BELFAST, Northern Ireland , Jan. 12, 2026 /PRNewswire/ — PulseAI, a rapidly emerging leader in AI-enabled cardiac diagnostics, today announced the closing of its seed funding round, led by Innovation Ulster Limited, with participation from The Mortara Group and The Francis Crick…
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YorLabs Completes First Clinical Procedure Using FDA-Cleared Zero-CapEx Intracardiac Imaging System
BEAVERTON, Ore., Jan. 12, 2026 /PRNewswire/ — YorLabs, Inc., a medical technology company pioneering next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC), today announced the successful completion of the first clinical procedure…
Orchestra BioMed to Receive Up to $21 Million in Proceeds from Acquisition of Vivasure by Haemonetics
$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.
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…



