Author: Ken Dropiewski

JenaValve Presents Late-Breaking JENA-VAD Data at TCT 2026, Demonstrating High Technical Success and 30 Day Safety of the Trilogy System in LVAD Patients Under IDE

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– Data reflects outcomes from 50 patients with Left Ventricular Assist Devices (LVADs) and Clinically Significant Aortic Regurgitation (AR) treated with the Trilogy System- Demonstrated 96% technical success with no deaths or strokes, at 30 days in a patient population with significant comorbidities and limited options- Data simultaneously published in the Journal of the American College of Cardiology (JACC)- Additionally, the Company successfully presented a live Trilogy case from Cedars-Sinai IRVINE, Calif., Nov. 10, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy Transcatheter Heart Valve (THV) System, today announced highlights from the 2026 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Diego, CA. JenaValve presented late-breaking data from the JENA-VAD Registry investigational study in the US, a prospective, multicenter registry evaluating the Trilogy System in patients with an LVAD and clinically significant AR. Early outcomes were shown from fifty patients, demonstrating high technical success with no adverse events or serious complications and early improvements in functional status and patient-reported quality of life. Dr. Torsten Vahl, director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center presented the results of the JENA-VAD Registry, which were simultaneously published in the Journal of the American College of Cardiology (JACC), linked here. AR has historically been reported in up to 20% to 30% of patients within two to three years of continuous-flow LVAD support. In these patients, AR creates a recirculation loop between the pump and the left ventricle, which reduces systemic flow and leads to congestion and recurrent heart failure. Surgical options carry high risk in this population. Transcatheter valves designed for aortic stenosis often anchor poorly in the noncalcified anatomy typical of AR, which can lead to migration or the need for a second valve. The Trilogy System instead uses locators that clip the native aortic leaflets, so it does not depend on annular calcification to anchor. “Many patients with LVADs develop aortic regurgitation, yet treatment options remain extremely limited, considering the very high risk of surgery. The continuous mechanical support provided by the LVAD, combined with the absence of leaflet calcification, creates a particularly high risk of valve embolization with TAVR devices developed for aortic stenosis,” said Dr. Vahl. “In the JENA-VAD Registry, the Trilogy valve was successfully implanted in 50 patients with LVADs, with no instances of valve migration, embolization or need for a second valve. We observed high rates of technical and device success without any deaths or strokes within 30 days, and no significant paravalvular leak. These results are exceptionally encouraging and demonstrate the feasibility of the Trilogy valve in this particularly challenging patient population. We are excited that this technology may finally offer a meaningful treatment option for patients with LVADs who develop aortic regurgitation.” Fifty patients were treated in the JENA-VAD Registry at 14 U.S. centers. All patients were NYHA class III or IV at baseline, and all had undergone prior open-heart surgery. Technical success and 30-day device success were each 96.0%. Ninety percent of patients were free from the VARC-3 early safety composite at 30 days. There were no deaths or strokes within 30 days and no moderate or greater prosthetic regurgitation. No patient had valve migration or needed a second valve. Early findings also point to improvements in symptoms: at 30 days, 72.3% of patients assessed had mild or no heart failure symptoms (NYHA class I or II), compared with none before the procedure. JENA-VAD is being conducted under an investigational device exemption (IDE) and is nested within the ALIGN-AR trial. “Historically, patients with an LVAD who develop AR have had very few good options, and the functional improvements we saw in JENA-VAD are highly encouraging,” said Ravi Ramana, DO, Heart Care Centers of Illinois and national principal investigator of the prospective JENA-VAD Registry. “It remains early, but we look forward to continuing to follow these patients. The thrombosis findings and open questions about anticoagulation in this population call for systematic imaging and longer follow-up, and the one-year results will be essential.” “The JENA-VAD Registry reflects our commitment to evaluating the Trilogy System rigorously in patients with few alternatives and to reporting what we learn transparently,” said Gabriel Sayer, MD, Associate Director of Advanced Heart Failure, Cardiac Transplantation and Mechanical Circulatory support at New York-Presbyterian and national principal investigator of the JENA-VAD Registry. “These results provide promising data in a very high-risk population and we look forward to continued follow up and further research to better define what this device may mean for LVAD patients with AR in the future.” An additional highlight of TCT 2026 was a live case broadcast from Cedars-Sinai Medical Center in Los Angeles, featuring the successful implantation of the Trilogy transcatheter heart valve in a patient with severe aortic regurgitation. The procedure was performed by Raj Makkar, MD, of Cedars-Sinai Medical Center, providing attendees with a real-time demonstration of the Trilogy system in clinical practice. About JenaValveJenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis (AS) who are at high surgical risk. The Trilogy THV System has regulatory approvals in the United States and Europe for its intended use, and reflects JenaValve’s focus on addressing unmet clinical needs in aortic valve disease, including aortic regurgitation. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany. JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited. Additional information is available at www.jenavalve.com. JenaValve Contact:Daniel Sun dsun@jenavalve.com Investor Contacts:Marissa BychGilmartin Group LLCmarissa@gilmartinir.com

