Coronary/Structural Heart

NewAmsterdam Pharma to Present at the Stifel 2025 Virtual Cardiometabolic Forum

NAARDEN, The Netherlands and MIAMI, Sept. 24, 2025 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that John Kastelein, Chief Scientific Officer, and Matthew Philippe, Executive Vice President, Head of Investor Relations, will participate in a virtual fireside chat at the Stifel 2025 Virtual Cardiometabolic Forum on Tuesday, September 30, 2025 at 11:00 a.m. ET. A live webcast of the fireside chat will be available through the investor relations section of the NewAmsterdam Pharma website at ir.newamsterdampharma.com. Following the live webcast, an archived replay will be available on the Company’s website. About NewAmsterdam NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe, well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. Company ContactMatthew PhilippeP: 1-917-882-7512matthew.philippe@newamsterdampharma.com Media ContactReal Chemistry on behalf of NewAmsterdamChristian EdgingtonP: 1-513-310-6410cedgington@realchemistry.com Investor ContactPrecision AQ on behalf of NewAmsterdamAustin MurtaghP: 1-212-698-8696 austin.murtagh@precisionaq.com

Cytokinetics Announces Call for Proposals for Its Eighth Annual Communications Grant Program

Program to Provide Support of Communications and Outreach for Patient Advocacy Organizations Focused on Cardiovascular Diseases Deadline for Applications is November 3rd, 2025 SOUTH SAN FRANCISCO, Calif., Sept. 24, 2025 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced a call for proposals for the eighth annual Cytokinetics Communications Grant Program. The program will award five grants to patient advocacy organizations serving the hypertrophic cardiomyopathy (HCM) and heart failure communities. The grants are intended to support increased communications, awareness building and community engagement. “A persistent funding gap for patient advocacy organizations is in the area of communications. Without adequate resources, patients and caregivers may miss out on important resources and information, while organizations struggle to effectively engage their communities, donors and partners,” said Mary Pomerantz, Cytokinetics’ Senior Director of Patient Advocacy and Engagement. “Through our Communications Grant Program, now in its eighth year, we are proud to support innovative, high-impact initiatives that amplify patient voices, strengthen connections and broaden reach.” The Cytokinetics Communications Grant Program supports patient advocacy organizations in expanding their reach, awareness and community engagement by providing resources for new or crucial communications, marketing or outreach initiatives that would otherwise be challenging to implement. Funding from the Cytokinetics Communications Grant Program may help with programming or personnel, depending on each organization’s needs. The recipients of the 2025 Cytokinetics Communications Grants were the AICARM APS (Italian Association of Cardiomyopathies), HeartBrothers Foundation, HeartCharged Corporation, Hypertrophic Cardiomyopathy Association (HCMA) and Stichting Cardiomyopathie Onderzoek Nederland (Foundation Cardiomyopathy Research the Netherlands). Eligible organizations must have nonprofit organization or registered charity status in the United States, Canada, Europe or United Kingdom and serve the patient communities in HCM or heart failure. Organizations applying for the grant are required to submit a proposal outlining communication activities that the funding would support and the potential impact of the funding. Applications will be evaluated by a committee of representatives from Cytokinetics based on the proposal’s alignment with selection criteria. More details can be found at the application portal listed below. Recipients are responsible for providing an outcomes report to Cytokinetics to measure the impact and results of the funding at the end of the year. Applications may now be submitted at https://www.cybergrants.com/Cytokinetics/communications_grant. The deadline to apply is November 3, 2025, and the grant recipients will be announced in January 2026. For more information on the program, including eligibility guidelines, visit https://cytokinetics.com/responsibility/grants-and-giving/. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a cardiac myosin inhibitor, following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. In addition, Cytokinetics is developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), ulacamten, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer  Aficamten, omecamtiv mecarbil, ulacamten and CK-089 are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact:CytokineticsDiane WeiserSenior Vice President, Corporate Affairs(415) 290-7757

Heartflow Announces FDA 510(k) Clearance and Launch of Next Generation Heartflow Plaque Analysis Platform

AI-Powered Heartflow Plaque Analysis to be Covered by Cigna Health Plans Nationwide
Next Generation Heartflow Plaque Analysis

Our Next Generation Plaque Analysis platform harnesses an FDA-cleared updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualization to deliver unprecedented insight into plaque type, volume, and distribution. This update marks the most sophisticated iteration of Heartflow’s technology – empowering clinicians to make confident care decisions with ease.

