The Latest Cardiac and Vascular News
SAN FRANCISCO, Nov. 11, 2026 /PRNewswire/ — Skribe Medical, a U.S. medical technology company developing wearable cardiac monitoring for cancer care, today announced progress in its clinical development program following selection of its Aurora System for the U.S. Food and Drug…
NASHVILLE, Tenn.–(BUSINESS WIRE)–Mosaic Clinical Technologies, Inc.™ (Mosaic) today announced results from an ongoing, internal research study of how investigational vision-language models (VLMs)* performed on more than 237,000 CT and X-ray exams. Across all 50 conditions evaluated, VLMs developed by Cognita Imaging, Inc.™ (Cognita), Mosaic’s advanced AI lab, identified additional clinically important findings as confirmed by expert radiologists, enhancing detection by an average of approxima
CORTLANDT MANOR, N.Y.–(BUSINESS WIRE)–Polymedco, LLC has been awarded a national group purchasing agreement for National Group Purchasing Agreement with Premier, Inc. Effective November 1, 2026, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the PATHFAST® point-of-care (POC) analyzer and cardiac biomarker testing menu. “Polymedco is thrilled to be named a contracted supplier to Premier Inc.,” said Chr
MINNEAPOLIS and BRISBANE, Australia, Nov. 10, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended September 30, 2026, and provided a corporate update. Q3 2026 Highlights Continued execution of the PARADIGM Trial, with enrollment progressing across active sites in the U.S., Canada, Denmark, the Netherlands and France. Subsequent to quarter-end, the trial received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and advanced in Australia following HREC approval and TGA authorization under the Clinical Trial Notification pathway.Assumed occupancy of the Northcross facility in Minnesota, providing additional capacity to scale production of the DurAVR® THVs and ComASUR® Delivery System, in preparation for commercialization.Appointed Brent Moen as Chief Financial Officer, effective September 11, to support the Company’s financial and governance priorities as it advances the DurAVR THV toward commercialization. “Q3 saw continued progress on multiple fronts. The PARADIGM Trial recruitment is advancing along with capacity expansion in line with our clinical and commercial plan. The Company also brought in some key hires to strengthen our operating model and future capabilities,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. Business & Operations During the quarter, the Company continued to execute the global pivotal PARADIGM Trial across active sites in the United States, Canada and Europe. The Company increased site activation in the United States and expanded the PARADIGM Trial into Canada and France, where sites are active and enrolling, following completion of key start-up activities, including site qualification, investigator training and operational readiness. Subsequent to quarter end, the trial received regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM), supporting its expansion into Germany. In Australia, the trial received Human Research Ethics Committee (HREC) approval and authorization from the Therapeutic Goods Administration (TGA) under the Clinical Trial Notification (CTN) pathway, further extending the trial’s geographic reach. On September 1, the Company assumed occupancy as the primary tenant of the Northcross facility in Brooklyn Park, Minnesota. The facility provides additional capacity to scale production of the DurAVR THVs, the ComASUR Delivery System and related components in preparation for commercialization. The ComASUR Delivery System is designed to support controlled deployment and accurate placement of the balloon-expandable DurAVR THV, a new class of biomimetic transcatheter aortic valve. Financial Results The financial results for Anteris for the quarter ended September 30, 2026, are presented below. All amounts in $ refer to U.S. dollars. The Company’s net operating cash outflows for the three months ended September 30, 2026, were $22.9 million, primarily attributable to clinical, regulatory and manufacturing requirements to support the ongoing PARADIGM Trial. Operating expenditures reflected the phased execution of the clinical program during the quarter, including the timing of U.S. site activation activities following receipt of the CMS coverage determination in April 2026. R&D expenses of $21.3 million were driven by the scaling of manufacturing and quality capabilities, including process development and validation activities and expanded headcount, together