Combination broadens iRhythm’s cardiac monitoring portfolio, advances its multi-vitals strategy and expands iRhythm’s addressable market across the continuum of care. iRhythm’s commercial scale, health system relationships, market access expertise, and integrated clinical service capabilities are expected to accelerate VitalConnect’s growth and expand customer access. Transaction is expected to enhance iRhythm’s […]
Financial
Baird Medical Highlights Global Expansion and Strategic Progress During Third Quarter 2026
Quarter included presentation at H.C. Wainwright Global Investment Conference, strategic partnership with Alpmed, new regulatory registrations, and continued physician trainingNEW YORK, Oct. 05, 2026 (GLOBE NEWSWIRE) — Baird Medical Investment Holdings Ltd. (“Baird Medical” or the “Company”) (NASDAQ: BDMD), a medical device company focused on the development and commercialization of minimally invasive treatment technologies, today highlighted key business and operational developments from the third quarter of 2026, including expansion into new international markets, continued physician training initiatives and the addition of irreversible electroporation (IRE) technology to its broader technology portfolio through a strategic partnership. “During the third quarter, we continued to execute on the priorities that we believe will drive Baird Medical’s long-term growth, including extension of our geographic reach, strengthening physician adoption and broadening our technology portfolio, while continuing to share our exciting story with the investment community,” said Haimei Wu, Chairwoman and CEO of Baird Medical. “These milestones reflect the progress we are making to build a more diversified global business and create additional opportunities for growth.” Presenting Baird Medical’s Growth Strategy at H.C. Wainwright In September, Baird Medical participated in the H.C. Wainwright Global Investment Conference in New York, where U.S. CEO Mark Saxton and Chief Strategy Officer Daphne Huang shared details on the Company’s progress and plans for continued growth. The presentation highlighted Baird Medical’s expanding U.S. presence, growing adoption of its microwave ablation (MWA) technology and plans to build on its established international business. Management also discussed the Company’s efforts to expand its technology portfolio and reach more physicians and patients across a broader range of markets. “Our focus this quarter was on execution, including bringing our technology into new markets, working directly with physicians, and adding new capabilities to our portfolio,” said Mark Saxton, U.S. Chief Executive Officer of Baird Medical. “At H.C. Wainwright, we had the opportunity to share that progress with investors and discuss where we see the business going from here. The work underway across our U.S. and international operations gives us a strong foundation as we head into the final months of the year.” Expanding the Technology Portfolio Through Alpmed Partnership In August, Baird Medical entered into a strategic partnership with Alpmed focused on the global development and commercialization of next-generation irreversible electroporation (IRE) technology. The partnership adds another minimally invasive treatment modality alongside Baird Medical’s existing MWA business and provides a path to introduce IRE technology across international markets. The collaboration is part of the Company’s effort to build a broader portfolio of technologies for physicians performing minimally invasive procedures. Advancing Regulatory and Commercial Expansion in International Markets Baird Medical also made progress expanding the availability of its MWA technology in new markets during the quarter. In August, the Company received registrations from the Drug Regulatory Authority of Pakistan (DRAP) for its BD-GT microwave ablation system and T-1610 microwave ablation needle. The registrations allow Baird Medical to bring these products to the Pakistani market and represent another step in the Company’s international expansion. The Company also marked the completion of first procedures using its MWA technology in Vietnam and Argentina during the quarter, extending the use of its technology into two additional markets. Connecting with Physicians at Global Medical Conferences Baird Medical continued its engagement with the international medical community during Q3 through participation in major industry meetings, including the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2026 Annual Congress and the Asia Pacific Society of Cardiovascular and Interventional Radiology (APSCVIR) Annual Scientific Meeting. These meetings provided opportunities for the Baird Medical team to connect directly with interventional radiologists and other specialists from around the world, exchange clinical experience, present the