MOUNTAIN VIEW, Calif., Sept. 22, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume, and distribution, empowering clinicians with the insights needed to make confident care decisions with ease. Heartflow also announced that Heartflow Plaque Analysis will be covered by Cigna across all of its lines of business, including Commercial and Medicare Advantage plans, beginning in October. Advanced Heartflow Plaque Analysis Platform Provides Clarity in 3D Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, using blinded core lab adjudication.1 The latest algorithm advancement shows 21% improvement in plaque detection compared to the first-generation algorithm, so clinicians can be confident in their diagnosis and management of CAD.2 “Understanding not only how much plaque is present, but also plaque type and distribution, is critical in predicting patient risk and guiding personalized treatment,” said Matthew Budoff, M.D., Professor of Medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical Center. “With these enhanced capabilities, Heartflow Plaque Analysis provides clinicians with the clarity we need to move from detection to decision with speed and confidence.” Leveraging enhanced AI, this new Plaque Analysis update marks the most sophisticated iteration of Heartflow’s technology. It provides clinicians with an intuitive visual representation of plaque types, enabling rapid assessment of CAD location and severity. Heartflow’s enhanced nomogram is powered by data from ~273,000 patients—a dataset 9x larger than any current plaque quantification study.3 Cigna Adds Nationwide Coverage for Heartflow Plaque Analysis Cigna is the second national insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, following a similar decision by UnitedHealthcare. The updated coverage will become effective on October 1, 2025 for Cigna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-69% stenosis) identified on coronary CTA. “Heartflow is proud to lead the way in coronary plaque analysis with our Next Gen platform, delivering the most representative visualization and context available for assessing patients’ disease and risk. Cigna’s decision to cover Heartflow Plaque Analysis is a testament to the power of our technology to positively impact care for its members across the United States,” said John Farquhar, President and CEO of Heartflow. “Heartflow Analyses give clinicians a view of coronary plaque by type and impact on blood flow with FFRCT that’s key to informing management strategies. These latest advancements build on Heartflow’s record of proven innovation, leveraging clinical rigor and the world’s largest dataset of coronary CTA images to continually improve our technology for clinicians and patients.” Heartflow’s continued advancement of plaque analysis technology follows the company’s recent unveiling of the landmark DECIDE Registry data, which showed Heartflow Plaque Analysis led to medical management change in over 50% of patients beyond coronary CTA alone, resulting in an expected ~15% event reduction.4,5 Heartflow is dedicated to reshaping cardiovascular care and ensuring that physicians and patients have access to comprehensive, accurate, and efficient solutions for precision coronary care. 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 clinicians with actionable insights into plaque volume and composition and its impact on blood flow – without the need for invasive procedures. Supported by ACC/AHA guidelines and more than 600 peer-reviewed publications, Heartflow has helped clinicians manage nearly 500,000 patients worldwide. Discover how we’re shaping the future of cardiovascular care at heartflow.com. 1 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.2 U.S. Food and Drug Administration. 510(k) Premarket Notification: K250902. https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250902.pdf3 Tzimas, et al., Presentation SCCT July 2025.4 DECIDE Registry. Rinehart, et al., Presented at SCCT July 2025.5 Collins et al. Lancet 2016. DOI: 10.1016/S0140-6736(16)31357-5 Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5f268838-f806-4612-995b-af3aa4676cc0

New Leaders Join Children’s Hospital of Philadelphia Cardiovascular Institute, Advancing Pediatric Research and Cardiac Care

Andrew Landstrom, MD, PhD, Appointed Inaugural Director of Translational Research at CHOP’s Cardiovascular Institute PHILADELPHIA, Sept. 22, 2025 /PRNewswire/ — Children’s Hospital of Philadelphia (CHOP) is pleased to announce the selection of Andrew Landstrom, MD, PhD, as the inaugural…

