Author: Ken Dropiewski

ARMGO Pharma raises $35 million to progress clinical studies of lead molecule ARM210 in cardiac and skeletal muscle diseases

ARMGO Pharma raises $35 million to progress clinical studies of lead molecule ARM210 in cardiac and skeletal muscle diseases Series B investment led by Forbion and joined by Pontifax and Kurma Partners Investment will fund clinical studies of ARMGO’s lead molecule ARM210, an oral treatment, in development for cardiac and skeletal […]

Elucid Announces American Medical Association (AMA) Instates CPT Code for Lipid-Rich Necrotic Core Quantification to Assess Atherosclerotic Plaque Stability

Quantification of the structure and composition of the vessel wall and assessment of lipid-rich necrotic core plaque (CPT 0710T-0713T) BOSTON–(BUSINESS WIRE)–Elucid, a Boston-based medical technology company harnessing scientific imaging and artificial intelligence to enable the precise diagnosis and treatment of the world’s leading cause of death announced a new CPT […]

Vesper Medical Announces Completion of Enrollment in the VIVID Clinical Trial

Company Achieves Key Milestone in the Development of Its Next Generation Deep Venous Stent System WAYNE, Pa.–(BUSINESS WIRE)–Vesper Medical, Inc., a developer of medical devices for deep venous disease, today announced the completion of enrollment in its pivotal study – Venous stent for the Iliofemoral Vein Investigational clinical trial using the Vesper DUO Venous Stent […]

BioMarin and Skyline Therapeutics Announce Strategic Collaboration to Develop Novel Gene Therapies for Cardiovascular Diseases

SAN RAFAEL, Calif. and SHANGHAI, Dec. 16, 2021 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Skyline Therapeutics (formerly Geneception), a gene and cell therapy company focused on developing novel treatments for unmet medical needs, today announced a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated Virus (AAV) gene therapies to […]

Thubrikar Aortic Valve Announces Authorization to Initiate Patient Implants Toward CE Mark Approval of Optimum TAV™, and Development of Its Novel Precision 2™ Delivery Catheter

NORRISTOWN, Pa.–(BUSINESS WIRE)–Thubrikar Aortic Valve, Inc., announced today that it received approval from a Competent Authority in Poland to conduct initial patient implants with its Optimum Transcatheter Aortic Valve Implantation (TAVI) system™. The Company will sponsor this CE Mark-enabling pilot study on patients with severe Aortic Stenosis and begin to […]

HeartBeam Reports Third Quarter and Nine Months 2021 Financial Results

Closes Successful $16.5 Million IPO and Commences Trading on the Nasdaq SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage digital healthcare company with a proprietary ECG telemedicine technology to bring new capabilities to cardiovascular disease, has reported its financial and operational results for the third quarter and nine months […]

European Society of Cardiology Heart Failure Journal Publishes New Plasma Volume Heart Failure Study Data from FAST BioMedical

The ESC Heart Failure Journal shares additional results from FAST BioMedical’s EMPAKT CHF clinical study.   INDIANAPOLIS (Dec. 10, 2021) — FAST BioMedical (FAST), a privately held late clinical-stage medical technology company, today announces theEuropean Society of Cardiology (ESC) Heart Failure Journal has published additional results from its fourth human […]

Fist Assist Devices Receives FDA “Breakthrough Device” Designation for the World’s First Wearable Vein Dilation Device for ESRD Patients

Indication for Pre-Surgical Vein Dilation Use to Promote AV Fistula Creation LAS VEGAS–(BUSINESS WIRE)–Fist Assist Devices, LLC, an innovative medical device company focused on vein dilation to facilitate the Chronic Kidney Disease (CKD) patient’s journey through End-Stage Renal Disease (ESRD), announced today that it received “Breakthrough Device” designation from the […]

Sky wins FDA clearance to market the geko™ device for venous insufficiency and ischemia – a therapy area sorely in need of innovation.

The geko™ device increases blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia. DARESBURY, England, Dec. 16, 2021 /PRNewswire/ — Medical devices company, Sky Medical Technology Ltd, has today announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the geko™ device for increasing microcirculatory blood flow in […]