Author: Ken Dropiewski

FDA Awards Genetesis Breakthrough Device Designation for CardioFlux® Imaging Technology

MASON, Ohio–(BUSINESS WIRE)–Genetesis, Inc. announced today that its flagship product, CardioFlux®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. CardioFlux®, the most advanced commercially available magnetocardiograph (MCG), […]

Corindus Announces Global Launch of technIQ™1 Smart Procedural Automation Series for CorPath® GRX System

New automations receive FDA clearance for use in coronary and peripheral robotic-assisted procedures WALTHAM, Mass.–(BUSINESS WIRE)–Corindus, A Siemens Healthineers Company and one of the leading developers of precision vascular robotics, announced today the global launch of a new set of automated robotic movements in the technIQ Series designed for the […]

Quantum Genomics Enters into Exclusive Licensing and Collaboration Agreement with Faran

Quantum Genomics to receive up to $12.1 million in upfront and milestone payments plus double-digit royalties on sales Faran to receive an exclusive license to develop and commercialize firibastat for the treatment of difficult to treat/resistant hypertension in Greece PARIS and NEW YORK, Dec. 15, 2020 (GLOBE NEWSWIRE) —  Quantum Genomics (Euronext Growth […]

BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

SAN CARLOS, Calif., Dec. 14, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) today announced it has entered into definitive agreements with investors for the purchase and sale of 1,888,889 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering […]

CHF Solutions Announces Meta-Analysis Demonstrates Ultrafiltration is Better than Diuretic Therapy for the Management of Volume Overload in ADHF

EDEN PRAIRIE, Minn., Dec. 15, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, today announced a meta-analysis published in Heart Failure Reviews concludes that ultrafiltration (UF) increases fluid removal and weight loss and reduces rehospitalization and the […]

Neovasc Receives Nasdaq Notification Regarding Minimum Bid Price Deficiency

VANCOUVER and MINNEAPOLIS, Dec. 14, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (Nasdaq, TSX: NVCN) announced today that it has received written notification (the “Notification Letter”) from The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that it is not in compliance with the minimum bid […]

Neovasc Announces First Neovasc Reducer™ Implants in France

VANCOUVER and MINNEAPOLIS, Dec. 15, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced today that it has completed the first three Neovasc Reducer™ (“Reducer”) implants in France. The implants are an important step for Neovasc as the Company continues to expand access for Reducer therapy to […]

ARCA biopharma Announces First Patients Enrolled in ASPEN-COVID-19 Phase 2b Clinical Trial Evaluating rNAPc2 (AB201) as a Potential Treatment for COVID-19

rNAPc2 development focused on unmet need for treatments in hospitalized COVID-19 patients, including after availability of vaccines rNAPc2 is the only novel compound being developed for COVID-19 Associated Coagulopathy Topline trial data anticipated in the second quarter of 2021 Data from this development program will also inform potential development in […]

Mesoblast Provides Topline Results From Phase 3 Trial of Rexlemestrocel-L for Advanced Chronic Heart Failure

NEW YORK, Dec. 14, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced top-line results from the landmark DREAM-HF Phase 3 randomized controlled trial of its allogeneic cell therapy rexlemestrocel-L (REVASCOR®) in 537 patients with advanced chronic heart failure1. Over […]