CRISPR Therapeutics and Sirius Therapeutics Announce First Patient Dosed in Phase 2 Trial of SRSD107 for Thromboembolic Disorders in Europe

ZUG, Switzerland and BOSTON and SAN DIEGO and SHANGHAI, Sept. 22, 2025 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Sirius Therapeutics, a clinical stage biotech company developing innovative small interfering RNA (siRNA) therapies for global markets, today announced that the first patient has been dosed in a Phase 2 clinical trial of SRSD107, a next-generation, long-acting Factor XI (FXI) siRNA for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA). SRSD107 is being co-developed by CRISPR Therapeutics and Sirius Therapeutics as part of a strategic collaboration to advance innovative treatments for cardiovascular and clotting-related diseases. “We are pleased to announce that our Phase 2 clinical trial is now underway, and the first patient has been dosed,” said Naimish Patel, M.D., Chief Medical Officer of CRISPR Therapeutics. “Until now, existing anticoagulant options have been limited by bleeding risk, frequent dosing, and complex management challenges for patients with high thrombotic risk. SRSD107 offers the potential to reduce pathological thrombosis while minimizing bleeding risk, with sustained but reversible pharmacodynamic effects and the possibility of infrequent dosing. We look forward to exploring how this differentiated approach could meaningfully improve outcomes for patients in need.” “We are very excited to announce that the first patient has been dosed in our Phase 2 trial of SRSD107, marking a significant milestone for this program,” said Patrick Yue, M.D., Chief Medical Officer of Sirius Therapeutics. “This study will evaluate clinical efficacy as proof of concept for Factor XI inhibition using our siRNA approach, building on the positive results from our Phase 1 trials, and we look forward to the progress of this trial.” The ongoing Phase 2 clinical trial is a randomized, multicenter, global study evaluating the safety and efficacy of SRSD107 for the prevention of VTE in patients undergoing TKA. The trial will assess the anticoagulant effects and pharmacological profile of SRSD107 and help inform dose selection for future pivotal studies, with the goal of confirming its potential as a differentiated approach for reducing thrombotic risk in patients. SRSD107 is designed to selectively inhibit FXI, a key driver of pathological thrombosis, with minimal impact on normal hemostasis. In prior Phase 1 clinical trials conducted in Australia and China, single doses of SRSD107 were well tolerated and demonstrated strong, sustained pharmacodynamic effects, including reductions of over 93% in FXI levels, along with more than a twofold increase in activated partial thromboplastin time (aPTT) relative to baseline. These effects were sustained, with responses maintained for up to six months post-dosing. SRSD107 has the potential to be a best-in-class FXI inhibitor, achieving deep reductions in FXI with the possibility of infrequent, semi-annual subcutaneous administration and offering reversibility not observed with other anti-FXI modalities. The addressable population includes patients with atrial fibrillation, VTE, cancer-associated thrombosis, chronic Coronary Artery Disease (CAD), chronic Peripheral Vascular Disease (PVD), end-stage renal disease requiring hemodialysis, and patients undergoing major orthopedic surgery, where bleeding risk limits existing therapies. About Thromboembolic DisordersThrombosis, or blood clot formation, is the common underlying mechanism of most cases of myocardial infarction, ischemic stroke, and venous thromboembolism. Published data in The Lancet1 estimate that thromboembolic disorders are estimated to account for approximately one in four deaths worldwide. About SRSD107SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA), that is designed to target the human coagulation factor XI (FXI) mRNA and inhibit FXI protein expression. By modulating the intrinsic coagulation pathway, SRSD107 has the potential to provide anticoagulant and antithrombotic effects. About the CRISPR Therapeutics and Sirius Therapeutics CollaborationCRISPR Therapeutics and Sirius Therapeutics entered into a strategic collaboration in 2025 to develop and commercialize novel small interfering RNA (siRNA) therapies for thromboembolic disorders and other serious diseases. The lead