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SS Innovations Strengthens Management Team in Preparation for Global Sales Expansion

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Promotes Dr. Vishwa Srivastava to President and Appoints Gary Lo as Chief Financial Officer FORT LAUDERDALE, Fla., Nov. 13, 2026 (GLOBE NEWSWIRE) — via IBN —  SS Innovations International, Inc. (the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced the promotion of Dr. Vishwa Srivastava to President of the Company and the appointment of Gary Lo as Chief Financial Officer. Dr. Vishwa Srivastava previously served as the Company’s Chief Executive Officer – Asia Pacific. Both executives are based in the United States. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “At this critical juncture in SS Innovations’ growth journey, we are excited to announce the promotion of Dr. Vishwa Srivastava to President of the Company and the appointment of Gary Lo as Chief Financial Officer. Vishwa has been instrumental in the development and growth of our Asia Pacific region, and we are confident in his ability to successfully build our US business and lead our global operations during the next phase of expansion.” Dr. Vishwa Srivastava said, “We have established a leading position in our immense home market of India, and I look forward to working closely with the team to build the required infrastructure and operations to further increase the presence of our advanced, cost-effective SSi Mantra surgical robotic system in the United States and globally in preparation for expansion. On that note, we have been responding to all queries raised by the U.S. Food and Drug Administration during its review of our 510(k) premarket notification for the SSi Mantra and we are simultaneously continuing along the pathway toward CE marking certification in the European Union.  Additionally, we have been working at our R&D facility in India finalizing a pipeline of future disruptive healthcare technologies that we plan to roll out in the coming months.” Dr. Sudhir Srivastava continued, “Gary brings to SS Innovations more than three decades of financial leadership experience and a proven track record of driving profitable growth and value creation across a range of prominent technology companies, including in the medical technology sector. We expect to benefit from his capital markets expertise, multinational company experience, financial planning and analysis skills, and strategic acumen as we build a truly global organization.” Mr. Lo said, “I am thrilled to be joining the SSi team and supporting its mission to democratize access to advanced surgical robotic care. I believe that the SSi Mantra’s cutting-edge surgical robotic technology, differentiated features, user-friendliness, training capabilities, proven track record of clinical success, and cost efficiency all distinguish SS Innovations in a large and growing global market.” About Mr. Lo  Gary Lo has more than three decades of financial and executive leadership experience across medical technology, healthcare, robotics, enterprise software and global technology businesses. Prior to joining the Company, Mr. Lo served as Chief Financial Officer of Subsense, Inc., a deep-technology company developing a bidirectional brain-computer interface. He previously served as Chief Financial Officer of Beyeonics Vision, a commercial-stage medical technology company developing a fully digital microscope for ophthalmic surgery; Vice President of Finance and subsequently Chief Financial Officer of Cellares Corporation, a cell therapy manufacturing robotics company; Vice President of Finance for Legrand’s Building Control Systems division, a global business with operations in North America and Asia; Vice President of Business Development (M&A) and IT at Sparta Systems; and Chief Financial Officer of 1WorldSync, a global cloud-based product data management company. At the start of his career, Mr. Lo held progressively senior finance and technology leadership positions at Johnson & Johnson, finance leadership positions at Siebel Systems and Boston Scientific, and a senior auditor role at PricewaterhouseCoopers. Mr. Lo is a licensed Certified Public Accountant (CPA). He earned a Master of Business Administration from the University of Chicago Booth School of Business and a Bachelor of Science in Accounting, magna cum laude, from Boston College. About SS Innovations SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical robotic procedures, including cardiac surgery. Headquartered in India, SS Innovations is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates. About the SSi MantraThe SSi Mantra surgical robotic system is a modular, multi-arm system with advanced technology features, including 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch-panel monitor for displaying all patient-related information, a virtual real-time image of the robotic patient-side arm carts, and the ability to superimpose 3D models of diagnostic imaging. The optional SSi MantrAsana tele-surgeon console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that is intended to provide equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5 mm instruments for the pediatric population and ENT surgeries. A vision cart is designed to provide the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 190 different types of surgical procedures. Forward-Looking StatementsThis press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Investor Contact:The Equity Group        Kalle Ahl, CFA              T: (303) 953-9878        kalle.ahl@theequitygroup.com Devin Sullivan, Managing Director T: (212) 836-9608devin.sullivan@theequitygroup.com Media Contact:RooneyPartners LLCKate BarretteT: (212) 223-0561kbarrette@rooneypartners.com

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CytoSorbents Reports Third Quarter 2026 Financial Results, Achieves Operating Cash Flow Breakeven, and Provides Business and Regulatory Update

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Delivering on the First of Four Distinct Value Drivers PRINCETON, N.J., Nov. 12, 2026 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported…

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POTS Phase 2 Trial Shows Baloncibart, a First-in-Class NPR1 Blocking Antibody, Reduced Orthostatic Heart Rate and Improved Orthostatic Symptoms

