Author: Ken Dropiewski

Quantum Genomics Initiates its Pivotal Phase III FRESH Trial in Difficult-to-Treat and Resistant Hypertension

PARIS and NEW YORK, Dec. 19, 2019 (GLOBE NEWSWIRE) — Quantum Genomics (Euronext Growth – FR0011648971 – ALQGC, OTCQX – QNNTF), a biopharmaceutical company specializing in developing a new drug class that directly targets the brain to treat resistant hypertension and heart failure, today announced the initiation of its pivotal Phase III FRESH study […]

CryoLife and Misonix Enter Into Distribution Agreement for NeoPatch

CryoLife Will Supply NeoPatch, a Chorioamniotic Membrane Tissue, to Misonix ATLANTA, Dec. 19, 2019 /PRNewswire/ — CryoLife, Inc. (“CryoLife”;NYSE: CRY), a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has entered into an agreement whereby Misonix (NASDAQ: MSON) will  have exclusive US commercialization rights for CryoLife’s NeoPatch product to […]

Results Demonstrating Favorable Outcomes with TCAR vs. TF-CAS in Patients with Carotid Artery Stenosis Published in the Journal of the American Medical Association (JAMA)

SUNNYVALE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced that positive results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project comparing TCAR and transfemoral carotid artery stenting (TF-CAS) have been published in The Journal […]

FDA Grants ‘Breakthrough’ Designation to Eko’s ECG-based Low Ejection Fraction Screening Algorithm, Designed to Improve Detection of Heart Failure

Developed in collaboration with Mayo Clinic, the algorithm would help healthcare providers detect heart failure during a standard physical exam San Francisco, CA, Dec. 18, 2019 (GLOBE NEWSWIRE) — Eko, a digital health company applying artificial intelligence (AI) in the fight against heart disease, today announced the U.S. Food and Drug Administration […]

ANI Pharmaceuticals Announces Launch of Bretylium Tosylate Injection, USP 50 mg/mL

BAUDETTE, Minn., Dec. 18, 2019 /PRNewswire/ — ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced the launch of Bretylium Tosylate Injection USP, 50 mg/mL.  Bretylium Tosylate is a class III antiarrhythmic medication approved for the treatment of ventricular fibrillation and life-threatening ventricular arrhythmias such as ventricular tachycardia.  ANI estimates that the current annual U.S. […]

Medicure Announces the Completion of Shortened AGGRASTAT® Versus Integrilin® in Percutaneous Coronary Intervention (SAVI-PCI) Study

WINNIPEG, Dec. 17, 2019 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the completion of the Shortened AGGRASTAT® (tirofiban hydrochloride) injection versus Integrilin® (eptifibatide) in Percutaneous Coronary Intervention (SAVI-PCI) Clinical Trial. SAVI-PCI was a randomized, multicenter, open-label study enrolling 535 patients at 13 sites […]

Velano Secures Additional Funding to Meet Commercial Demand for PIVO, Fueled by Industry Move to One-Stick Hospitalization

Latest funding caps year of groundbreaking milestones for transformative vascular access company; new capital will be used to meet rapidly growing hospital and patient demand San Francisco, Calif. – December 17, 2019 – Vascular access technology pioneer Velano Vascular today announced that it has closed the second tranche of a $25 million growth financing […]

iRhythm Announces Participation in GUARD-AF Study Focused on Undiagnosed Atrial Fibrillation

SAN FRANCISCO, Dec. 16, 2019 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC) today announced its participation in a new, randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals), sponsored by the Bristol-Myers Squibb-Pfizer Alliance (the Alliance).  The study seeks to determine if earlier detection of atrial […]

TransThera Biosciences Announces IND Approval from FDA for Clinical Studies of TT-00920 to Treat Chronic Heart Failure

NANJING, China, Dec. 16, 2019 /PRNewswire/ — TransThera Biosciences Co. Ltd, a clinical-stage biotechnology company based in Nanjing, China, announced today that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for TT-00920, a novel small molecule inhibitor of Phosphodiesterase 9 (PDE 9) for the treatment of chronic heart failure. […]