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Nanox.AI Advances Commercial Collaboration with Dosy Health to Bring AI Cardiac Solution to Thailand

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Collaboration builds on Dosy Health’s established relationships with Mahidol University, Thammasat University and hospitals within the BDMS network, supporting planned distribution and commercialization in Thailand PETACH TIKVA, Israel, [DATE] (GLOBE NEWSWIRE) — Nano-X Imaging Ltd. (NASDAQ: NNOX) (“Nanox” or the “Company”), a leader in innovative medical imaging technology, today announced that its subsidiary, Nanox AI Ltd. (“Nanox.AI”), is advancing a commercial collaboration with Dosy Health (“Dosy”), a Thailand-based healthcare technology company, to support the planned introduction and commercialization of Nanox.AI’s CT-based cardiac solution in Thailand. The parties have signed a distribution agreement for Nanox.AI’s cardiac solution, HealthCCSng. The proposed collaboration represents a step in Nanox.AI’s strategy to expand its international commercial footprint and bring CT-based imaging analytics to additional healthcare markets. Dosy Health maintains existing business relationships with Mahidol University and Thammasat University, alongside healthcare software activities with hospitals within the Bangkok Dusit Medical Services (BDMS) network. Its local healthcare relationships and software-integration capabilities could support engagement with healthcare stakeholders, evaluation of integration requirements and future market development. Following participation by Dosy Health’s CEO, Sahatus Asawadilockchai, in the Global Medical AI Summit in Thailand, several hospitals expressed interest in the proposed solutions, according to Dosy Health. These discussions remain preliminary and do not constitute purchase commitments.Nanox.AI develops imaging analytics designed to extract additional clinical insights from existing CT scans. HealthCCSng analyzes routine non-contrast, non-gated CT scans that include the entire heart to provide coronary artery calcium measurements and categorization for clinician review. Product availability and permitted uses vary by market and remain subject to applicable regulatory requirements. “Every routine CT scan can hold insights that may otherwise go unnoticed, and expanding our international presence is a key part of Nanox.AI’s commercialization strategy,” said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. “Our developing collaboration with Dosy Health offers an opportunity to introduce our Cardiac solution, to Thailand’s healthcare market. By combining our imaging analytics with Dosy’s local market knowledge and software-integration capabilities, we aim to help clinicians see what matters, and to build a foundation for future commercial opportunities.” “We’re seeing growing momentum for medical imaging AI in Thailand. The country has a large CT scanner base, with more scanners per capita than several Southeast Asian peers. For us, that’s a significant opportunity to unlock more clinical value from existing CT scans and better inform patient care. We are proud to collaborate with Nanox.AI, which brings deep expertise in medical imaging AI and has developed U.S. FDA-cleared software. At Dosy, we bring experience developing AI and integrating software for Thai hospitals, including those in one of the country’s largest private hospital groups. We have strong relationships with major hospitals, medical schools and public-sector organizations in Thailand. Together, we’ll start with cardiac imaging and focus on bringing AI findings into the systems Thai clinicians already use, with room to explore bone and liver imaging over time,” said Sahatus Asawadilockchai, Chief Executive Officer of Dosy Health. The companies expect to continue discussions regarding proposed commercial arrangements, product training and regulatory preparation. Future commercialization is subject to definitive agreements, applicable regulatory requirements and market-development progress. About Nanox Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform. Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes. The Nanox ecosystem includes Nanox.ARC X, a multi-source digital tomosynthesis system designed to make advanced 3D imaging accessible in more clinical settings; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provides access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery. The Nanox.ARC X was selected as one of TIME’s Best Inventions of 2026. By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit https://www.nanox.vision. About Nanox.AI Nanox.AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox.AI solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI, Nanox.AI helps clinicians extract valuable and actionable clinical insights from medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit www.nanox.vision/ai. Forward-Looking Statements This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of Nanox’s liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; (iv) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (v) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (vi) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vii) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (viii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (ix) Nanox’s ability to conduct business globally; (x) changes in global, political, economic, business, competitive, market and regulatory forces; (xi) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xii) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xiii) potential litigation associated with our transactions. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2025, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations. Contacts Media Contact:Ben ShannonICR HealthcareNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Healthcaremike.cavanaugh@icrhealthcare.com