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Data presented today for the first time at the American Autonomic Society (AAS) annual meeting POTS (postural orthostatic tachycardia syndrome) is a debilitating condition characterized by a marked increase in heart rate upon standing and associated orthostatic symptoms, with no FDA-approved treatments available A single dose of baloncibart reduced the exaggerated heart rate response to standing and improved orthostatic symptoms through four weeks; biomarker changes were consistent with plasma volume expansion, the intended effect of NPR1 blockade Potentially pivotal Phase 3 trial planned for first half of 2027 TARRYTOWN, N.Y., Nov. 12, 2026 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced results from the Phase 2 PINNACLE trial in adults with postural orthostatic tachycardia syndrome (POTS) evaluating baloncibart, a novel, investigational, first-in-class monoclonal antibody that blocks natriuretic peptide receptor 1 (NPR1). The data were presented for the first time at the American Autonomic Society’s (AAS) 37th International Symposium on the Autonomic Nervous System in San Diego, CA. POTS is a chronic disorder in which heart rate rises abnormally upon standing. Patients may experience palpitations, dizziness, fatigue, exercise intolerance, cognitive difficulties, gastrointestinal symptoms and chronic pain. Although historically underdiagnosed, recent estimates suggest it affects between 500,000 and several million people in the U.S., and the vast majority are young women. While the cause of POTS is unknown, it is believed to be associated with low blood volume. Baloncibart is designed to increase the volume of blood in circulation in an effort to reduce the increase in heart rate and symptoms that occur in people with POTS. “POTS causes debilitating symptoms that can profoundly disrupt daily life, and patients have no FDA-approved treatment options. In the trial, a single injection of baloncibart 450 mg reduced the exaggerated heart rate response to standing and improved orthostatic symptoms through four weeks,” said Satish R. Raj, M.D., Professor of Cardiac Science at the University of Calgary’s Cumming School of Medicine, and investigator in the trial. “The results are consistent with the rationale for NPR1 blockade in POTS, with biomarker changes pointing to an increase in blood volume alongside lower heart rate and better symptoms.” The randomized, double-blind, Phase 2 PINNACLE trial evaluated a single subcutaneous dose of baloncibart 150 mg (n=27) or 450 mg (n=28) compared to placebo (n=27) in patients with POTS. The primary endpoint was the change in heart rate from lying down to standing (DeltaHR) at day 8; no formal hypothesis testing was prespecified. Improvements were observed with baloncibart on DeltaHR and other key measures of the disease (i.e., symptoms and function) as assessed by the Living With POTS Questionnaire (LWPQ). The LWPQ is a novel patient-reported outcome tool to assess POTS symptoms and function in clinical trials, which is being developed by Regeneron in accordance with the FDA patient-focused drug development guidance. Baloncibart 450 mg reduced DeltaHR versus placebo at day 8 (primary endpoint) with a least-squares (LS) mean difference of -11.4 beats per minute (bpm; nominal p=0.0007), and at day 29 (secondary endpoint) with an LS mean difference of -7.4 bpm (nominal p=0.0124). Baloncibart 150 mg reduced DeltaHR versus placebo at day 8 (LS mean difference: -9.5 bpm; nominal p=0.0045), but the effect was not maintained at day 29. Baloncibart 450 mg improved orthostatic symptoms, physical functioning, and activities of daily living versus placebo at day 29, as measured by the LWPQ. Domain scores range from 0 to 100, with lower scores indicating fewer symptoms or less impairment. The LS mean differences in change from baseline for each domain were as follows: Orthostatic symptoms (baseline mean: 45.5): -12.9 points (nominal p=0.0096)Physical functioning (baseline mean: 55.1): -13.8 points (nominal p=0.0073)Activities of daily living (baseline mean: 48.7): -8.7 points (nominal p=0.1035)Overall across the three domains, there was no obvious improvement with baloncibart 150 mg compared to placebo Additionally at day 8, both doses of baloncibart led to changes in biomarkers consistent with the anticipated beneficial plasma volume expansion driven by NPR1 blockade, including an increase in NT-proBNP and reductions in standing norepinephrine and hemoglobin. Average standing systolic blood pressure increased for both doses, with observed mean changes from baseline at day 29 of 8.7 mmHg to a mean of 118.8 mmHg for baloncibart 450 mg and 5.4 mmHg to a mean of 114.0 mmHg for baloncibart 150 mg. In the trial, single doses of baloncibart up to 450 mg were generally well tolerated. Treatment-emergent adverse events (TEAEs) were mostly mild or moderate and occurred in 13 patients (48.1%) receiving placebo, 18 patients (66.7%) receiving baloncibart 150 mg, and 19 (67.9%) receiving baloncibart 450 mg; one severe TEAE occurred in the trial in the placebo group. TEAEs that occurred in ≥10% of patients in any treatment group, including placebo, baloncibart 150 mg and baloncibart 450 mg, were: injection site reaction (14.8%, 3.7%, and 17.9%), headache (0%, 11.1%, and 10.7%), syncope (11.1%, 14.8%, and 3.6%), heavy menstrual bleeding (0%, 11.1%, and 0%), and nasopharyngitis (11.1%, 0%, and 0%). Two serious TEAEs were reported: one case of headache with baloncibart 150 mg and one case of syncope with baloncibart 450 mg. No TEAE led to discontinuation. “POTS is a condition that disproportionately impacts younger women and has been under-recognized and under-served for too long, which is why it was critical to incorporate the patient experience in our trial design and measure symptoms that reflect how patients actually feel and function,” said Boaz Hirshberg, M.D., Senior Vice President, Clinical Development, Internal Medicine at Regeneron. “These initial results show the potential of baloncibart for people living with POTS and we look forward to advancing this novel therapy into a Phase 3 clinical trial in 2027.” The safety and efficacy of baloncibart have not been evaluated by any regulatory authority. About Regeneron’s VelocImmune TechnologyRegeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce fully optimized human antibodies. When Regeneron’s Co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor, Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn), Veopoz® (pozelimab-bbfg), and Pasatru® (garetosmab-grts). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. A total of 11 antibody and bispecific products have been approved or authorized worldwide that were invented or derived using VelocImmune technologies. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn, Instagram, Facebook or X. Forward-Looking Statements and Use of Digital MediaThis press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation baloncibart (REGN7544); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as baloncibart for the treatment of adults with postural orthostatic tachycardia syndrome as discussed in this press release; uncertainty of the utilization, market acceptance, and/or commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as baloncibart); the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as baloncibart) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes to drug pricing regulations and requirements and Regeneron’s pricing strategy, including in connection with Regeneron’s April 2026 agreements with the U.S. government; other changes in laws, regulations, and policies affecting the healthcare industry; competing products and product candidates (including biosimilar products) that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron’s business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney’s Office for the District of Massachusetts), risks associated with intellectual property of the Company or other parties and pending or future litigation or patent office proceedings relating thereto (including without limitation patent litigation and other related proceedings relating to Regeneron’s Products), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2025 and its Form 10-Q for the quarterly period ended September 30, 2026. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals). Contacts:   Media RelationsJulie BlockTel: +1 914-826-7083julie.block@regeneron.comInvestor RelationsMark HudsonTel: +1 914-847-3482mark.hudson@regeneron.com

