FDA Fast-Track designation was granted to investigate abelacimab for the prevention of stroke and systemic embolism in patients with atrial fibrillation LILAC-TIMI 76 trial is the third Phase 3 study with abelacimab initiated by Anthos Therapeutics Abelacimab is a dual-acting, once-monthly, fully human monoclonal antibody targeting both Factor XI and […]
Author: Ken Dropiewski
Investor Insights: Rob Barmann – Non-Traditional MedTech Services (Part 5)
McDermott + Bull Partner Ken Dropiewski interviews Endeavour Venture Partner Rob Barmann in his series, Investor Insights in Life Sciences + MedTech. In the conversations below, Ken and Rob discuss a range of topics from typical investment sizes to non-traditional MedTech services.
HeartBeam Issues Shareholder Letter and Provides Corporate Update
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only 3D-vector electrocardiogram (VECG) platform for heart attack detection anytime, anywhere, today issued a letter to shareholders from its Chief Executive Officer and Founder, Branislav Vajdic, PhD. Dear Fellow Shareholders, 2022 was a transformative […]
CytoSorbents Receives $5M in Non-Dilutive Debt Financing from Bridge Bank and Extends Loan Agreement
Non-dilutive debt capital at market favorable terms strengthens the balance sheet and provides additional working capital to fund key clinical and commercial initiatives PRINCETON, N.J., Dec. 29, 2022 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary […]
FDA Grants Appeal for Ardelyx’s XPHOZAH® (tenapanor)
Office of New Drugs directs the Division of Cardiology and Nephrology to work with Ardelyx to develop a label to support the commercialization of XPHOZAH; Ardelyx to resubmit NDA in the first half of 2023 Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a […]
Acutus Medical Announces Acceptance of the AcQForce Flutter Abstract for Presentation during the Late-Breaking Clinical Trials and First Report Investigations sessions at the 2023 AF Symposium
CARLSBAD, Calif., Dec. 29, 2022 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the acceptance of the AcQForce Flutter abstract titled “AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low […]
Inspira™ Technologies Signs Strategic OEM Agreement with Terumo Cardiovascular
Terumo Cardiovascular is a division of Terumo Corporation, a leading medical device company operating in 160+ countries and regions RA’ANANA, Israel, Dec. 27, 2022 /PRNewswire/ — Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company” or “Inspira Technologies”), a groundbreaking respiratory support technology company, announced today that it has signed an exclusive OEM (Original Equipment Manufacturing) agreement […]
Koya Medical Announces the Addition of Chief Medical Officer Dr. Thomas Maldonado to Their Executive Leadership Team
Dr. Maldonado joins Koya as Chief Medical Officer and member of the Medical Advisory Board OAKLAND, Calif., Dec. 27, 2022 /PRNewswire/ — Koya Medical, a healthcare company on a mission to transform lymphatic and venous care through a comprehensive suite of innovative, people-centric platforms, today announced the addition of Dr. Thomas Maldonado as Chief […]
TAVI or TAVR is a Boon for Patients with Critical Heart Valve-Related Conditions – Opine Experts at Manipal Hospital Sarjapur
BENGALURU, India, Dec. 26, 2022 /PRNewswire/ — In the field of Cardiac science, a relatively new but safe and successful non-surgical technique (TAVI/TAVR) is advocated, giving new hope for life to patients with specific heart-valve-related conditions. Patients who have Aortic Stenosis, meaning narrowed aortic valves can be benefitted from this procedure. The aortic valve […]
Owlet Announces FDA Software-as-a-Medical Device Submission for Heart Rate and Oxygen Displays and Notifications
Owlet submitted a de novo classification request to the FDA for an over-the-counter software-as-a-medical-device that offers heart rate and oxygen displays and notifications in conjunction with Owlet’s existing Dream Sock sleep monitoring capabilities. December 22, 2022 04:05 PM Eastern Standard Time LEHI, Utah–(BUSINESS WIRE)–Owlet, Inc. (NYSE: OWLT) (the “Company”) announces that the U.S. […]