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Adagio Medical Provides Business Update: 22 Patients Treated with Next-Generation vCLAS™ Ultra System as FULCRUM-VT IDE Sub-Study Advances

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LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today provided a business update highlighting continued execution of its FULCRUM-VT IDE study and FULCRUM-VT IDE sub-study, as well as progress of its previously announced review of strategic alternatives. Clinical Update To date, the Company has treated a total of 22 patients with the Com

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GE HealthCare announces intent to establish MAGNUS Neuro Alliance to unlock new possibilities in MRI for neuroscience

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CHICAGO–(BUSINESS WIRE)–GE HealthCare (Nasdaq: GEHC) today announced the intent to establish a collaborative research network focused on advancing neuroscience research leveraging an ultra high-gradient head-only 3.0T MR system1. The MAGNUS2 Neuro Alliance will bring together researchers and clinicians with expertise in neurology, radiology, psychiatry, oncology, and several other subject areas, to explore how high-performance MR imaging may enable new scientific questions and research approa

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Bayer’s SUNHARBO® (asundexian), 50 mg tablets, the First and Only Factor XIa Inhibitor, Approved by the U.S. FDA to Reduce the Risk of Stroke in Adults With Recent Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack…

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WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer Bayer’s SUNHARBO® (asundexian), 50 mg tablets, the First and Only Factor XIa Inhibitor, Approved by the U.S. FDA to Reduce the Risk of Stroke in Adults With Recent Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack, in Combination With Antiplatelet Therapy Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved SUNHARBO® (asundexian), 50 mg tablets, a first-in-class, once daily, Factor XIa inhibitor indicat

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NEW DATA AT AHA 2026 DEMONSTRATES THE VALUE OF TREATMENT WITH REPATHA® EARLIER IN THE CARDIOVASCULAR RISK CONTINUUM

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Independent VESALIUS-CV Analysis Finds Repatha Highly Cost-Effective in High-Risk Patients Without a Prior Heart Attack or Stroke Long-Term FOURIER External-Control Analysis Shows Repatha Associated With 29% Lower Risk of Major Cardiovascular Events in Patients Living With ASCVD THOUSAND…

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New Data at 2026 American Heart Association Scientific Sessions Highlight Cardiovascular Effects of Sotagliflozin on Thrombus Formation and in Hypertrophic Cardiomyopathy