Company’s technology in live settings, and discuss developments in minimally invasive treatment. Expanding Hands-On Physician Training Physician education remained an important area of focus during the quarter, with Baird Medical supporting training programs in both the U.S. and China. In the U.S., the Company supported hands-on MWA training in New Orleans, where participating physicians observed procedures and gained practical experience with MWA techniques and applications. In China, Baird Medical hosted a four-day MWA Master Class for Vietnamese physicians at The Eighth Affiliated Hospital of Sun Yat-sen University, combining clinical observation and hands-on training across multiple MWA applications. Looking Ahead As Baird Medical enters the fourth quarter of 2026, the Company remains focused on expanding its presence in key markets, supporting physician education and training, and advancing a broader portfolio of minimally invasive treatment technologies. The Company expects to continue building on the clinical, commercial, and strategic progress achieved during the third quarter as it works to bring its technologies to more physicians and patients worldwide. About Baird Medical Baird Medical is a global, pioneering medical device company specializing in minimally invasive ablation technologies for a range of solid tumors. The Company’s lead product, a microwave ablation (MWA) system, is FDA-cleared for soft tissue ablation and is being launched in the U.S. primarily for the treatment of benign thyroid nodules. In addition, the Company is expanding its minimally invasive technology portfolio, including IRE-based products and an AI-powered robotic ablation system. Baird Medical’s MWA solutions have been adopted by a growing number of leading U.S. institutions and private practice groups, including the Mayo Clinic, Columbia University Medical Center, and The George Washington University Hospital. The company is rapidly expanding its global commercial footprint, with sales now reaching markets across multiple continents. Forward-Looking Statements This press release includes certain statements that are not historical facts but 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 relate to future events or Baird Medical’s future financial or operating performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “could”, “should”, “expect”, “intend”, “might”, “will”, “estimate”, “anticipate”, “believe”, “budget”, “forecast”, “intend”, “plan”, “potential”, “predict”, or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Baird Medical and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Baird Medical does not undertake any duty to update these forward-looking statements. Actual results may vary materially from those expressed or implied by forward-looking statements based on a number of factors, including, without limitation: (1) the risk that Baird Medical may not be successful in expanding its business in China or the United States; (2) changes in general economic conditions; (3) regulatory conditions and developments; (4) changes in applicable laws or regulations; (5) the nature, cost and outcome of pending and future litigation and other legal proceedings instituted against Baird Medical or others; and (6) other risks and uncertainties from time to time described in the Registration Statement relating to the Business Combination and the transition report, including those listed under the sections titled “Risk Factors” therein, and in ExcelFin’s other filings with the SEC. The foregoing list of factors is not exclusive. Additional information concerning certain of these, and other risk factors is contained in ExcelFin’s most recent filings with the SEC and in the Registration Statement described above filed by Baird Medical in connection with its business combination with ExcelFin. All subsequent written and oral forward-looking statements concerning Baird Medical, the business combination described herein, or other matters attributable to Baird Medical or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements above. Readers are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Baird Medical expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Contact: Lee RothBurns McClellan for Baird MedicalLroth@burnsmc.com
Endologix Rebrands as Rhevera Medical
SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix Holdings, LLC today announced Rhevera Medical as its new corporate brand. The new identity reflects the company’s broader commitment to partnering with physicians who treat complex vascular disease and supporting patients whose lives, mobility and independence depend on the company’s technologies. For decades, Endologix has worked alongside physicians who care for patients with serious vascular conditions, including abdominal aortic aneurysms and p
