NBA legend Muggsy Bogues joins effort to detect and manage coronary artery disease in retired players using AI-powered Heartflow AnalysisMOUNTAIN VIEW, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced a significant expansion of its groundbreaking GAMEFILM Registry. Building on a successful initial phase enrolling retired National Football League (NFL) athletes, the study will now extend to include former players from the National Basketball Association (NBA) and the National Hockey League (NHL), broadening Heartflow’s initiative to protect the heart health of professional athletes across major sports. Retired NBA star Muggsy Bogues was one of the first former professional basketball players to join the GAMEFILM Registry and receive a CAD assessment with Heartflow’s AI-driven technology. “My 14-year career as a professional athlete taught me the importance of staying on top of your health, especially heart health. I joined Heartflow’s GAMEFILM Registry as soon as I heard about it because I’ve lost too many friends to cardiovascular disease,” said former NBA point guard Muggsy Bogues. “Many of us push our bodies to the limits, and sometimes the signs of underlying issues can be overlooked. Heartflow Analysis offers an easy way to get a precise picture of what’s going on inside, without invasive procedures. I’m excited to see this technology benefit more athletes, giving them and their doctors a powerful tool for proactive heart care.” Heart disease is the leading cause of death in the United States and worldwide. It is known as the “silent killer” because it can progress for years without obvious signs or symptoms. For professional athletes who place immense, continuous demands on their cardiovascular systems, underlying heart issues can be easily masked. Heartflow Plaque Analysis provides a thorough understanding of coronary plaque burden, which is essential for physicians to identify high-risk patients early and enable timely, preventative interventions. Four out of five heart attacks and strokes are preventable with lifestyle and nutrition changes if patients at high risk are identified early.1 The GAMEFILM Registry has already enrolled over 140 retired athletes from the NFL, NBA, and NHL. The study, currently active at 15 sites across the United States, aims to enroll up to 300 former players to better understand the prevalence, risk factors, severity, and treatment protocols for cardiovascular disease in this population. To do so, the registry addresses how advanced coronary computed tomography angiography (CCTA) imaging and AI-powered insights from Heartflow’s first-of-its-kind non-invasive technology can identify different types of plaque in the coronary arteries — including those most likely to cause a cardiac event — and measure the effect on blood flow to the heart.2 “Expanding our GAMEFILM Registry to include NBA and NHL athletes marks a pivotal moment for Heartflow, demonstrating our mission to revolutionize how heart disease is diagnosed, measured and managed,” said John Farquhar, President and CEO of Heartflow, and an NFL alumnus. “Heartflow’s precision diagnostic capability will not only advance the health and safety of these athletes, but also generate invaluable insights that will benefit cardiovascular care more broadly.” The expansion of the GAMEFILM registry will deepen understanding of how high-performance sports impact heart health over time. This data is expected to contribute significantly to the development of tailored screening protocols, preventative strategies, and personalized treatment plans. “Cardiovascular disease in former professional athletes is a paramount concern, but there’s much we still don’t understand about the disease in this population,” said Jeffrey L. Boone, M.D., GAMEFILM Registry Primary Investigator and Founder and Medical Director of the Boone Heart Institute. “We’ve seen the invaluable insights gained from our work with NFL alumni, identifying risks and guiding interventions. Bringing this same proactive, precision cardiovascular care to basketball and hockey players, who are also at unique risk due to the physical intensity of their sports, is a vital step in ensuring their long-term health.” Heartflow is actively collaborating with organizations supporting former professional athletes to facilitate enrollment and to integrate the GAMEFILM Registry’s insights into existing health and wellness programs. This initiative underscores Heartflow’s dedication to managing heart disease through partnering with physicians to generate robust, high-quality clinical evidence. To learn more and enroll in the GAMEFILM Registry, visit heartflow.com/GAMEFILM. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide.3 Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com 1 World Heart Federation. Prevention. https://world-heart-federation.org/what-we-do/prevention/ Accessed Feb. 10, 2026.2 Williams, Michelle C., et al. “Low-Attenuation SCOT-HEART Trial.” pp. 1452–1462, https://doi.org/10.1161/CIRCULATIONAHA.119.044720.3 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol.
Coronary/Structural Heart
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SUNNYVALE, Calif., Feb. 10, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported it has completed its Pre-Submission to FDA under its Q-Submission program for the approval of its Helix Transendocardial Delivery Catheter (“Helix”) for intramyocardial therapeutic and diagnostic agent delivery. The data supporting safety and effectiveness for the Helix Pre-Submission is from fifteen well-controlled clinical trials of cell and gene therapy delivery to the heart using Helix, where patients were enrolled in three primary cardiac clinical indications. The Helix Pre Submission has been made under the CardiAMP Cell Therapy System FDA Breakthrough Designation, which the Helix underlies. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval in the next 45 days. An application for market clearance could soon follow. “This Pre-Submission and discussion with FDA should lead to our Helix catheter being the first approved transendocardial delivery catheter system in the United States,” said Peter Altman, PhD, BioCardia’s President and CEO. “FDA clearance of Helix will streamline the future approvals of BioCardia’s autologous and allogeneic cell therapies for the treatment of Heart Failure and Chronic Myocardial Ischemia. Approval should also reduce development risk for biopharmaceutical and biotechnology partners seeking to employ our best-in-class minimally invasive delivery technology for cardiovascular cell, gene, and protein development programs aiming to address enormous unmet medical needs.” About the Helix Transendocardial Delivery CatheterThe Helix transendocardial delivery catheter is an enabling platform for minimally invasive targeted delivery of therapeutic and diagnostic agents to the heart intramyocardially. It enables agents to be delivered precisely within the heart with superior retention over other therapeutic delivery modalities, and to many regions of the heart that other delivery methods cannot reach. The Helix includes a specialized small distal helical needle which engages the heart tissue from within the chamber of the heart and provides stability within the dynamic beating heart to safely enable agent delivery. The Helix delivery catheter is intended to be used by interventional cardiologists, electrophysiologists, and cardiac surgeons trained to perform endovascular and transendocardial procedures. In independent reviews of clinical experience with Helix relative to other transendocardial delivery catheters, it has shown superior procedural safety1 and in pre-clinical studies has demonstrated a three-fold increase in effective dosing compared to open surgical access intramyocardial biotherapeutic delivery and eighteen-fold increase compared to intracoronary artery infusion2. The Helix catheter is further enhanced by BioCardia’s FDA approved Morph® DNA™ steerable introducer product, which physicians use to navigate the Helix with superior control in the heart. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation platforms. For more information visit: www.BioCardia.com. References: Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. Forward-Looking Statements This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the approval of the Helix Transendocardial Delivery Catheter, delivery partnerships, the efficacy and safety of our products, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.com Phone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
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