OXFORD, England, March 28, 2025 /PRNewswire/ — Ultromics, a pioneer in AI-driven cardiology solutions, has unveiled the latest enhancement to EchoGo® Heart Failure: the introduction of a first-of-its-kind AI-powered probability scoring system for assessing heart failure with preserved…
Author: Ken Dropiewski
Catheter Precision, Inc. Announces Fourth Quarter and Full Year 2024 Update and Financial Results
FORT MILL, S.C., March 28, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (NYSE American: VTAK), a U.S.-based innovative medical device company focused on electrophysiology products, today announced its financial results and operational update for the period ending December 31, 2024.
Humacyte Announces Fourth Quarter and Year End 2024 Financial Results and Provides Business Update
– Received U.S. Food and Drug Administration (FDA) approval of Symvess™ (acellular tissue engineered vessel-tyod) for the treatment of extremity vascular trauma –
Elutia Announces GPO Agreement with Advantus Health Partners to Expand Access to EluPro™
Seventh GPO Agreement Signed Since EluPro’s Launch SILVER SPRING, Md., March 27, 2025 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, announced that it has entered into an agreement with Advantus Health Partners (“Advantus”), to provide access of Elutia’s EluPro™ Antibiotic Eluting BioEnvelope to Advantus’ core group purchasing organizations (GPO) solutions portfolio. “Teaming up with Advantus is another major step forward in meeting the strong customer demand for EluPro,” said Dr. Kimberly Mulligan, GM and VP of Elutia’s Cardiovascular Division. “Our pilot launch of EluPro has exceeded our expectations as physicians recognize the unique value that this antibiotic envelope brings in preventing infection for patients that use a cardiac implantable electronic device. Broadening our GPO coverage with Advantus allows us to benefit from their sustainable contracting solutions, making EluPro more widely available to physicians nationwide.” EluPro is the world’s first and only antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration for use with cardiac implantable electronic devices (CIEDs) and neurostimulators. Combining powerful antibiotics with a natural extracellular matrix that regenerates into the patient’s own tissue, EluPro addresses critical post-surgical challenges, including infection, migration, and skin erosion, offering a transformative solution for both patients and clinicians. With the addition of Advantus, Elutia has now secured agreements with seven major national group purchasing organizations. Advantus Health Partners is a health care solutions company that makes supply chain easier for its clients through streamlined supply chain management, organizational purchasing, operations and cost-savings efficiencies. With innovation at the forefront, and an advanced operational model, Advantus provides a portfolio of solutions to further drive value beyond contracting, all with the singular goal of reducing health care costs across the U.S. Advantus is committed to helping organizations meet business goals through its distinct solutions. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning the launch and market reception of EluPro, including the timing and anticipated success thereof. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to successfully commercialize, market and sell our newly approved EluPro product; our ability to continue as a going concern; our ability to achieve or sustain profitability; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits and claims related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits and claims; our ability to prevail in lawsuits and claims seeking indemnity, contribution and insurance coverage for FiberCel and other viable bone matrix product liabilities; the continued and future acceptance of our products by the medical community; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations that could adversely affect our sales and profitability; our ability to obtain regulatory approval or other marketing authorizations by the FDA and comparable foreign authorities for our products and product candidates; our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2024, as such factors may be updated from time to time in Elutia’s other filings with the SEC, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com This press release was published by a CLEAR® Verified individual.
Abbott Receives CE Mark for its Volt™ Pulsed Field Ablation System to Treat Patients with Abnormal Heart Rhythms
Abbott’s Volt™ PFA System is designed to provide a new therapy option for people battling heart rhythm disorders such as atrial fibrillation Pulsed field ablation – or PFA – uses high energy electrical pulses for ablation procedures that may offer benefits to targeting and treating tissue…
Route 92 Medical Receives Australian Therapeutic Goods Administration Approval for its Portfolio of Neurovascular Interventional Products for Treating Patients with Acute Ischemic Stroke
Route 92 Medical receives Australian Therapeutic Goods Administration approval for its portfolio of neurovascular interventional products.
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 […]