Author: Ken Dropiewski

Preliminary Results from IDE Study on Ringer™ Perfusion Balloon Catheter (PBC) Reported from Podium at CTO Plus Conference

Prospective Multicenter Study Investigates Ringer™ PBC for Management of Coronary PerforationsWAYNE, Pa., March 27, 2025 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the preliminary results from its Ringer™ PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York by the study’s principal investigator, David E. Kandzari, MD, FACC, MSCAI, Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute, Atlanta, GA.* Ringer™ PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter with a unique helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations.1 The Ringer™ PBC study is a limited prospective, multi-center, single-arm IDE study, undertaken at four sites in the United States investigating the Ringer™ PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention (PCI) procedures. The study enrolled 30 participants, and analysis was performed based upon intention-to-treat. The primary efficacy endpoint required successful Ringer™ PBC delivery and inflation at the perforation site, control of extravasation (defined as residual Ellis grade 0 or 1), and preservation of antegrade coronary flow (Thrombolysis in Myocardial Infarction [TIMI] grade 2 or 3). Of 30 participants enrolled, the primary efficacy endpoint was observed in 22 participants (73.3%), with successful Ringer™ PBC delivery in 26 participants (86.7%). Among those participants with successful delivery, control of extravasation with perfusion was achieved in 22 participants (84.6%). Twelve participants were treated with a covered stent following perforation management with the Ringer™ PBC. One participant required emergency surgery for complications of pericardiocentesis, and three participants died despite control of extravasation from the index perforation. “I believe these preliminary study results are important,” said Dr. Kandzari. “Treatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.” For the investigational use of the management of coronary perforations, Ringer™ PBC was granted the FDA’s Breakthrough Device Designation, a program intended to provide patients and healthcare providers with timely access for certain medical devices that could potentially provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and DeNovo marketing authorizations. “Teleflex is committed to generating the clinical evidence to help physicians make confident decisions when selecting the right products for their patients’ needs,” said Teleflex Medical Director, Christopher Buller, MD. Ringer™ PBC is currently indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion. The Ringer PBC in this study is an investigational device and not available for sale. Data from the study is intended to support a premarket application recently submitted to FDA. About Teleflex IncorporatedAs a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Forward-Looking StatementsAny statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management’s current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. *Dr. Kandzari is a paid consultant of Teleflex Incorporated or its affiliates. References: Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, Quik-Clot, Ringer, Rüsch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries.  © 2025 Teleflex Incorporated. All rights reserved. MC-010629 Rev 0. Contacts: For Teleflex Incorporated:Lawrence KeuschVice President, Investor Relations and Strategy Developmentinvestor.relations@teleflex.com 610.948.2836

