Author: Ken Dropiewski

Bitterroot Bio to Present Detailed Results from Phase 1 Study of BRB-002 at American College of Cardiology Annual Scientific Session 2025

PALO ALTO, Calif. and NEEDHAM, Mass., March 17, 2025 (GLOBE NEWSWIRE) — Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, announced today that the Company will present results from the Phase 1 study of BRB-002 in healthy volunteers at the American College of Cardiology (ACC) Annual Scientific Session 2025, taking place in Chicago, Illinois, March 29 – 31, 2025. The Phase 1 single ascending dose study evaluated the safety, tolerability and target engagement of BRB-002 in healthy volunteers. The trial achieved its primary objective, demonstrating encouraging safety at all doses tested with no serious adverse events reported. Target engagement increased in a dose-dependent manner, with CD47 receptor occupancy ranging up to 100% at the highest doses evaluated. ACC Abstract Details Development of BRB-002, a Novel Next-Generation Anti-CD47 Molecule, for Atherosclerotic Cardiovascular Disease Session: Basic and Translational Discovery and Innovations in Cardiovascular Disease Prevention; Moderated Poster Theater 2 (901-03)Time: Saturday, March 29, 2025, at 9:30am CTPresenting Author: Alexander Yi, MD, PhD The poster presentation will be available on the Bitterroot Bio website after the presentation. About BRB-002BRB-002 is a novel protein therapy that is being evaluated as an investigational agent in atherosclerotic cardiovascular disease (ASCVD).  BRB-002 is an immuno-modulatory agent that inhibits the CD47 cell surface receptor (“don’t eat me” signal) to ameliorate the underlying causes of atherosclerosis and reduce inflammatory plaque burden. A Phase 1 clinical study of BRB-002 was completed by Bitterroot Australia Pty Ltd, a wholly owned subsidiary of Bitterroot Bio, Inc. About Bitterroot BioBitterroot Bio, Inc. is a pioneer in the field of cardio-immunology, which investigates the interplay between the immune system and cardiovascular health. Bitterroot Bio’s research seeks to uncover critical roles that immune modulators play in the progression of cardiovascular disease. By targeting these diseases in this novel way, Bitterroot Bio’s mission is to transform the lives of patients suffering from cardiovascular diseases. For more information, please visit https://www.brbio.com or follow us on Facebook LinkedIn, or X. Media Contact: Pablo Fenton (Bitterroot Bio), media@brbio.com

Bracco Diagnostics Inc. Launches Update to HeartSee™ With New Features and Expanded Access to Cutting-edge Technology for Coronary Artery Disease Diagnosis

PRINCETON, N.J., March 17, 2025 /PRNewswire/ — Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A, one of the world’s leading companies in the diagnostic imaging business, announced today significant upgrades to its innovative HeartSee™ software, a leading diagnostic tool…

Kestra Medical Technologies, Ltd. Announces Full Exercise and Closing of Underwriters’ Over-Allotment Option in Initial Public Offering

KIRKLAND, Wash., March 14, 2025 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (“Kestra”), a wearable medical device and digital healthcare company, announced today that the underwriters of Kestra’s initial public offering exercised in full their previously disclosed over-allotment option and have purchased 1,782,352 shares of common stock at a public offering price of $17.00 per share. After giving effect to the sale of over-allotment option, the total number of shares sold by Kestra in the initial public offering was 13,664,704 and the total gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Kestra, were approximately $232 million. The issuance and sale of the over-allotment option closed today. BofA Securities, Goldman Sachs & Co. LLC and Piper Sandler acted as lead bookrunners for the offering. Wells Fargo Securities and Stifel acted as bookrunners and Wolfe | Nomura Alliance acted as co-manager for the offering. A registration statement relating to the common shares sold in this offering was filed with the Securities and Exchange Commission and became effective on March 5, 2025. The offering was made only by means of a prospectus. Copies of the prospectus may be obtained from BofA Securities, Attention: Prospectus Department, NC1-022-02-25, 201 North Tryon Street, Charlotte, NC 28255-0001, or by email at dg.prospectus_requests@bofa.com; from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by facsimile at 212-902-9316, by email at Prospectus-ny@ny.email.gs.com, or by calling 1-866-471-2526; or Piper Sandler, by email at prospectus@psc.com, or by calling (800) 747-3924. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. About Kestra Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. Disclaimer “Wolfe | Nomura Alliance” is the marketing name used by Wolfe Research Securities and Nomura Securities International, Inc. in connection with certain equity capital markets activities conducted jointly by the firms. Both Nomura and Wolfe Research Securities are serving as underwriters in the offering described herein. In addition, Wolfe Research Securities may provide sales support services, investor feedback, investor education, and/or other independent equity research services in connection with the offering. CONTACT: Investor Contact

Neil Bhalodkar
neil.bhalodkar@kestramedical.com

HeartBeam Reports Fourth Quarter and Full Year 2024 Results

Received FDA Clearance for the HeartBeam System – an At-Home, High-Fidelity Heart Monitoring Technology Commenced Early Access Program to Attain Key Insights and Establish Sales Funnel in Preparation for Commercialization Submitted 510(k) Application to FDA for Groundbreaking 12-lead Electrocardiogram (ECG) Synthesis Software Gross Proceeds of ~$11.5 Million from Public Offering […]

HeartSciences Provides Business Update and Reports Third Quarter Fiscal 2025 Financial Results

Southlake, TX, March 13, 2025 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (“AI”)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today reported financial results for the third quarter fiscal 2025 ended January 31, 2025 and provided a business update.

NuPulse Announces Physician Call on the NuPulse Voyage™ for Chronic Heart Failure – The First Minimally Invasive, Ambulatory Option That Allows Discharge Home

Leading cardiologists discuss promising clinical trial results, advantages of innovative investigational treatment option and large unmet need Pivotal trial upcoming RALEIGH, N.C., March 13, 2025 /PRNewswire/ — NuPulse, a medical device company focused on transforming the treatment of…

Valcare Medical Receives FDA Approval to Initiate Early Feasibility Study for its Novel AMEND™ Trans-Septal System

HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device…