$11 million in proceeds expected to be received during 2026, with remainder of expected proceeds to be received in future revenue earnoutsVivasure Medical Limited (“Vivasure”) has been a strategic holding of Orchestra BioMed since the Company’s formation NEW HOPE, Pa., Jan. 12, 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 risk-reward sharing partnerships, today announced that it expects to receive up to $21 million in cash proceeds in connection with the acquisition of Vivasure, an Ireland-based company pioneering next-generation technology for percutaneous vessel closure, by Haemonetics Corporation (NYSE: HAE, “Haemonetics”), which closed on January 9, 2026. Vivasure was a strategic holding of Orchestra BioMed prior to the transaction. In connection with the closing of the transaction, Orchestra BioMed expects to receive $11 million of proceeds in 2026 made up of approximately $5 million upfront and approximately $6 million in a first milestone payment. The remainder of the proceeds are expected to be received in future revenue earnouts based on the achievement of certain milestones. Vivasure’s PerQseal® Elite system uses a proprietary bioabsorbable patch to seal large-bore (up to 26 F) arteriotomies and venotomies from inside the vessel, offering a sutureless, fully absorbable solution for structural heart and endovascular procedures. In 2025, Vivasure submitted a Premarket Approval application to the U.S. Food and Drug Administration for the PerQseal Elite arterial closure system and received CE Mark approval in Europe for both arterial and venous indications. Results from the prospective, single-arm, multi-center ELITE arterial study demonstrated ease of use with no need for pre-close, with 0% major complications at 30-day follow-up, and immediate median time to hemostasis.1,2 David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed, who also served as an active board observer of Vivasure stated, “Vivasure has been a strategic holding since the formation of Orchestra BioMed, and we have been active and intentional in supporting the company for many years. We are very proud of the outstanding clinical results from the PerQseal product platform which we believe clearly positions it as a best-in-class solution for large diameter percutaneous vessel closure. This transaction represents a clear realization of our preferred approach to device development, powered by long-term, strategically aligned partnerships. We wish Haemonetics every success as it takes PerQseal forward commercially.” Andrew Glass, Chief Executive Officer of Vivasure Medical Limited commented, “Orchestra BioMed has been a deeply engaged partner since the earliest days of Vivasure. Their co-founders helped to lead our initial financing and supported the development of our PerQseal technology from concept stage. With Orchestra BioMed CEO, David Hochman, serving as an active board observer since 2019, and COO, Darren Sherman as an original board member through 2016, their strategic insight and guidance contributed meaningfully to the development of our product and its evolution to this next chapter.” “We recognize and appreciate the meaningful role Orchestra BioMed played as a long-term strategic partner in the development of Vivasure,” said Rajeev Varma, Senior Vice President, Strategy and Corporate Development of Haemonetics. “Vivasure has built a clinically differentiated closure device technology with PerQseal Elite, supported by strong clinical performance and safety data, representing a compelling opportunity to strengthen our impact in the large-bore closure market and structural heart and endovascular procedures.” About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered as a firmware upgrade to a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designation for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary ISR, coronary small vessel disease and below-the-knee peripheral artery disease. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. About HaemoneticsHaemonetics is a global medical technology company dedicated to improving the quality, effectiveness and efficiency of health care. Haemonetics innovative solutions addressing critical medical needs include a suite of hospital technologies designed to advance standards of care and help enhance outcomes for patients; end-to-end plasma collection technologies to optimize operations for plasma centers; and products to enable blood centers to collect in-demand blood components. To learn more about Haemonetics, visit www.haemonetics.com. About Vivasure Medical LimitedBased in Galway, Ireland, Vivasure is focused on the development of advanced polymer implants and delivery systems, primarily focused on minimally invasive vessel closure in cardiology, interventional radiology and vascular surgery. Vivasure operates a fully integrated R&D and ISO 13485 certified manufacturing facility. PerQseal and PerQseal Elite are not available for sale in the United States. For more information, please visit www.vivasuremedical.com. Forward-Looking StatementsCertain 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 results of the acquisition of Vivasure by Haemonetics including the proceeds expected to be received by the Company pursuant to the achievement of certain milestones. 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, 2024, which was filed with the SEC on March 31, 2025 and the risk factor discussed under the heading “Item 1A. Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, which was filed with the SEC on May 12, 2025. The Company operates in a very competitive and rapidly changing environment. New risks emerge from time to time. Given these risks and uncertainties, the Company cautions against placing undue reliance on these forward-looking statements, which only speak as of the date of this press release. The Company does not plan and undertakes no obligation to update any of the forward-looking statements made herein, except as required by law. Investor Contact:Silas NewcombOrchestra BioMedSnewcomb@orchestrabiomed.com Media Contact:Kelsey Kirk-EllisOrchestra BioMedkkirkellis@orchestrabiomed.com References Miegham, First in man use of the Vivasure PerQseal® Elite for large hole arterial closure, PCR London Valves Meeting 2024.Miegham, First in Man (FIM) Experience of the Vivasure PerQseal® ELITE System for Large Hole Closure: The ELITE and ELITE Venous Studies, Transcatheter Cardiovascular Therapeutics Meeting 2024.
Author: Ken Dropiewski
SynCardia and Hydrix Enter into Development Collaboration to Advance the Emperor, SynCardia’s Next Generation Total Artificial Heart
TUCSON, Ariz., Jan. 12, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard” or the “Company”), parent company of SynCardia Systems LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today announced that on January 5, 2026 SynCardia entered into a development collaboration agreement (the “Agreement”) with Hydrix Services Pty Ltd (“Hydrix”), a wholly owned subsidiary of Hydrix Limited (ASX: HYD), to commence an initial development phase for SynCardia’s next-generation, fully implantable Total Artificial Heart (TAH) technology, known as the Emperor. As a fully implantable TAH, Emperor would eliminate the use of an external driver and offer both greater convenience and increased freedom related to patient mobility. SynCardia selected Hydrix as a development partner based on its proven expertise in complex critical engineering and its strong track record developing regulated medical devices, including mechanical circulatory support systems. The collaboration reflects Picard Medical’s focus on partnering with world-class engineering organizations capable of supporting long-term, high-value development programs for mission-critical, life-sustaining technologies. Patrick N.J. Schnegelsberg, CEO of SynCardia Systems, commented, “Hydrix’s expertise and demonstrated track record in advancing complex cardiovascular technologies will support our shared objective of developing transformative solutions for patients with advanced heart failure. As we advance the Emperor program into its next phase of development, the structure may also allow Picard to benefit from Australian R&D tax incentives of approximately 43% of eligible expenditure, subject to qualification and review.” “We are excited to commence this critical development with SynCardia, a highly regarded global leader in advanced heart replacement technology,” said Gavin Coote, Executive Chairman of Hydrix. “It endorses our capability to deliver complex, medical device development programs for leading international medical technology companies.” Under the agreement, Hydrix will perform development work for Picard and SynCardia through the end of 2026 as a first phase within a broader staged development program for the Emperor. The program is structured as a multi-stage, multi-year effort advancing through defined engineering verification and regulatory milestones with continuation between stages dependent on demonstrated technical progress performance and safety validation regulatory alignment. About Hydrix Limited and Hydrix Services Hydrix Limited (ASX: HYD) is a powerful product innovation company. Hydrix’s purpose is to enhance the health, safety, and well-being of a billion lives. The Company leverages its powerful product innovation capability across three business segments: Services: design, engineer and deliver world-first products and innovation; Ventures: invest in high potential MedTech clients; and Medical: distribute disruptive cardiovascular products. About Picard Medical and SynCardia Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the SynCardia Total Artificial Heart is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission at www.sec.gov. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company 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 the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Registration Statement and related prospectus filed in connection with the initial public offering with the SEC. Copies are available on the SEC’s website, http://www.sec.gov. Contact: InvestorsEric RibnerManaging DirectorLifeSci Advisors LLCeric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLCIR@picardmedical.com General/MediaBrittany Lanzablanza@syncardia.com
Ventaris Surgical, Inc. Announces $30M Series A to Advance a Next-Generation System for Complete Kidney Stone Treatment
SAN CARLOS, Calif., Jan. 9, 2026 /PRNewswire/ — Ventaris Surgical, Inc., a San Carlos, CA-based medical device company developing a next-generation system for kidney stone treatment, announced today the completion of a $30 million Series A financing. The financing was led by Longitude Capital, with additional participation from new investor Vensana Capital […]
Elucid Announces Broad Reimbursement for Quantitative Coronary Plaque Analysis
Widespread Reimbursement Advancements Recognize the Clinical Value of Plaque Analysis for Physicians and Patients BOSTON–(BUSINESS WIRE)–Elucid today announced that, effective January 1, 2026, its Plaque-IQ™ coronary plaque analysis has received a new Category I Current Procedural Terminology (CPT®) designation, alongside increasingly widespread coverage and reimbursement from both public and private payors. […]
FineHeart Secures €83 Million to Support Its Growth and Establish Itself as a Future European Leader in Active Implantable Medical Devices (AIMDs)
€35 million Series C funding to accelerate the clinical and industrial development of FlowMaker® €48 million in grants from the IPCEI Tech4Cure program to structure the European Active Implantable Medical Devices (AIMD) sector BORDEAUX, France–(BUSINESS WIRE)–FineHeart, a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announced today […]
Pulse Biosciences, Inc. Appoints Maria Sainz to its Board of Directors
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced the appointment of Maria Sainz to its Board of Directors effective as of January 9, 2026. “We are delighted to welcome Maria […]
Vivasure Medical Announces Acquisition by Haemonetics Corporation
GALWAY, Ireland–(BUSINESS WIRE)–Vivasure Medical®, a company pioneering novel fully absorbable technology for percutaneous vessel closure, today announced that the company has been acquired by Haemonetics Corporation (NYSE: HAE) in a transaction valued up to €185M (~$215M) on completion of certain milestones. Based in Galway, Ireland, Vivasure is focused on the […]
Major Medical Devices Secures Strategic Funding to Advance Novel AAA Repair Device to Market
NEW YORK, Jan. 9, 2026 /PRNewswire/ — Major Medical Devices, Inc. (http://www.majormedicaldevices.com) (MMD), an emerging innovator in vascular intervention technologies with a highly differentiated, potentially quick to market device in a $3 billion market, announces strategic funding…
Tenaya Therapeutics Announces 2026 Strategic Priorities and Anticipated Milestones
Aims to Build on Positive 2025 Interim TN-201 Results in First Half of 2026 with Longer-Term Follow-Up Data for Cohorts 1 and 2 from MyPEAK™-1 Trial of Adults with MYBPC3-Associated HCM Expects to Report One-Year Cohort 1 Data and Early Cohort 2 Data from RIDGE™-1 Study of TN-401 for PKP2-Associated ARVC in First Half of 2026 Plans to Pursue Alignment on Regulatory Pathways for Lead Gene Therapy Programs in 2026 Raised $60 Million in 4Q25 to Support Runway Through mid-2027 SOUTH SAN FRANCISCO, Calif., Jan. 09, 2026 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today provided an update on its clinical development programs and outlined its strategic priorities for 2026. “2025 was a momentous year for Tenaya as we demonstrated early evidence of safety