Other News

FDA grants Jardiance® Breakthrough Therapy designation for heart failure with preserved ejection fraction

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction RIDGEFIELD, Conn. and INDIANAPOLIS, Sept. 9, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) granted Breakthrough […]

Longeveron Announces Final Results of Phase 1 Clinical Study of Lomecel-B Injection in Hypoplastic Left Heart Syndrome Patients

–Study meets primary safety endpoint: no major adverse cardiac events (MACE), nor any treatment-related infections during the first month post-treatment. –Secondary endpoints measured per protocol suggest Lomecel-B injection may improve patient long-term clinical outcome after surgery: 100% of infants alive and heart-transplant free, with follow-up ranging two to 3.5 years […]

Etiometry and Terumo Cardiovascular Announce Partnership to Deliver Enhanced Monitoring Insights for Adult Cardiac Surgery Patients

New partnership will enable clinical decision-support solutions to improve perioperative care BOSTON & ANN ARBOR, Mich.–(BUSINESS WIRE)–Etiometry, a leader in clinical decision-support software for critical care, today jointly announced a new collaboration with Terumo Cardiovascular, a global leader in cardiovascular surgery technologies and a subsidiary of Japan-based Terumo Corporation (TSE: 4543). The partnership […]

Vektor Medical’s vMap™ Mapping System Reported as Feasible and Effective as Part of a Non-Invasive Workflow for Arrhythmia Management When Using Stereotactic Ablative Radiotherapy

An article published by the Heart Rhythm Society’s journal Heart Rhythm O2 concludes that Vektor’s Computational ECG Mapping System (vMap™) and protocol-based respiratory gating may help facilitate radioablation planning and maintain efficacy during therapy. CARLSBAD, Calif.–(BUSINESS WIRE)–Vektor Medical, Inc., a private company founded to develop the next-generation in arrhythmia mapping systems, today […]

Tenaya Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Updates

– TN-201 MYBPC3 gene therapy product candidate for the leading genetic cause of hypertrophic cardiomyopathy granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) – Expanded leadership team appointing Leone Patterson as Chief Financial and Business Officer and Matt Pollman, MD, as SVP, Clinical Development – Completed Initial Public […]

atHeart Medical Appoints Seasoned Medtech Executive Andrew Cleeland to Board of Directors

BAAR, Switzerland and MOUNTAIN VIEW, Calif., Sept. 8, 2021 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced the appointment of Andrew Cleeland to the company’s Board of Directors. With over thirty years of experience, including specific expertise bringing game-changing technologies to […]

GNT Pharma Announces Approval of IND Application for the Phase III RODIN Trial of Nelonemdaz for Acute Ischemic Stroke Patients

PIII Study for 496 ischemic stroke patients treated with endovascular thrombectomy First multi-target neuroprotectant for the intervention of ischemic brain injury Safety and efficacy verified in two phase II studies for ischemic stroke patients with recanalization therapy YONGIN, South Korea, Sept. 08, 2021 (GLOBE NEWSWIRE) — GNT Pharma Inc. today […]

Resverlogix Announces Apabetalone Meets Primary Endpoint in a Pulmonary Arterial Hypertension Pilot Study

Apabetalone, a First-in-Class Epigenetic Therapeutic Candidate, Met Key Endpoint of Lowering Pulmonary Vascular Resistance (PVR) and Was Well Tolerated Successful Completion and Promising Results of Investigator-led APPROACH-p Trial Sets the Stage for a Larger Multicenter Trial CALGARY, Alberta, Sept. 08, 2021 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix” or the “Company”) […]

TransMedics Receives FDA Approval for its OCS Heart System Enabling Broader Utilization of Donor Hearts for Transplantation in the U.S.­

ANDOVER, Mass., Sept. 7, 2021 /PRNewswire/ — TransMedics Group, Inc. (“TransMedics”) (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its OCS Heart System for […]