with PARADIGM trial related activities, including clinical costs associated with patient enrollment and the scaling of our field-based clinical team. These costs were partly offset by reduced DurAVR THV product research costs. Please see the detailed financial information contained in Anteris’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR Transcatheter Heart Valve (“THV”) compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1,000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR THV System is comprised of the DurAVR valve, the ADAPT tissue, and the balloon-expandable ComASUR Delivery System. DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use. Forward-Looking Statements This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, clinical development timelines and potential commercialization. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Actual future events may vary from these forward-looking statements and readers are cautioned not to put undue reliance on forward-looking statements. Other than as required by law, Anteris gives no representation or guarantee that the occurrence of any of the events or circumstances expressed or implied in these statements will occur. In addition, except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor RelationsInvestor Relations (US)investors@anteristech.com mchatterjee@bplifescience.com Debbie Ormsby Malini Chatterjee, Ph.D. Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269 Website www.anteristech.com X @AnterisTechLinkedIn https://www.linkedin.com/company/anteristech
BACKBEAT Global Pivotal Trial evaluating AVIM Therapy completed enrollment and exceeded enrollment target, with a total of 349 patients randomized.BACKBEAT Trial primary endpoint data planned to be submitted for late-breaking presentation at the Heart Rhythm Society 2027 (“HRS 2027”).Medtronic planning to submit AVIM Therapy Premarket Approval (“PMA”) supplement to the FDA following data presentation, assuming positive trial results.Site activation and patient enrollment accelerating in the Virtue Trial, the Company’s U.S. Investigational Device Exemption (“IDE”) pivotal trial comparing Virtue SAB head-to-head with the commercially available AGENT™ paclitaxel-coated balloon for coronary In-Stent Restenosis.Raised approximately $80.5 million in net proceeds through an underwritten public offering of common stock, which closed on November 9, 2026, including proceeds from the underwriters’ full exercise of their option to purchase additional shares. $101.9 million of cash and cash equivalents, and marketable securities as of September 30, 2026 and public offering proceeds provide projected cash runway through 2028.Company hosting R&D Day on Thursday, November 12, 2026, in New York City and via live webcast, featuring in-depth reviews of AVIM Therapy and Virtue SAB with leading physician investigators. NEW HOPE, Pa., Nov. 10, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies, today announced financial results for the third quarter ended September 30, 2026, and provided a business update on its two pivotal-stage investigational cardiovascular programs: Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) for the treatment of uncontrolled hypertension, for which the Company has a strategic collaboration with Medtronic (NYSE: MDT) for the treatment of pacemaker-indicated patients, and Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”) for the treatment of coronary artery disease. David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, stated, “With the completion of enrollment of the BACKBEAT Trial, AVIM Therapy is nearing pivotal primary endpoint results. Alongside our collaborators at Medtronic, we now move to the completion of three-month follow-up in all patients, locking the primary endpoint database, and submitting a robustly powered data set for late-breaking presentation at HRS 2027 in May. We believe the results from the BACKBEAT Trial could set AVIM Therapy on a clear course to redefining the clinical impact of cardiac pacing and provide a powerful new therapeutic option for millions of higher-risk hypertensive patients who remain above blood pressure target despite medication.” Hochman continued, “The third quarter also saw Virtue Sirolimus AngioInfusion™ Balloon advance in its own IDE pivotal, randomized trial. The Virtue® Trial is testing Virtue SAB’s fundamentally different approach to arterial drug delivery, liquid infusion of SirolimusEFR™ directly into the vessel wall without the need for a fragile balloon coating. We are also grateful to our new and