Coronary/Structural Heart

OneMedNet Adds 2.7M Annual Cardiovascular Studies, Expanding Network

MINNEAPOLIS, Aug. 20, 2025 (GLOBE NEWSWIRE) — OneMedNet Corporation (Nasdaq:ONMD) (“OneMedNet” or the “Company”), a leader in AI-powered Real-World Data (RWD), announced the addition of 85 cardiovascular centers and data sources, expanding its Cardiovascular network thereby positioning OneMedNet as one of the largest providers for Cardiovascular Real-World data. Cardiovascular diseases (CVDs) remain the world’s leading cause of death, responsible for approximately 19.8 million deaths in 2022, accounting for roughly 32% of all global mortality1. Economically, the burden is staggering: CVD drives an estimated $320 billion annually in the United States alone, and more than $1 trillion globally each year in direct healthcare costs and lost productivity2. Such pervasive health and financial pressures make OneMedNet’s enriched multimodal cardiovascular data network ideally suited for pharmaceutical and insurance sectors. For drug developers, this real-time, expansive data offers deeper insights into disease progression, treatment responses, and outcomes—fueling more efficient, evidence-based R&D and accelerating the development of novel therapeutics. This expansion enhances OneMedNet’s network, delivering de-identified cardiovascular imaging, diagnostic reports, and electrocardiograms (ECG) at unprecedented scale and clinical depth to life sciences companies, AI developers, and medical device manufacturers, with data that is continually updated to reflect the latest clinical insights and advancements. The addition of these new sites solidifies OneMedNet’s position as the premier source for high-quality, regulatory-grade cardiovascular RWD, fueling innovation, supporting clinical evidence generation, and improving patient outcomes through the most robust ecosystem in the industry. “By combining de-identified cardiovascular imaging, structured reports, and ECG signals from this vast network, we’re providing real-world clinical insights that accelerate innovation in diagnostics, therapeutics, and AI model development. This is the clinically rich, longitudinal data the industry has been demanding—and we’re delivering it at scale, with continual updates ensuring the most current and relevant information,” said Aaron Green, President and CEO of OneMedNet. World Health Organization Cardiovascular Disease – https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29World Heart Federation 2025 Report – https://world-heart-federation.org/resource/world-heart-report-2025/ About OneMedNet Corporation OneMedNet is revolutionizing how the world unlocks Real-World Data (RWD), harnessing the untapped potential of over 1,750 healthcare sites through its iRWD™ platform. This isn’t just data—it’s the lifeblood of innovation, from de-identified medical imaging to electronic health records, fueling breakthroughs for drugmakers, medical device pioneers, and AI visionaries. With a network spanning rare diseases, oncology, cardiology, and beyond, OneMedNet delivers precision insights that redefine patient care and power the next wave of healthcare disruption. Beyond healthcare OneMedNet’s proprietary AI anonymizes data for industries like finance, retail, and telecom, unlocking endless possibilities—rigorously testing production system upgrades, de-risking complex projects, and securely sharing sensitive data by stripping out personal information. Learn more at www.onemednet.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. We base these forward-looking statements on our current expectations and projections about future events, which we derive from the information presently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of OneMedNet; our ability to keep pace with new technology and changing market needs; the competitive environment of our business; risks inherent with investing in Bitcoin, including Bitcoin’s volatility; and our ability to implement our Bitcoin treasury strategy and its effects on our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations. OneMedNet Contacts: Michael Wong, VP Marketing Email: michael.wong@onemednet.com

CORRECTION – Bringing Advanced Vascular Diagnostics to the Western US with the SmartVascular Dx™ Test

IRVINE, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) — MorningStar Laboratories, LLC., (“MSL” or “the Company”), a leading developer of precision diagnostic tests that addresses unmet clinical needs, announced today corrections to the second paragraph of its press release under the same headline sent out on August 8, 2025. The corrected release follows:

New Novartis ESC data highlights strength of cardiovascular portfolio

PRESS RELEASE Two VictORION studies will highlight Leqvio’s impact on patient quality of life, and as a cholesterol lowering monotherapyLp(a)FRONTIERS APHERESIS study will assess effect of pelacarsen on reducing need for lipoprotein apheresis – a cholesterol removal procedure similar to dialysisPARACHUTE-HF study will highlight the efficacy and safety of Entresto to treat heart failure with reduced ejection fraction due to chronic Chagas diseaseAdditional presentations will assess the safety of new pipeline asset abelacimab in atrial fibrillation Basel, August 18, 2025 – Novartis will present data from 19 abstracts across its cardiovascular portfolio at the 2025 European Society of Cardiology (ESC) Congress in Madrid from August 29 to September 1, 2025. “The latest data we are presenting at ESC will showcase how Novartis is pioneering groundbreaking treatments that can transform cardiovascular outcomes,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal and Metabolic Development Unit, Novartis. “With established treatments Entresto and Leqvio, we continue to explore new ways to improve patient care whilst also investigating broader populations who may benefit. With promising pipeline assets, pelacarsen and abelacimab, we are tackling areas of significant unmet need to address the myriad of factors that cause or worsen heart disease.” Key highlights of data accepted by ESC include: Medicine   Presentation Title   Presentation Details Pelacarsen   Pelacarsen reduces the need for lipoprotein apheresis in patients with elevated lipoprotein(a) and cardiovascular disease: The Phase 3 Lp(a)FRONTIERS APHERESIS trial   Station 12 (Research Gateway) Moderated ePoster August 29, 09:15-10:00 CEST           Pelacarsen   Association of elevated lipoprotein(a) with future major adverse cardiovascular events in recurrent ASCVD patients: analysis of a large US electronic health record database   Station 2 (Research Gateway) Moderated ePoster August 30, 17:15 – 18:00 CEST       Pelacarsen   Economic burden of elevated lipoprotein(a) in secondary prevention of atherosclerotic cardiovascular disease cohort from England   Discovery Pole (North Convention Centre) Poster August 29, 15:15 CEST       Leqvio   VICTORION-Difference study: Inclisiran-based strategy vs standard of care   Madrid (Main Auditorium) Hot Line August 30, 17:00 CEST       Leqvio   VICTORION-Mono China: efficacy and safety of inclisiran as monotherapy in Chinese adults with low or moderate ASCVD risk and elevated LDL-C   Discovery Pole (North Convention Centre) Poster August 29, 10:00 CEST       Abelacimab     Prior anticoagulation experience, bleeding risk, and safety of factor XI inhibition in atrial fibrillation: an analysis of AZALEA-TIMI 71   Science Box 3 (Research Gateway) Poster September 1, 14:30 CEST       Abelacimab   Renal function and factor XI inhibition in atrial fibrillation: a pre-specified analysis of AZALEA-TIMI 71   Science Box 3 (Research Gateway) Poster September 1, 15:00 CEST       Entresto   PARACHUTE-HF: Randomized trial comparing sacubitril/valsartan with enalapril in patients with HFrEF caused by chronic Chagas cardiomyopathy   Madrid (Main Auditorium) Hot Line September 1, 8:15 CEST       About Novartis in Cardiovascular DiseaseAt Novartis, our mission is to ensure no heart is lost too soon. We envision a world where preventable CV deaths are no longer part of our lives. We’re proud of the positive impact we’ve made over the past 40 years and remain dedicated to tackling the most challenging problems in CVD. Through cutting-edge science and technology, we are focusing on areas of high unmet need, including scaling our xRNA platform across multiple risk factors and pioneering breakthroughs for genetically driven CVD risk factors and common heart conditions, including atrial fibrillation. We also work with patients, healthcare professionals, and organizations around the world to improve CV care beyond medicine alone. Together, we can help people with CVD enjoy longer, healthier lives and more time with their loved ones. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # Novartis Media RelationsE-mail: media.relations@novartis.com   Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com 

Simpson Interventions Announces First Patients Treated in Clinical Trial for its Acolyte™ Catheter System

The first patients were treated at Emory University Hospital using the Acolyte Image-Guided Crossing and Re-Entry Catheter System Trial sites are planning to treat a minimum of 103 lesions, at as many as 15 sites The Acolyte Catheter System is intended to provide interventional cardiologists real-time visualization of intravascular morphology […]

Orchestra BioMed Announces Publication of AVIM Therapy Clinical Data in JACC: Advances Demonstrating Potential to Improve Cardiac Function in Patients with Hypertension and Diastolic Dysfunction

