MIAMI LAKES, Fla.–(BUSINESS WIRE)– #Cordis–Cordis, a global leader in interventional cardiovascular and endovascular technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) for the treatment of coronary in-stent restenosis (ISR), marking a major milestone in expanding treatment options for one of the most complex challenges in interventional cardiology. Physicians now have immediate access to the
Coronary/Structural Heart
HFSA’s 2026 Annual Scientific Meeting to Feature Late-Breaking Trials That Could Reshape Heart Failure Treatment
October 9-12, 2026 | Phoenix, Arizona — New data spans pharmacotherapy, imaging and diagnostics, and device therapy for patients with cardiomyopathy WASHINGTON, Sept. 18, 2026 /PRNewswire/ — The Heart Failure Society of America (HFSA) today announced the Late-Breaking Clinical Research…
Catheter Precision Expands LockeT Commercialization Across Latin America Following Successful Launch in Brazil
LockeT Has Expanded to Six Hospitals in Brazil Since Its August Launch Company Engages Experienced Cardiology Group to Support Expansion Across Argentina, Chile, Colombia and Additional Latin American Markets FORT MILL, S.C., Sept. 17, 2026 (GLOBE NEWSWIRE) — Catheter Precision Inc. (NYSE American: VTAK), Catheter Precision, Inc. (NYSE American: VTAK) (“Catheter Precision” or the “Company”), a U.S.-based medical device company specializing in cardiac electrophysiology, today announced the expansion of its LockeT commercialization efforts across Latin America following the product’s successful introduction in Brazil. LockeT launched commercially in São Paulo in August through the Company’s distribution agreement with Ablacor and has since expanded to six hospitals in Brazil, with additional interest from healthcare institutions in the market. Building on the initial traction in Brazil, Catheter Precision has expanded its relationship with an experienced cardiology group with extensive clinical knowledge and longstanding relationships throughout Latin America to support the Company’s continued commercial expansion across the region. The Company is now pursuing opportunities to expand LockeT into additional Latin American markets, including Argentina, Chile and Colombia, as well as other countries throughout the region. “The early response to LockeT in Brazil has been very encouraging and has given us confidence to broaden our efforts across Latin America,” said David Jenkins, Chief Executive Officer of Catheter Precision. “Expanding to six hospitals in a relatively short period demonstrates the potential we see for LockeT internationally. We believe the clinical experience and established relationships of the cardiology group we are working with can be valuable as we introduce LockeT into additional markets throughout the region.” Building on Early Commercial Traction in Brazil Catheter Precision entered the Brazilian market through a distribution agreement with Ablacor, initially launching LockeT in São Paulo in August 2026. Since that introduction, LockeT has expanded to six hospitals, providing the Company with an initial commercial foundation in one of Latin America’s largest healthcare markets. The Company believes the early progress in Brazil provides a model for expanding LockeT’s international commercial presence across additional markets where electrophysiology procedures are performed. Catheter Precision is now working with an experienced cardiology group with expertise in electrophysiology and established relationships throughout the region to support the next phase of that expansion. The Company intends to build upon its presence in Brazil while pursuing commercial opportunities across Argentina, Chile, Colombia and additional markets throughout Latin America. “Latin America represents an important opportunity for LockeT,” Jenkins continued. “Our focus is on building the market thoughtfully, working alongside experienced clinical groups and establishing strong relationships within each country we enter. Brazil was an important first step, and we are excited to continue expanding LockeT’s presence across the region.” The expansion of LockeT in Latin America is part of Catheter Precision’s broader strategy to increase the international commercial reach of its cardiac electrophysiology product portfolio and establish relationships with physicians, hospitals and healthcare organizations in new markets. About LockeT Catheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “expect,” “anticipate,” “potential,” “will,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, expectations regarding potential strategic transactions, valuation outcomes, market opportunities, and the Company’s growth strategy. These statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks, please refer to the Company’s filings with the SEC, including its most recent Forms 10-K and 10-Q. The Company undertakes no obligation to update any forward-looking statements. CONTACTS: Investor Relations973-691-2000IR@catheterprecision.com # # #