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BioCardia Reports Third Quarter 2026 Business Highlights and Financial Results

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SUNNYVALE, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) — BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported financial results for the third quarter 2026 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2026 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. “We believe that our CardiAMP autologous cell therapy is on track to be the first approved minimally invasive biologic therapy for the treatment of heart failure in a first world country based on the recent interactions with Japan’s Pharmaceutical and Medical Devices Agency,” said Peter Altman, PhD, Chief Executive Officer of BioCardia. “In addition, in the coming months, we aim to be able to submit our Helix transendocardial delivery platform for FDA approval, which would be the first delivery system of its type approved in the United States. This promises to be an exciting year ahead.” Recent Business Highlights CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01) In November, the Company announced it had successfully completed the process with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan. Questions remaining to be addressed in advance of submission have been addressed to PMDA’s satisfaction.We continue to prepare clinical data sets for submission to Japan’s PMDA and the U.S. FDA. We are working with partners to complete the electronic trial master file, conduct good clinical practice audits, and structure clinical research data in accordance with CDISC Standards, which support data consistency, traceability, and regulatory compliance. We have engaged a Designated Marketing Authorization Holder, or DMAH, as the local regulatory representative required for foreign medical device and pharmaceutical companies seeking to sell products in Japan without establishing a local office. In Japan, the DMAH designation may be transferred together with the underlying product approval.BioCardia continues to actively enroll in the CardiAMP HF II trial. Four clinical sites have enrolled in the study and are actively recruiting patients.  Seven additional world class sites are being onboarded.Near term catalysts ahead for this program include publication of the peer reviewed manuscript for CardiAMP HF, submission for approval in Japan, acceptance of the submission by PMDA, and ongoing enrollment in the CardiAMP HF II trial. Helix™ Biotherapeutic Delivery System In August, FDA accepted our minutes from our Q2 Pre Submission Meeting for De Novo approval of the Helix transendocardial delivery catheter as formal minutes without changes.   In September, based on these minutes, we submitted our revised Pre-Submission to FDA, which was accepted by FDA in October. The FDA aims to issue written feedback or hold a meeting within 70 calendar days.  We expect to hear from the FDA on this Pre-Submission in the next six weeks.With FDA alignment on the De Novo approval pathway for Helix, we expect to complete the De Novo submission in the first quarter of 2027 with approval in mid-2027 if FDA meets its official target goal of 150 review days under Medical Device User Fee Amendments (MDUFA) guidelines.In addition to its role for our own therapeutic development activities, the investigational Helix system has potential to become the leading development platform for biologic therapies to treat heart disease, as it provides efficient delivery and control for these investigational agents to the heart. Helix performance for all developers is expected to be further enhanced by our Heart3D fusion imaging platform. Heart3D™ Fusion Imaging The investigational Heart3D system enhances real time two-dimensional X-ray imaging by fusing pre-procedure three-dimensional anatomical heart models created from high-quality MRI and CT images for the interventional cardiologist with a focus on cardiac biotherapeutic interventions and biopsies.  With Helix, it enables an elegant approach to cell, gene, and protein-based therapies for cardiac indications. We are working closely with our development and commercial partner, CART-Tech, to perform a number of studies with CardiAMP Cell Therapy in addition to gene therapy partners in parallel to advancing this platform into the clinic in 2027. Third Quarter 2026 Financial Results: Net cash used in operations for the three months ended September 2026 was $1.7 million, comparable to the $1.7 million for the three months ended September 2025, and increased to $5.1 million for the nine months ended September 2026, as compared to $4.9 million for the nine months ended September 2025, primarily due to the timing of supplier payments.The Company ended the quarter with cash and cash equivalents totaling $2.2 million, providing anticipated runway into 2027.Research and development expenses increased to $1.2 million for the three months ended