Author: Ken Dropiewski

Concept Medical Announces First Patient Enrollment in STARS DAPT Randomized Clinical Trial Evaluating Abluminus NP Polymer-Free DES

TAMPA, Fla.–(BUSINESS WIRE)–Concept Medical Inc., a global pioneer in innovative drug delivery technology, is proud to announce the successful enrollment of the first patients in the STARS DAPT (ST-Segment Elevation Myocardial InfArction treated with a Polymer-Free Sirolimus-based NanocarrieR Eluting Stent and a P2Y12 inhibitor-based Single Antiplatelet Strategy after a Short Dual Antiplatelet Therapy […]

Affera™ momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE first cases for Sphere-360™ PFA catheter to treat paroxysmal atrial fibrillation

First-of-its-kind, rotation-free single-shot PFA catheter supported by strong safety and efficacy data adds to the groundbreaking Affera family of technologies in Europe Successful completion of first cases at multiple sites kicks off Horizon 360 IDE pivotal trial in the United States…

CVRx Announces Initiation of BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population

Study is Expected to Be One of the Largest Therapeutic Cardiac Device Trials in Heart Failure Ever Performed, and is Supported by CMS Category B IDE CoverageMINNEAPOLIS, Jan. 22, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced initiation of the BENEFIT-HF clinical trial, a landmark randomized study supported by CMS Category B IDE coverage and designed to evaluate the impact of Barostim™ in a significantly expanded heart failure population. Barostim™ is an implantable device that delivers electrical signals to baroreceptors located on the carotid artery, increasing baroreflex signaling, rebalancing the autonomic nervous system, and improving heart failure symptoms. Barostim™ received FDA approval in 2019 following its designation under the FDA’s Breakthrough Devices Program and is now commercially available in both the U.S. and Europe. The BENEFIT-HF trial is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, randomizing 2,500 patients in approximately 150 centers in the United States and Germany. The primary endpoint will be a composite of all-cause mortality and heart failure decompensation events. Enrollment is expected to begin in the first half of 2026. The BENEFIT-HF trial is designed to evaluate Barostim in patients with heart failure who: Remain symptomatic after receiving optimized guideline-directed medical and device therapies (GDMT)Have a left ventricular ejection fraction (LVEF)

Anteris Announces Strategic Investment from Medtronic to Continue Advancing TAVR in $320 Million Aggregate Capital Raises

MINNEAPOLIS and BRISBANE, Australia, Jan. 22, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, announced today it has completed a $90 million strategic investment from Medtronic, plc (Galway, Ireland) (NASDAQ: MDT) (Medtronic), the world’s largest medical technology company. The investment closed immediately following Anteris’ underwritten offering of common stock, for a combined $320 million in gross proceeds, which supports execution of the global pivotal PARADIGM trial and advances the Company toward global commercialization of the DurAVR® Transcatheter Heart Valve (THV). Anteris and Medtronic are aligned around the belief that reshaping the Transcatheter Aortic Valve Replacement (TAVR) market requires advancing clinical science and valve design while maintaining rigorous standards for durability, hemodynamics, and long‑term patient outcomes. “This strategic investment, along with our underwritten offering of common stock, represent an important milestone for our company. It also provides strong validation of our program from the capital markets and a major strategic innovator,” said Wayne Paterson, Anteris Vice Chairman and CEO. “The investment is one aspect of a collaboration that may expand into other strategic areas in the future. Anteris has developed a clinically important, evidence-supported product designed to improve the lives of patients with aortic stenosis as we advance toward regulatory approval.” “The Board is excited to welcome Medtronic to its stockholder community,” said John Seaberg, Chairman of the Anteris Board. “This investment aligns two organizations in their commitment to advancing valve science in a way that is disciplined and focused on long‑term patient benefit.” “Medtronic is a pioneer in TAVR innovation and evidence,” said Jorie Soskin, Vice President and General Manager of the Structural Heart business in Medtronic’s Cardiovascular portfolio. “Our investment in differentiated innovation like the DurAVR® THV technology — which has the potential to offer improved valve performance in a balloon-expandable platform — is core to our commitment to define and drive the future of TAVR, meeting the needs of more aortic stenosis patients and heart teams with a comprehensive portfolio.” The Medtronic investment and the underwritten public offering of common stock position Anteris to continue to execute the global PARADIGM Trial and to continue investing in research that can transform the treatment of aortic stenosis. Wells Fargo Securities acted as sole placement agent in connection with the Medtronic investment. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. The PARADIGM Trial has commenced recruitment with the first patients enrolled and implanted during the fourth quarter of 2025. For further information, please refer to ClinicalTrials.gov (ClinicaTrials.gov ID NCT07194265). The planned expansion across other geographies includes additional cohorts. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® Transcatheter Heart Valve (THV), was designed in partnership with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including statements in the quotations contained herein and regarding the use of proceeds from the Private Placement and the underwritten public offering, future collaboration between the company, the PARADIGM Trial, the potential for approval of DurAVR® THV and its ability to improve the lives of patients with aortic stenosis, and the testing of the DurAVR® THV technology. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2025, each of which was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Investor Relations Investor Relations (US)investor@anteristech.com mchatterjee@bplifescience.comDebbie Ormsby Malini Chatterjee, Ph.D.Anteris Technologies Global Corp. Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200 +1 917 330 4269 Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech 