Conavi Medical Announces Peer-Reviewed Case Report Highlighting Clinical Utility of Hybrid IVUS-OCT Imaging, and Provides Update on Management Team
Latest publication adds to growing body of clinical evidence supporting hybrid IVUS-OCT imaging in complex coronary procedures Chief Technology Officer Amandeep Thind to lead continued innovation TORONTO, Sept. 17, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced the publication of a peer-reviewed case report highlighting the clinical utility of hybrid intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) imaging in guiding treatment decisions following stent placement. The case report, titled “Detection of Post-Stent Medial Dissection and White Thrombus Using Hybrid IVUS OCT Imaging may Help Guide Management,” was published in Catheterization and Cardiovascular Interventions. The report was authored by Megha Prasad, M.D., M.S., of Columbia University Irving Medical Center/NewYork-Presbyterian Hospital, together with Khady N. Fall, M.D., Jeffrey W. Moses, M.D., and Natali Sorajja, M.S.“Hybrid IVUS-OCT imaging provided complementary information that was important in assessing the post-stent findings in this case,” said Dr. Jeffrey Moses, author and Chairman of Cardiology at Good Samaritan University Hospital. “The ostial location necessitated IVUS for initial imaging. OCT was then essential in evaluating the dissections after stent placement. The distal medial edge dissection was easily visualized on OCT but less easily discernable on IVUS. IVUS alone may have failed to demonstrate the dissection, which required timely management. Having both modalities available helped guide management and apply treatment guidelines, including the decision to place an additional distal stent while managing the proximal dissection medically.” The report describes the treatment of a 66-year-old patient undergoing percutaneous coronary intervention (“PCI”) of the right coronary artery. Following stent placement, the clinical team used Conavi’s hybrid IVUS-OCT imaging to identify proximal and distal edge dissections, as well as white thrombus. IVUS was used for vessel sizing and plaque assessment, while OCT’s higher resolution helped characterize the extent and depth of the dissections. IVUS also helped confirm an irregular protrusion seen on OCT as white thrombus rather than a calcified nodule. The authors noted that without identification of the thrombus, in-stent thrombosis could have led to further vessel occlusion and a potentially catastrophic event. The authors noted that this combined evaluation may be important in helping prevent acute vessel closure, major adverse cardiovascular events and target revascularization. The latest publication is available at:https://onlinelibrary.wiley.com/doi/10.1002/ccd.70821 “This case provides a very clear example of why combining IVUS and OCT can matter clinically,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “The two modalities provided complementary information that helped physicians identify and assess post-stent complications and determine when an additional stent was warranted and when medical management was appropriate. Together with other recent case reports, this publication adds to the clinical evidence supporting the potential value of hybrid imaging in complex coronary procedures.” The publication follows other previously published case reports highlighting the use of Conavi’s hybrid IVUS-OCT technology in complex coronary interventions. In July 2026, a Journal of the Society for Cardiovascular Angiography & Interventions (“JSCAI”) case report highlighted the use of hybrid imaging in the contrast-sparing management of eruptive calcified nodules in a patient with impaired renal function. In July 2025, another JSCAI case report highlighted the use of hybrid imaging to identify plaque rupture and guide ostial stent placement in a complex coronary procedure. Together, these publications add to a growing body of clinical evidence highlighting the potential utility of hybrid IVUS-OCT imaging across a range of complex coronary procedures. Previously Announced Case Reports July 8, 2026 JSCAI case report, “Versatility of Hybrid OCT and IVUS Imaging Enhances Contrast-Sparing Management of Eruptive Calcified Nodules”:https://www.jscai.org/article/S2772-9303(26)01244-5/fulltext July 30, 2025 JSCAI case report, “The Role of Comprehensive Hybrid Imaging in Identification of Plaque Rupture and Ostial Stent Placement: Case Report”:https://doi.org/10.1016/j.jscai.2025.103814 Innovation Leadership UpdateAmandeep Thind, Chief Technology Officer and Co-Founder, will assume leadership of Conavi’s research and development efforts. A co-inventor of the Company’s hybrid IVUS-OCT technology, Mr. Thind brings deep technical expertise and continuity as Conavi advances commercialization following the system’s recent FDA clearance. Sumeet Dham, Vice President of Research and Development, will be departing the Company. Conavi thanks Mr. Dham for his years of leadership and valuable contributions to its technology and key development milestones, and wishes him continued success. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. Notice on forward-looking statementsThis press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. 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” 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 annual information form of the Company dated February 26, 2026 (available on the Company’s profile at www.sedarplus.ca). Although the Company 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 the Company 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. CONTACT:Chief Financial Officer: Mark Quick, 416-483-0100Investors: Christina Cameron, 416-483-0100 ext. 121, IR@conavi.com
Catalyst MedTech Helps Imaging Providers See What’s Next in Nuclear Cardiology at ASNC 2026
Company to Showcase Expanded Digirad® Cardiac SPECT Portfolio, PET/CT Solutions, Windows 11 Modernization and Nationwide Imaging Service PITTSBURGH, Sept. 14, 2026 (GLOBE NEWSWIRE) — Catalyst MedTech today announced it will showcase its expanded nuclear cardiology portfolio at the 31st Annual Scientific Session & Exhibition of the American Society of Nuclear Cardiology (ASNC 2026), September 16–19, 2026, at Caesars Palace in Las Vegas. At Booth #121, Catalyst will feature Digirad® cardiac SPECT systems, PET/CT solutions, Windows 11 modernization, nationwide multi-vendor service, and cardiac imaging lifecycle support. Guided by the conference theme, “Be Part of What’s Next in Nuclear Cardiology,” the meeting will bring together the world’s leading cardiovascular imaging professionals to explore the latest advances in cardiac PET, SPECT, artificial intelligence, molecular imaging, and next-generation technologies. At Booth #121, Catalyst MedTech will demonstrate how providers can prepare for what’s next through an integrated approach that extends beyond imaging equipment—bringing together OEM innovation, modernization, nationwide service, clinical expertise, and lifecycle support to help healthcare organizations strengthen and grow their cardiac imaging programs. “The future of nuclear cardiology isn’t defined by a single technology—it’s defined by access, modernization, and the ability to continually evolve,” said Martin Shirley, President and CEO of Catalyst MedTech. “At Catalyst, we’re helping providers prepare for what’s next by combining OEM innovation, nationwide service, clinical expertise, and long-term lifecycle support in a way that few organizations can. Our goal is to give providers more options and greater flexibility to build the imaging programs their patients will need next.” See What’s Next at Booth #121 Visitors will have the opportunity to explore Catalyst MedTech’s expanding Digirad® OEM portfolio while learning how the company helps providers modernize existing imaging programs, maximize equipment performance, and plan for long-term growth. At ASNC 2026, Catalyst will highlight: CorCam™ dedicated cardiac SPECT system (formerly CardioMD®), now part of the expanded Digirad® OEM portfolioCardius® Series dedicated cardiac SPECT systemsX-ACT+® cardiac SPECT system with attenuation correction Windows 11 modernization for eligible legacy cardiac SPECT systemsISO-refurbished PET & PET/CT systemsNationwide OEM and multi-vendor service for cardiac SPECT, PET and PET/CT systemsImaging lifecycle management and modernization Cardiac PET program planning and implementation support Catalyst MedTech provides cardiac imaging solutions across SPECT and PET/CT, including new and refurbished imaging systems, equipment modernization, nationwide multi-vendor service, and clinical and program support. Beyond technology demonstrations, attendees will learn how Catalyst MedTech serves as a long-term partner by helping providers evaluate imaging strategies, modernize aging systems, improve operational performance, and support clinical growth through every stage of the imaging lifecycle. Meaningful Conversations About the Future of Cardiac Imaging As an ASNC 2026 Industry Collaboration Sponsor, Catalyst MedTech will participate in interactive small-group discussions with imaging leaders responsible for cardiac imaging strategy, modernization, and program development. Discussion topics will include: Replacing and modernizing aging cardiac SPECT systemsModernizing legacy cardiac SPECT systems to Windows 11Evaluating cardiac PET and PET/CT alongside existing SPECT programsProtecting imaging investments through lifecycle planningLeveraging nationwide OEM-trained, multi-vendor service support Whether organizations are replacing aging equipment, evaluating cardiac PET or PET/CT, modernizing existing technology, or seeking a trusted long-term imaging partner, Catalyst MedTech is helping providers navigate what’s next with more options, greater flexibility, and expertise across the imaging lifecycle. Attendees are invited to visit Catalyst MedTech at Booth #121 to experience the expanded Digirad® cardiac imaging