Other News

PhaseBio Announces European Licensing Agreement with Alfasigma S.p.A for Commercialization of Bentracimab

Agreement provides PhaseBio with $20 million upfront payment and eligibility to receive up to $245 million in development and commercial milestones in addition to tiered double digit royalties on sales Collaboration reinforces global bentracimab opportunity Establishes accessibility to bentracimab, if approved, for the largest pool of ticagrelor patients in the […]

United Therapeutics Announces FDA Acceptance of Tyvaso DPI™ New Drug Application For Priority Review

FDA action expected in October 2021 SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., June 16, 2021 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension […]

MedTech Innovator Unveils Top 50 Medtech Startups Selected for Annual Showcase and Accelerator

LOS ANGELES — June 15, 2021 — MedTech Innovator, the largest accelerator of medical device companies in the world, today announced the 50 companies selected to participate in the organization’s flagship four-month Showcase and Accelerator program, featuring the industry’s most transformative device, diagnostic, and digital health technologies from around the […]

Artio Medical Hires Key Sales and Marketing Leaders to Prepare for Commercial Launch of First Product in U.S.

PRAIRIE VILLAGE, Kas., June 15, 2021 /PRNewswire/ — Artio Medical, Inc., a medical device company developing innovative products for the peripheral vascular, neurovascular, and structural heart markets, today announced the hiring of Jeff Weinrich as Head of Global Sales and Chris Parker as Senior Director of Marketing. Weinrich and Parker have joined Artio to prepare the company […]

Mezzion Appoints William Breitenbach as Chief Commercial Officer for Mezzion’s Global Commercial Operations

SEOUL, Republic of Korea, June 15, 2021 /PRNewswire/ — Mezzion Pharma Co., Ltd. (140410.KQ), and Mezzion Pharmaceuticals, Inc. (individually or collectively, “Mezzion”), a leader in the field of rare single ventricle congenital heart disease (“SVHD”) and SVHD patients with Fontan circulation, is pleased to announce that Bill Breitenbach has joined Mezzion as the Chief Commercial […]

Dutch MedTech STENTiT appoints Golo von Basum as Chief Operating Officer

EINDHOVEN, Netherlands, June 15, 2021 /PRNewswire/ — STENTiT, a medical device company bringing a novel class of regenerative stents for sustained endovascular repair, has appointed Dr. Golo von Basum (picture) as its Chief Operating Officer (COO). He will be responsible for the strategic implementation to scale and standardize the product development and company operations. […]

VoluMetrix’s NIVA|HF for Heart Failure Patients Designated as Breakthrough Device by U.S. FDA

NIVA|HF is an investigational device designed to monitor the venous waveform, a novel physiologic signal, in heart failure patients. As a Breakthrough Device, NIVA|HF will receive pre-market developmental assistance and prioritized regulatory review from FDA. NIVA|HF is the first application of VoluMetrix’s proprietary venous waveform technology. NASHVILLE, Tenn., June 15, 2021 /PRNewswire/ […]

Establishing TAVR for the Treatment of Aortic Regurgitation(1)

JenaValve Marks the 100th Implant of the Trilogy™ Heart Valve System IRVINE, Calif., June 15, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of a novel transcatheter aortic valve replacement (TAVR) system, is pleased to announce today the 100th global implant of the Trilogy™ Heart Valve System. This milestone […]

Cytokinetics Announces Completion of Enrollment in METEORIC-HF, The Second Phase 3 Clinical Trial of Omecamtiv Mecarbil in Patients With Heart Failure With Reduced Ejection Fraction

Top Line Results of METEORIC-HF Expected in Early 2022 Company Plans to Submit NDA in 2H 2021 Based on Positive Results of GALACTIC-HF SOUTH SAN FRANCISCO, Calif., June 15, 2021 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the completion of patient enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility […]