The Latest Cardiac and Vascular News
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…
$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.
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
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 […]
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. […]
€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 […]
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 […]
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 […]
PETAH TIKVA, Israel & BOCA RATON, Fla.–(BUSINESS WIRE)–Biobeat Technologies, Ltd., developer of the first FDA-cleared, 24-hour ambulatory blood pressure monitoring (ABPM) system that is a patch-worn, cuff-less solution for diagnosis and treatment of hypertension, announced today the closing of a $50 million Series B equity financing. The time has arrived […]
NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES A&R FINAL PROSPECTUS WILL BE ACCESSIBLE ON SEDAR+ TORONTO, Jan. 07, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (“Conavi” or the “Company”), a commercial stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures, is pleased to provide an update in respect of its previously announced public offering (the “Offering”) of common shares of the Company (“Common Shares”) and/or pre-funded common share purchase warrants of the Company in lieu of Common Shares (“Pre-Funded Warrants” and, together with the Common Shares, the “Securities”). The Offering is being conducted on a commercially reasonable efforts agency basis for the issuance of a minimum of 26,666,667 Securities and a maximum of 33,333,333 Securities at a price of $0.45 per Common Share or $0.44999 per Pre-Funded Warrant, for gross proceeds of between $12,000,000 and $15,000,000. Each Pre-Funded Warrant issued in lieu of a Common Share at the election of any purchaser entitles the holder thereof to acquire one Common Share at an exercise price of $0.00001 per Common Share. The Pre-Funded Warrants will not expire and may be exercised on a “net” or “cashless” basis. The Company intends to use the net proceeds from the Offering to obtain US FDA 510(k) clearance of the next generation Novasight Hybrid system, as well as complete a targeted market release in the United States. The Company also intends to use the net proceeds for working capital and other general corporate purposes. The Offering is expected to be completed pursuant to the terms and conditions of an amended & restated agency agreement entered into between the Company and Bloom Burton Securities Inc. (the “Agent”). The Company filed an amended and restated final short form prospectus (the “A&R Final Prospectus”) on January 7, 2026, with the securities regulatory authorities in the provinces of Alberta, British Columbia, and Ontario, which amends and restates the final short form prospectus filed on December 18, 2025. There will not be any sale of the Securities until a receipt for the A&R Final Prospectus has been issued. The Offering may be completed in one or more tranches and is expected to close initially on or about January 13, 2026, or such other date as may be mutually agreed to by the Company and the Agent (the “Closing Date”). The Offering is subject to the satisfaction of customary closing conditions, including the receipt of all necessary regulatory and stock exchange approvals, including approval of the TSX Venture Exchange (“TSXV”). The Company will pay to the Agent a cash fee equal to 6.5% of the gross proceeds raised under the Offering, and grant the Agent compensation options equal to 6.5% of the aggregate number of Securities issued under the Offering (the “Compensation Options”), provided however, the Agent will receive a reduced cash commission of 3.25% and no Compensation Options in respect of Securities sold to certain purchasers on a president’s list to be agreed to between the Company and the Agent. Each Compensation Option shall entitle the holder to buy one Common Share at the same price per Common Share as under the Offering. The Compensation Options shall be exercisable until that date which is 24 months following the Closing Date. In addition, the Securities are anticipated to be offered by way of private placement in certain jurisdictions outside of Canada pursuant to and in compliance with applicable securities laws. This press release is not an offer to sell or the solicitation of an offer to buy the Securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The Securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”), and such Securities may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons except pursuant to an exemption from the registration requirements under the U.S. Securities Act and applicable U.S. state securities laws. “United States” and “U.S. persons” have the meanings ascribed to them in Regulation S under the U.S. Securities Act. Access to the A&R Final Prospectus and any amendments to such documents will be provided in accordance with securities legislation relating to procedures for providing access to a short form prospectus and any amendment thereto. The A&R Final Prospectus (when filed) will be accessible on SEDAR+ at www.sedarplus.ca. Alternatively, an electronic or paper copy of the A&R Final Prospectus (when filed), as well as any amendment to such documents, may be obtained without charge from the Agent by email at ECM@bloomburton.com, by telephone at 416-640-7585 or by providing the contact with an email address or address, as applicable. The A&R Final Prospectus (when filed) contains important, detailed information about the Company and the Offering. Prospective investors should read the A&R Final Prospectus (when filed) before making an investment decision. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ System is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single device, enabling simultaneous and co-registered imaging of coronary arteries. The first-generation Novasight Hybrid™ System has 510(k) regulatory clearance in the U.S., Canada, China, and Japan. For more information, visit http://www.conavi.com. CONTACT:Christina Cameron IR@conavi.com Notice on forward-looking statements: This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Conavi and its business, which may include, but are not limited to, statements with respect to the anticipated terms and jurisdictions of the Offering; securities offered thereunder; the timing of the Offering, including the anticipated Closing Date and timing for the A&R Final Prospectus; use of proceeds from the Offering; fees anticipated to be paid to the Agent and terms thereof; and regulatory and exchange approvals, including the listing of the Common Shares offered pursuant to the Offering on the TSXV. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the A&R Final Prospectus (which, when filed, will be available on the Company’s profile at www.sedarplus.ca). Although Conavi has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Conavi does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.