Echocardiographic data analysis demonstrated favorable impact of atrioventricular interval modulation (“AVIM”) therapy on MODERATO II study patients with diastolic dysfunction, a key component in the development of heart failure with preserved ejection fraction (“HFpEF”)Hypertension is the leading cause of diastolic dysfunction and the most common comorbidity in older patients indicated for a pacemaker NEW HOPE, Pa., Aug. 14, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the publication of clinical data in JACC: Advances demonstrating that AVIM therapy significantly improved cardiac function in patients with hypertension and diastolic dysfunction (“DD”), key contributors to the development of HFpEF. The publication, titled “Effects of AtrioVentricular Interval Modulation (AVIM) Therapy in Subjects with Hypertension and Diastolic Dysfunction,” reports findings from a retrospective treatment-blinded analysis of MODERATO II patients. The analysis demonstrated that AVIM therapy significantly reduced systolic blood pressure (SBP) and improved echocardiographic markers of DD, a key contributor to HFpEF – a common comorbidity in patients with isolated systolic hypertension (ISH). These results were previously presented in a late-breaking session at the 2025 Technology and Heart Failure Therapeutics Meeting and are now published in JACC: Advances. Key findings: AVIM therapy significantly reduced both office and ambulatory SBP in patients with DD over 6 months, with office SBP reduced by 12.1±12.8 mmHg and ambulatory SBP by 8.3±9.7 mmHg (both p

Analytics For Life Completes Clinical Study of Non-Invasive Point-of-Care Test for Elevated Pulmonary Capillary Wedge Pressure (PCWP) Using Machine Learning

Study achieves primary sensitivity endpoint, advancing diagnostics for heart failure with preserved ejection fraction (HFpEF) and pulmonary hypertension (PH)Results build on data previously presented at ACC.25 in March 2025 TORONTO and BETHESDA, Md., Aug. 14, 2025 (GLOBE NEWSWIRE) — Analytics For Life, in collaboration with its U.S. commercial partner CorVista Health, today announced the successful completion of the clinical study evaluating a machine learning-based algorithm for non-invasively identifying patients with elevated pulmonary capillary wedge pressure (PCWP) – a key indicator of both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF). The study met its primary endpoint for sensitivity, marking a significant milestone in the advancement in point-of-care diagnostics for heart failure patients. The results of the study will be submitted for peer-reviewed publication and presented at an upcoming scientific conference. Currently, PCWP is measured through an invasive right heart catheterization (iRHC) procedure, typically performed by a cardiologist, pulmonologist or intensivist. The CorVista capture device collects non-invasive signals for 3.5 minutes in patients at rest, potentially providing a novel method to aid in the assessment of patients being evaluated for pulmonary hypertension or heart failure. “Reaching our primary endpoint in sensitivity is a testament to the dedication of our team to pushing the boundaries of cardiovascular diagnostics. Our ability to deliver non-invasive, rapid assessment of PCWP could be a game-changer, making early detection of HFpEF, HFrEF and PH subtypes more accessible for patients,” said Charles R. Bridges, M.D., Sc.D., Executive Vice President and Chief Scientific Officer, Analytics for Life and CorVista Health. “With the clinical study now complete, we plan to initiate dialogue with regulatory agencies in preparation for the next phase of development.” Adrian