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— In a randomized crossover study, sotagliflozin significantly reduced ex vivo thrombus formation from baseline under both arterial and venous flow conditions — — Study in living human heart tissue indicate sotagliflozin acutely and directly reduces myocardial work in hypertrophic cardiomyopathy (HCM) — — Findings add mechanistic insight into sotagliflozin’s dual SGLT1/SGLT2 inhibition ahead of SONATA-HCM topline results in Q1 2027 — THE WOODLANDS, Texas, Nov. 09, 2026 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a leading cardiometabolic biopharmaceutical company, today announced new data highlighting the cardiovascular effects of its dual SGLT1/2 inhibitor, sotagliflozin, which were shared in two poster presentations at the American Heart Association (AHA) Scientific Sessions 2026. The investigator-initiated studies were sponsored by Lexicon and conducted by investigators at the Ichan School of Medicine at Mount Sinai and Penn Cardiovascular Institute. In the first presentation, “Zafar et al. Effects of Sotagliflozin and Empagliflozin on Thrombus Formation in Healthy Volunteers: A Randomized Crossover Trial”, researchers from the Ichan School of Medicine examined whether sotagliflozin reduces the blood’s tendency to form clots, which are the leading cause of heart attacks and strokes. In the 4-week, randomized, open-label crossover study, 15 healthy adults received once-daily sotagliflozin 400 mg and the selective SGLT2 inhibitor empagliflozin 10 mg in random order. Researchers measured clot formation in participants’ blood before and after each treatment, using an ex vivo laboratory model in which blood is drawn over a system that mimics a damaged artery and at speeds that replicate arterial and venous blood flow. Sotagliflozin significantly reduced clot formation from baseline under both arterial-like (11.9%; p=0.043) and venous-like (15.6%; p=0.012) conditions. Reductions with empagliflozin did not reach statistical significance. The second presentation, “Taichman et al. Load-Dependent Effects of Sodium Glucose Co-Transporter Inhibitors on Work in Human Hypertrophic Cardiomyopathy Living Myocardial Slices,” examined whether sotagliflozin acts directly on human heart muscle affected by HCM. Researchers at Penn Cardiovascular Institute used heart tissue removed from patients with HCM during septal myectomy, a surgery to relieve obstruction, along with tissue from non-failing donor hearts. In an ex vivo model using living myocardial slices, myocardial work was studied across a physiologic range of afterloads, or the pressures the heart pumps against. Short-term exposure to sotagliflozin and empagliflozin directly reduced the work performed by the heart muscle. Sotagliflozin showed increased potency versus empagliflozin at higher afterloads, which mimics the HCM condition. The findings indicate that sotagliflozin can act directly on the heart, independent of its effects on the kidneys and metabolism. The findings were simultaneously published in JACC: Basic to Translational Science. “A growing body of research continues to suggest that adding SGLT1 inhibition may contribute to cardiovascular effects beyond those seen with SGLT2 inhibition alone,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer of Lexicon. “The thrombosis data point to a potential mechanism behind the reductions in heart attack and stroke seen in SCORED, while the human tissue findings show a direct effect of sotagliflozin on the hypercontractile heart muscle that characterizes HCM. Together, these new datasets strengthen the scientific rationale for sotagliflozin in HCM and reinforce our excitement for the pivotal readout of our SONATA-HCM study.” The ongoing Phase 3 SONATA-HCM trial is evaluating sotagliflozin as a potential treatment option for patients with symptomatic obstructive and non-obstructive HCM. Topline results are expected in the first quarter of 2027. About Sotagliflozin Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract and the heart. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for hypertrophic cardiomyopathy (HCM). About Lexicon Pharmaceuticals Lexicon Pharmaceuticals is a biopharmaceutical company pursuing novel medicines for patients with serious cardiometabolic diseases. Building on a proven legacy in genetic target discovery, Lexicon is advancing a clinical pipeline in areas of significant and often underserved need, with programs in hypertrophic cardiomyopathy (HCM), type 1 diabetes (T1D), obesity and other related metabolic conditions. Lexicon is committed to developing differentiated therapies that can be integrated broadly into clinical practice, with the goal of expanding treatment options for patients. Its capabilities extend from early-stage target discovery through clinical development and commercialization, strategically paired with high-impact collaborations to maximize the global reach of its medicines. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin, including in hypertrophic cardiomyopathy. In addition, this press release may also contain forward-looking statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries: Dave Belian Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com

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Pivotal Study Validates Cordio Medical’s Smartphone-Based Voice Analysis for Remote Heart Failure Monitoring

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Results Presented as Late-Breaking Science at the American Heart Association (AHA) Scientific Sessions 2026 Blinded, Multicenter Study of 563 Patients Identified Risk 24.6 Days in Advance and Saw 85% Compliance and High Patient Satisfaction CHICAGO, Nov. 9, 2026 /PRNewswire/ — Cordio…

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Humacyte Highlights First-in-Human Coronary Bypass Study at American Heart Association Scientific Sessions 2026

