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Heartflow Builds Evidence Base Across the Heart Disease Care Continuum, From Precision Risk Stratification to CT-Guided Intervention Planning

Heartflow PCI Navigator is the only integrated, AI-driven PCI planning tool that gives interventional cardiologists a patient-specific 3D model detailing anatomy, plaque composition, and lesion-specific physiology, all aligned to optimize potential stent placement.

Three presentations at ACC reinforce Heartflow’s AI-powered technology predicts MACE, drives superior lipid outcomes and results in cost-effective care First patient enrolled in pioneering NAVIGATE-PCI Registry assessing impact of Heartflow PCI Navigator on clinical strategy, efficiency and physician confidence across 5,000 patients  MOUNTAIN VIEW, Calif., March 16, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced new clinical evidence and a landmark registry launch that together advance the company’s vision of transforming CAD management across every stage of the patient journey. At the American College of Cardiology (ACC) Annual Scientific Session, Heartflow is presenting new clinical evidence that further establishes AI-powered Heartflow Plaque Analysis as the leading tool for identifying high-risk patients earlier and guiding more effective medical management. Simultaneously, Heartflow has enrolled the first patient in the NAVIGATE-PCI Registry, the first large-scale effort to evaluate the real-world impact of CT-guided percutaneous coronary intervention (PCI) planning on clinical strategy, procedural efficiency and physician confidence. The registry is evaluating how often treatment plans change when physicians use the AI-driven insights provided by Heartflow PCI Navigator compared to angiography alone. “These milestones reflect tremendous progress toward Heartflow’s goal of 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,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The Heartflow Plaque Analysis data presented at ACC and the launch of the NAVIGATE-PCI Registry represent important steps in building the rigorous real-world evidence needed to support AI-driven decision-making across the full continuum of cardiovascular care. From identifying high-risk patients earlier and improving how they are managed to generating the evidence needed to guide more precise interventions when required, Heartflow is giving physicians deeper insights and greater confidence so they can deliver better outcomes for patients.” Heartflow Plaque Analysis: New Clinical Evidence for Earlier Risk Stratification and Management Heartflow Plaque Analysis will be featured in three ACC 2026 presentations, covering long-term validation of risk stratification, real-world comparative effectiveness in lipid management, and economic sustainability. Collectively, these data reinforce Plaque Analysis as a personalized, clinically actionable and cost-effective solution for CAD management. AI-Based Coronary Plaque Analysis and Adverse Cardiovascular Events: The Mass General Brigham CCTA Registry (Poster 1082-09, March 29, 10:06 a.m. CDT)This cohort, based on a large-scale registry tracking over 15,000 patients, with up to 16 years of follow-up, demonstrated that Plaque Analysis is a powerful predictor of major adverse cardiovascular events (MACE), even after accounting for traditional risk factors and the severity of coronary stenosis. The findings reveal that patients with extensive plaque volume face a fourfold higher risk of such events. This robust, real-world data solidifies Heartflow Plaque Staging as the most powerful CTA-based independent predictor for personalized risk stratification, enabling clinicians to identify high-risk individuals beyond conventional metrics. “Stenosis has long been our primary lens for evaluating coronary risk, but it tells an incomplete story, as this registry demonstrates. With over 15,000 patients and 16 years of follow-up, we now have compelling real-world evidence that total plaque volume independently drives adverse events, regardless of risk factors or the presence of anatomical stenosis,” said Ron Blankstein, M.D., Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These findings catalyze a meaningful shift in how we approach risk stratification by more accurately identifying patients who might otherwise have been characterized as having lower risk based on conventional assessment and optimizing management based on their actual disease burden.” Comparative Effectiveness of Coronary Computed Tomographic Angiography With or Without AI-Plaque Analysis and Stress Testing on Lipid Lowering After One Year: A Primary Analysis of the DECIDE Registry (Poster 1469-058, March 29, 12:30 p.m. CDT)This analysis, involving nearly 3,800 patients, compared patient management guided by CCTA with Plaque Analysis versus traditional stress-test-guided care over a one-year follow-up. A significantly higher portion of patients whose care was informed by Plaque Analysis initiated lipid-lowering therapy and achieved guideline-recommended LDL goals (

Unnatural Products Raises $45 Million Series B Financing to Advance Macrocyclic Peptide Therapeutics