Investor Insights: Jan and Jeff from Arboretum Share Their Outlook on MedTech Investing
AngioDynamics and The PERT Consortium® Name Jacobi Hospital as ALPHA-PE Research Fund Award Recipient to Advance Real-World Pulmonary Embolism Evidence
LATHAM, N.Y.–(BUSINESS WIRE)–AngioDynamics, Inc. (NASDAQ: ANGO), a medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced that Dr. Jonathan Alis, Dr. Seth I. Sokol and their team at Jacobi Hospital in Bronx, New York have been selected as an ALPHA-PE Research Fund award recipients. The independent, investigator-led study, supported in partnership with The PERT C
Quotient Sciences and Acesion Pharma Announce Collaboration on AI-Enhanced Formulation Development to Advance Atrial Fibrillation Pipeline
New AI-enhanced solution helps identify promising drug formulations, compressing early clinical decision-making for new treatments NOTTINGHAM, England, Oct. 2, 2026 /PRNewswire/ — Quotient Sciences, a global integrated CRDMO (contract research, development and manufacturing…
Mount Sinai Medical Center Appoints Dr. Olcay Aksoy as Chief of Cardiology
MIAMI BEACH, Fla., Oct. 1, 2026 /PRNewswire/ — Mount Sinai Medical Center is proud to announce the appointment of Olcay Aksoy, MD, a nationally recognized academic cardiologist, structural heart specialist, and physician leader, as Chief of Cardiology. Dr. Aksoy joins the medical center…
Kestra Medical Technologies Earns Five-Star Rating on Newsweek’s List of America’s Greatest Mid-Market Companies
KIRKLAND, Wash., Oct. 01, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, has earned a five-star rating on Newsweek’s list of America’s Greatest Mid-Market Companies 2026. Only 30 of the 100 honorees earned five stars, and Kestra was the only company in the Medical Equipment Manufacturing category to receive that rating. “In less than a decade, our team brought the ASSURE® WCD to market and built a rapidly growing commercial business, giving clinicians a differentiated choice for protecting patients during periods of cardiac risk and recovery,” said Brian Webster, President and Chief Executive Officer of Kestra Medical Technologies. “This five-star rating reflects the strength of the Kestra team and the company we’ve built. We’re now positioned to extend our reach, advance our Cardiac Recovery System® platform, and pursue a bigger vision for wearable cardiac protection.” For its inaugural ranking, Newsweek and Plant-A Insights Group assessed publicly traded U.S. mid-market companies across financial performance, workforce experience, innovation, and sustainability. Their analysis drew on business metrics, third-party workforce data, and more than 2.7 million company reviews. “Newsweek’s ranking of America’s Greatest Mid-Market Companies recognizes businesses that are proving that meaningful growth and lasting impact aren’t limited to the largest corporations,” added Ryan Kinney, Senior Vice President, Newsweek. “The ranking shines a spotlight on midsize companies that are strengthening their industries, creating opportunities for team members and customers, and demonstrating the ambition and resilience needed to succeed in a competitive marketplace.” About KestraKestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, please visit www.kestramedical.com. Forward-Looking StatementsThis press release contains forward-looking statements that involve risks and uncertainties. Actual results may differ materially from those expressed or implied by these statements. For a discussion of factors that could cause actual results to differ, see Kestra’s filings with the U.S. Securities and Exchange Commission. Kestra undertakes no obligation to update any forward-looking statements except as required by law. CONTACT: Media contact
Rhiannon Pickus
rhiannon.pickus@kestramedical.com
Terumo Neuro Signs Agreement to Acquire Arsenal Medical – Advancing Next-Generation Liquid Embolic Innovation for Treating Chronic Subdural Hematoma (cSDH)
Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio.
NeoCast
The next-generation in liquid embolics
Aliso Viejo, CA, Sept. 30, 2026 (GLOBE NEWSWIRE) — Terumo Neuro Signs Agreement to Acquire Arsenal Medical – Advancing Next-Generation Liquid Embolic Innovation for Treating Chronic Subdural Hematoma (cSDH) Proposed acquisition would add NeoCast™, an investigational technology designed for controlled delivery and predictable distal penetration, to Terumo Neuro’s neurovascular portfolio. Aliso Viejo, Calif. – September 29, 2026 – Terumo Neuro today announced that it has signed an agreement to acquire Arsenal Medical Inc., a privately held, clinical-stage biomaterials company developing NeoCast™, an investigational next-generation liquid embolic technology for the treatment of chronic subdural hematoma (cSDH). Upon completion, the proposed acquisition would expand Terumo Neuro’s liquid embolic portfolio, advance its strategy to bring