Author: Ken Dropiewski

LianBio Completes Enrollment in Pivotal Phase 3 EXPLORER-CN Trial of Mavacamten in Chinese Obstructive Hypertrophic Cardiomyopathy Patients

• Topline data expected mid-2023 • EXPLORER-CN trial, together with PK study conducted in healthy Chinese volunteers, expected to support registration of mavacamten in China SHANGHAI, China and PRINCETON, N.J., Aug. 10, 2022 (GLOBE NEWSWIRE) — LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in […]

Aziyo Biologics Co-Founder and Regenerative Medicine Pioneer, Dr. Randy Mills, appointed Chief Executive Officer

SILVER SPRING, Md., Aug. 09, 2022 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company, today announced that Aziyo co-founder C. Randal (Randy) Mills, Ph.D. has assumed the President and Chief Executive Officer role on an on-going basis. Dr. Mills, who is internationally recognized for his […]

AccurKardia joins Innovators’ Network at American Heart Association Center for Health Technology & Innovation

American Heart Association consortium advances development of evidence-based health tech solutions NEW YORK–(BUSINESS WIRE)–AccurKardia, a software company that provides device-agnostic and automated ECG analytics, has joined the American Heart Association Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and fostering health technology […]

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

GENEVA, Aug. 9, 2022 /PRNewswire/ — SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION […]

Ionis reports second quarter financial results and recent business achievements

Reported positive eplontersen ATTRv-PN data, on track to file NDA in H2:22 Tofersen NDA under priority review, PDUFA January 25, 2023 Completed enrollment in pelacarsen Lp(a) HORIZON and olezarsen BALANCE Phase 3 studies On track to achieve 2022 financial guidance Webcast today, August 9, 2022, at 11:30 a.m. Eastern Time CARLSBAD, Calif., Aug. 9, […]

Exciting New Research Partnership: Vironix Health Has Teamed Up with Oxford University to Develop Novel Prediction Methods for Proactive Intervention on Congestive Heart Failure

Oxford University mathematics program paired students & faculty with Vironix technologists to develop and validate algorithms for synthetic patient data generation and detection of Congestive Heart Failure decompensation.    AUSTIN, Texas, Aug. 9, 2022 /PRNewswire/ — Digital Health Company, Vironix Health, has teamed up with the Mathematical Modelling and Scientific Computing MSc, based within […]

CereVasc Announces FDA Approval of Second IDE Study of the eShunt® System

US Based Pilot Study to enroll patients who develop communicating hydrocephalus following subarachnoid hemorrhage BOSTON, Aug. 9, 2022 /PRNewswire/ — CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational device exemption […]

Stereotaxis Reports 2022 Second Quarter Financial Results

ST. LOUIS, Aug. 09, 2022 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2022. “Despite macro pressures and the poor optics of our financial results, Stereotaxis is making significant progress […]

Shockwave Medical Reports Second Quarter 2022 Financial Results

SANTA CLARA, Calif., Aug. 08, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (Nasdaq: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, today reported financial results for the three months ended June 30, 2022. Recent Highlights Recognized revenue of $120.7 million […]