portfolio, meet the team, and See What’s Next in Nuclear Cardiology. To learn more or schedule a meeting, visit: https://catalystmedtech.com/asnc-2026/https://catalystmedtech.com/asnc-2026-meeting/ About Catalyst MedTechCatalyst MedTech is a leading provider of nuclear medicine and molecular imaging solutions, including SPECT, PET and PET/CT, delivering OEM imaging systems, multi-vendor service, modernization, clinical support, and lifecycle management to healthcare providers across the United States. Through its expanding Digirad® OEM portfolio and nationwide service organization, Catalyst helps providers strengthen imaging programs, improve operational performance, and expand access to advanced diagnostic imaging. Guided by its purpose to provide value and access to advanced diagnostic imaging and related therapies that positively change people’s lives, Catalyst MedTech helps customers see what’s possible. www.catalystmedtech.com Media Contact:Kate KinsellDirector of MarketingCatalyst MedTechkkinsell@catalystmedtech.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/528c342d-8661-4d26-8f03-f22fcf1ff69e
New Cardiovascular Device Approved in Japan: Elixir Medical Announces Regulatory Approval of DynamX® Coronary Bioadaptor System
MILPITAS, Calif. and TOKYO , Sept. 14, 2026 (GLOBE NEWSWIRE) — New Cardiovascular Device Approved in Japan: Elixir Medical Announces Regulatory Approval of DynamX® Coronary Bioadaptor System MILPITAS, Calif. and TOKYO — Elixir Medical today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the DynamX® Coronary Bioadaptor System for the treatment of coronary artery disease, making DynamX® the first and unique coronary implant approved in Japan to restore arterial function known as hemodynamic modulation after percutaneous coronary intervention (PCI) procedure, with demonstrated improved patient survival and reduced re-interventions compared to drug-eluting stents (DES). The approval establishes bioadaptor as a new medical device category in Japan, highlighting MHLW and PMDA’s leadership in adopting the latest clinical innovations to advance cardiovascular treatment in Japan. “The DynamX® bioadaptor represents a major new treatment in PCI by providing restoration of the artery function,” – remarked Shigeru Saito, M.D., principal investigator of BIOADAPTOR RCT trial and Director of the Cardiac Center at Shonan Kamakura General Hospital in Kamakura, Japan. “With demonstrated evidence of restored hemodynamic modulation and the significant improvement in clinical outcomes in randomized trials, I believe this will become the new standard of care for coronary artery disease treatment.” “Coronary arteries perform two main functions – conduct blood flow and maintain healthy wall function that adapts to changing cardiac workload through pulsatility, elastic expansion and contraction, compliance, known together as hemodynamic modulation. This important function is disrupted when atherosclerotic plaques thicken the artery wall and progress into severe blockages,” noted Professor Stefan Verheye, M.D., Ph.D., leading bioadaptor researcher and interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium. “For decades we focused on opening artery blockages with stents and balloons to establish flow but did not address the hemodynamic modulation function of the artery resulting in adverse events increasing over time. DynamX bioadaptor is the first and only CAD treatment to achieve restoration of blood flow by both, opening the blockage and regaining hemodynamic modulation function of the artery, leading to demonstrated significant improvement in outcomes compared to current treatments.” DynamX® approval is supported by strong clinical evidence generated from two large RCT trials, the BIOADAPTOR RCT and INFINITY-SWEDEHEART randomized controlled trials, which compare DynamX® bioadaptor system with the standard-of-care Resolute Onyx™ drug-eluting stent. In the global BIOADAPTOR RCT trial, DynamX® demonstrated restoration of pulsatility, compliance and increased blood flow volume, representing for the first time restoration of both, blood flow and arterial functions. Recent long-term four-year results from BIOADAPTOR RCT presented at EuroPCR 2026 conference showed a significant 66% reduction versus DES in target lesion failure rate (2.8% vs 7.8%; p =0.02) DynamX® vs. DES, along with a significant 88% improvement in cardiovascular survival (cardiovascular death rate of 0.5% versus 3.7%, p=0.02), reduction in new heart attacks, and fewer repeat revascularization procedures. In the large European INFINITY-SWEDEHEART study of 2,400 complex patients and patients with acute coronary syndrome, DynamX® demonstrated similar and consistent 48% improvement in clinical outcomes over drug-eluting stent following activation of bioadaptor’s mechanism of restoring hemodynamic function six months post implant. The approval of DynamX® bioadaptor in Japan as a new medical device category for the treatment of coronary artery disease in addition to FDA’s