Financing led by The Venture Collective with participation from Merck Global Health Innovation Fund, Artis Ventures, First Spark Ventures, argenx, Droia Ventures and existing investorsSANTA CRUZ, Calif., March 16, 2026 (GLOBE NEWSWIRE) — Unnatural Products, a biotech developing orally-delivered macrocyclic peptides to address previously undruggable targets, today announced the closing of a $45 million Series B financing led by The Venture Collective (TVC), with participation from argenx, Droia Ventures and existing investors Merck Global Health Innovation Fund, Artis Ventures, and First Spark Ventures. The funding will support development of the company’s proprietary drug discovery platform and advance its pipeline of macrocyclic peptide therapeutics designed to address historically difficult-to-drug or “undruggable” targets. Last month, Unnatural Products announced a licensing agreement with Novartis to develop macrocyclic peptide therapeutics for historically undruggable cardiovascular targets, including up to $100 million upfront and up to $1.7 billion in total potential milestones. “Macrocyclic peptides represent a powerful new therapeutic modality,” said Cameron Pye, Chief Executive Officer and Co-Founder, Unnatural Products. “Our platform unlocks the precision of biologics with the delivery advantages of small molecules, enabling us to target complex intracellular pathways that have historically been out of reach. We can also provide oral solutions to targets only currently addressable with costly injectables. This financing allows us to accelerate development of our pipeline and advance our lead programs toward the clinic.” “Unnatural Products has developed a differentiated platform capable of unlocking new therapeutic opportunities across challenging disease targets,” said Nicholas Shekerdemian, Founding Partner, The Venture Collective. “We believe the company’s approach to engineering synthetic macrocyclic peptides has the potential to create an important new class of medicines, and we are excited to support the team as they expand their pipeline and move programs toward clinical development.” Unnatural Products has developed an integrated discovery platform capable of repeatedly engineering synthetic macrocyclic peptides at scale. Macrocyclic peptides combine key attributes of both biologics and small molecules, enabling highly selective binding while retaining the potential for cell permeability and oral delivery. The company’s platform integrates advanced computational design, automated chemistry, and high-throughput biological testing to rapidly move from initial discovery hits to optimized drug candidates. The company is also advancing a pipeline of macrocyclic peptide therapeutics for the treatment of cardiometabolic, inflammatory and immunological diseases. Unnatural Products has also established collaborations with leading pharmaceutical and biotechnology companies including Novartis, Merck, BridgeBio and argenx to apply its macrocyclic platform across multiple therapeutic areas. About Unnatural Products, Inc.Unnatural Products, Inc. (UNP), a Santa Cruz, California biotech company, has developed a platform that addresses the complexities of medicinal chemistry in the macrocycle space through a combination of parallel experimentation and machine learning. Founded by macrocycle pioneers whose academic work uncovered how Nature’s macrocycles work, UNP is developing a portfolio of therapeutic macrocycles against high-value and traditionally difficult-to-drug targets. For more information, visit www.unnaturalproducts.com. For partnering opportunities, email: contact@unnaturalproducts.com.Media ContactKimberly HaKKH Advisors917-291-5744kimberly.ha@kkhadvisors.com

HeartBeam Reports Fourth Quarter and Full Year 2025 Results

HeartBeam Enters New Growth Phase Following FDA Clearance for First-Ever, Cable-Free Synthesized 12-Lead ECG for At-Home Arrhythmia Assessment First Commercial Partner ClearCardio™ to Bring HeartBeam’s 3D ECG Technology to High-Growth Preventive Cardiology Market First Patients Enrolled in Heart Attack Detection Pilot Study, A Key Step Toward Future FDA Indication Expansion […]

How Scientists Measure the Circulation You Actually Feel — Not Just the Arteries They Can See