program, SRSD107, is a long-acting siRNA targeting Factor XI (FXI) with the potential to offer best-in-class efficacy and safety. Under the agreement, the companies will co-develop SRSD107 and share costs and profits equally. CRISPR Therapeutics will lead commercialization in the U.S., while Sirius will lead in Greater China. The collaboration also provides CRISPR Therapeutics with the option to license up to two additional siRNA programs. This partnership expands CRISPR Therapeutics’ therapeutic portfolio into RNA-based medicines, complementing its ongoing efforts in gene editing and broadening its impact across serious and chronic diseases. For Sirius, the collaboration marks a major milestone in its mission to deliver innovative RNA-based therapies globally, leveraging deep expertise in siRNA design and delivery. About CRISPR TherapeuticsSince its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit www.crisprtx.com. CRISPR THERAPEUTICS® standard character mark and design logo are trademarks and registered trademarks of CRISPR Therapeutics AG. CASGEVY® and the CASGEVY logo are registered trademarks of Vertex Pharmaceuticals Incorporated. All other trademarks and registered trademarks are the property of their respective owners.  About Sirius TherapeuticsSirius is a global, clinical-stage biotech company developing innovative siRNA therapies focusing on the treatment of chronic diseases. The Company’s pipeline is centered around three key franchises with mega blockbuster potential: coagulation disorders, cardiometabolic diseases, and obesity. Sirius’ most advanced investigational programs include SRSD107, a FXI inhibitor targeting the anticoagulation market, SRSD216, an inhibitor of Lp(a) synthesis intended to address atherosclerotic cardiovascular disease, and SRSD384, an INHBE inhibitor for managing obesity. Founded in 2021 by a world-class leadership team and investors, Sirius has established an innovation center in the United States and a translational medicine center in China. Sirius has raised nearly US$150 million in funding to date from OrbiMed, Creacion Ventures, Hankang Capital, Delos Capital, and BioTrack Capital. CRISPR Therapeutics Forward-Looking StatementStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements made by Drs. Patel and Yue in this press release, as well as regarding any or all of the following: (i) CRISPR Therapeutics’ preclinical studies, clinical trials and pipeline products and programs, including, without limitation, expectations regarding data, safety and efficacy generally; (ii) data included in this press release, as well as the ability to use data from ongoing and planned clinical trials for the design and initiation of further clinical trials; (iii) the status and clinical progress of the SRSD107 clinical program and development timelines for such program; (iv) CRISPR Therapeutics’ strategy and goals; (v) the future activities of the parties pursuant to the collaboration and the expected benefits of CRISPR Therapeutics’ collaboration with Sirius Therapeutics; and (vi) the therapeutic value, development, and commercial potential of gene editing and delivery technologies and therapies, including CRISPR/Cas9. Risks that contribute to the uncertain nature of the forward-looking statements include, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in its most recent annual report on Form 10-K and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law. This press release discusses investigational therapies and is not intended to convey conclusions about efficacy or safety as to those investigational therapies or uses of such investigational therapies. There is no guarantee that any investigational therapy will successfully complete clinical development or gain approval from applicable regulatory authorities.  Sirius Therapeutics Forward Looking StatementThis press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Sirius Therapeutic’s current beliefs, assumptions and expectations, commonly identified by words such as “would”, “may”, “expects”, “believes”, “plans”, “intends”, “projects” and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain, and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law. Investor Contact:+1-617-307-7503ir@crisprtx.com Media Contact:+1-617-315-4493media@crisprtx.com 1 Lozano R, Naghavi M, Foreman K, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380, 2095-1128.

