Opsens Announces Graduation to TSX

Opsens Announces Graduation to TSX

February 28, 2017 / Portfolio News

QUEBEC CITY, Feb. 28, 2017 /CNW Telbec/ – Opsens Inc. (“Opsens” or the “Company”) (TSXV: OPS) (OTCQX: OPSSF) is pleased to announce that it has received final approval for the listing of the Corporation’s common shares (the “Common Shares”) on the Toronto Stock Exchange (“TSX”).

The Common Shares will commence trading on the TSX effective as of the open of the market on March 1, 2017. Upon listing on the TSX, the Common Shares will continue to trade under the symbol “OPS”. In conjunction with listing on the TSX, the Common Shares will be voluntarily delisted from the TSX Venture Exchange prior to the commencement of trading on March 1, 2017.

“This is a significant achievement for Opsens,” said Louis Laflamme, President and Chief Executive Officer of Opsens. “The TSX is Canada’s most significant stock exchange and this move will provide us with greater visibility in the marketplace and access to a broader and more diverse range of international and institutional investors. This move will also help Opsens develop a stronger profile in the investment community, as our penetration grows, on a global scale, in the field of interventional cardiology,” Mr. Laflamme added.

Opsens aims to become a key player in the guidewire FFR market with the OptoWire, a nitinol-based, fiber optic guidewire. The OptoWire provides intra-coronary blood pressure measurements with unique, patented optical pressure guidewire technologies. It is immune to undesired effects related to blood contact, and allows easy and reliable connectivity that leads to reliable FFR measurements in extended conditions of usage. The OptoWire is also designed to provide cardiologists with a guidewire that provides optimal performance to navigate coronary arteries and cross blockages with ease and safety. Based on industry sources, the FFR market represented more than US$300 million in sales in 2014 and is expected to reach US$1 billion in the medium-term.

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. The Company develops, manufactures and installs innovative fibre optic sensing solutions for critical applications such as the monitoring of oil wells and other demanding industrial 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 Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

SOURCE OPSENS INC.

For further information: Thierry Dumas, CPA, CA, Chief Financial Officer, 418.781.0333; Louis Laflamme, CPA, CA, Chief Executive Officer, 418.781.0333

BAROnova Announces Completion of ENDObesity® II Pivotal Clinical Trial Enrollment

January 25, 2017 / Portfolio News

SAN CARLOS, Calif., Jan. 25, 2017 /PRNewswire/ — BAROnova, Inc., announced completion of its randomized cohort enrollment in the ENDObesity II Study, a multicenter randomized pivotal clinical trial designed to test the safety and effectiveness of the TransPyloric Shuttle® (TPS®), which treats obesity.

Richard Rothstein, MD, the lead investigator of the study and the Joseph M. Huber Professor and Chair of the Department of Medicine at the Geisel School of Medicine at Dartmouth in Hanover, NH and a gastroenterologist and Chief Academic Officer at the Dartmouth-Hitchcock Medical Center, said, “This is the first non-surgical weight-loss device inserted into the stomach for a year-long residence time in US pivotal studies. The TPS device is easily endoscopically placed and removed. The pilot data showed that this device was well tolerated by individuals who received it with impressive weight loss results. We await the full analysis of this randomized trial to verify its safety and efficacy. The TPS device has great potential for widespread clinical use.”

David Thrower, CEO of BAROnova added, “With the completion of pivotal trial enrollment, BAROnova has achieved an important milestone. Based upon our pilot clinical results, we are optimistic that the BAROnova TPS device will prove to be a safe, effective, non-surgical treatment for obese individuals with significant advantages in efficacy and duration of treatment. We look forward to bringing this important advancement in the treatment of obesity to market.”

The ENDObesity II Study completed enrollment of 270 patients in 9 sites in the United States in December of 2016. The results from this study will be used to support an FDA application for TransPyloric Shuttle approval and subsequent domestic commercialization of the device.

About the TransPyloric Shuttle

BAROnova’s novel weight-loss device, the TransPyloric Shuttle (TPS), is inserted and removed trans-orally using standard endoscopic techniques. In a previous feasibility study of the TPS, patients with a BMI of 30-40 kg/m2 demonstrated an average total body loss of 14.7% after six months. Over 100M people in the United States are classified as medically obese. If approved, the TransPyloric shuttle will be the first intra-gastric device with a twelve-month dwell time in the stomach, potentially leading to additional efficacy and duration of weight-loss.

About BAROnova, Inc.

BAROnova is a clinical-stage medical technology company developing devices for the treatment of obesity. BAROnova’s technology focuses on slowing gastric emptying, a known mechanism of action for weight loss. 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.