and potentially disease-modifying activity for our gene therapy programs for MYBPC3-associated hypertrophic cardiomyopathy and PKP2-associated arrhythmogenic cardiomyopathy—devastating inherited heart conditions with limited treatment options,” said Faraz Ali, Chief Executive Officer of Tenaya. “These encouraging results offer real hope to patients and families in need of transformative therapies. On the strength of these data, we successfully raised additional capital to advance both programs through key clinical milestones in 2026, including more mature data readouts from both programs. We remain steadfast in our mission to deliver potentially curative therapies for those living with serious genetic heart diseases.” Program Updates and Anticipated 2026 Milestones: TN-201 – Gene Therapy for MYBPC3-Associated Hypertrophic Cardiomyopathy (HCM) In the first half of 2026, Tenaya expects to share interim data for Cohort 2 patients dosed with 6E13 vg/kg of TN-201, as well as updates from Cohort 1 patients who received 3E13 vg/kg doses of TN-201 in the MyPEAK-1 Phase 1b/2 clinical trial for the potential treatment of HCM due to MYBPC3 mutations.In the second half of 2026, one-year Cohort 2 data and two-year Cohort 1 data from MyPEAK-1 are anticipated.Tenaya plans to pursue regulatory alignment on TN-201 pivotal studies over the course of 2026 with an update to be released in the second half of the year.In November 2025, Tenaya presented promising data from the MyPEAK-1 trial. The interim data reported included safety, biopsy and leading indicators of efficacy results for the three patients enrolled in Cohort 1 with follow-up ranging from Week 52-78, as well as initial safety data and biopsy and efficacy results for Cohort 2 patients as of the July 2025 data cut off. Key findings included: TN-201 was generally well tolerated at both dose levels. No dose-limiting toxicities were observed, and all patients have successfully tapered off immunosuppressive medicine.MyBP-C protein levels increased over time, with a substantial increase in protein levels observed commensurate with higher dose in Cohort 2.Multiple parameters associated with risk of complications and/or survival improved among a majority of patients with greater than 26 weeks of follow-up.These data were presented at the 2025 American Heart Association Annual Scientific Sessions and simultaneously published in Cardiovascular Research. To date, seven patients have been enrolled in the MyPEAK-1 trial. Following implementation of modest protocol amendments in alignment with U.S. Food and Drug Administration (FDA) input, Tenaya expects to resume enrollment in the 6E13 vg/kg dose expansion cohort to generate additional safety and efficacy data in 2026 TN-401 – Gene Therapy for PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) In the first quarter of 2026, the DSMB for the RIDGE-1 Phase 1b/2 clinical trial of TN-401 gene therapy for the potential treatment of adults with ARVC caused by mutations in the plakophilin-2 gene, (PKP2) is expected to convene. The DSMB will review all available safety data for the three patients dosed at 3E13 vg/kg (Cohort 1) and three patients dosed at 6E13 vg/kg (Cohort 2,) dose levels. Following DSMB review, Tenaya plans to continue to enroll patients in RIDGE-1 at one or both dose levels.Tenaya expects to present one-year data for Cohort 1 and initial Cohort 2 data in the first half of 2026. Additional Cohort 2 data is anticipated in the second half of 2026.Tenaya plans to pursue regulatory alignment on TN-401 pivotal studies in the second half of 2026 and to share an update by year-end, as available.In December 2025, Tenaya presented positive initial Cohort 1 data in the ongoing RIDGE-1 clinical trial. The data reported included safety, biopsy and arrhythmia results from Cohort 1 as of the October 2025 data cut off, with follow-up ranging from 20-40 weeks post-dose. Key findings included: TN-401 was well tolerated at the 3E13 vg/kg dose, and no dose-limiting toxicities were observed. Adverse events (AEs) were generally mild, asymptomatic and manageable and deemed unrelated to TN-401 treatment.Biopsies demonstrated robust transduction and expression in all patients within first eight weeks.Clinically meaningful improvements in electrical instability were observed in the first two patients with greater than six months follow-up after TN-401 dosing.Enrollment and dosing of Cohort 2 is complete with no new serious AEs related to TN-401 reported in the cohort to date. In July 2025, the RIDGE-1 trial DSMB reviewed all