Lam, President and Chief Executive Officer, CorVista Health, added, “This milestone demonstrates the power of our rapid, point-of-care solution and represents an important step toward expanding the clinical utility of the CorVista System. Adding PCWP and heart failure capabilities would allow our system to provide diagnostic support to more than 70% of all people with symptomatic cardiovascular disease – itself the leading cause of death worldwide. As we pursue a PCWP add-on, our goal is to bring advanced diagnostic accuracy into the primary care setting, enabling faster and more accurate treatment decisions while reducing the overall cost of care.” HFpEF accounts for over 50% of all heart failure cases and carries the highest rates of morbidity and mortality. Underdiagnosis of HFpEF remains one of the greatest unmet needs in cardiovascular medicine today, contributing an estimated $25 billion in direct costs to the U.S. healthcare system each year. Pulmonary hypertension, similarly underdiagnosed, requires accurate subtype classification to guide life-saving, guideline-directed therapy. The proposed PCWP add-on represents a major advancement in cardiology with far-reaching implications for early diagnosis, equitable care, and cost reduction. The CorVista System Add-On for elevated PCWP is currently an investigational device, limited by U.S. federal law to investigational use and not commercially available. About CorVista System® Developed by Analytics For Life and commercialized in the U.S. by CorVista Health, the CorVista System is a point-of-care digital health solution that detects multiple heart conditions in a single, non-invasive test. The system uses machine learned algorithms to quickly analyze heart signals and detect issues like blocked arteries or elevated pulmonary artery pressure—all in under 30 minutes, allowing clinicians to interpret results and guide treatment decisions in a single visit. The system received clearance from the U.S. Food and Drug Administration (FDA) for coronary artery disease in September 2023 and Pulmonary Hypertension in April 2024, with additional indications, including heart failure, in active development. In 2022, the CorVista System’s PH indication was awarded an FDA Breakthrough Device Designation—marking the first major advancement in PH diagnostics in over 40 years and setting a new standard for patient care. About Analytics For Life Analytics 4 Life stands at the forefront of digital health, dedicated to propelling next-generation technologies that revolutionize point-of-care diagnostics. Headquartered in Toronto, Canada, Analytics For Life specializes in pioneering non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System®. The innovative CorVista System offers a non-invasive, point-of-care solution enabling physicians to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. Spearheading its introduction in the United States is our exclusive commercial partner, CorVista Health. For more information on Analytics For Life, please visit: www.analytics4life.com About CorVista Health CorVista Health is on a mission to transform cardiovascular care with diagnostics that shorten the path from symptoms to diagnosis, empowering earlier treatment and better patient outcomes. We are dedicated to enabling more equitable care by providing access to immediately actionable, high-quality cardiovascular test results for previously underserved patient populations – with the goal of contributing to a future where everyone has timely access to life-saving cardiovascular care. For more information on CorVista Health, please visit: www.corvista.com Media Contact:media@corvista.com