Related Links

http://www.baronova.com

Celtaxsys Welcomes New Board Member Abel De La Rosa

January 9, 2017 / Portfolio News

Atlanta, GA. – Celtaxsys, a clinical stage pharmaceutical development company focused on advancing novel anti-inflammatory treatment for rare and orphan diseases, announced today the appointment of Dr. Abel De La Rosa to the company board of directors. He currently serves as Chief Scientific Officer for the Drug Innovations Venture at Emory (DRIVE) and the Emory Institute for Drug Development (IDD), both based at Emory University, Atlanta, Georgia. He was formerly Senior Vice President of Business Development and Scientific Affairs at Pharmasset, Inc. before it was acquired by Gilead in 2012. Prior to Pharmasset, he was Vice President of Product Development at Visible Genetics leading the design and development of commercial molecular diagnostic tests for HIV, HCV, and HBV, such as the TruGene HIV-1 genotyping test and OpenGene DNA Sequencing System, the first FDA-approved genotyping sequencing-based test. He previously held scientific positions at Innogenetics, Boston Biomedica, and Digene, developing commercial molecular diagnostic tests for infectious diseases. He is an inventor and author on several U.S. patents and publications relating to his work.

“We are excited to have Dr. De La Rosa join our board,” said Celtaxsys CEO Greg Duncan. “He brings a wealth of experience in drug development and business transactions that will enhance our thought process.”

Celtaxsys is currently conducting a landmark phase 2 clinical trial of its flagship compound once-daily oral acebilustat in adult cystic fibrosis patients (EMPIRE-CF). The trial is being conducted in the US, Canada, and the EU. For more information about the EMPIRE-CF trial, please visit https://clinicaltrials.gov/ct2/show/NCT02443688.

About Cystic Fibrosis: Cystic fibrosis (CF) is a life-threatening disease that affects the lung and digestive system and impacts about 70,000 patients worldwide. CF is caused by mutations in the Cystic Fibrosis Transmembrane conductance Regulator (CFTR) gene leading to abnormal CFTR protein functioning, the result of which causes the body to accumulate excessive levels of unusually thick mucus in the lungs. Respiratory distress in CF, defined as acute difficulty in breathing, infection and/or hospitalization, is most commonly related to lung infection and inflammation induced lung tissue damage. Treatment of lung inflammation is thought to be key to improving CF patients’ lung health and well-being. For more information on cystic fibrosis, go to www.cff.org.

About acebilustat (formerly CTX-4430): Acebilustat is a once-daily oral drug candidate being tested for the treatment of inflammatory diseases. 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). LTA4H and LTB4 have been strongly implicated in the pathogenesis of many diseases involving inflammation, including cystic fibrosis.

About Celtaxsys: Celtaxsys, Inc. is a privately-held pharmaceutical discovery and development company focused on advancing medicine to treat patients suffering from serious inflammatory diseases. The company is developing a sustainable pipeline of first-in-class immune-modulators, including its flagship compound acebilustat (formerly CTX-4430). Our follow-on molecules enable new intellectual property and exhibit differentiated properties that allow optimization for alternate routes of administration. For more information, please visit: http://www.celtaxsys.com.

Zymeworks Announces the Successful Achievement of a Research Milestone with Lilly in Bispecific Antibody Collaboration

January 5, 2017 / Portfolio News

January 05, 2017 05:00 AM Eastern Standard Time

VANCOUVER, British Columbia–(BUSINESS WIRE)–Zymeworks Inc. (“Zymeworks”), a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer, today announced the successful achievement of a research milestone in a second immune-modulating bispecific antibody in its collaboration with Eli Lilly and Company (“Lilly”) using Zymeworks’ proprietary Azymetric™ platform. In accordance with the terms of the licensing and collaboration agreement, Zymeworks is to receive an undisclosed milestone payment from Lilly.

“This is the second research milestone we have reached as part of our collaboration with Lilly, and we are excited with the progress that has been made to ultimately bring novel immunotherapies towards the clinic,” said Dr. Ali Tehrani, President & CEO of Zymeworks. “We believe that the achievement of another successful milestone further validates our Azymetric™ platform as a generator of leading-edge bispecific antibody therapeutics, and we look forward to the continued advancement of other therapeutic programs under our agreements with Lilly.”

Under the terms of the agreement, Zymeworks has granted Lilly a worldwide, royalty-bearing license to research, develop and commercialize certain bispecific therapeutic candidates toward Lilly’s therapeutic targets. For this program, Zymeworks is eligible to receive further development and commercial milestone payments as well as tiered royalties on product sales.

About the Azymetric™ Platform

The Azymetric™ platform consists of a library of proprietary amino acid substitutions that enable the transformation of monospecific antibodies into bispecific antibodies, which gives them the ability to simultaneously bind two non-overlapping epitopes, or antigens. Azymetric™ bispecific technology enables the development of biotherapeutics with dual-targeting of receptors/ligands and simultaneous blockade of multiple signaling pathways, increasing tumor-specific targeting and efficacy while reducing toxicities and the potential for drug-resistance. Additionally, the dual-targeting of Azymetric™ antibodies has demonstrated synergistic efficacy in preclinical studies through simultaneous binding relative to the application of an equivalent dose of the corresponding monospecific antibodies. Azymetric™ bispecifics can also be engineered to enhance internalization of the antibody into the tumor cell and consequently increase the delivery of cytotoxic payloads.