September 2026 as compared to $936,000 in the three months ended September 2025, primarily due to a bonus accrual at a higher level, coupled with increased expenses from regulatory activities to advance CardiAMP in Japan and enrollment in the CardiAMP HF II Trial Research and development expenses decreased to $3.4 million in the nine months ended September 30, 2026 as compared to $3.8 million in the nine months ended September 30, 2025 primarily due to closeout of the CardiAMP Heart Failure Trial, partially offset by early enrollment in the CardiAMP Heart Failure II Trial and regulatory activities to advance CardiAMP in Japan.Selling, general and administrative expenses increased to $600,000 in the three months ended September 30, 2026 as compared to $552,000 in the three months ended September 30, 2025.  Selling, general and administrative expenses remained consistent at $2.4 million in the nine months ended September 30, 2026 and in the nine months ended September 30, 2025.Our net loss was $1.9 million for the three months ended September 2026 compared to $1.5 million for the three months ended September 2025.  Our net loss decreased to $5.8 million for the nine months ended September 2026 compared to $6.2 million for the nine months ended September 2025, primarily due to lower research and development expenses.  ANTICIPATED UPCOMING MILESTONES AND EVENTS: CardiAMP Cell Therapy Shonin Submission to Japan PMDA Q4 2026 / Q1 2027CardiAMP HF Trial Peer Reviewed Manuscript Q1 2027Helix transendocardial delivery system FDA De Novo Pre-submission Meeting Q4 2026Heart3D FDA Submission Q1 2027Gene therapy study with partner(s) using Helix and Heart3D Q1/2027 Conference call access: Participants can register for the conference by navigating to https://dpregister.com/sreg/10213286/10535c5b644. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the U.S. should call 1-833-316-0559 and international callers should call 1-412-317-5730 and ask to be connected to the BioCardia call. All callers should dial-in approximately 10 minutes prior to the scheduled start time and ask to be joined into the BioCardia call. The conference call will also be available through a live webcast, which can be accessed through the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=O8EiucRo. A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/Canada) and 1-412-317-0088 (international toll) by using access code 3063624. 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 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 product platforms, and soon the Heart3DTM fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. 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 sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s Pharmaceutical and Medical Device Agency, product clearances, the efficacy and safety of our products and therapies, preliminary conclusions about new data, 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 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 24, 2026, under the caption titled “Risk Factors BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.   BioCardia, Inc.Condensed Consolidated Statements of Operations(Unaudited In thousands, except share and per share amounts)                  Three Months endedSeptember 30,  Nine Months endedSeptember 30,     2026  2025   2026  2025 Costs and expenses:          Research and development$1,235 $936  $3,363 $3,834  Selling, general and administrative 600  552   2,361  2,431   Total costs and expenses 1,835  1,488   5,724  6,265   Operating loss (1,835) (1,488)  (5,724) (6,265)Other income (expense):           Total other income, net  18  5   35  21 Net loss$(1,817)$(1,483) $(5,689)$(6,244)             Net loss per share, basic and diluted$(0.12)$(0.24) $(0.45)$(1.17)             Weighted-average shares used in computing         net loss per share, basic and diluted 15,137,085  6,277,848   12,696,206  5,330,465   BioCardia, Inc.Selected Balance Sheet Data(amounts in thousands)        September 30,  December 31,  2026(1)  2025(1)      Assets:     Cash and cash equivalents$2,224 $2,496Other current assets 108  236Property, plant and equipment and other noncurrent assets 739  681Total assets$3,071 $3,413Liabilities and Stockholders’ Equity     Current liabilities$2,092 $2,432Operating lease liability – noncurrent 144  86Total stockholders’ equity 835  895Total liabilities and stockholders’ equity$3,071 $3,413      (1)  September 30, 2026 amounts are unaudited. December 31, 2025 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, 2025, filed with the U.S. Securities and Exchange Commission on March 24, 2026.CONTACT: Media Contact:
Miranda Peto, Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120

Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120

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InspireMD Announces FDA Approval of the CGuard® Prime TransCarotid Stent System for Transcarotid Artery Revascularization (TCAR) Procedures