Genesis MedTech J-VALVE® TF Approved by NMPA, China’s First Transfemoral TAVR for Aortic Regurgitation

Clinical data demonstrate low mortality, fewer complications and faster patient recovery with a minimally invasive alternative to open-heart surgery SINGAPORE, Sept. 17, 2025 /PRNewswire/ — Genesis MedTech’s structural heart subsidiary, Suzhou Jiecheng, has received approval from China’s National Medical Products Administration (NMPA) for the J-VALVE® Transfemoral Transcatheter Aortic Valve Replacement (TAVR) System (J-VALVE TF), the […]

BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced Angina Episodes at Six-Month Primary Follow-up

SUNNYVALE, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. (NASDAQ: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the primary endpoint results of the open label roll-in cohort of the CardiAMP® Cell Therapy in Chronic Myocardial Ischemia Trial. Results from the open label roll-in cohort patients having chronic myocardial ischemia with refractory angina show that the minimally-invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events. All patients were on guideline-directed medical therapy (GDMT) and responded positively to the autologous cell therapy. Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six-month primary endpoint when compared to measurements prior to cell therapy treatment. Sixty percent of the patients showed substantial improvements in both measures. These early, open-label results compare favorably to those demonstrated by current FDA approved therapies such as Ranolazine and Enhanced External Counter Pulsation (EECP) (1,2,3). Patients already on Ranolazine experienced dramatic reduction in angina episodes at the six-month follow-up. These results are in line with previous compelling investigational trial results utilizing cost prohibitive cell therapy (4).  “With these final roll-in results, this novel investigational therapy shows promise in addressing debilitating refractory angina, a significant unmet need for patients with chronic myocardial ischemia,” said Carl Pepine, MD, MACC, Professor of Medicine, Division of Cardiovascular Medicine, University of Florida at Gainesville. “We are working with our investigators to submit these results for peer reviewed scientific publication,” said Peter Altman, President and CEO. “The results from this roll-in cohort supports our continued development of this novel therapeutic approach for chronic myocardial ischemia with refractory angina and enhances the value of our CardiAMP cell therapy platform.” About Chronic Myocardial Ischemia with Refractory Angina Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1.8 million patients in the United States. Up to 15% of patients who have ischemia or angina and undergo cardiac catheterization are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. Promising results in treating this patient population with an autologous bone marrow derived cell therapy have been shown previously (4). About the CardiAMP Cell Therapy Program Designated by the FDA as a Breakthrough Therapy for Ischemic Heart Failure, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures. CAUTION – Limited by United States law to investigational use.  About BioCardia®BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in 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 product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Reference: 1Stone PH, Gratsiansky NA, Blokhin A, Huang IZ, Meng L; ERICA Investigators. Antianginal efficacy of ranolazine when added to treatment with amlodipine: the ERICA (Efficacy of Ranolazine in Chronic Angina) trial. J Am Coll Cardiol. 2006 Aug 1;48(3):566-75. doi: 10.1016/j.jacc.2006.05.044. Epub 2006 Jun 15. PMID: 16875985. 2 Sendón JL, Lee S, Cheng ML, Ben-Yehuda O; CARISA study investigators. Effects of ranolazine on exercise tolerance and angina frequency in patients with severe chronic angina receiving maximally-tolerated background therapy: analysis from the Combination Assessment of Ranolazine In Stable Angina (CARISA) randomized trial. Eur J Prev Cardiol. 2012 Oct;19(5):952-9. doi: 10.1177/2047487312450133. Epub 2012 Jun 11. PMID: 22689417. 3 Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0. PMID: 10362181. 4Henry TD, Losordo DW, Traverse JH, Schatz RA, Jolicoeur EM, Schaer GL, Clare R, Chiswell K, White CJ, Fortuin FD, Kereiakes DJ, Zeiher AN, Sherman W, Hunt AS, and Povsic TJ. Autologous CD34 cell therapy improves exercise capacity, angina frequency and reduces mortality in no-option refractory angina: a patient-level pooled analysis of randomized double-blinded trials, European Heart Journal, 2018. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements may include, among other things, statements relating to the continued development and cost of BioCardia’s autologous cell-based therapies, the probability of success of the CardiAMP clinical trials, ability to offset clinical costs utilizing Medicare reimbursement and the ultimate success of our clinical cell therapy programs. These forward-looking statements are made as of the date of this press release. 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. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully advance its clinical trials. 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,” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. MEDIA CONTACT:Miranda Peto, Investor Relations mpeto@biocardia.com (650) 226-0120 INVESTOR CONTACT:David McClung, Chief Financial Officerinvestors@biocardia.com (650) 226-0120