First-generation bispecific platforms significantly alter the structure of monoclonal antibodies or rely upon complex and proprietary manufacturing processes. Azymetric™ bispecifics, in contrast, retain the desirable drug-like qualities of monoclonal antibodies, including long half-life, stability and low immunogenic potential, which increases their probability of success. Azymetric™ bispecifics are also compatible with standard manufacturing processes with high yields and purity, which accelerates manufacturing timelines and reduces costs.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. 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.

Contacts

Zymeworks Inc.

David Poon, Ph.D., 604-678-1388

Executive Director, External R&D and Alliances

bd@zymeworks.com

or

Investor Inquiries

David Matousek, 604-678-1388

Senior Manager, Investor Relations & Corporate Communications

ir@zymeworks.com

or

ICR Inc.

Stephanie Carrington, 646-277-1282

stephanie.carrington@icrinc.com

or

Media Inquiries

Michael Lampe, 484-575-5040

michael@scientpr.com

Exact Imaging secures CDN $21.5 Million in financing to support the commercialization of its new disruptive ExactVu™ micro-ultrasound for prostate imaging and biopsy

January 5, 2017 / Portfolio News

TORONTO, Jan. 5, 2017 /PRNewswire/ – Exact Imaging (www.exactimaging.com), the world’s leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has secured CDN $21.5 million in a Series C investment to commercialize its ExactVu™ micro-ultrasound system. The financing, which closed late in 2016, was co-led by Lumira Capital (Toronto, ON) and Vesalius Biocapital (Luxembourg) with participation from numerous new investors including PMV (Participatiemaatschappij Vlaanderen) (Brussels, Belgium) and strong support from existing investors including iGan Partners/Rowanwood Ventures (Toronto, ON).

“We are very pleased to have been able to achieve an investment of this magnitude from such a high quality investment syndicate. This financing will allow us to scale our commercial organization, aggressively implement our product roadmap, and help us to realize the significant opportunity in the prostate biopsy and imaging marketplace,” says Randy AuCoin, Exact Imaging’s President and CEO.

“We have followed the evolution of the Exact Imaging story for a number of years and in May of 2016 we participated in bridge financing to support this financing process and to allow the company to achieve regulatory approvals in key markets. Having met those milestones, we are very pleased to be a co-lead on this financing which is one of largest financing rounds for a private Canadian medical device company in Canada for 2016,” said Peter van der Velden, Managing General Partner of Lumira Capital. “The Lumira Investment reflects both our view that the technology addresses a significant unmet market and patient need and that the Exact team is the right team to successfully scale the business globally,” said Dr. Jacki Jenuth, Principal at Lumira Capital.

Dr. Gaston Matthyssens, Managing Partner of Vesalius Biocapital, noted, “Exact Imaging’s micro-ultrasound technology has the potential to change the standard of patient care in the urological practice by providing the urologist with the very tool they have been seeking. Specifically, a solution for prostate biopsies that provides much better resolution, is controlled by the urologist and is based on a known technology and workflow. With resolution down to 70 microns or 0.07 of a millimeter, the ExactVu high resolution system provides a 300% improvement in imaging resolution compared to the traditional standard-of-care urological ultrasound systems. Urologists now have a tool, designed around their workflow, to facilitate the detailed interrogation and visualization of suspicious regions and perform targeted prostate biopsies.”

PMV’s Dr. Alexandra Tolia added, “Our participation in Exact Imaging’s Series C financing reflects our fund’s investment strategy in healthcare. Specifically, we invest in companies with a disruptive technology, a unique product pipeline that addresses a highly unmet medical need and with an excellent management team committed to bringing these products to market and, consequently, to the patient. Through this financing, we are excited to support Exact Imaging in realizing their international development plan, including the creation of its European headquarters in Flanders, which will be spearheading the commercial roll-out efforts for the ExactVu system in Europe.”

“As a founding investor in Exact Imaging and longtime supporter of the company, we have always believed in the potential of this high resolution micro-ultrasound technology and the impact it could have on the urology marketplace,” says Mr. Sam Ifergan, CEO of iGan Partners/Rowanwood Ventures. “Having worked with this management team in the past on other successful ventures, we were fully confident to further invest in this round to support the Company’s future and the pursuit of this next level of commercialization.”

Mr. van der Velden, Dr. Matthyssens and Dr. Tolia will be joining Exact Imaging’s Board of Directors along with existing Board members Mr. Ifergan (co-founder, iGan Partners/Rowanwood Ventures), Mr. William Wortman (Private Investor), Dr. Harold Wodlinger (Wodlinger Consulting) and Exact Imaging’s President and CEO, Mr. AuCoin.

About Exact Imaging:

Exact Imaging (www.exactimaging.com)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 being an extension of the current urological workflow. Using the Exact Imaging platform, urologists will now be able to visualize areas of interest in the prostate and specifically target biopsies at those areas in addition to performing systematic biopsy protocols. The ExactVu™ micro-ultrasound system has recently been granted regulatory approval in the European Union (CE Mark) and the United States (FDA 510(k) where the company will initiate its commercialization focus. Exact Imaging was founded in 2013 by Mr. Sam Ifergan (iGan Partners) and Mr. Randy AuCoin to develop and commercialize this novel high resolution technology in order to disrupt the market and enable new levels of clinical imaging.

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