Breakthrough Device Designation status, reflect growing recognition of bioadaptor implant’s unique mechanism of action, proven treatment effects, and demonstrated clinical improvement in PCI outcomes compared to existing standard of care. “MHLW approval marks an important milestone for patients and physicians in Japan and for the evolution of coronary artery disease treatment,” said Motasim Sirhan, Chief Executive Officer of Elixir Medical. “We developed DynamX® to move beyond the limitations of metallic drug-eluting stents and the “leave nothing behind” approaches by freeing the vessel while providing ongoing structural dynamic support to the diseased segment of the vessel, enabling the artery to regain its normal function after PCI. This approval is a big win for patients.” Pending reimbursement approval, Elixir Medical plans to work closely with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and leading cardiology centers across Japan to introduce this new treatment option to patients with coronary artery disease. About DynamX® Sirolimus Eluting Coronary Bioadaptor System The DynamX® bioadaptor is the first coronary implant technology designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, and adaptive increase in blood flow volume, and providing plaque stabilization and regression. With its unique mechanism of action (MOA), it addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds (BRS) with remarkably low clinical event rates that showed a plateau from six months through four-year clinical follow-up. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is CE-marked. The DynamX® Sirolimus Eluting Coronary Bioadaptor System is an investigational device, limited by Federal (or United States) law to investigational use. About Elixir Medical Elixir Medical Corporation, a privately held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Elixir Medical was named to Fast Company’s prestigious list of the World’s Most Innovative Companies of 2025. Visit us at www.elixirmedical.com and on LinkedIn. ### Media Contact:Richard LaermerRLM PRelixir@rlmpr.com(212) 741-5106 X 216
Tenaya Therapeutics Granted U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for TN-401 for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy
RMAT Designation Supported by Positive Interim Data from RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 which Demonstrated Reduced Arrhythmia Burden Additional Data and Updates on Regulatory Discussions Anticipated in 4Q 2026 SOUTH SAN FRANCISCO, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to TN-401, Tenaya’s gene therapy candidate for the treatment of PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC). “RMAT designation underscores the continued recognition by regulators of the seriousness of PKP2-associated ARVC and the potential of TN-401 gene therapy to change the course of disease by addressing its underlying cause. This designation is supported by the encouraging interim data generated to date from our RIDGE-1 trial, which demonstrated clinically meaningful reductions in daily rates of PVCs and NSVTs, as well as a favorable tolerability profile,” said Faraz Ali, Chief Executive Officer of Tenaya Therapeutics. “Together with Fast Track and Orphan Drug designations, RMAT enhances our ability to engage with the FDA as we strive to advance TN-401 toward a pivotal trial in order to bring this potentially transformative treatment to patients as quickly as possible. We look forward to sharing additional data from RIDGE-1 in the fourth quarter and providing an update on our ongoing discussions with regulators regarding pivotal trial plans for TN-401.” Tenaya’s RMAT application included data presented at the American Society for Gene and Cell Therapy (ASGCT) Annual Meeting in May 2026. Interim results from the RIDGE-1 clinical trial of TN-401 showed improvements in multiple electrical stability measures, including reduced rates of premature ventricular contractions (PVCs) and non-sustained ventricular tachycardias (NSVTs), two of the most frequently occurring forms of ventricular arrhythmias that characterize ARVC. RMAT designation is an FDA expedited program intended to facilitate the development and review of regenerative medicine therapies for serious conditions where preliminary clinical evidence indicates the potential to address unmet medical needs. RMAT designation provides enhanced opportunities for interaction with the FDA, including early and ongoing guidance regarding clinical development, manufacturing and potential regulatory pathways, and it may provide eligibility for accelerated approval, priority review and rolling review. About PKP2-Associated ARVCPlakophilin-2 (PKP2) mutations are the most common genetic cause of arrhythmogenic right ventricular cardiomyopathy (ARVC, also known as arrhythmogenic cardiomyopathy or ACM), occurring in approximately 40 percent of the overall ARVC population. The prevalence of PKP2-associated ARVC is estimated at more than 70,000 people in the