Author: Ken Dropiewski

January Issue of the Journal of Cardiac Failure Highlights Prevention, Innovation, and New Strategies to Improve Outcomes Across the Heart Failure Spectrum

WASHINGTON, Jan. 13, 2026 /PRNewswire/ — A novel approach to removing excess fluid through the skin and a new strategy to prevent right ventricular failure after LVAD implantation are among the highlights of the January issue of the Journal of Cardiac Failure (JCF). Together, these…

Conavi Medical Corp. Announces Closing of $12M Public Offering

NOT FOR DISTRIBUTION TO U.S. NEWS WIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES TORONTO, Jan. 13, 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 announce that it has closed its previously announced equity offering for aggregate gross proceeds of approximately $12 million (the “Offering”). 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 initiate 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. Bloom Burton Securities Inc. acted as sole and exclusive agent for the Offering. Under the Offering, subscribers purchased a total of 26,666,670 common shares of the Company (the “Common Shares”) at a price of $0.45 per Common Share, for gross proceeds of $12,000,001.50. “This Offering positions Conavi to initiate a targeted market release of Novasight, following U.S. FDA clearance,” said Tom Looby, President and Chief Executive Officer of Conavi. “The strong participation from U.S. strategic healthcare investors reflects confidence in our technology and commercial strategy, as well as growing interest in intravascular imaging technologies. The proceeds will support our commercialization efforts and continued advancement of our intravascular imaging platform.” In Canada, the Common Shares purchased pursuant to the Offering were qualified for sale by way of an amended and restated short form prospectus dated January 7, 2026, which was filed in British Columbia, Alberta and Ontario. The Common Shares were also purchased by way of private placement in the United States, pursuant to exemptions from the registration requirements under the U.S. Securities Act of 1933 (the “U.S. Securities Act”), and pursuant to all applicable U.S. state securities laws. The securities described herein have not been, and will not be, registered under the U.S. Securities Act, or any U.S. state securities laws, and accordingly, may not be offered or sold to, or for the account or benefit of, persons in the United States or to U.S. Persons (as such terms are defined in Regulation S under the U.S. Securities Act), except in compliance with the registration requirements of the U.S. Securities Act and applicable U.S. state securities requirements or pursuant to exemptions therefrom. This press release does not constitute an offer to sell or a solicitation of an offer to buy any of the Company’s securities. The Agent (together with its sub-agents) received a total cash commission of $701,479.49 and 1,558,843 compensation options of the Company (“Compensation Options”). Each Compensation Option entitles the holder to buy one Common Share at a price of $0.45 per Common Share until expiry on January 13, 2028. 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: Chief Financial Officer: Mark Quick, 416-483-0100 Investors: Christina Cameron, 416-483-0100 ext.121, 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 use of proceeds from the Offering. 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 amended and restated short form prospectus dated January 7, 2026 and the joint information circular of the Company dated August 30, 2024 (both of which are 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.

AliveCor Announces FDA Clearance of New Cardiac Determinations for Kardia 12L ECG System, Bringing Total to 39

KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design. KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design.

Kestra Medical Technologies Announces Strategic Collaboration with Biobeat Technologies to Expand Diagnostic Insight for Wearable Defibrillator Patients During Cardiac Recovery

KIRKLAND, Wash., Jan. 13, 2026 (GLOBE NEWSWIRE) — Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a leading wearable medical device and digital healthcare company, today announced a strategic collaboration with Biobeat Technologies, Ltd. to expand diagnostic insight for patients prescribed the ASSURE® Wearable Cardioverter Defibrillator (WCD). The agreement is anchored by an exclusive license and co-development arrangement and includes a $5 million equity investment in Biobeat’s recently announced Series B financing. Biobeat has developed the only clinically validated, FDA-cleared cuffless, patch-worn ambulatory blood pressure monitoring (ABPM) device, leveraging photoplethysmography-based sensing to deliver continuous, noninvasive blood pressure measurement over a 24-hour period for hypertension diagnosis and management in the outpatient cardiac recovery setting. Kestra intends to integrate Biobeat’s technology into its product portfolio to make ABPM data available for patients prescribed the ASSURE WCD. Kestra recently published the largest prospective real-world study of wearable defibrillators to date and insights from ASSURE Wearable Cardioverter Defibrillator Clinical Evaluation Post-Approval Study (ACE-PAS) underscore the clinical relevance of the collaboration with Biobeat. Seventy-two percent (72%) of the patients studied in ACE-PAS were hypertensive, highlighting the complexity of managing blood pressure during cardiac recovery, particularly during guideline-directed medical therapy (GDMT) optimization. “Health care providers have consistently told us that better visibility to blood pressures during cardiac recovery would meaningfully support clinical decision making,” said Brian Webster, President and CEO of Kestra. “This collaboration allows us to expand the clinical insights available during recovery while reinforcing ASSURE as a flexible platform designed to support at-home patient care.” Arik Ben Ishay, CEO of Biobeat, added, “Kestra has built a scalable platform focused on protecting and supporting patients during cardiac recovery. We are excited to collaborate with Kestra as they explore how our FDA-cleared, 24-hour blood pressure monitoring for hypertension diagnosis may complement their Cardiac Recovery System® platform and expand the clinical insights available to care teams managing complex cardiac patients.” About Kestra Kestra Medical Technologies, Ltd. is a leading 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.  About BiobeatBiobeat is an innovative company with operations in Tel Aviv, Israel and Boca Raton, Florida. Biobeat is focused on revolutionizing the blood pressure monitoring landscape by expanding the use of ABPM for hypertensive patients and providing 24-hour blood pressure data that allows for patient comfort and uninterrupted sleep while capturing critical nighttime blood pressure measurements seamlessly and accurately. For more information visit https://www.bio-beat.com Forward-Looking StatementsExcept where otherwise noted, the information contained in this press release is as of January 13, 2026. Statements in this press release that express a belief, expectation or intention, as well as those that are not historical fact, are forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Given their forward-looking nature, these statements involve substantial risks, uncertainties and potentially inaccurate assumptions, and we cannot ensure that any outcome expressed in these forward-looking statements will be realized in whole or in part. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: risks related to our limited operating history and history of net losses; our ability to successfully achieve substantial market adoption of our products; competitive pressures; our ability to adapt our manufacturing and production capacities to evolving patterns of demand, governmental actions and customer trends; product defects or complaints and related liability; our ability to obtain and maintain adequate coverage and reimbursement levels for our products; our ability to comply with changing laws and regulatory requirements and resulting costs; our dependence on a limited number of suppliers; and other risks and uncertainties, including those described under the heading “Risk Factors” in Kestra’s  Annual Report on Form 10-K for the fiscal year ended April 30, 2025 filed with the U.S. Securities and Exchange Commission (“SEC”) on July 17, 2025, and in other periodic reports filed by Kestra with the SEC. These filings are available on the Investor Relations section of our website at https://investors.kestramedical.com/ and on the SEC’s website at https://sec.gov/. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9f7a5dd8-eb80-4db2-b977-db8bba695bf8 CONTACT: Media contact 
Rhiannon Pickus 
rhiannon.pickus@kestramedical.com 

Investor contact 
Neil Bhalodkar 
neil.bhalodkar@kestramedical.com 

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. […]