Orchestra BioMed Announces Rollout of FDA-Approved BACKBEAT Global Pivotal Study Protocol Update Significantly Expanding Patient Eligibility

FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocolExpanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements NEW HOPE, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the roll out of a protocol update, approved by the U.S. Food and Drug Administration (“FDA”), that significantly expands patient eligibility criteria for enrollment of the BACKBEAT study evaluating AVIM therapy in pacemaker-indicated patients with uncontrolled hypertension despite the use of antihypertensive medications. Key updates to eligibility criteria now include patients with: Medtronic Astra or Azure dual-chamber pacemakers with sufficient battery life implanted for any reason;Medtronic Astra or Azure dual-chamber pacemakers that are first device implants or implanted to replace an existing pacemaker; andNew York Heart Association (“NYHA”) class I or class II symptomatic heart failure. Orchestra BioMed estimates that the BACKBEAT study protocol update increases the eligible potential patient pool at participating study centers by more than 24-fold as compared to the original protocol and supports the Company’s mid-2026 target for completion of enrollment. The Company initiated rollout of the updated protocol in the third quarter of 2025 with full implementation expected in the fourth quarter. “These expanded eligibility criteria significantly increase the pool of potentially eligible patients available for enrollment in the BACKBEAT study at participating study centers. They also better align the study patient population with the key characteristics of the FDA Breakthrough Device Designation for AVIM therapy, which we estimate represents a patient population of millions of U.S. patients who need better therapeutic options to manage elevated systolic blood pressure and the corresponding higher risk of heart attack, stroke, heart failure and other morbid and mortal events,” said David Hochman, Chairman and CEO of Orchestra BioMed. “We believe these updates reinforce the relevance and potential impact of the BACKBEAT study as well as better position us to complete the BACKBEAT study in a timely manner.” “Unlike traditional antihypertensive therapies, AVIM therapy has been designed specifically to address the needs of the older, higher risk hypertensive patients who often also need a pacemaker,” commented Andrea Russo, M.D., Academic Chief, Division of Cardiology, Director of Cardiac Electrophysiology and Arrhythmia Services, Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT study. “The ability to activate AVIM therapy during the 10 to 12-year typical device lifecycle of a pacemaker reflects the practical and transformative potential of this therapy for this group of patients. With expanded patient eligibility criteria, the BACKBEAT study population will now better encompass a real-world population of older, pacemaker-indicated patients with uncontrolled hypertension and increased cardiovascular risk.” About Orchestra BioMedOrchestra BioMed (Nasdaq: OBIO) is a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships with leading medical device companies. Orchestra BioMed’s partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful global commercialization of products it develops. Orchestra BioMed’s lead product candidate is AVIM therapy for the treatment of uncontrolled hypertension, the leading risk factor for death worldwide. Orchestra BioMed is also developing Virtue SAB for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Orchestra BioMed has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for development and commercialization of AVIM therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients, and a strategic partnership with Terumo, a global leader in medical technology, for development and commercialization of Virtue SAB for the treatment of artery disease. The Company has received four Breakthrough Device Designations from the U.S. FDA across these two core programs, reflecting the significant potential of its technologies to address high unmet needs in cardiovascular care. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. References to Websites and Social Media Platforms References to information included on, or accessible through, websites and social media platforms do not constitute incorporation by reference of the information contained at or available through such websites or social media platforms, and you should not consider such information to be part of this press release. About AVIM Therapy AVIM therapy is an investigational therapy compatible with standard dual-chamber pacemakers designed to substantially and persistently lower blood pressure. It has been evaluated in pilot studies in patients with uncontrolled hypertension who are also indicated for a pacemaker. MODERATO II, a double-blind, randomized pilot study, showed that patients treated with AVIM therapy experienced net reductions of 8.1 mmHg in 24-hour ambulatory systolic blood pressure (aSBP) and 12.3 mmHg in office systolic blood pressure (oSBP) at six months when compared to control patients. In addition to reducing blood pressure, clinical results using AVIM therapy demonstrate improvements in cardiac function and hemodynamics. The BACKBEAT (BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT) global pivotal study will evaluate the safety and efficacy of AVIM therapy in lowering blood pressure in patients who have systolic blood pressure above target despite anti-hypertensive medication and who are indicated for or have recently received a dual-chamber cardiac pacemaker. AVIM therapy has been granted Breakthrough Device Designation by the FDA by using cardiac physiologic pacing for the treatment of uncontrolled hypertension in patients who have preserved left ventricular systolic function and are at increased cardiovascular risk. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the effect of study protocol on the potentially eligible patient pool, the timing of completion of enrollment for the BACKBEAT study, the timing of full implementation of updated study protocol, , the potential benefits of Breakthrough Device Designation, the potential of the Company’s technologies to address high unmet needs in cardiovascular care, realizing the clinical and commercial value of AVIM therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, and the ability of the Company’s partnerships to accelerate clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor ContactSilas NewcombOrchestra BioMed Snewcomb@orchestrabiomed.com Media ContactKelsey Kirk-EllisOrchestra BioMedKkirkellis@orchestrabiomed.com