differentiated neurovascular technologies to physicians and patients, and support its continued focus on innovations to preserve and restore brain health. “NeoCast represents a compelling opportunity to advance what could be a game-changing innovation in the treatment of chronic subdural hematoma,” said Carsten Schroeder, CEO, Terumo Neuro. “As MMA embolization emerges as an important new treatment option, this purpose-developed, next-generation liquid embolic technology has the potential to make a meaningful impact for physicians and patients, while supporting our mission to preserve and restore brain health. We are impressed by the progress Arsenal Medical has made and look forward to combining our global neurovascular expertise with its differentiated technology platform following the close of the transaction.” cSDH is a significant and growing neurological condition, particularly among aging populations. The condition may cause cognitive decline and disability, has been described as a potential cause of reversible dementia, and can be associated with substantial mortality within one year. While surgical drainage remains a common treatment approach, recurrence after surgery continues to be a clinical challenge. Middle meningeal artery embolization has emerged as a promising adjunctive or alternative approach by targeting the vascular pathology believed to contribute to hematoma persistence and recurrence.1,2,3 Arsenal Medical has developed NeoCast, a next-generation, solvent-free, non-adhesive biomaterial intended for embolization of the middle meningeal artery (MMA). It is engineered for controlled delivery and predictable distal penetration, without solvents or adhesives associated with many embolic devices. Arsenal Medical has advanced NeoCast through first-in-human clinical experience in cSDH and recently received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for RADIANT, a pivotal randomized, multicenter study evaluating NeoCast adjunctively with surgery for symptomatic subacute and chronic subdural hematoma.4 The first patients have been enrolled in RADIANT. Final results from the EMBO-02 first-in-human study showed that NeoCast met its primary feasibility and safety endpoints, with 96% of subjects achieving at least 50% hematoma volume reduction and 75% achieving complete hematoma resolution at final follow-up. Notably, 79% of 24 patients were treated with embolization alone, and 10 subjects were treated without general anesthesia.4 The study also reported functional outcome improvements, with 79% of patients demonstrating better functional status based on mRS and quality-of-life measures compared with baseline through 180 days. These findings are preliminary and provide supporting clinical context as NeoCast advances into RADIANT, a prospective, randomized, multicenter pivotal study comparing NeoCast to Onyx LES for the treatment of symptomatic subacute and chronic subdural hematoma adjunctively with surgery.5,6 “Arsenal Medical was founded on the idea that advanced materials can transform the way challenging medical conditions are treated,” said Upma Sharma, PhD, President and CEO, Arsenal Medical. “NeoCast is a powerful example of that vision. It was designed to provide physicians with controlled delivery and consistent distal penetration without the use of solvents or adhesives. Terumo Neuro’s leadership in neurovascular innovation makes it the ideal organization to help realize the full potential of NeoCast through its next stage of development following the close of the transaction.” NeoCast is an investigational device and is not approved for commercial sale in the United States. The proposed transaction is subject to customary closing conditions. Financial terms of the agreement were not disclosed. For more information, contact:Rebecca Janzon, Terumo Neuro, Global Director Corporate CommunicationsEmail: Rebecca.janzon@microvention.com About Terumo NeuroTerumo Neuro is on a mission to preserve and restore brain health by advancing innovation that changes what’s possible in neurovascular care. Working shoulder to shoulder with physicians, customers, and Associates, we turn deep clinical insight into proven, refined solutions that elevate practice and improve patient outcomes — the kind of game-changing impact that redefines neuro-endovascular treatment. Founded in 1997 as MicroVention and acquired by Terumo Corporation in 2006, Terumo Neuro offers a comprehensive portfolio for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Headquartered in Aliso Viejo, California, our products are sold in more than 70 countries.For more information, please visit www.terumoneuro.com. About Terumo CorporationTerumo (TSE: 4543) is a global medical innovation company. Guided by an unwavering commitment to patients, and driven by the passion of our associates, we strive to fulfill our Group