Other News

XyloCor Therapeutics Completes Oversubscribed $41.9 Million Series A Financing To Advance Novel Gene Therapy Pipeline For Coronary Artery Disease

Company closes additional $22.6 million in new financing Proceeds will fund initiation of new clinical trial for lead gene therapy candidate XC001 as adjunctive therapy for patients undergoing coronary artery bypass graft surgery MALVERN, Pa.–(BUSINESS WIRE)–XyloCor Therapeutics, a private clinical-stage biopharmaceutical company focused on the development of gene therapy for […]

Cardiovascular Systems, Inc. Announces Acquisition of Peripheral Support Catheters From WavePoint Medical, LLC

Agreement also includes development of portfolio of CTO products ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII) announced today that it has acquired a line of peripheral support catheters from WavePoint Medical, LLC. Peripheral support catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to enable […]

VALBIOTIS Obtains ISO 9001 Certification for Its Activities in “Design, Development and Production Control of Solutions for Preventing and Combating Metabolic and Cardiovascular Diseases”

LA ROCHELLE, France–(BUSINESS WIRE)–Regulatory News: VALBIOTIS (Paris:ALVAL) (FR0013254851 – ALVAL / eligible for the PEA/SME), a French Research & Development company committed to scientific innovation for preventing and combating metabolic diseases, announces that it has obtained ISO 9001 certification for its Quality Management System (QMS) deployed on its three sites. […]

U.S. Food and Drug Administration (FDA) Accepts Bristol Myers Squibb’s Application for Mavacamten in Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

U.S. FDA has assigned a target action date of January 28, 2022 Application based on results from the Phase 3 EXPLORER-HCM trial PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for mavacamten, an investigational, novel, […]

SANUWAVE Health Announces Distribution Agreement with Labb Solutions

SANUWAVE to Distribute dermaPACE® System and UltraMIST® System in Turkey and in Select Eastern Europe and Middle East Countries SUWANEE, GA, March 19, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — SANUWAVE Health, Inc. (OTCQB: SNWV), focused on the development and commercialization of a robust and innovative advanced wound care product portfolio for the repair […]

JenaValve Technology Welcomes Jane Metcalf as Vice President, Regulatory Affairs and Quality

IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve […]

Cytokinetics Announces Secondary Analysis From GALACTIC-HF to Be Presented in Late Breaking Clinical Trial Session at American College of Cardiology 70th Annual Scientific Session & Expo (ACC.21)

SOUTH SAN FRANCISCO, Calif., March 18, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from a secondary analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) assessing the effect of omecamtiv mecarbil on clinical outcomes in relationship to patient baseline ejection fraction will be presented in a Late Breaking Clinical Trial […]