BioCardia Reports Second Quarter 2025 Business Highlights and Financial Results

SUNNYVALE, Calif., Aug. 11, 2025 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the second quarter of 2025 and filed its quarterly report on Form 10-Q for the three and six months ended June 30, 2025 with the Securities and Exchange Commission. The Company will also hold a conference call at 4:30 PM ET today in which it will discuss business highlights. Following management’s formal remarks, there will be a question-and-answer session. Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) Two-year results from the double-blind randomized placebo-controlled Phase 3 CardiAMP HF Trial of CardiAMP autologous minimally invasive cell therapy for the treatment of ischemic heart failure in patients with reduced ejection fraction (HFrEF) were presented as a late-breaking clinical trial at the American College of Cardiology’s Annual Scientific Sessions on March 30, 2025. For study subjects, all on stable guideline directed medical therapy, the CardiAMP HF treatment group had a lower incidence of both all cause death and non-fatal MACCE than the control group during the entire 24-month period of the CardiAMP HF study (p=0.17) and the composite endpoint of all cause death, non-fatal MACCE, and quality of life was statistically significant in the subgroup of patients with elevated NTproBNP (p =0.02).CardiAMP HF Trial data has been submitted to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and we have requested a meeting to receive advice to align with PMDA on the acceptability of the clinical data and positioning of the CardiAMP system for Japanese patients with heart failure. We anticipate an in-person consultation in the fourth quarter of 2025, the outcome of which could enable us to submit for approval of the CardiAMP system for market entry in Japan.We have reported parallel ongoing efforts towards requesting a meeting with the FDA on the approvability of the FDA Designated Breakthrough CardiAMP System based on this clinical data in the fourth quarter 2025.The confirmatory CardiAMP HF II phase 3 trial is underway in the United States, with four sites actively enrolling patients and additional sites being onboarded. This trial focuses on patients with active heart stress with a primary composite endpoint of all cause death, non-fatal MACCE, and quality of life achieved in CardiAMP HF (p=0.02). CardiAMP HF II includes using the cell population analysis at screening to define treatment doses, which enables more patients to be eligible for the therapy, and improvements to the Helix system, with the use of the FDA approved Morph DNA steerable platform. Medicare reimbursement for both treated and controlled patients under C9782 is currently $17,500, which helps offset the costs of this study and reported as a reduction in R&D expense. CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02) Results from the open-label roll-in cohort of patients having chronic myocardial ischemia with refractory angina to date have shown an average 107 second increase in exercise tolerance and an 82% average reduction in angina episodes at the primary six-month follow-up endpoint compared to before receiving the study treatment. The CardiAMP cell therapy procedure for chronic myocardial ischemia is also reimbursed by CMS under reimbursement code C9782, which covers both treated and controlled patients. The last roll-in cohort patient has reached this six-month primary endpoint, and we intend to prepare the primary results of this cohort for publication and presentation. CardiALLO allogeneic cell therapy in Ischemic Heart Failure (BCDA-03) The Investigational New Drug application (IND) for a Phase 1/2 trial to deliver our allogeneic MSC for the treatment of HFrEF follows our previous cosponsored TRIDENT and POSEIDON clinical trials enrolling 45 patients at dosages up to 100 million cells delivered with our Helix transendocardial catheter. The current trial includes a 3+3 roll-in dose escalation up to a dose of 200 million cells followed by a 30-patient randomized double-blind controlled study based on a recent IND amendment to right size the study for nondilutive funding opportunities which are under discussion. The low dose cohort of 20 million cells has been completed and there have been no treatment-emergent adverse events, arrhythmias, rejection, or allergic responses. The independent Data Safety Monitoring Board recommended that the study proceed as designed in April 2025 based on the 30-day data safety assessment from this cohort. Helix Biotherapeutic Delivery The Helix transendocardial biotherapeutic delivery system is a therapeutic-enabling platform for minimally invasive targeted delivery of biologic agents to the heart and underlies BCDA-01, 02, and 03 programs. We recently announced our intent to submit for approval of the Helix transendocardial system as a DeNovo 510(k) in the third quarter 2025. Intellectual Property The Company’s intellectual property portfolio was strengthened with the issuance of another patent this past quarter. In June, the Company announced that the that United States Patent Office has granted US patent No. 12,311,127 titled “Radial and Trans-endocardial Delivery Catheter.” The patent describes the Company’s minimally invasive interventional biotherapeutic delivery catheter systems to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal, site-specific treatment, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed patent protects BioCardia’s helical needle-tipped catheter technology platform, which the scientific literature supports is the safest1 and most efficient2 approach for biotherapeutic delivery to the heart. “Heart failure remains a large, unmet need, impacting the lives of 56 million people worldwide, and we have made significant progress advancing our autologous CardiAMP cell therapy candidate intended to promote increased microvascular density and reduce fibrosis for a significant subgroup of these patients,” said BioCardia CEO Peter Altman, Ph.D. “Our active discussions on the approvability of the CardiAMP Cell Therapy System, as well the anticipated