The Human Vascular System Stretches Up to 100,000 Miles — Standard Imaging Captures Only a Fraction of ItThe Endothelial Glycocalyx: A Microscopic Lining That Helps Regulate How Blood Moves Through the Smallest VesselsHow Patented Microfluidic Chip Technology Allows Researchers to Study Vascular Function Under Realistic ConditionsWhat This Means for the Millions of People Searching for Answers About Circulation, Energy, and Whole-Body Vitality A closer look at how microcirculation research is expanding what we understand about blood flow, oxygen delivery, and why the body’s smallest vessels may matter more than the largest ones Scottsdale, AZ, March 13, 2026 (GLOBE NEWSWIRE) — Calroy Health Sciences, a science-driven dietary supplement company focused on foundational vascular health, has published a comprehensive educational resource on microcirculation, blood flow, and the endothelial glycocalyx — the micro-thin, gel-like lining that coats the inside of every blood vessel in the body. The resource explores why this recently discovered structure is foundational to vascular health and total-body vitality, and why standard medical imaging often cannot assess the very network where oxygen and nutrient delivery actually occurs. The cardiovascular system is frequently visualized as a network of major arteries and veins — the primary conduits that transport blood to and from the heart. While these large vessels are essential for systemic circulation, they represent a small chapter of a much larger biological story. The vast majority of the vascular network is composed of microscopic vessels so narrow that red blood cells must travel single file to pass through them. This is the microcirculation — the capillary-level system where oxygen and nutrients are delivered directly to tissue. Standard medical imaging tools, including CT scans and angiograms, are designed to evaluate the body’s primary supply routes. They can confirm that the main conduits are open and functioning. However, these tools lose resolution long before they reach the capillary beds where the final exchange between blood and tissue actually occurs. “I often use a tree analogy,” explains Dr. Joel Kahn, MD, known as “America’s Holistic Heart Doc” and best-selling author and integrative cardiologist at the Kahn Center for Cardiac Longevity in Bingham Farms, Michigan, and a frequent educator for Calroy Health Sciences.. “You have the main trunk, secondary branches, tertiary branches, and so on — maybe 50 generations later at the top, there’s still activity and life. The arterial system works the same way. We can image the main trunk and maybe three or four generations of branches, but we’re really limited in imaging the microcirculation — that 10th, 40th, 50th generation of vessels.” This technological limitation means it is entirely possible for someone to pass a standard vascular screening with clear results while still experiencing fatigue, cold extremities, or mental fog — signals that may reflect what is happening at the microvascular level, not the arterial level. Lining the interior of every blood vessel in the body is a delicate, gel-like structure known as the endothelial glycocalyx (EGX). Only recently discovered and often overlooked, this micro-thin lining is foundational to vascular health and total-body vitality. It performs critical functions: it acts as a semi-permeable barrier, it facilitates smooth blood flow, and it houses the enzymes involved in the production of nitric oxide — the molecule, first identified in Nobel Prize–winning research, that signals blood vessels to relax and support healthy circulation. “There’s a single layer of cells — the endothelium — that separates the blood inside a blood vessel from the artery wall structure,” notes Dr. Kahn. “It’s almost like a Spanish-style tile floor of interlocking cells. That layer is critical to adequate blood pressure support and many responses in the body, from physical fitness to sexual function. You need a healthy endothelium. The glycocalyx sits on top of the endothelium, which consists of hair-like, protein-sugar structures resembling cake frosting. It’s very dynamic. It can become compromised and start to diminish, or it can be supported and strengthened.” When the glycocalyx is supported, it helps maintain the slippery-smooth quality of the vessel interior — facilitating the efficient transit of red blood cells through capillaries and supporting nutrient and oxygen delivery at the tissue level. Peer-reviewed research has examined specific markers of vascular elasticity and endothelial integrity that may be associated with this structure’s function. For decades, vascular research relied on static testing environments — observing cells in a stationary petri dish. While informative, this approach could not capture the dynamic behavior of the EGX under the physical shear stress of flowing blood. Calroy Health Sciences addressed this gap by utilizing a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel – including the endothelial glycocalyx. Instead of testing compounds in a motionless setting, researchers can observe the endothelial glycocalyx in a dynamic state, under conditions that more closely mirror what happens inside the human body. Through this approach, Calroy identified Monostroma nitidum, a rare marine algae containing the sulfated polysaccharide Rhamnan sulfate. A patented extract of this compound, trademarked as MonitumRS®, became the core of Arterosil HP® — a dietary supplement specifically formulated to support the integrity of the endothelial glycocalyx.* MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† Millions of people turn to search engines and AI tools every month asking about blood flow and circulation. In most cases, they are not looking for a clinical label — they are trying to make sense of the subtle shifts they experience throughout the day: afternoon energy dips, cold fingers and toes, or thinking that feels less sharp than it used to. The language people use — “How do I support circulation?” — is often a description of microvascular function. The experience of “flow” is frequently the experience of capillary efficiency, governed by the very structure that standard imaging cannot see. As vascular research continues to advance, the endothelial glycocalyx is emerging as a foundational area of focus for understanding how the body delivers oxygen and nutrients to every organ, every day. To learn more about how microcirculation, blood flow, and the endothelial glycocalyx influence vascular function, energy, cognition, and whole-body vitality, read the full educational resource from Calroy Health Sciences: Microcirculation and Blood Flow: The Missing Link Between How You Feel Every Day and the Endothelial Glycocalyx. FREQUENTLY ASKED QUESTIONSWhat is microcirculation and why does it matter? Microcirculation refers to the network of microscopic blood vessels — capillaries, arterioles, and venules — where the body’s actual exchange of oxygen and nutrients at the tissue level takes place. While the heart and major arteries are responsible for bulk transport, it is the microcirculation that determines whether oxygen and nutrients reach their final destination. The human vascular system stretches approximately 60-100,000 miles, and the vast majority of that distance exists at the capillary level. Supporting healthy microcirculation is foundational to whole-body vitality, including energy, cognition, and vascular well-being.* Every organ and system in the body from the brain, to sexual organs, to the joints rely on healthy microcirculation to function.* Calroy Health Sciences has published a comprehensive educational resource on this topic at calroy.com/education/microcirculation-and-blood-flow/. What is the endothelial glycocalyx? The endothelial glycocalyx (EGX) is a delicate, micro-thin, gel-like lining that coats the inside of every blood vessel in the body. Only recently discovered and often overlooked, it is foundational to vascular health and total-body vitality. The EGX acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production — the molecule that helps blood vessels relax and support healthy circulation. When the glycocalyx is strong and healthy, circulation is supported and every organ feels the impact. Why do standard heart health screenings sometimes miss what people actually feel? Standard imaging tools like CT scans and angiograms are designed to evaluate large vessels — the body’s primary supply routes. They can confirm that the main conduits are open. However, they lose resolution before reaching the capillary beds where the actual exchange between blood and tissue occurs. This means it is possible to receive clear results from a standard vascular screening while still experiencing everyday shifts like fatigue, cold extremities, mental fog, or changes in sexual wellness — signals that may relate to microvascular function rather than large-vessel mechanics. How does Calroy Health Sciences study vascular function differently? Calroy utilizes a patented microfluidic chip — a lab-on-a-chip technology that simulates the living environment inside a blood vessel. Unlike static testing methods, this approach replicates the physical shear stress of flowing blood, allowing researchers to observe the endothelial glycocalyx in a dynamic state. Through this technology, Calroy identified and validated MonitumRS® (Rhamnan sulfate from Monostroma nitidum), the proprietary extract at the core of Arterosil HP® with MonitumRS®, which is specifically formulated to support the integrity of the endothelial glycocalyx.* Calroy’s published research is available in peer-reviewed journals. What is MonitumRS® and how is it different from other vascular support ingredients? MonitumRS® is a proprietary extract of Rhamnan sulfate derived from Monostroma nitidum, a rare marine algae. It is the core ingredient in Arterosil HP® with MonitumRS®. What distinguishes it is that it works. In the microfluidic chip study, it repaired the glucose-damaged endothelial glycocalyx cells up 103.8% from baseline in just 24 hours.*† †As demonstrated in an independent third-party laboratory in vitro study. Does circulation affect brain function and cognition? The brain is one of the body’s most oxygen-dependent organs. It relies on continuous, efficient blood flow to support cognitive function, mental clarity, and focus throughout the day. Because the brain’s oxygen supply depends on the microvascular delivery network — not just the major arteries — the health of the microcirculation and the endothelial glycocalyx are foundational to cognitive well-being. Supporting healthy circulation means supporting the system that delivers oxygen and nutrients to the brain at the tissue level. What is nitric oxide and what role does it play in circulation? Nitric oxide (NO) is a tiny molecule naturally produced by the body that plays a central role in the cardiovascular system. First identified in Nobel Prize–winning research, it helps blood vessels relax and widen, supporting healthy circulation and helping maintain healthy blood pressure already in the normal range.* The endothelial glycocalyx houses the enzymes responsible for nitric oxide production, making the health of this microscopic lining essential to the body’s ability to maintain vascular tone and flexibility. PUBLISHED RESEARCH & RESOURCES Research on the Endothelial Glycocalyx — Practitioner ResourcesResearch on Rhamnan Sulfate from Monostroma Nitidum — Practitioner ResourcesResearch on Nitric Oxide and the Vascular System — Practitioner ResourcesMarkers of Vascular Elasticity and Endothelial Integrity — PubMedCalroy’s Published Research — Calroy Health SciencesCalroy’s Patents — Calroy Health SciencesScience and Medical Advisory Board — Calroy Health Sciences About Calroy Health Sciences Calroy Health Sciences is a science-driven dietary supplement company dedicated to supporting foundational health. Co-founded by CEO Ed Hoyt and Chief Scientific Officer Chen Chen, PhD, Calroy brings more than three decades of combined experience in the dietary supplement industry. The company’s breakthrough products — Arterosil HP® with MonitumRS®, Vascanox HP® with Noxa24®, and Cartigenix HP® with RestorCel™ — are developed through a research-first approach that includes studying the finished formulated product, not just individual ingredients.  Calroy’s research has been published in peer-reviewed journals and is conducted in partnership with major academic institutions, leading clinicians and researchers. The company also holds patents on its products and its microfluidic chip testing technology. For more information, visit calroy.com. SME Available for Commentary: Joel Kahn, MD — Integrative Cardiologist, Kahn Center for Cardiac Longevity *These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. CONTACT: Sarah Evans
Partner, Head of PR, Zen Media
sarah@zenmedia.com