Mission of “Contributing to Society through Healthcare.” Founded in Tokyo in 1921, we provide a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions. About Arsenal MedicalArsenal Medical is a privately-held, venture-backed, clinical-stage company developing innovative biomaterials to address challenging and underserved medical problems. Its lead product targets neurovascular conditions. The company was founded by academic luminaries Robert Langer and George Whitesides, together with entrepreneur investor Carmichael Roberts, who shared a vision for how materials can transform medical devices. Learn more at www.arsenalmedical.com. References Levitt MR, Hirsch JA, Chen M. Middle meningeal artery embolization for chronic subdural hematoma: an effective treatment with a bright future. J Neurointerv Surg. 2024 Mar 14Shankar JJS, Alcock S, Kashani N, et al.; EMMA-Can investigators. Management of Chronic Subdural Hematoma With Adjunctive Embolization of Middle Meningeal Artery: The EMMA-Can Randomized Clinical Trial. JAMA. Published online April 30, 2026Mascitelli Justin R, et al.; Current state of the field and recommendations for middle meningeal artery embolization in chronic subdural hematoma: A Report of the SNIS Standards and Guidelines Committee, Endorsed by ANZSNR and ESMINT. Journal of NeuroInterventional Surgery, April 2026Next-generation liquid embolic leads to “substantial” cSDH resolution and functional outcome gains. NeuroNews, July 24, 2026Arsenal Medical. Treatment with NeoCast, a Next-Generation Liquid Embolic, Results in Substantial Chronic Subdural Hematoma Resolution and Functional Outcome Gains in Final EMBO-02 First-in-Human Results. Press announcement issued July 22, 2026U.S. Food and Drug Administration. PMA Supplement Approval Letter: Onyx Liquid Embolic System (LES), P030004/S035. December 8, 2025 Contact Info Rebecca Janzonrebecca.janzon@microvention.com+1 949-685-4391
Attachments
Terumo Neuro Acquires Arsenal Medical
NeoCast
AnaCardio raises €62.5 million Series B financing to advance transformational novel therapy in heart failure towards Phase 3 readiness
Financing co-led by Novo Holdings and the Ljungström family office, with participation from the originator Helsinn, existing investors Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie, LLD Nybohov Invest AB and new investor Innovestor Life ScienceProceeds will fund Phase 2b development of AC01, a first-in-class oral therapy designed to improve cardiac contractility and outcomes in patients with advanced heart failurePhase 1b/2a GOAL-HF1 study demonstrated clinical proof of concept, with a 22% increase in cardiac output and a 4.8 percentage point improvement in ejection fraction after only four weeks treatment, alongside a favorable safety and tolerability profileIf confirmed in later-stage trials, GOAL-H1’s findings suggest AC01 could meaningfully improve clinical outcomes, including mortality and morbidity, in advanced heart failurePhase 2b GOAL-HF2 study is expected to enroll the first participant in Q4 2026, with the aim of advancing AC01 towards Phase 3 readiness by 2028 STOCKHOLM, Sweden, 30 September 2026 – AnaCardio, a clinical-stage biopharmaceutical company developing novel therapies for heart failure, today announced the successful completion of a €62.5 million Series B financing. The round was co-led by Novo Holdings and the Ljungström family office, with participation from the originator Helsinn, existing investors Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie and LLD Nybohov Invest AB, alongside new investor Innovestor Life Science. The financing will fully fund the advancement of AnaCardio’s lead candidate, AC01, through Phase 2b clinical development in patients with chronic advanced heart failure with reduced ejection fraction (HFrEF), with the aim of establishing a Phase 3-ready asset by 2028. Heart failure remains a significant global health challenge, with substantial unmet need. Despite advances in treatment, approximately one-third of patients with HFrEF do not respond adequately to, or cannot tolerate, standard of care guideline-directed medical therapy (GDMT) and risk progressing to advanced disease, where two-year mortality can reach 50%. Conventional inotropic therapies increase cardiac contractility, but safety concerns, including arrhythmias, ischaemia and increased mortality, generally restrict their use to short-term treatment. AC01 is a first-in-class oral ghrelin receptor agonist designed to improve cardiac contractility through a differentiated calcium-sensitizing mechanism, without the safety concerns associated with conventional inotropes. The program builds on pioneering research led by Professor Lars Lund at Karolinska Institutet, which demonstrated that activation of the ghrelin signaling pathway could improve cardiac function in patients with HFrEF. Patrik Strömberg, Chief