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– Approval doubles the CGuard Prime platform’s total addressable market in the U.S. with additional access to over 35,000 TCAR procedures annually – – Approval supported by CGUARDIANS II pivotal trial data, which demonstrated 100% acute device success and zero death, stroke, myocardial infarction or stent thrombosis reported at 30 days – MIAMI, Nov. 12, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Premarket Approval (“PMA”) Supplement for the CGuard® Prime TransCarotid Stent System for use in transcarotid artery revascularization (“TCAR”) procedures. The approval allows physicians in the U.S. to use the CGuard® Prime TransCarotid Stent System, which features an 80 cm delivery system, in transcarotid artery revascularization (“TCAR”) procedures when used in conjunction with an embolic protection system specified in the labeling. This gives physicians performing TCAR procedures access to the CGuard Prime stent and its proprietary MicroNet™ technology, a permanent protective micromesh that covers the self-expanding nitinol stent. “Today’s approval is a major milestone for InspireMD and for the physicians and patients who may benefit from TCAR as a treatment option for carotid artery disease,” said Marvin Slosman, Chief Executive Officer of InspireMD. “This approval extends our CGuard implant to TCAR procedures and is expected to provide a strong near-term growth driver for InspireMD. We believe InspireMD is the first and only company to approach carotid revascularization and stroke prevention with both CAS and TCAR delivery options and an implant-first mission, and we view this TCAR approval as an incredibly important step in advancing our leadership in this field. We look forward to providing patients and physicians with this next-generation stent, which we believe delivers unmatched clinical results.” The approval of the CGuard® Prime TransCarotid Stent System is supported by data from the Company’s CGUARDIANS II pivotal trial. This prospective, multicenter, single-arm U.S. study enrolled 50 pivotal patients across 11 investigational sites and evaluated the CGuard® Prime TransCarotid Stent System platform with TCAR using the FDA-cleared ENROUTE Transcarotid Neuroprotection System (“NPS”) in a high-surgical-risk population. At 30 days, the study achieved 100% acute device success, with no deaths, strokes, myocardial infarctions, or stent thrombosis reported, and complete stent patency observed in evaluable subjects. The availability of the CGuard® Prime TransCarotid Stent System with an existing FDA-cleared NPS allows InspireMD to enter the TCAR market independently of the Company’s ongoing development of its proprietary SwitchGuard™ NPS.   SwitchGuard is an investigational device and is not available for sale in the United States. “TCAR has become an increasingly important technique for carotid revascularization in the U.S., and we believe the availability of CGuard Prime for TCAR gives physicians a differentiated stent option designed around sustained embolic protection,” said Patrick J. Geraghty, M.D., Professor of Surgery and Radiology at Washington University School of Medicine in St. Louis and co-lead investigator of the CGUARDIANS II study. “The ability to combine CGuard’s MicroNet technology with transcarotid access and existing flow-reversal neuroprotection provides physicians with an important new option for treating patients with carotid artery disease.” With more than 35,000 TCAR procedures performed annually in the United States, the approved TCAR indication doubles the CGuard Prime platform’s total addressable market by extending its use beyond CAS procedures. Together, TCAR and CAS represent approximately 75,000 annual carotid stenting procedures in the United States, based on Company estimates. The approval also represents an important step in InspireMD’s broader TCAR strategy. Initially, the CGuard® Prime TransCarotid Stent System can be used in TCAR procedures with an existing FDA-cleared embolic protection system as specified in the labeling. The Company has developed a full suite of TCAR platform devices including SwitchGuard, its next generation transcarotid NPS, which is being evaluated in the CGUARDIANS III pivotal trial that is currently enrolling. If cleared by the FDA, SwitchGuard is expected to complement the CGuard® Prime TransCarotid Stent System and provide InspireMD with a fully integrated proprietary carotid stent and neuroprotection platform for TCAR procedures, along with a proprietary micro puncture access kit expanding the Company’s opportunity to capture value across the full TCAR procedure. Indication for Use The CGuard® Prime TransCarotid Stent System, when used in conjunction with an embolic protection system specified in the labeling, is indicated for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria specified in the labeling. Use of the device carries risks, including stroke, death, myocardial infarction, stent thrombosis or occlusion, vessel dissection and access-site complications. Rx only. Refer to the Instructions for Use for complete indications, contraindications, warnings, precautions and potential adverse events. About InspireMD, Inc. InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is listed on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com. Forward-looking Statements This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. In particular, forward-looking statements in this press release include the anticipated commercial launch and timing of sales of the CGuard Prime 80 cm stent system for TCAR procedures, the Company’s estimates of the size of the TCAR and CAS markets and its addressable market, the Company’s expectations regarding enhancements to the CGuard Prime 135 cm delivery system, the Company’s expectations regarding the CGUARDIANS III pivotal trial and potential FDA clearance of SwitchGuard; the Company’s ability to compete effectively in the carotid stenting market with both TCAR and CAS delivery systems and increase adoption of its products; expectations regarding market penetration, commercialization, revenue growth and future operating performance; and the Company’s strategic priorities, growth plans and future business prospects. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the voluntary U.S. recall of the CGuard Prime 135 cm delivery system, including current and future costs associated with the recall, including refunds or inventory write-off costs and other remediation costs, loss of sales and customers due to the recall or otherwise, our ability to effectively implement enhancements to CGuard Prime 135 cm delivery system, potential actions by regulators or other governmental entities associated with the recall, potential claims and lawsuits by customers and patients, including class action product liability lawsuits, other operational impacts and consequences of the recall, such as business disruption and distraction of management and other key employees; the Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise. Investor Contacts: Jeff WarrenLifeSci Advisorsjwarren@lifesciadvisors.cominvestor-relations@inspiremd.com