ACCESS GPO Announces Preferred Strategic Commercial Agreement to Provide Affera™ Mapping and Ablation System with Sphere-9™ Catheter to Ambulatory Surgery Centers

NEW YORK–(BUSINESS WIRE)–ACCESS GPO today announced a preferred, multi-year agreement with Medtronic to support availability of the Affera™ Mapping and Ablation System with Sphere-9™ Catheter in ambulatory surgery centers (ASCs) across the United States. The agreement is designed to help physician-led ASCs gain earlier access to next-generation technology for treatment of cardiac arrhythmias in the ASC setting. Pulsed field ablation (PFA) is emerging as one of the most important advances in t

XCath Secures $30 Million Series C to Improve Global Outcomes in Neurovascular Care

HOUSTON–(BUSINESS WIRE)–XCath, a medical device company pioneering neuro-endovascular surgical robotics, announced today that it has secured $30 million in Series C funding, bringing the total raised since the company’s inception to $92 million. The round was co-led by Crescent Enterprises and by Dr. Fred Moll, Chairman of the XCath Board of Directors. These latest funds will support XCath’s ongoing efforts to bring the world’s first commercially-practical endovascular robot to the market and

Orchestra BioMed Reports Full Year 2025 Financial Results and Provides Fourth Quarter Business Update

