Author: Ken Dropiewski

BridgeBio Pharma Reports Month 12 Topline Results from Phase 3 ATTRibute-CM Study

– ATTRibute-CM did not meet its primary endpoint at Month 12. Mean observed six-minute walk distance (6MWD) decline for the acoramidis and placebo arms were 9 meters and 7 meters, respectively. Both declines are similar to healthy elderly adults and less than prior untreated ATTR-CM cohorts – The company observed […]

Infraredx, a Nipro Company, Announces Enrollment of First Patient in EXPANSE PTCA Study

The objective of this study is to evaluate safety and effectiveness of the Lacrosse NSE ALPHA coronary dilatation catheter during PCI in subjects with stenotic coronary arteries. BEDFORD, Mass.–(BUSINESS WIRE)–Infraredx, a Nipro Company, a pioneer in intravascular imaging for mapping coronary artery disease, announced today the enrollment of the first […]

Philips receives FDA De Novo Clearance for IVC Filter Removal Laser Sheath – CavaClear – with Breakthrough Device Designation

December 22, 2021 Philips IVC Filter Removal Laser Sheath – CavaClear – is intended to safely ablate tissue to remove embedded IVC filters CavaClear is a first-in-class FDA-cleared solution for advanced IVC filter removal It is estimated that in the United States more than one million patients with IVC filters […]

CARMAT Announces the Completion of Its Investigations on Previously Identified Quality Issues

PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, announces the completion of investigations on its prostheses. Following the occurrence of […]

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

– With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol) reduction(1) – Leqvio provides effective and sustained LDL-C reduction of up to 52% vs. placebo for certain people with atherosclerotic cardiovascular disease (ASCVD) on maximally tolerated statin […]

Hyperfine Closes Business Combination with HealthCor Catalio Acquisition Corp and Liminal Sciences

Hyperfine Closes Business Combination with HealthCor Catalio Acquisition Corp and Liminal Sciences, Will Begin Trading under the Ticker “HYPR” on the Nasdaq Global Market – Business combination results in over $160 million in gross cash proceeds to Hyperfine – Funds to catalyze commercial expansion of the world’s first FDA-cleared portable […]

Claritas to Develop R-107 for Treatment of PPHN, a Potentially Fatal Pulmonary Disorder in Newborns

SAN FRANCISCO, CA, and TORONTO, ON, Dec. 22, 2021 (GLOBE NEWSWIRE) — Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the “Company” or “Claritas“) today announced that it will develop R-107 for the treatment of persistent pulmonary hypertension of the newborn (“PPHN”). PPHN is fatal in up to 50% of newborn patients […]

HeartBeam Appoints Alan Baumel as Chief Operating Officer

Commercial Medical Device Veteran to Lead Rollout of HeartBeam Platform Technology 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 appointed Alan Baumel as Chief Operating Officer. For over 35 years, Mr. […]

Alnylam Comments on FDA Approval of Leqvio®, the First siRNA (RNAi Therapeutic) Approved to Reduce LDL-C

– Leqvio® Becomes Fourth RNAi Therapeutic Approved by U.S. FDA and First and Only for Lowering LDL-C in Atherosclerotic Cardiovascular Disease (ASCVD) Which Can Affect Up to 30 Million Americans – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today highlighted the significance of the U.S. Food and […]

GE Healthcare Completes Acquisition of BK Medical

Acquisition expands GE Healthcare’s $3 billion Ultrasound business from diagnostics into surgical and therapeutic interventions Adds capability in fast-growing advanced surgical visualization segment, and significant synergies expected to further strengthen BK Medical’s world-renowned business. BOSTON–(BUSINESS WIRE)–GE (NYSE:GE) today announced that it has completed its previously announced acquisition of BK Medical, […]