CORXEL Announces $287 million Series D1 Financing to Further Advance Its Cardiometabolic Pipeline including Oral Small Molecule GLP-1 Receptor Agonist

BERKELEY HEIGHTS, N.J., Jan. 22, 2026 (GLOBE NEWSWIRE) — Corxel Pharmaceuticals Limited (CORXEL), a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for patients with cardiometabolic conditions around the world, today announced the successful completion of its Series D1 financing, raising up to $287 million in capital. Proceeds from the round are expected to support the advancement of CX11, a differentiated oral small molecule GLP-1 RA for obese and overweight patients currently being evaluated in a Phase 2 trial conducted by CORXEL in the United States and a Phase 3 trial conducted by Vincentage in China, and other cardiometabolic programs, including for acute ischemic stroke and hypertension.

Kardium Announces Publication of PULSAR Pivotal Trial Results in JACC

VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., an emerging leader in advanced solutions for atrial fibrillation, is proud to announce the publication of the PULSAR clinical trial results in the Journal of the American College of Cardiology (JACC). This landmark study evaluated the Globe® Pulsed Field System by Kardium for the treatment of paroxysmal atrial fibrillation […]

January Issue of Journal of Cardiac Failure-Intersections Examines How Innovation, Advanced Mechanical Support, and Prescribing Design Are Reshaping Heart Failure Care

The third issue of the open-access journal showcases multidisciplinary heart failure research and the many intersections that shape patient care. WASHINGTON, Jan. 21, 2026 /PRNewswire/ — The January issue of Journal of Cardiac Failure-Intersections brings together new analyses and…

BioAge Announces Proposed Public Offering

EMERYVILLE, Calif., Jan. 20, 2026 (GLOBE NEWSWIRE) — BioAge Labs, Inc. (Nasdaq: BIOA) (“BioAge”, “the Company”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced a proposed underwritten public offering in which it intends to offer and sell, subject to market and other conditions, up to $75.0 million of shares of its common stock. In addition, BioAge intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares of common stock are being offered by BioAge. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Goldman Sachs & Co. LLC, Piper Sandler and Citigroup are acting as joint book-running managers for the proposed offering. BioAge intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund research, clinical and process development and manufacturing of its product candidates, including BGE-102 and further development of its NLRP3 and APJ programs, working capital, capital expenditures, reduction of indebtedness and for other general corporate purposes. The shares are being offered by BioAge pursuant to a registration statement on Form S-3 (No. 333-290688) that became effective on November 25, 2025. A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the Securities and Exchange Commission (the “SEC”). When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Piper Sandler & Co., Attention: Prospectus Department, 350 North 5th Street, Suite 1000, Minneapolis, MN 55401, by telephone at (800) 747-3924, or via email at prospectus@psc.com; or Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the SEC’s website at http://www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of BioAge, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging. The Company’s lead product candidate, BGE-102, is a potent, orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed for cardiovascular risk and retinal diseases. A Phase 1 SAD/MAD trial of BGE-102 is underway, with topline data including additional MAD cohorts anticipated in 1H26. The Company is also developing long-acting injectable and oral small molecule APJ agonists for obesity. BioAge’s additional preclinical programs, which leverage insights from the Company’s proprietary discovery platform built on human longevity data, address key pathways involved in metabolic aging. Forward-looking statements This press release contains “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the completion, timing of the closing and size of the underwritten offering, the grant of the option to purchase additional shares and the anticipated gross proceeds of the offering and the use thereof. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “potential,” “possible,” “will,” “would,” and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop, obtain regulatory approval for and commercialize our product candidates; the timing and results of preclinical studies and clinical trials; the risk that positive interim results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; failure to protect and enforce our intellectual property, and other proprietary rights; failure to successfully execute or realize the anticipated benefits of our strategic and growth initiatives; risks relating to technology failures or breaches; our dependence on collaborators and other third parties for the development of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions, including due to the imposition of tariffs and other trade barriers; risks associated with current and potential future healthcare reforms; risks relating to attracting and retaining key personnel; changes in or failure to comply with legal and regulatory requirements, including shifting priorities within the U.S. Food and Drug Administration; risks relating to access to capital and credit markets; and the other risks and uncertainties that are detailed under the heading “Risk Factors” included in BioAge’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) on November 6, 2025, and BioAge’s other filings with the SEC filed from time to time. BioAge undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. ContactsPR: Chris Patil, media@bioagelabs.com IR: Dov Goldstein, ir@bioagelabs.com Partnering: Peng Leong, partnering@bioagelabs.com