$106.5 million cash position as of December 31, 2025 to be further enhanced by $35 million expected from Medtronic and Ligand in Q2 2026 from previously announced transactions, as well as Haemonetics’ Vivasure acquisition proceeds$33.5 million in 2025 non-recurring revenue primarily driven by impact of new Virtue SAB agreement with Terumo that was announced in October 2025Strong balance sheet supports focused execution of pivotal trials for both AVIM Therapy and Virtue SAB programs NEW HOPE, Pa., March 12, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading global medical device companies, today reported its full year 2025 financial results and provided a fourth quarter business update. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed stated, “We are very proud of our significant clinical, strategic and financing accomplishments in 2025. We are now in an excellent financial and operational position to achieve upcoming value-driving milestones for both of our pivotal stage programs. In the second half of 2025, we leveraged our partnership-driven business model to substantially strengthen our financial position with nearly $150 million in new capital and capital commitments, including strategic transactions with Medtronic, Ligand and Terumo. With a strong balance sheet in place, we are fully focused on driving pivotal trial execution for both AVIM Therapy and Virtue SAB, high impact therapies designed to address major unmet needs in large, established global procedure markets.” Hochman continued, “As we enter 2026 with two pivotal trials underway, we remain focused on disciplined execution and long-term value creation for patients, clinicians and shareholders. We are encouraged by the accelerated pace of enrollment in the BACKBEAT global pivotal study following protocol amendments implemented in the fourth quarter and we plan to provide a substantive update in our next quarterly report. We are also pleased with the early progress of the Virtue Trial, which we initiated during the fourth quarter of 2025. We expect to provide additional updates on this trial, which is randomizing coronary in-stent restenosis patients to treatment with Virtue SAB versus the AGENT™ paclitaxel-coated balloon, as we gain further visibility into enrollment trends over the course of the year.” Q4 2025 and Recent Business Highlights: Accelerated patient enrollment of the BACKBEAT global pivotal study, in collaboration with Medtronic (NYSE: MDT), evaluating the efficacy and safety of Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension in patients indicated for a pacemaker.Initiated patient enrollments in the Virtue SAB U.S. pivotal trial, a randomized head-to-head IDE registrational clinical trial comparing Virtue SAB with the commercially available AGENT paclitaxel-coated balloon for the treatment of coronary in-stent restenosis (the “Virtue Trial”).Entered into an agreement with Terumo (“ROFR Agreement”) pursuant to which we and Terumo terminated our distribution agreement, and Orchestra BioMed granted Terumo a right of first refusal (the “ROFR”) with respect to certain strategic transactions relating to Virtue® Sirolimus AngioInfusionTM Balloon (“Virtue SAB”) for the treatment of coronary artery disease globally in exchange for a fee of $10.0 million. In connection with the ROFR Agreement, Terumo invested an additional $20.0 million in Orchestra BioMed through a new series of non-voting convertible preferred stock (the “Series A Preferred Stock”), which is convertible into common stock in the future, subject to certain conditions, at a minimum of $12 per share.Up to $21 million in total proceeds expected in connection with the acquisition of Vivasure Medical, previously a strategic holding of Orchestra BioMed, by Haemonetics. Orchestra BioMed expects to receive up to $10.7 million of these proceeds in 2026, including an initial upfront payment of $4.7 million received in January 2026 and the remainder expected later in the year as a first-milestone payment. The Company may receive additional proceeds in the future associated with potential revenue earnouts. Financial Results for the Year Ended December 31, 2025 Revenue for 2025 was $33.5 million, compared with $2.6 million for 2024, which represents an increase of 1,539%. The increase is primarily due to recognizing the remainder of the deferred revenue from our prior distribution agreement with Terumo of $15.4 million as a result of the termination of that agreement, $10.0 million in consideration for the ROFR, and $7.4 million associated with the premium paid above the fair market value of the Series A Preferred Stock.Research and development expenses for 2025 were $58.2 million, compared with $42.8 million for 2024, which represents an increase of 36%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT global pivotal study and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for 2025 were $26.9 million, compared with $23.9 million for 2024, which represents an increase of 12%. The increase was primarily due to an increase in professional fees.Net loss attributable to common stockholders for 2025 was $52.7 million, or ($1.11) per share, compared with a net loss attributable to common stockholders of $61.0 million, or ($1.66) per share, for 2024 which represents a decrease of 14%. Net loss attributable to common stockholders for the year-ended 2025 included non-cash stock-based compensation expense of $12.0 million, compared with $10.6 million for the same period in 2024, representing an increase of 13%.Net cash used in operating activities and for the purchase of fixed assets excluding the payment for the ROFR and the Series A Preferred Stock premium, which was recognized as revenue, was $66.9 million during 2025, compared with $50.8 million for 2024, with the primary driver of this increase being increased cash outflows for research and development, including clinical trial activities, during 2025.Cash and cash equivalents and Marketable securities totaled $106.5 million as of December 31, 2025. The Company has commitments from Ligand and Medtronic to receive a combined $35.0 million in additional proceeds on or before May 1, 2026, based on the terms of agreements with those parties and subject to the conditions therein. Additionally, in January 2026, Haemonetics closed on the acquisition of Vivasure in which we expect to receive up to $10.7 million of proceeds in 2026, consisting of an upfront payment of approximately $4.7 million, which has already been received, and approximately $6.0 million expected to be received in a first milestone payment. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. 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 proceeds expected to be received by the Company pursuant to the achievement of certain milestones in connection with the acquisition of Vivasure by Haemonetics; and the timing of any update on anticipated enrollment completion and potential primary endpoint results with respect to the BACKBEAT global pivotal study as well as the provision of any update on the Virtue Trial. 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, 2025, which was filed with the SEC on March 12, 2026.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 Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Balance Sheets(in thousands, except share and per share data)(unaudited)            December 31,     December 31,   2025  2024 ASSETS        CURRENT ASSETS:       Cash and cash equivalents $34,690  $22,261 Marketable securities  71,822   44,551 Accounts receivable, net  95   92 Inventory  310   173 Prepaid expenses and other current assets  994   2,094 Total current assets  107,911   69,171 Property and equipment, net  1,715   1,384 Right-of-use assets  1,496   2,103 Strategic investments  2,495   2,495 Deposits and other assets  1,240   1,020 TOTAL ASSETS $114,857  $76,173        LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY        CURRENT LIABILITIES:        Accounts payable $6,095  $5,134 Accrued expenses and other liabilities  9,890   6,084 Operating lease liability, current portion  751   550 Deferred revenue, current portion  —   4,439 Total current liabilities  16,736   16,207 Deferred revenue, less current portion  —   10,989 Royalty purchase agreement  16,482   — Loan payable  14,268   14,292 Derivative liability  2,749   — Operating lease liability, less current portion  936   1,687 Other long-term liabilities  308   40 TOTAL LIABILITIES  51,479   43,215        Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at December 31, 2025 and 0 issued and outstanding at December 31, 2024; aggregate liquidation preference of $20,000 at December 31, 2025  9,808   —        STOCKHOLDERS’ EQUITY        Preferred stock, $0.0001 par value, 10,000,000 shares authorized;  —   — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 57,032,963 and 38,194,442 shares issued and outstanding as of December 31, 2025 and December 31, 2024, respectively.  6   4 Additional paid-in capital  416,083   342,780 Accumulated other comprehensive income  60   52 Accumulated deficit  (362,579)  (309,878)TOTAL STOCKHOLDERS’ EQUITY  53,570   32,958 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY $114,857  $76,173  ORCHESTRA BIOMED HOLDINGS, INC.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)            Year Ended December 31,   2025  2024 Revenue:        Partnership revenue $32,871  $2,005 Product revenue  611   633 Total revenue  33,482   2,638 Expenses:        Cost of product revenues  190   204 Research and development  58,185   42,804 Selling, general and administrative  26,914   23,931 Total expenses  85,289   66,939 Loss from operations  (51,807)  (64,301)Other (expense) income:        Interest (expense) income, net  (1,148)  3,356 Change in the fair value of derivative liability  254   — Loss on fair value of strategic investments  —   (68)Other expense  —   (11)Total other (expense) income  (894)  3,277 Net loss  (52,701)  (61,024)Adjustment to carrying value of Series A Preferred Stock  (254)  — Net loss attributable to common stockholders $(52,955) $(61,024)       Net loss attributable to common stockholders per share        Basic and diluted $(1.11) $(1.66)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted  47,747,078   36,821,042 Comprehensive loss       Net loss $(52,701) $(61,024)Unrealized gain on marketable securities  8   62 Comprehensive loss $(52,693) $(60,962)

Milestone Pharmaceuticals to Announce Fourth Quarter and Full-Year 2025 Financial Results on March 20, 2026

Conference Call and Webcast Scheduled for Friday, March 20 at 8:30am ETMONTREAL and CHARLOTTE, N.C., March 12, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that it will report fourth quarter and full-year 2025 results and provide a business update on Friday, March 20, 2026, before the market opens. The announcement will be followed by a conference call and webcast for investors at 8:30am ET. Conference Details: Conference Dial-in:1-877-407-0792International Dial-in:1-201-689-8263Conference ID:13759195Webcast link:click here Call me™: Participants can use Guest dial-in numbers above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. The Call me™ link will be made active 15 minutes prior to scheduled start time. A replay of the audio webcast of the call will be available under the “Investors and Media” section of Milestone’s corporate website, www.milestonepharma.com. About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular medicines to benefit people living with certain heart conditions. Milestone’s lead product is CARDAMYST™ (etripamil) nasal spray, a novel calcium channel blocker, which is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults.  Etripamil is also in development for the control of symptomatic episodic attacks associated with AFib-RVR.  Contact: Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com Media Relations Rebecca Novak, rnovak@milestonepharma.com