existing shareholders that participated in the oversubscribed public equity offering we closed yesterday. The net proceeds from our public offering along with the over $100 million we had at the end of the quarter provide funding through 2028. We are in a strong position to deliver key value-creating milestones for both pivotal stage programs and support Medtronic as they drive toward potential global commercialization of AVIM Therapy. We look forward to showcasing both of our high-impact therapeutic device platforms at our investor R&D Day this Thursday, where leading physician investigators will join us to examine the clinical and commercial potential of AVIM Therapy and Virtue SAB.” Q3 2026 and Recent Business Highlights: Completed enrollment in the BACKBEAT Trial in collaboration with Medtronic. A total of 349 patients with uncontrolled hypertension and an implanted dual-chamber pacemaker were randomized across 92 sites in 15 countries. Orchestra BioMed and Medtronic intend to submit primary endpoint results for late-breaking presentation consideration at HRS 2027.Received written confirmation from FDA that Medtronic’s marketing submission for AVIM Therapy will be a PMA supplement. The submission is planned to be made promptly following presentation of the primary endpoint results of the BACKBEAT Trial, assuming positive trial results. Advanced site activation and patient enrollment in the Virtue Trial, the Company’s U.S. IDE pivotal trial comparing Virtue SAB head-to-head with the commercially available AGENT™ paclitaxel-coated balloon for coronary in-stent restenosis (“ISR”). The prospective, multicenter, randomized, single-blind, non-inferiority trial has a planned enrollment of approximately 740 patients, with an enrollment completion target date by the end of 2027.Virtue SAB mechanistic and clinical evidence presented at Transcatheter Cardiovascular Therapeutics 2026. On November 1, 2026, Allen Jeremias, MD, Co-Principal Investigator of the Virtue Trial, presented Virtue SAB’s differentiated mechanism of action for infusing a large liquid volume of submicron, particle-encapsulated SirolimusEFR™ directly into the vessel wall. Dr. Jeremias also outlined existing preclinical and clinical evidence and the pivotal IDE trial design.AVIM Therapy was featured in two sessions at HRX Live 2026 in Atlanta, including a sponsored roundtable on the Medtronic–Orchestra BioMed strategic collaboration and a panel exploring the expanding role of permanent cardiac pacing beyond bradycardia. The discussions highlighted AVIM Therapy’s mechanism of action, clinical evidence and potential in hypertensive heart disease. A recording of the roundtable is available on the Company’s website.Received a $6.1 million milestone payment on September 14, 2026, in connection with Haemonetics Corporation’s (NYSE: HAE) acquisition of Vivasure Medical Limited (“Vivasure”). Together with approximately $5 million received in January 2026, total cash proceeds received from the transaction are approximately $11 million. The FDA recently approved the PerQseal® Elite vascular closure system, originally developed by Vivasure, for large-bore arterial procedures. Public Offering On November 9, 2026, the Company closed an underwritten public offering of 17,250,000 shares of its common stock at a price to the public of $5.00 per share, resulting in net proceeds to the Company of approximately $80.5 million (including proceeds from the underwriters’ full exercise of their option to purchase additional shares), after deducting underwriting discounts and commissions and estimated offering expenses (the “Public Offering”). R&D Day: Thursday, November 12, 2026 The Company will host its R&D Day on Thursday, November 12, 2026, at 3:00 p.m. ET in New York City and via live webcast. Company leadership, leading cardiologists and trial investigators will discuss the clinical and treatment burden associated with uncontrolled hypertension in pacemaker-indicated patients and restenosis in coronary stent interventions, the potential for AVIM Therapy and Virtue SAB to address these unmet needs, key upcoming clinical milestones and the commercial potential of AVIM Therapy and Virtue SAB. Physician speakers include Vivek Reddy, MD, Marat Fudim, MD, Dean Kereiakes, MD, and Allen Jeremias, MD. Webcast of the R&D Day is available for registered participants and a replay of the event will be available through the Investors section of the Company’s website. Financial Results for the Third Quarter Ended September 30, 2026 Cash and cash equivalents and Marketable securities