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– Humacyte has initiated the CABG clinical study and looks forward to the commencement of screening for potential patients.  – “Moving it into a first-in-human study is the step that will tell us whether an off-the-shelf conduit can perform in the coronary position,” says cardiothoracic surgeon Alan Kypson, M.D. DURHAM, N.C., Nov. 09, 2026 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced that it has initiated the Phase 2a study of its investigational coronary tissue engineered vessel (CTEV) in patients undergoing coronary artery bypass grafting (CABG). The CTEV and the Company’s regenerative medicine platform were highlighted in three presentations at the American Heart Association (AHA) Scientific Sessions 2026 in Chicago, Illinois. The AHA Scientific Sessions is one of the world’s largest gatherings of cardiovascular clinicians and scientists. On Saturday, November 7, John H. Alexander, M.D., M.H.S., Professor of Medicine/Cardiology, Duke Clinical Research Institute at Duke University and Alan Kypson, M.D., Cardiothoracic Surgeon at UNC Rex Hospital, presented the design of the Phase 2a study in “First-in-Human Phase 2a Study Design of a Bioengineered Human Coronary Artery for Coronary Artery Bypass Grafting.” The FDA accepted Humacyte’s Investigational New Drug (IND) application in July 2026, and the study will evaluate the safety and efficacy of the CTEV as a vascular conduit in ten adult patients with coronary artery disease. Patency will be assessed two months after implant, and patients will be followed for up to three years. The study is now open for enrollment. “Every cardiac surgeon has faced the patient who needs a bypass, but doesn’t have usable vein, and our options in those cases are limited,” said Dr. Kypson. “I have worked with this vessel in large-animal models for years and moving it into a first-in-human study is the step that will tell us whether an off-the-shelf conduit can perform in the coronary position.” More than 400,000 coronary arterial grafts are placed each year in the United States. The current conduits used for CABG are autologous vessels harvested from the patient, most often the saphenous vein in the leg. However, saphenous vein graft patency at one year is often as low as 75%, and harvesting the vein can cause surgical wound complications such as infection, and some patients do not have adequate vein available. The CTEV is a small-diameter bioengineered vessel designed as an off-the-shelf conduit for CABG and is produced using the same manufacturing system as Humacyte’s FDA-approved acellular tissue engineered vessel (ATEV). On Saturday, November 7, Dr. Niklason delivered an invited talk, “Engineering the Microenvironment to Accelerate Vascular Regeneration,” in a special session on bioengineering human tissue for congenital heart disease, describing how Humacyte’s acellular engineered vessels are designed to be repopulated by a patient’s own cells after implantation, and may serve as materials to form biological heart valves that could grow with the pediatric patient. “The Phase 2a CABG study marks the first time our bioengineered vessel technology will be evaluated in coronary bypass surgery, and it builds on years of preclinical work in multiple large-animal models,” said Dr. Niklason. “Our goal with the CTEV is to give cardiac surgeons an off-the-shelf conduit that can repopulate with a patient’s own cells, without the need to harvest a vein from the leg or an artery from the arm.” On Sunday, November 8, Robert Kirkton, Ph.D., Executive Director of New Product and Process Development at Humacyte, presented results from porcine and ovine CABG models in “Evaluation of Tissue Engineered Human Vessels in Porcine and Ovine Models of Coronary Artery Bypass Grafting.” These results included successful implantation of ~12 cm-long CTEV bypasses for up to three months in sheep demonstrating patency and host recellularization of the CTEV wall with smooth muscle cells as well as luminal endothelial cells along the length of the CTEV CABG conduit. This work builds on a previous preclinical CABG study in baboons, published in JACC: Basic to Translational Science, in which the CTEV maintained mechanical integrity and conduit patency for up to six months while becoming recellularized with host vascular smooth muscle and endothelial cells. The CTEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. About Humacyte Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma and for advanced PAD also have received RMAT designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our ability to design, initiate and successfully complete clinical trials and other studies for our product candidates and our plans and expectations regarding our ongoing or planned clinical trials; the anticipated characteristics and performance of our ATEVs; the implementation of our business model and strategic plans for our business; our ability to execute and achieve the expected benefits of our cost-saving measures and whether our efforts will result in further actions or additional asset impairment charges that adversely affect our business; and the timing or likelihood of regulatory filings, acceptances and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Form 10-Q for the quarter ended March 31, 2025, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release. Humacyte Investor Contact:Joyce AllaireLifeSci Advisors LLC+1-617-435-6602jallaire@lifesciadvisors.cominvestors@humacyte.com Humacyte Media Contact:Rich LuchettePrecision Strategies+1-202-845-3924rich@precisionstrategies.commedia@humacyte.com

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