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Heartflow Reports Third Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

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SAN FRANCISCO, Nov. 12, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing and managing coronary artery disease (CAD), today reported financial results for the third quarter ended September 30, 2026. Third Quarter 2026 Highlights Total revenue of $72.9 million, a 57% increase year-over-yearGross margin of 83.6%, non-GAAP gross margin of 83.8%Net operating loss of $13.8 million; non-GAAP net operating loss of $5.0 million 2026 Annual Guidance Total revenue of $262 million to $264 million (approximately 49% to 50% growth year-over-year), compared to previous guidance of $246 million to $250 million (approximately 40% to 42% growth year-over-year)Non-GAAP gross margin of approximately 82.5%, compared to previous guidance of approximately 82% “Our third quarter was excellent, with revenue accelerating for the third consecutive quarter and U.S. revenue growing at its fastest pace in 11 quarters,” said John Farquhar, President and CEO of Heartflow. “Our core FFRCT business remains durable, our installed base continues to expand rapidly, and activations of Heartflow Plaque Analysis are ramping ahead of plan, with utilization broadening across a wider share of applicable CCTAs. The CCTA market continues to grow rapidly and remains significantly underpenetrated. Strong performance across our diagnostic platform, along with disciplined execution of our commercial, innovation and clinical initiatives, gives us the confidence to raise our 2026 guidance once again. With continued momentum and a scaling business, we believe we are well positioned to extend our market leadership, and we have increased confidence in our path to profitability.” Third Quarter 2026 Financial ResultsTotal revenue was $72.9 million, a 57% increase year-over-year. U.S. revenue was $67.9 million, a 60% increase year-over-year. International and other revenue was $4.9 million, a 29% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT revenue case volume and an increase in total U.S. Plaque revenue case volume. Gross profit was $60.9 million, compared to $35.4 million in the prior year period. Non-GAAP gross profit was $61.1 million, compared to $35.5 million in the prior year period. Gross margin was 83.6%, compared to 76.5% in the prior year period. Non-GAAP gross margin was 83.8%, compared to 76.8% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in total revenue case volume, an increase in total U.S. Plaque revenue case volume, and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel. Total operating expenses were $74.8 million, or 103% of total revenue, compared to $50.5 million, or 109% of total revenue, in the prior year period. Non-GAAP total operating expenses were $66.1 million, or 91% of total revenue, compared to $46.7 million, or 101% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research. Net operating loss was $13.8 million, compared to $15.1 million in the prior year period. Non-GAAP net operating loss was $5.0 million, compared to $11.1 million in the prior year period. Net loss was $11.5 million, or ($0.13) net loss per share, compared to $50.9 million, or ($1.04) net loss per share, in the prior year period. Net loss in the prior year period included a $32.1 million noncash charge from the remeasurement of the fair value of the Company’s warrant liability, a $4.8 million noncash benefit from the remeasurement of the fair value of the Company’s derivative liability, and a $6.4 million loss on extinguishment of debt from the full prepayment of the Company’s term loan in August 2025. Non-GAAP net loss was $2.7 million, or ($0.03) non-GAAP net loss per share, compared to $13.2 million, or ($0.27) non-GAAP net loss per share, in the prior year period. Adjusted EBITDA was ($3.6) million, compared to ($9.8) million in the prior year period. Cash, cash equivalents and investments totaled $253.0 million as of September 30, 2026. For additional information regarding non-GAAP financial measures, see “Use of non-GAAP Measures,” “Heartflow GAAP to non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below. Webcast and Conference Call DetailsHeartflow will host a conference call today, November 12, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its third quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and Research Heartflow’s technology is redefining precision diagnostic testing and management for coronary artery disease (CAD) through clinically proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 800,000 patients worldwide.1 Key benefits include: Unmatched proprietary data pipeline: Built from the world’s largest database of more than 250 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible diagnostic insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001. About Heartflow, Inc. Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Use of Non-GAAP MeasuresTo supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, loss on extinguishment of debt, certain litigation expenses and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, certain litigation expenses, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their Non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry. The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety. The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to Non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure. Forward-Looking StatementsThis press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our two products, Heartflow FFRCT Analysis and Heartflow Plaque Analysis; healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Investor ContactNick Laudiconlaudico@heartflow.com Media ContactElliot Levyelevy@heartflow.com HEARTFLOW, INC. Consolidated Statements of Operations Data(unaudited, in thousands, except share and per share data)                             Three Months Ended   Nine Months Ended    September 30,   September 30,    2026   2025   2026   2025              Revenue $72,857  $46,276  $189,526  $126,904 Cost of revenue  11,940   10,861   33,255   30,770 Gross profit  60,917   35,415   156,271   96,134 Operating Expenses:            Research and development  29,487   17,297   77,368   46,253 Selling, general and administrative  45,276   33,217   132,671   96,197 Asset impairment charge  –   –   7,482   – Total operating expenses  74,763   50,514   217,521   142,450 Loss from operations  (13,846)  (15,099)  (61,250)  (46,316)Interest income  2,284   1,725   7,053   2,903 Interest expense  (5)  (3,451)  (8)  (15,165)Change in fair value of common stock warrant liability  –   (32,117)  –   (34,586)Change in fair value of derivative liability  –   4,818   –   7,311 Loss on extinguishment of debt  –   (6,360)  –   (6,360)Other income (expense), net  