available data and endorsed dose escalation to the 6E13 vg/kg level and expanding enrollment of Cohort 1, per protocol. Cash Position and Updated Guidance Tenaya ended the third quarter of 2025 with $56.3 million in cash, cash equivalents and investments in marketable securities. With the additional proceeds of $60 million from the December 2025 public offering (prior to deducting underwriting discounts and commissions and offering expenses), the company expects that such resources will be sufficient to fund planned operations through mid-2027. About TN-201 Gene Therapy and the MyPEAK-1 Phase 1b/2 Clinical TrialTN-201 is an adeno-associated virus serotype 9 (AAV9)-based gene therapy designed address the underlying cause of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM) by delivering a working MYBPC3 gene to heart muscle cells via a single intravenous infusion and thereby increasing insufficient MyBP-C protein levels with the aim of halting or even reversing disease after a single dose. The U.S. Food and Drug Administration has granted TN-201 Fast Track, Orphan Drug and Rare Pediatric Drug Designations. TN-201 has also received orphan medicinal product designation from the European Commission. The ongoing MyPEAK-1 Phase 1b/2 clinical trial (Clinicaltrials.gov ID: NCT05836259) is a multi-center, open-label, dose-escalating (3E13 vg/kg and 6E13 vg/kg) study of symptomatic adults (up to 24) who have been diagnosed with MYBPC3-associated HCM. MyPEAK-1 is designed to assess the safety, tolerability and clinical efficacy of a one-time intravenous infusion of TN-201 gene replacement therapy. MyPEAK-1 has tested doses of 3E13 vg/kg and 6E13 vg/kg in two cohorts of three patients each. In July 2025, Tenaya reported that the trial’s independent Data Safety Monitoring Board (DSMB) concluded that TN-201 had an acceptable safety profile to allow enrollment of expansion cohorts at either the 3E13 vg/kg (Cohort 1) or 6E13 vg/kg (Cohort 2) dose levels. To learn more about gene therapy for HCM and participation in the MyPEAK-1 study, please visit HCMStudies.com. About TN-401 Gene Therapy and the RIDGE-1 Phase 1b/2 Clinical TrialTN-401 is an investigational AAV9-based gene therapy being developed for the treatment of arrhythmogenic right ventricular cardiomyopathy (ARVC, also known as arrhythmogenic cardiomyopathy or ACM) due to mutations in the Plakophilin-2 (PKP2) gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute of Regenerative Medicines (CIRM). The RIDGE-1 Phase 1b/2 clinical trial of TN-401 in patients with PKP2-associated ARVC is a multi-center, open-label, dose escalation study being conducted in the U.S. and UK. RIDGE-1 is intended to assess the safety, tolerability and preliminary clinical efficacy of a one-time intravenous infusion of TN-401. RIDGE-1 will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and are at increased risk for arrhythmias as determined by premature ventricular count (PVC) during screening. In July 2025, Tenaya announced that the RIDGE-1 trial’s independent Data Safety Monitoring Board (DSMB) endorsed dose escalation per protocol following a review of available data from three patients dosed at 3E13 vg/kg (Cohort 1). Enrollment in the 6E13 vg/kg dose cohort is complete and additional enrollment in the RIDGE-1 will be considered following a review of all available safety data by the trial’s DSMB. To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com or ClinicalTrials.gov (NCT06228924). About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, and multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com. Forward Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “aims,” “expects,” “plans,” “potentially,” “anticipated,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the planned timing to report additional data from MyPEAK-1 and RIDGE-1 and pursue regulatory alignment for the TN-201 and TN-401 programs; the sufficiency of Tenaya’s cash runway to support operations through mid-2027; the clinical, therapeutic and commercial potential of, and expectations regarding the safety and efficacy of TN-201 and TN-401; Tenaya’s expectations regarding enrollment in MyPEAK-1; expectations regarding the upcoming DSMB review of RIDGE-1 safety data and plans to continue to enroll patients in one or both dose cohorts; statements regarding the continued development of TN-201 and TN-201 and TN-401 clinical outcomes, which may materially change as more patient data become available; and statements made by Tenaya’s Chief Executive Officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of