totaled $101.9 million as of September 30, 2026, not including the $80.5 million in net proceeds from the Public Offering.Net cash used in operating activities and for the purchase of fixed assets was $19.9 million during the third quarter of 2026, compared with $14.9 million for the third quarter in 2025, with the primary drivers being increased research and development costs, including clinical trial activities, as well as personnel and consulting expenditures during the third quarter of 2026.Research and development expenses for the third quarter of 2026 were $17.7 million, compared with $14.0 million for the third quarter in 2025, which represents an increase of 26%. The increase was primarily due to additional costs associated with the ongoing BACKBEAT Trial and to advance the Virtue SAB program, including the Virtue Trial.Selling, general and administrative expenses for the third quarter of 2026 were $5.6 million, compared with $7.1 million for the third quarter of 2025, which represents a decrease of 21%. The decrease was primarily due to a decrease in legal and professional fees.Net loss attributable to common stockholders for the third quarter of 2026 was $19.6 million, or ($0.30) per share, compared with a net loss attributable to common stockholders of $20.8 million, or ($0.40) per share, for the third quarter of 2025, which represents a decrease of 6%. Net loss attributable to common stockholders for the third quarter of 2026 included $3.4 million in net interest expense for the third quarter of 2026 as compared to $1.2 million for the same period in 2025, of which a portion was non-cash in each period. Non-cash stock-based compensation expense was $2.3 million as compared to $3.0 million for the same period in 2025. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates, Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB), are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial, and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough Device Designations. The BACKBEAT Trial has completed enrollment. Virtue SAB is a first-of-its-kind, non-coated drug delivery AngioInfusion balloon system designed to infuse a large liquid dose of a proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB exceeded the published tissue concentrations of leading limus drug-eluting stents and demonstrated positive three-year clinical data in coronary ISR in the SABRE study, a multicenter, prospective, independent core laboratory–adjudicated pilot clinical study of 50 patients conducted in Europe. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease, and below-the-knee peripheral artery disease, in each case, within specified parameters. The Virtue Trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis is currently enrolling patients. CAUTION: Investigational devices. Limited by United States law to investigational use. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements relating to the enrollment, timing, implementation, results and design of the Company’s ongoing pivotal trials, the timing of the presentation of clinical data, the timing of regulatory submissions, realizing the clinical and commercial value of AVIM Therapy and Virtue SAB, the potential safety and efficacy of the Company’s product candidates, the size of the potential markets for the Company’s product candidates, the ability of the Company’s partnerships to accelerate clinical development and the Company’s projected cash runway. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as and must not be relied on as a guarantee, an assurance, a prediction, or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and may differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties, including changes in domestic and foreign business, market, financial, political, and legal conditions; risks related to regulatory approval of the Company’s commercial product candidates and ongoing regulation of the Company’s product candidates, if approved; the timing of, and the Company’s ability to achieve expected regulatory and business milestones; the impact of competitive products and product candidates; and the risk factors discussed under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 12, 2026. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Balance Sheets(in thousands, except share and per share data)(Unaudited) September 30, December 31, 2026 2025ASSETS CURRENT ASSETS: Cash and cash equivalents$27,761 $34,690 Marketable securities 74,146 71,822 Accounts receivable, net 56 95 Inventory 221 310 Prepaid expenses and other current assets 987 994 Total current assets 103,171 107,911 Property and equipment, net 2,284 1,715 Right-of-use assets 1,001 1,496 Strategic investments — 2,495 Deposits and other assets 1,280 1,240 TOTAL ASSETS$107,736 $114,857 LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable$5,030 $6,095 Accrued expenses and other liabilities 8,367 9,890 Operating lease liability, current portion 831 751 Total current liabilities 14,228 16,736 Royalty purchase agreement 36,795 16,482 Note payable 21,152 — Loan payable 14,462 14,268 Derivative liability 1,593 2,749 Operating lease liability, less current portion 304 936 Other long-term liabilities 456 308 TOTAL LIABILITIES 88,990 51,479 Series A Preferred Stock, $0.0001 par value per share; 200,000 issued and outstanding at September 30, 2026 and December 31, 2025; aggregate liquidation preference of $20,000 10,964 9,808 STOCKHOLDERS’ EQUITY Preferred stock, $0.0001 par value, 10,000,000 shares authorized — — Common stock, $0.0001 par value per share; 340,000,000 shares authorized; 61,453,041 and 57,032,963 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively. 6 6 Additional paid-in capital 433,704 416,083 Accumulated other comprehensive (loss) income (153) 60 Accumulated deficit (425,775) (362,579)TOTAL STOCKHOLDERS’ EQUITY 7,782 53,570 TOTAL LIABILITIES, SERIES A PREFERRED STOCK AND STOCKHOLDERS’ EQUITY$107,736 $114,857 ORCHESTRA BIOMED HOLDINGS, INC.Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(Unaudited) Three Months Ended September 30, 2026 2025Revenue: Partnership revenue$— $721 Product revenue 91 140 Total revenue 91 861 Expenses: Cost of product revenues 28 49 Research and development 17,734 14,027 Selling, general and administrative 5,625 7,098 Total expenses 23,387 21,174 Loss from operations (23,296) (20,313)Other income (expense): Interest expense, net (2,463) (515)Change in the fair value of derivative liability 867 — Gain on sale of strategic investments 6,142 — Total other income (expense) 4,546 (515)Net loss (18,750) (20,828)Adjustment to carrying value of Series A Preferred Stock (867) — Net loss attributable to common stockholders$(19,617) $(20,828) Net loss attributable to common stockholders per share Basic and diluted$(0.30) $(0.40)Weighted-average shares used in computing net loss attributable to common stockholders per share, basic and diluted 64,620,127 52,186,503 Comprehensive loss Net loss$(18,750) $(20,828)Unrealized (loss) gain on marketable securities (72) 29 Comprehensive loss$(18,822) $(20,799)
52-week data presented at AHA Scientific Sessions 2026 further strengthen BHB-1893’s potential differentiation, with encouraging clinical activity and support for a highly simplified dosing regimen LIONHEART-HCM oHCM Phase 3 enrolling with interim analysis expected in second half of 2027; TRUEHEART-HCM fixed-dose oHCM Phase 2b and NOBLEHEART-HCM Phase 3 in nHCM on track to initiate in first half of 2027 Cash, cash equivalents and investments of $503.5 million; cash runway expected into 2029 SAN FRANCISCO, Nov. 10, 2026 (GLOBE NEWSWIRE) — Braveheart Bio, Inc. (Nasdaq: BRVE), a clinical-stage biopharmaceutical company developing next-generation therapeutics for hypertrophic cardiomyopathy (“HCM”) and other serious cardiovascular diseases, today reported unaudited financial results for the third quarter ended September 30, 2026, and provided a business update. “BHB-1893 continues to show a consistent, potentially differentiated profile across multiple clinical studies and our mechanistic work,” said Travis Murdoch, M.D., President and Chief Executive Officer of Braveheart Bio. “The 52-week data presented at AHA showed rapid, deep responses that continued to improve over time, including meaningful improvements in pVO2 and KCCQ-CSS, and evidence supporting a highly simplified dosing regimen. These results inform our updated development strategy, including TRUEHEART-HCM, which will evaluate a fixed dose in oHCM on top of standard of care. With LIONHEART-HCM enrolling, NOBLEHEART-HCM on track to initiate in the first half of 2027 and a strong balance sheet, we are focused on delivering a potential best-in-disease profile with a simple dosing paradigm for patients with HCM.” Recent Business Highlights AHA Scientific Sessions 2026 Clinical Data Presentations 52-Week Open-Label Extension in Obstructive HCM (“oHCM”): Braveheart Bio and partner Hengrui Pharma presented 52-week open-label extension (“OLE”) data from the Phase 2 study of BHB-1893 in 42 patients with oHCM in a late-breaking oral presentation. Mean peak oxygen uptake (“pVO2”) and Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (“KCCQ-CSS”) improved by 2.7 mL/kg/min and 17.3 points, respectively, from OLE baseline. By Week 1, before any titration, 67% of patients achieved a Valsalva left ventricular outflow tract gradient (“LVOT-G”) below 30 mmHg; 90% reached this threshold at one or more visits during 52 weeks of treatment. At Week 52, 57% of patients remained on the 40 mg twice-daily starting dose. In an exploratory analysis, gradient and NT-proBNP levels after washout were lower following 52 weeks of treatment than following 12 weeks, consistent with potential reverse remodeling. BHB-1893 was generally well tolerated, with no on-treatment severe or serious adverse events.New data supporting differentiated mechanism of action: Braveheart Bio presented preclinical mechanistic data from engineered heart tissue models and an ad hoc pooled analysis of the Phase 2 study of BHB-1893 in non-obstructive HCM (“nHCM”). BHB-1893 improved indices of diastolic function while preserving systolic performance, both in vitro and in patients; at Week 12, a majority of BHB-1893-treated patients had normal septal and lateral e′ velocities (59% and 57%, respectively, compared with 14% and 18% of placebo-treated patients). 52-week data from the nHCM Phase 2 OLE are expected in the first half of 2027. Development Strategy Update On November 6, 2026, Braveheart Bio hosted an investor event, “HCM Spotlight: Advancing a Next-Generation Cardiac Myosin Inhibitor,” featuring leading HCM experts, and outlined its updated clinical development strategy for BHB-1893, which is designed to minimize titration while optimizing efficacy. A replay is available in the Investors section of Braveheart Bio’s website.LIONHEART-HCM, Global Phase 3 Trial in oHCM: LIONHEART-HCM is enrolling patients. It is a global, randomized, double-blind, active-comparator-controlled Phase 3 trial evaluating the efficacy and safety of BHB-1893 compared to metoprolol in patients with symptomatic oHCM, using a 40 mg twice-daily starting dose with a single potential titration step to 60 mg at Week 4. The primary endpoint is change in pVO2 from baseline to Week 24; secondary endpoints include LVOT gradient, NT-proBNP and KCCQ-CSS. Results from an interim analysis of LVOT gradient at Week 12 are expected in the second half of 2027.Hengrui Pharma’s Study 301, a Phase 3 Trial in oHCM in China: Hengrui Pharma, Braveheart Bio’s collaboration partner in Greater China, has completed enrollment in its Phase 3 trial of HRS-1893 on top of standard of care, with topline results expected in the first half of 2027.NOBLEHEART-HCM, Global Phase 3 Trial in nHCM: Braveheart Bio has completed its end-of-Phase 2 meeting with the FDA and plans to initiate NOBLEHEART-HCM in the first half of 2027. NOBLEHEART-HCM is a planned global, randomized, double-blind, placebo-controlled Phase 3 trial evaluating BHB-1893 in adults with symptomatic nHCM. The trial design includes a potential single titration step at Week 4. The dual primary endpoints are change in pVO2 and KCCQ-CSS from baseline to Week 36.TRUEHEART-HCM, Phase 2b Fixed-Dose Trial in oHCM: TRUEHEART-HCM is a planned Phase 2b trial evaluating a fixed 40 mg twice-daily dose of BHB-1893, with no titration visits, on top of standard of care in patients with symptomatic oHCM. Braveheart Bio has received supportive FDA feedback on the fixed-dose approach and is finalizing the protocol to enable trial initiation in the U.S. in the first half of 2027.Braveheart Bio completed its upsized initial public offering in August 2026, selling 24,437,500 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares, at $18.00 per share for gross proceeds of approximately $439.9 million. Braveheart Bio’s common stock began trading on the Nasdaq Global Market under the ticker symbol “BRVE” on August 6, 2026. Third Quarter 2026 Financial Results Cash, cash equivalents and investments were $503.5 million as of September 30, 2026, compared to $89.2 million as of December 31, 2025. Based on the current operating plan, Braveheart Bio estimates that its existing cash, cash equivalents and investments will be sufficient to fund its projected operating expenses and capital expenditure requirements into 2029. Research and development (R&D) expenses were $17.5 million for the three months ended September 30, 2026, compared to less than $0.1 million for the same period in 2025. The increase was primarily due to clinical and manufacturing costs to support the initiation and enrollment of LIONHEART-HCM, higher personnel-related costs and a $1.0 million