85   (341)  (355)  (94)Loss before provision for income taxes  (11,482)  (50,825)  (54,560)  (92,307)Provision for income taxes  (23)  (30)  (68)  (89)Net loss $(11,505) $(50,855) $(54,628) $(92,396)Comprehensive loss:            Net loss $(11,505) $(50,855) $(54,628) $(92,396)Other comprehensive loss:            Foreign currency translation gain (loss)  (26)  205   227   260 Unrealized loss on investments, net  (669)  –   (1,395)  – Total other comprehensive gain (loss)  (695)  205   (1,168)  260 Total comprehensive loss $(12,200) $(50,650) $(55,796) $(92,136)             Net loss per share, basic and diluted $(0.13) $(1.04) $(0.63) $(4.47)Weighted-average shares used to compute net loss per share, basic and diluted 87,249,228   49,106,752   86,435,123   20,686,526  HEARTFLOW, INC.Consolidated Balance Sheets Data(unaudited, in thousands, except par value)         September 30, December 31,  2026 2025Assets      Current assets      Cash and cash equivalents $31,649  $44,776 Short-term investments  136,088   132,010 Accounts receivable, net  48,195   29,343 Prepaid expenses and other current assets  19,573   14,075 Total current assets  235,505   220,204 Long-term investments  85,254   103,365 Property and equipment, net  10,091   8,587 Operating lease right-of-use assets  14,123   17,488 Restricted cash  4,702   4,709 Other non-current assets  5,664   5,099    Total assets $355,339  $359,452        Liabilities and stockholders’ equity      Current liabilities      Accounts payable $4,916  $3,169 Accrued expenses and other current liabilities  41,613   33,279 Operating lease liabilities, current portion  6,881   5,922    Total current liabilities  53,410   42,370 Operating lease liabilities, non-current portion  19,052   16,132 Other non-current liabilities  340   303    Total liabilities  72,802   58,805 Stockholders’ equity      Preferred stock, $0.001 par value  –   – Common stock, $0.001 par value  88   85 Additional paid-in capital  1,426,420   1,388,737 Accumulated other comprehensive loss  (1,593)  (425)Accumulated deficit  (1,142,378)  (1,087,750)Total stockholders’ equity  282,537   300,647    Total liabilities and stockholders’ equity $355,339  $359,452  HEARTFLOW, INC. GAAP to Non-GAAP Reconciliations(unaudited, in thousands except per share amounts and percentage data)                 Three Months Ended September 30, 2026    Three Months Ended September 30, 2025    GAAP  Adjustments  Non-GAAP  GAAP  Adjustments  Non-GAAP                   Gross profit $60,917  $164 (a)$61,081  $35,415  $127 (a)$35,542 Gross margin  83.6%  0.2%  83.8%  76.5%  0.3%  76.8%                   Operating Expenses:                  Research and development $29,487  $(2,732)(a)$26,755  $17,297  $(959)(a)$16,338 Selling, general and administrative $45,276  $(5,936)(b)$39,340  $33,217  $(2,874)(a)$30,343 Total operating expenses $74,763  $(8,668) $66,095  $50,514  $(3,833) $46,681                    Loss from operations $(13,846) $8,832  $(5,014) $(15,099) $3,960  $(11,139)                   Net loss $(11,505) $8,832 (c)$(2,673) $(50,855) $37,619 (d)$(13,236)Net loss per share, basic and diluted $(0.13) $0.10  $(0.03) $(1.04) $0.77  $(0.27)                   (a) Represents adjustments related to stock-based compensation expense(b) Represents adjustments for: (i) stock-based compensation expense of $4.7 million; and (ii) certain litigation expenses of $1.3 million(c) Represents adjustments for: (i) stock-based compensation expense of $7.6 million; and (ii) certain litigation expenses of $1.3 million(d) Represents adjustments for: (i) stock-based compensation expense of $4.0 million; (ii) change in fair value of common stock warrant liability of $32.1 million; (iii) change in fair value of derivative liability of $4.8 million; and (iv) loss on extinguishment of debt of $6.4 million HEARTFLOW, INC. GAAP to Non-GAAP Reconciliations(unaudited, in thousands except per share amounts and percentage data)                 Nine Months Ended September 30, 2026    Nine Months Ended September 30, 2025    GAAP  Adjustments  Non-GAAP  GAAP  Adjustments  Non-GAAP                   Gross profit $156,271  $503 (a)$156,774  $96,134  $229 (a)$96,363 Gross margin  82.4%  0.3%  82.7%  75.7%  0.2%  75.9%                   Operating Expenses:                  Research and development $77,368  $(7,602)(a)$69,766  $46,253  $(1,887)(a)$44,366 Selling, general and administrative $132,671  $(17,674)(b)$114,997  $96,197  $(6,589)(a)$89,608 Asset impairment charge $7,482  $(7,482) $-  $-  $-  $- Total operating expenses $217,521  $(32,758) $184,763  $142,450  $(8,476) $133,974                    Loss from operations $(61,250) $33,261  $(27,989) $(46,316) $8,705  $(37,611)                   Net loss $(54,628) $33,261 (c)$(21,367) $(92,396) $42,340 (d)$(50,056)Net loss per share, basic and diluted $(0.63) $0.38  $(0.25) $(4.47) $2.05  $(2.42)                   (a) Represents adjustments related to stock-based compensation expense(b) Represents adjustments for: (i) stock-based compensation expense of $13.9 million; and (ii) certain litigation expenses of $3.7 million   (c) Represents adjustments for: (i) stock-based compensation expense of $22.0 million; (ii) certain litigation expenses of $3.7 million; and (iii) asset impairment charge of $7.5 million   (d) Represents adjustments for: (i) stock-based compensation expense of $8.7 million; (ii) change in fair value of common stock warrant liability of $34.6 million; (iii) change in fair value of derivative liability of $7.3 million; and (iv) loss on extinguishment of debt of $6.4 million    HEARTFLOW, INC. Reconciliation of GAAP Net Loss to Adjusted EBITDA(unaudited, in thousands)                Three Months Ended   Nine Months Ended    September 30,   September 30,   2026 2025 2026 2025             GAAP net loss $(11,505) $(50,855) $(54,628) $(92,396)Non-GAAP adjustments:            Interest (income) expense, net  (2,279)  1,726   (7,045)  12,262 Asset impairment charge  –   –   7,482   – Change in fair value of common stock warrant liability  –   32,117   –   34,586 Change in fair value of derivative liability  –   (4,818)  –   (7,311)Loss on extinguishment of debt  –   6,360   –   6,360 Other (income) expense, net  (85)  341   355   94 Provision for income taxes  23   30   68   89 Certain litigation expenses  1,259   –   3,740   – Depreciation and amortization  1,385   1,304   4,028   4,071 Stock-based compensation expense  7,573   3,960   22,039   8,705 Adjusted EBITDA $(3,629) $(9,835) $(23,961) $(33,540) 1 Gulati M, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCAI Guideline for the Evaluation and Diagnosis of Chest Pain. Circulation 2021; 144:e368–e454.2 Rinehart, et al. JACC Imaging. 2025.3 Narula, et al. EHJ CVI 2024.4 Danad, et al. JAMA Cardiol 2017.5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024. (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years).