MyPEAK-1 and RIDGE-1 data at the referenced time; the timing and progress of MyPEAK-1 and RIDGE-1; the potential failure of TN-201 and/or TN-401 to demonstrate safety and/or efficacy in clinical testing; the potential for any MyPEAK-1 or RIDGE-1 clinical trial results to differ from preclinical, interim, preliminary or expected results; the potential for the U.S. Food and Drug Administration and/or other regulatory agencies to conclude at any time that TN-201 and/or TN-401 may not have an appropriate risk/benefit profile; Tenaya’s ability to enroll and maintain patients in clinical trials, including MyPEAK-1 and RIDGE-1; risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early stage company; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue its product development plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in Tenaya’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2025, and other documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Tenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsPrecision AQ annemarie.fields@precisionaq.com MediaWendy RyanTen Bridge Communicationswendy@tenbridgecommunications.com
NewAmsterdam Pharma Highlights 2025 Achievements and Outlines 2026 Strategic Priorities
— EMA approval decision for obicetrapib and obicetrapib/ezetimibe fixed dose combo expected in 2H26 — — Phase 3 PREVAIL CVOT overall event rate tracking in line with observed rate in BROADWAY — — First patient enrolled in RUBENS Phase 3 trial of obicetrapib and obicetrapib/ezetimibe fixed dose combo (FDC) in patients with metabolic syndrome — — Year-end cash, cash equivalents and marketable securities balance of approximately $729 million (unaudited) — NAARDEN, the Netherlands and MIAMI, Jan. 09, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today provided an update on the obicetrapib clinical development program and outlined its strategic priorities for 2026. NewAmsterdam is developing obicetrapib, an oral, low-dose, once-daily, and highly selective cholesteryl ester transfer protein (“CETP”) inhibitor, alone or as a fixed-dose combination with ezetimibe, as preferred LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of cardiovascular disease with elevated LDL-C, for whom existing therapies are not sufficiently effective or well tolerated. “2025 was an important year for NewAmsterdam, as we continued to further the regulatory process for obicetrapib and the fixed-dose combo. In partnership with Menarini, the company is preparing for a potential commercial launch in Europe, contingent upon an EMA approval decision that is expected in 2H26. In PREVAIL, we are encouraged by the rate of overall MACE events (blinded) in this cardiovascular outcomes trial (“CVOT”), which suggest that the initial 12 month rate is tracking in line with the overall rate observed in the Phase 3 BROADWAY trial,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. “We are also excited to announce the RUBENS trial enrolled its first few patients in December and could allow for additional label enhancements, if approved, for patients with Type 2 Diabetes and/or Metabolic Syndrome that are not at their LDL-C risk-based goals. We expect topline results from the trial by the end of 2026.” “As we look to 2026, we remain committed to advancing our broader clinical development strategy, which includes three Phase 3 trials, PREVAIL, REMBRANDT, and RUBENS. In addition and based on the positive data from our Alzheimer’s disease (“AD’”) biomarker analysis from the BROADWAY trial, we are planning to start our first dedicated Alzheimer’s trial in 2026. This study could further demonstrate the potential of obicetrapib to modify key biomarkers and clinical pathology of AD. Lastly, we continue to make progress towards building out a portfolio of obicetrapib based combinations, conducting studies that could guide the development of proprietary fixed-dosed combinations in the future,” continued Dr. Davidson. Key 2025 Achievements: In June and July 2025, NewAmsterdam announced positive data from the prespecified AD biomarker analysis in the BROADWAY clinical trial and presented at the 2025 Alzheimer’s Association International Conference (“AAIC”). The pre-specified analysis was conducted to assess the effect of obicetrapib on plasma biomarkers of AD in both the full analysis set and in patients carrying the apolipoprotein E4 (“ApoE4”) gene, based on phenotypic analysis. NewAmsterdam observed statistically significant reductions in p-tau217, a key biomarker of AD pathology, in both the full analysis set (p



