founder of Endotronix. “His expertise will be a great asset as we prepare to commercialize the Cordella System later this year.”

Mr. Flavin most recently led the Polsky Center for Entrepreneurship and Innovation at the University of Chicago, where he founded the Polsky Exchange start-up incubator and helped raise over $135 million in philanthropic and corporate funding to support technology development, start-ups, and commercialization. Prior to that he held President and CFO roles at Advanced Life Sciences and MediChem Life Sciences where he oversaw corporate development and raised over $220 million in public and private capital, including two successful NASDAQ IPOs.

“I’ve spent much of my time at the University of Chicago fostering innovations that combine data science and healthcare, because I truly believe the combination will have the most direct impact on improving outcomes for complex health conditions,” Flavin said. “The Endotronix solution is an excellent example of this and I’m thrilled to be joining the team as they enter a new phase.”

Mr. Flavin is a board member at the Illinois Science and Technology Coalition, and he sits on Governor Bruce Rauner’s Illinois Innovation Council, Mayor Rahm Emanuel’s ChicagoNEXT technology council, and the City of Chicago’s Small Business Advisory Committee.

About Endotronix

Endotronix, Inc., a medical technology company, is developing an integrated platform to provide comprehensive, reimbursable health management innovations for patients suffering from advanced heart failure. The company’s solution, the Cordella™ Heart Failure System, includes a cloud-based disease management data system and at home hemodynamic management with a breakthrough implantable wireless pulmonary artery pressure sensor for early detection of worsening heart failure. 

Related Article: Endotronix Strengthens Management Team with Seasoned Medtech Executives

RESEARCH TRIANGLE PARK, N.C., March 12, 2018 (GLOBE NEWSWIRE) — G1 Therapeutics, Inc. (Nasdaq:GTHX), a clinical-stage oncology company, today announced the closing of an underwritten public offering of 3,910,000 shares of its common stock at a public offering price of $29.50, including 510,000 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares. G1 Therapeutics received approximately $108.4 million in proceeds from the offering, net of underwriting discounts and commissions, but before estimated offering expenses.

J.P. Morgan Securities LLC and Cowen and Company, LLC served as joint book-running managers for the offering.  Needham & Company, LLC and Wedbush Securities Inc. acted as lead managers for the offering.  BTIG, LLC acted as co-manager for the offering.

A registration statement relating to the offering was filed with the Securities and Exchange Commission and was declared effective on March 7, 2018. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; or from Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (631) 274-2806.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About G1 Therapeutics
G1 Therapeutics, Inc., is a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapeutics for the treatment of cancer. G1’s two clinical assets, trilaciclib and G1T38, are CDK4/6 inhibitors, a validated and promising class of targets for anti-cancer therapeutics. Trilaciclib and G1T38 have broad therapeutic potential in many forms of cancer and may serve as the backbone of multiple combination regimens. In addition, G1 is advancing G1T48, a potential first-/best-in-class oral selective estrogen receptor degrader, or SERD, which is targeted for the treatment of ER+ breast cancer. G1 is based in Research Triangle Park, NC.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this news release include, but are not limited to, the therapeutic potential of trilaciclib, G1T38 and G1T48, and are based on G1 Therapeutics’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause G1 Therapeutics’ actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in G1 Therapeutics’ filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein and include, but are not limited to, the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; G1 Therapeutics’ ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; G1 Therapeutics’ ability to recruit and enroll patients in its studies; competition in the industry in which G1 Therapeutics operates; and market conditions. Except as required by law, G1 Therapeutics assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:
Jeff Macdonald
Head of Investor Relations / Public Relations
919-907-1944
jmacdonald@g1therapeutics.com