Executive Officer of AnaCardio, said: “This €62.5 million Series B, co-led by Novo Holdings and the Ljungström family office, fully funds GOAL-HF2, AC01’s 400 patient Phase 2b trial across 12 countries, with a design agreed with the FDA and EMA. We’re really excited to move AC01 into Phase 2b development: we believe it’s a potentially transformative opportunity to improve patient outcomes in advanced heart failure. In GOAL-HF1, AC01 demonstrated highly encouraging improvements in cardiac output and ejection fraction over 28 days, with no tachycardia, arrhythmia, ischemia or hypotension observed. This funding round gives us the capital to complete the GOAL-HF2 Phase 2b study and deliver a first-in-class Phase 3-ready asset by 2028.” Jørgen Søberg Petersen, Senior Partner at Novo Holdings, commented: “Improving cardiac contractility safely remains a major unmet need in heart failure. AC01 is the first oral agent we have seen with the potential to overcome the safety limitations of traditional inotropes, supported by evidence from GOAL-HF1, the placebo-controlled proof of concept study published in The Lancet. This combination of a differentiated mechanism, clinical evidence and a phase 2b design agreed with the FDA and EMA underpins Novo Holdings’ decision to co-lead this Series B. The round takes AC01 through Phase 2b to deliver a Phase 3-ready dataset by 2028, a pivotal step towards what we believe could be a new category of heart failure treatments.” AC01 demonstrated clinical proof of concept in the Phase 1b/2a GOAL-HF1 study, with results published in The Lancet in June 2026. The study showed a favorable safety and tolerability profile alongside encouraging improvements in cardiac function. On Day 28, patients receiving AC01 3 mg twice daily showed a 22% increase in cardiac output from baseline and a 4.8 percentage point improvement in left ventricular ejection fraction, compared with 1.6 percentage points in the placebo group. The improvement in ejection fraction (the heart’s ability to pump) was comparable to or greater than improvements reported with established heart failure therapies over considerably longer treatment periods. Although based on separate trials, these findings support AC01’s potential to meaningfully improve clinical outcomes, including mortality and morbidity, in advanced heart failure. No evidence of tachycardia, new-onset sustained arrhythmias, ischaemia or symptomatic hypotension were observed. The Phase 2b GOAL-HF2 study is expected to enroll the first participant in Q4 2026. The randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of two dose levels of AC01 over 12 weeks in approximately 400 patients with chronic, advanced HFrEF across approximately 100 sites in 12 countries in North America and Europe. The AC01 development program has been informed by feedback from the FDA and EMA, and regulatory clearance has now been received to begin the GOAL-HF2 study. More information about the study is available at www.clinicaltrials.gov (NCT07584967). Media contact: Jessica Hodgson/Stephanie Cuthbert, ICR Healthcare: anacardio@icrhealthcare.com About the GOAL-HF1 HFrEF study GOAL-HF1 was a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AC01 in 58 patients with HFrEF across 14 sites in the Netherlands, United Kingdom, Sweden, and Italy. All patients had NYHA class II–III HFrEF (mean ejection fraction 31.4%), a transvenous implantable cardioverter-defibrillator (ICD) for primary prevention and were on maximum tolerated guideline-directed medical therapy. Phase 1b consisted of multiple ascending dose escalation in 32 patients across four sequential dose cohorts (0.1–3 mg twice daily, 7 days). In Phase 2a, 26 patients were equally randomized to 1 mg AC01, 3 mg AC01, or placebo orally twice daily for 28 days. More information about the study is available at www.clinicaltrials.gov (NCT05642507). About AnaCardio and AC01 AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class oral calcium-sensitizing contractile agent, is a ghrelin mimetic small-molecule that was in-licensed from Helsinn and is now being developed in heart failure patients. With proof-of-concept now published in The Lancet and positive scientific advice received from the FDA and EMA establishing a favorable development path, AnaCardio is advancing AC01 into Phase 2b clinical development. The company has raised around €100 million to date. AnaCardio is based in Stockholm, Sweden. Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn. About Novo Holdings Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading healthcare and life sciences investor. Through its Seed, Venture, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in healthcare and life science companies at all stages of development. As of year-end 2025, Novo Holdings had total assets of $109 billion. Learn more at www.novoholdings.dk.