Heartflow Closes $98 Million Convertible Notes Financing

Additional Capital to Support Broadening Adoption of a Leading Platform That Transforms Diagnosis and Management of Coronary Artery DiseaseMOUNTAIN VIEW, Calif., March 26, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc., the leader in AI technology for coronary artery disease (CAD), today announced additional investments in the company of approximately $98 million through the sale and issuance of convertible notes by its parent company, Heartflow Holding, Inc., including a new investment by Fidelity Management & Research Company and additional investments from existing investors including Janus Henderson Investors, Bain Capital Life Sciences, Hayfin, US Venture Partners (USVP), HealthCor, Capricorn Investment Group and Martis Capital. Certain members of Heartflow management and the Board of Directors also participated in the financing. Proceeds from the convertible notes financing will support research and development efforts to further support Heartflow’s continued advancement of the coronary computed tomography angiography (CCTA)+Heartflow pathway as the definitive standard for the non-invasive diagnosis and management of CAD. The Heartflow Platform is widely adopted, driven by its improved accuracy over traditional non-invasive tests, superior economic efficiency relative to the traditional CAD diagnosis pathway and strength of supporting clinical evidence, published in over 600 peer-reviewed publications. The Heartflow Platform is also supported by a large and growing database of over 100 million annotated CCTA images, and the training of its algorithms over more than 10 years. Heartflow was recently named one of Fast Company’s Most Innovative Companies in Medical Devices for 2025 and won the Innovation in Cardiac Imaging award at the Global Cardiovascular Awards 2025. “Heartflow pioneered the use of AI-driven technology to diagnose and manage coronary artery disease, delivering accurate and efficient non-invasive solutions from a single CCTA scan. Our technology has been used to help manage more than 400,000 patients worldwide, and we believe we continue to lead the market in transforming coronary care,” said John Farquhar, president and CEO of Heartflow. “This investment enables us to strengthen our leadership and accelerate our vision to rewrite the story for people living with CAD.” In the United States, CAD is estimated to be responsible for one heart attack every 40 seconds and one out of every five deaths.1 Heartflow is working to ensure that its technology not only helps clinicians identify and diagnose CAD earlier, but also transforms how they understand and manage the disease for life. About Heartflow, Inc.Heartflow is advancing coronary care by transforming coronary artery disease into a screenable, diagnosable, and manageable condition. Heartflow One is the only complete, non-invasive, precision coronary care platform providing patient insights throughout the guideline-directed CCTA pathway. The AI-driven platform – including Roadmap™ Analysis, FFRCT Analysis and Plaque Analysis – is supported by the ACC/AHA Chest Pain Guideline and backed by more than 600 peer-reviewed publications. Heartflow has helped clinicians manage over 400,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at www.heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com Reference1. Centers for Disease Control and Prevention. Heart Disease Facts. https://www.cdc.gov/heart-disease/data-research/facts-stats. Accessed March 19, 2025.

Supira Medical Secures $120M Oversubscribed Series E Financing and Completes Enrollment of SUPPORT I Early Feasibility Study in the United States

LOS GATOS, Calif., March 26, 2025 /PRNewswire/ — Supira Medical, Inc. (Supira), a clinical-stage Shifamed portfolio company, today announced the successful completion of an oversubscribed Series E financing round, raising $120M to accelerate the company’s mission of transforming the percutaneous ventricular assist device (pVAD) market. The round was led by new investors Novo Holdings and Qatar […]

Four New Studies Demonstrate that Viz.ai Finds New Patients with Hypertrophic Cardiomyopathy Earlier When Embedded into the Clinical Workflow

SAN FRANCISCO–(BUSINESS WIRE)–Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced new clinical data demonstrating how the Viz HCM module enables faster, accurate detection of signs of hypertrophic cardiomyopathy (HCM) to help ensure that more patients receive the care they need. Four studies, which will be […]

RenovoRx Pre-Clinical Results Supporting TAMP™ as a Targeted Locoregional Drug Delivery Platform to Receive Award at SIR 2025 Annual Scientific Meeting

Peer-reviewed paper will be honored as a Journal of Vascular and Interventional Radiology Award-Winning Paper Pre-clinical data show that TAMP increases intra-arterial pressure, improving drug delivery with 100-fold increase in local tissue concentration of the therapy TAMP offers the potential to increase efficacy, improve safety and widen therapeutic window of […]

InspireMD to Present at Upcoming 24th Annual Needham Virtual Healthcare Conference

MIAMI, March 26, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced management will present at the 24th Annual Needham Virtual Healthcare Conference on Wednesday, April 9, 2025, at 8:00AM Eastern Time / 5:00AM Pacific Time.

BioSig Technologies Confirms Full Compliance with Nasdaq Requirements for Continued Listing on The Nasdaq Capital Market

Los Angeles, CA, March 26, 2025 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (BSGM) (“BioSig” or the “Company”), a medical technology company delivering unprecedented accuracy and precision to intra-cardiac signal visualization, is pleased to announce that its common stock will continue trading on The Nasdaq Capital Market (“Nasdaq”).

Catheter Precision to Participate in and Share Data at Upcoming Industry Conferences

FORT MILL, S.C., March 26, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced their attendance at three upcoming conferences through April 2, 2025.