Author: Ken Dropiewski

preCARDIA Enrolls First Patient in Early Feasibility Study

Company initiates the VENUS-HF study in patients with Acute Decompensated Heart Failure (ADHF) ST. PAUL, Minn., Aug. 15, 2019 /PRNewswire/ — preCARDIA, Inc., a medical device company developing innovative technologies for the treatment of acute decompensated heart failure (ADHF), has enrolled the first patient in the VENUS-HF Early Feasibility Study at Tufts Medical […]

Cardax Files Registration Statement for Proposed $15 Million Follow-On Offering

– Maxim Group to serve as sole book running manager on a firm commitment basis – Funds to be used primarily for pharmaceutical development – Concurrent Nasdaq uplisting planned HONOLULU, Aug. 14, 2019 /PRNewswire/ — Cardax, Inc. (OTCQB:CDXI) announced today that it filed a registration statement on Form S-1 with the Securities […]

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent (AMDS)

Ascyrus Medical receives Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. BOCA RATON, FLA. (PRWEB) AUGUST 14, 2019 Ascyrus Medical announced today that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) […]

V-Wave’s Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure

CAESAREA, Israel, Aug. 15, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has just granted the company a Breakthrough Device Designation for its interatrial shunt for Heart Failure (HF). V-Wave’s minimally invasive, implanted interatrial […]

Renovacor Closes $11 Million Series A Financing to Advance First Gene Therapy for a Rare Cardiovascular Disease

– Funding supports preclinical development through IND submission for its BAG3 gene therapy, the first gene replacement product for genetic forms of dilated cardiomyopathy – Company announces leadership team and board of directors with leading scientists, physicians and experienced venture investors in cardiovascular and gene therapy fields August 14, 2019 10:11 AM […]

Silk Road Medical Announces Closing of Follow-on Public Offering and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

SUNNYVALE, Calif., Aug. 13, 2019 (GLOBE NEWSWIRE) — Silk Road Medical, Inc. (Nasdaq: SILK) (“Silk Road Medical”), a company focused on reducing the risk of stroke and its devastating impact, today announced the closing of a public offering of 4,200,000 shares of its common stock sold by selling stockholders, and […]

DynoSense Corp. Announces FDA Approval of Its Cloud Based Vital Signs Measurement System

SAN JOSE, Calif., Aug. 13, 2019 /PRNewswire/ — DynoSense Corp. announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its patented Vital Signs Measuring System, the world’s first most integrated and cloud-based vital signs measuring and recording platform. Its unique worldwide patented and award-winning design is as simple […]

Windtree Announces FDA Fast Track Designation for Istaroxime

WARRINGTON, Pa., Aug. 13, 2019 /PRNewswire/ — Windtree Therapeutics, Inc. (OTCQB: WINT), a biotechnology and medical device company focused on developing drug product candidates and medical device technologies to address acute cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for istaroxime for the […]