milestone under the Hengrui license agreement. There was no in-process research and development (“IPR&D”) expense for the three months ended September 30, 2026, compared to $58.8 million for the same period in 2025, which related to the in-license of BHB-1893 from Hengrui. General and administrative (G&A) expenses were $12.6 million for the three months ended September 30, 2026, compared to $0.5 million for the same period in 2025. The increase was primarily due to personnel-related costs, including stock-based compensation, and consultant and legal costs to support Braveheart Bio’s growth and operations as a public company. G&A expenses for the three months ended September 30, 2026 included $7.8 million of non-cash stock-based compensation expense, of which $6.1 million related to liability-classified modified executive restricted stock awards that are remeasured to fair value each reporting period. Net loss was $26.5 million, or $0.51 net loss per share, basic and diluted, for the three months ended September 30, 2026, compared to a net loss of $59.1 million, or $10.05 net loss per share, basic and diluted, for the same period in 2025. Braveheart Bio, Inc.Selected Condensed Statements of Operations Data (Unaudited)(in thousands, except share and per share data) Three Months Ended September 30,Nine Months Ended September 30, 2026 2025 2026 2025 Operating expenses: Research and development$17,542 $9 $39,581 $9 In-process research and development – 58,770 – 59,218 General and administrative 12,607 508 21,499 540 Total operating expenses 30,149 59,287 61,080 59,767 Loss from operations (30,149) (59,287) (61,080) (59,767)Total other income 3,654 169 5,317 169 Net loss$ (26,495)$ (59,118)$ (55,763)$ (59,598)Deemed dividends upon issuance of redeemable convertible preferred stock – – (3,615) – Net loss attributable to common stockholders$(26,495)$(59,118)$(59,378)$(59,598)Net loss per share, basic and diluted$(0.51)$(10.05)$(2.66)$(20.46)Weighted-average shares of common stock outstanding, basic and diluted 52,095,078 5,881,011 22,285,633 2,912,682 Selected Condensed Balance Sheet Data (Unaudited)(in thousands) September 30, 2026December 31, 2025Cash, cash equivalents and investments$503,520$89,161 Total assets 514,450 89,350 Total liabilities 16,848 5,333 Redeemable convertible preferred stock – 149,889 Total stockholders’ equity (deficit) 497,602 (65,872) About Braveheart Bio Braveheart Bio is a clinical-stage biopharmaceutical company focused on developing therapies for patients with hypertrophic cardiomyopathy (HCM) and other serious cardiovascular diseases. Braveheart Bio’s lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Braveheart Bio is aiming to address the limitations of currently available CMIs by designing BHB-1893 for rapid onset, consistent depth of response, preservation of systolic function, prompt reversibility, and a straightforward approach to titration and monitoring. For more information, please visit http://www.braveheart.bio. Forward-Looking Statements This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “should,” “will” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of BHB-1893 and other product candidates, including the initiation, timing, progress, results and future data releases of ongoing and planned clinical trials; the timing of enrollment, progress and expected results from the LIONHEART-HCM global Phase 3 trial; the potential for data from Hengrui’s Phase 3 trial of BHB-1893 in oHCM, together with the LIONHEART-HCM interim analysis, to support a New Drug Application submission; the timing of topline results from Hengrui’s Phase 3 trial and of 52-week data from the Phase 2 nHCM open-label extension; the timing of initiation as well as expected results from the NOBLEHEART-HCM global Phase 3 trial in nHCM; the timing of initiation, progress and expected results from the TRUEHEART-HCM Phase 2b fixed-dose study; Braveheart Bio’s interactions and communications with regulatory authorities and timing as well as anticipated results of submissions; the beneficial characteristics, and the potential safety, efficacy and therapeutic effects of Braveheart Bio’s product candidates; its ability to develop and advance its potential future product candidates and programs; and expectations for Braveheart Bio’s uses of capital, expenses and financial results, including its cash runway into 2029. Any forward-looking statements in this press release are based on Braveheart Bio’s current expectations and assumptions. These statements are neither promises nor guarantees and involve risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, risks relating to: Braveheart Bio’s research and development activities; Braveheart Bio’s ability to obtain the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to clinical development activities; Braveheart Bio’s reliance on clinical data generated by Hengrui and on Hengrui for the manufacture of BHB-1893; Braveheart Bio’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Braveheart Bio’s ability to attract, integrate and retain key personnel; risks related to Braveheart Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Braveheart Bio’s intellectual property protections; risks related to geopolitical developments and U.S. and Chinese laws and regulations, including the BIOSECURE Act; and risks related to the competitive landscape for Braveheart Bio’s product candidates; as well as the other risks and uncertainties described under the heading “Risk Factors” section in Braveheart Bio’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026 and any subsequent filings Braveheart Bio makes with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date of this press release. Except as required by applicable law, Braveheart Bio undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Braveheart Bio intends to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor Braveheart Bio’s Investor Relations website, in addition to following Braveheart Bio’s press releases, SEC filings, public conference calls, presentations, and webcasts. Investor Relations ContactAlexander SharifNew Street Investor RelationsAlexander@NewStreetIR.com Media ContactFGS GlobalBraveheart-bio@fgsglobal.com
Latest patent expands intellectual property protection for advanced physiological signal acquisition and processing THE WOODLANDS, TX, Nov. 10, 2026 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the issuance of U.S. Patent No. 12,793,841, titled “Medical Devices With Circuitry For Capturing And Processing Physiological Signals,” further strengthening the Company’s intellectual property portfolio supporting its proprietary catheter-based sensing technology. The newly issued patent covers medical devices and methods for capturing and processing physiological signals through advanced sensing and processing circuitry. The technology enables signal acquisition and processing near the biological source, supporting high-resolution sensing, efficient data transmission and real-time physiological monitoring. “This latest patent further strengthens the intellectual property foundation supporting our proprietary sensing technology and reinforces our commitment to advancing precision nerve-targeted interventions,” commented Brad Hauser, Chief Executive Officer of Autonomix. “Our ability to capture and process physiological signals directly at their source represents what we believe is a key differentiator of our platform. We believe this technology has the potential to provide physicians with greater insight into neural activity and support more precise, informed treatment decisions across a broad range of clinical applications.” The patented architecture incorporates distributed processing modules, configurable sensing capabilities and efficient data transmission designed to support high-density physiological signal acquisition within catheter-based devices. These capabilities may have applications across cardiovascular interventions, electrophysiology, pain management and other procedures requiring precise physiological monitoring. The new patent builds upon Autonomix’s existing U.S. and international intellectual property portfolio, further strengthening protection for its proprietary sensing technology as the Company advances its development programs and explores additional clinical applications. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Forward-looking statements in this press release include, but are not limited to, the anticipated significance of the Company’s intellectual property portfolio, the potential capabilities and applications of the Company’s patented sensing technologies, the versatility and scalability of the Company’s platform technology, and the potential for future clinical applications across multiple organ systems. Although the Company believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 27, 2026, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLC Jenene Thomas 908.824.0775 autonomix@jtcir.com
– 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
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
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