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Cyclarity Therapeutics Receives FDA Investigational New Drug Clearance for UDP-003 to expand Atherosclerosis Clinical Development Program into the United States

Coronary/Structural Heart by 0 comments

NOVATO, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) — Cyclarity Therapeutics, Inc., a clinical-stage biotechnology company developing cyclodextrin therapeutics to reverse atherosclerotic cardiovascular diseases and metabolic diseases of aging, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for UDP-003. UDP-003, designed by Cyclarity’s proprietary AI-enabled computational platform, is engineered to bind and extract oxidized cholesterol to restore cellular function and spur atherosclerotic plaque regression. The IND clearance authorizes the expansion of Cyclarity Therapeutics’ Phase 1b trials to the United States, complementing the ongoing study in Australia. The study (NCT06813339; CTx-001) is a multi-dose, intravenous administration trial evaluating the safety of UDP-003 in patients with Coronary Artery Disease. It includes pre- and post- CCTA imaging to evaluate coronary plaque status and inflammation. Cyclarity plans to launch an expanded Phase 1b trial in the U.S. in Q1 of 2027. “Clearance of the IND for UDP-003 represents a major milestone in the drug’s clinical development,” says Dr. Matthew O’Connor, co-CEO, “We are looking forward to executing Phase 1b trials at Cedars-Sinai Medical Center in Los Angeles. We are excited for the progress this accomplishment will bring.” About UDP-003UDP-003 is an investigational injectable small molecule (cyclodextrin) designed using Cyclarity’s proprietary AI-enabled computational platform to shrink plaque by the selective removal of oxidized cholesterol, and specifically 7-ketocholesterol. About Cyclarity TherapeuticsCyclarity Therapeutics, Inc. and Cyclarity Therapeutics Australia Pty Ltd., are pursuing a mission to treat the underlying causes of age-related disease. The company develops simple and direct interventions targeting oxidized cholesterol using rationally designed molecules, to provide the first true disease-modifying treatments for common age-related conditions such as atherosclerosis, heart attack, and stroke. Its products are based on novel derivatives of a well-known, safe compound and a new way of looking at cardiovascular disease. For more information, please visit www.cyclaritytx.com or send an email to press@cyclaritytx.com.

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Ventric health fda cleared vivio system

Ventric Health and Stellus Rx Collaborate to Bridge the Gap Between Early Heart Failure Detection and Guideline-Directed Medical Therapy

Coronary/Structural Heart by 0 comments

Strategic collaboration pairs point-of-care non-invasive diagnostics with EHR-embedded virtual pharmacy care management to accelerate GDMT titration, reduce hospitalizations and drive value-based care performance PASADENA, Calif., Nov. 12, 2026 /PRNewswire/ — Ventric Health and Stellus…

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