submission for approval of its dedicated Helix transendocardial biotherapeutic delivery catheter with even broader therapeutic impact have potential to be transformative for patients, physicians, and shareholders alike.” Second Quarter 2025 Financial Results: Research and development expenses increased to approximately $1.4 million for the three months ended June 2025 from approximately $0.8 million in the three months ended June 2024, and increased to approximately $2.9 million in the six months ended June 2025 from the six months ended June 2024, primarily due to closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Selling, general and administrative expenses decreased to approximately $0.7 million in the three months ended June 2025 compared to approximately $0.9 million for the three months ended June 2024, primarily due to lower professional fees and share-based compensation expense. Selling, general and administrative expenses remained consistent at approximately $1.9 million in the six months ended June 2025, as compared to approximately $1.9 million in the six months ended June 2024.Our net loss was approximately $2.0 million for the three months ended June 2025, compared to approximately $1.6 million for the three months ended June 2024, and was approximately $4.8 million for the six months ended June 2025, compared to approximately $3.9 million for the six months ended June 2024. These increases were due primarily to the increased expenses associated with closeout activities in the CardiAMP HF Trial and the beginning of enrollment in the CardiAMP HF II Trial.Net cash used in operations for the three months ended June 2025 was approximately $1.6 million, as compared to approximately $1.3 million for the three months ended June 2024. Net cash used in operations for the six months ended June 2025 was approximately $3.3 million, as compared to approximately $2.8 million for the six months ended June 2024.Our cash balance on June 30, 2025, was approximately $980,000. During the period from July 1, 2025 to August 8, 2025, we sold an aggregate of 296,422 shares of common stock under our ATM program at an average price of $2.59 per share to total gross proceeds of $769,000. This brings our current cash balance to approximately $1.1 million and provides runway into October 2025. ANTICIPATED UPCOMING MILESTONES AND EVENTS: BCDA-01 CardiAMP Autologous Cell Therapy in Heart Failure (HF) CardiAMP HF manuscript – Q4 2025CardiAMP HF Japan PMDA Clinical Review – Q4 2025CardiAMP HF FDA meetings on approvability based on subgroup and safety – Q4 2025CardiAMP HF II Enrollment – Ongoing            BCDA-02 CardiAMP Autologous Cell Therapy in Chronic Myocardial Ischemia CardiAMP CMI Top line Data Rollin Cohort – Q4 2025 BCDA-03 CardiALLO Allogeneic MSC Cell Therapy in Heart Failure CardiALLO HF Nondilutive Funding – Q1 2026 Helix Biotherapeutic Delivery System Helix biotherapeutic delivery FDA Submission for Approval – Q3 2025 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 CardiALLOTM allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its HelixTM biotherapeutic delivery and Morph® vascular navigation platforms. The CardiAMP Cell Therapy Trial for Heart Failure has been supported financially by the Maryland Stem Cell Research Fund and the Center for Medicare and Medicaid Services. For more information visit: www.BioCardia.com. 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 enrollment in our clinical trials, the availability of data from our clinical trials, filings and communications with the FDA and Japan’s PMDA, product clearances, the efficacy and safety of our products and therapies, the achievement of any of the anticipated upcoming milestones, our positioning for growth or the market for our products and therapies, the expected benefits of our intellectual property, future prospects, regulatory timelines, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans, the ability to enter into licensing and partnering arrangements and overall market conditions. We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control. Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent the development of our therapeutic candidates. 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.”  1. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021.2. 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.  BIOCARDIA, INC.             Consolidated Statements of Operations             (Unaudited In thousands, except share and per share amounts)                               Three Months endedJune 30,   Six Months endedJune 30,       2025  2024   2025  2024 Revenue:              Collaboration agreement revenue$— $3  $— $58 Costs and expenses:              Research and development 1,368  800   2,898  2,041  Selling, general and administrative 683  852   1,879  1,941   Total costs and expenses 2,051  1,652   4,777  3,982   Operating loss (2,051) (1,649)  (4,777) (3,924)Other income (expense):               Total other income, net  2  3   16  11 Net loss$(2,049) $(1,646)  $(4,761) $(3,913)                  Net loss per share, basic and diluted$(0.40) $(0.88)  $(0.98) $(2.20)                  Weighted-average shares used in computing             net loss per share, basic and diluted 5,059,736  1,877,069   4,848,922  1,776,305                   BioCardia, Inc.      Selected Balance Sheet Data      (amounts in thousands)               June 30,2025(1)   December 31,2024(1)            Assets:      Cash and cash equivalents$980  $2,371Other current assets 219   251Property, plant and equipment and other noncurrent assets 890   1,102Total assets$2,089  $3,724Liabilities and Stockholders’ Equity (Deficit)      Current liabilities$3,642  $2,321Operating lease liability – noncurrent 333   566Total stockholders’ equity (deficit) (1,886)  837Total liabilities and stockholders’ equity (deficit)$2,089  $3,724       (1) June 30, 2025 amounts are unaudited. December 31, 2024 amounts were derived from the audited Consolidated Financial Statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission on March 26, 2025.         Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120