U.S. alone. In PKP2-associated ARVC, mutations of the PKP2 gene results in insufficient expression of a protein needed for the proper functioning of the desmosomal complex that maintains physical connections and electrical signaling between heart muscle cells. As the desmosome structure degrades, cardiac muscle cells are replaced by fibrofatty tissue and electrical pulses in the heart become unstable, resulting in life potentially threatening heart rhythms. ARVC symptoms include arrhythmias, palpitations, lightheadedness, dizziness and fainting. It is typically diagnosed before age 40, and sudden cardiac arrest due to ventricular arrhythmia is frequently the first manifestation of disease. Current treatments include anti-arrhythmic medications, implantable cardioverter-defibrillators (ICDs) and ablation procedures, which do not address the underlying genetic cause of disease. About TN-401 Gene Therapy and the RIDGE-1 Clinical TrialTN-401 is an investigational AAV9-based gene therapy being developed for the treatment of ARVC due to mutations in the PKP2 gene. AAV9 was selected as the vector for delivery of Tenaya’s PKP2 gene therapy based on its extensive clinical and commercial safety record and demonstrated ability to target heart muscle cells. TN-401 has received Orphan Drug and Fast Track Designations from the U.S. Food and Drug Administration, as well as PRIME designation from the European Medicines Agency. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute for Regenerative Medicine (CIRM). The RIDGE-1 Phase 1b/2 clinical trial ClinicalTrials.gov (NCT06228924) of TN-401 in patients with PKP2-associated ARVC is a multi-center, open-label, dose escalation study being conducted in the U.S. and UK. RIDGE-1 is intended to assess the safety, tolerability and preliminary clinical efficacy of a one-time intravenous infusion of TN-401. RIDGE-1 seeks to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and are at increased risk for arrhythmias as determined by premature ventricular count (PVC) during screening. As part of its TN-401 development program, Tenaya is also conducting RIDGE ClinicalTrials.gov (NCT06311708), believed to be the largest natural history study of adults with PKP2-associated ARVC. To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com. About Tenaya TherapeuticsTenaya Therapeutics is a clinical-stage biotechnology company committed to a bold mission: to discover, develop and deliver potentially curative therapies that address the underlying drivers of heart disease. Tenaya’s pipeline includes clinical-stage candidates TN-201, a gene therapy for MYBPC3-associated hypertrophic cardiomyopathy (HCM); TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC); and TN-301, a highly specific small molecule HDAC6 inhibitor with broad potential clinical utility in cardiac, metabolic and muscular conditions, including heart failure with preserved ejection fraction (HFpEF) and Duchenne muscular dystrophy (DMD). Tenaya has employed a suite of integrated internal capabilities including modality agnostic target discovery and validation, to generate a portfolio of novel medicines based on genetic insights, aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. For more information, visit www.tenayatherapeutics.com. Forward Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Words such as “anticipated,” “potential,” “strive,” “look forward,” “may” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the plan and related timing to share additional data from RIDGE-1 and provide an update on regulatory discussions regarding pivotal trial plans for TN-401; the potential for TN-401 gene therapy to change the course of PKP2-associated ARVC by addressing the underlying cause of disease; the potential development and regulatory review opportunities for TN-401 due to RMAT designation; Tenaya’s efforts to advance TN-401 toward a pivotal trial; and statements by Tenaya’s Chief Executive Officer. The forward-looking statements contained herein are based upon Tenaya’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: availability of data at the referenced time; the timing and progress of RIDGE-1 and Tenaya’s other ongoing clinical trials; the potential failure of TN-401 and Tenaya’s other product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for the FDA and/or other regulatory agencies to conclude at any time that TN-401 may not have an appropriate risk/benefit profile; changes in Tenaya’s plans to develop and commercialize TN-401 and its other product candidates; the potential for RIDGE-1 clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; risks associated with the process of discovering, developing and commercializing therapies that are safe and effective for use as human therapeutics; Tenaya’s ability to develop, initiate or complete preclinical studies and clinical trials, and obtain approvals, for any of its product candidates; Tenaya’s continuing compliance with applicable legal and regulatory requirements; Tenaya’s ability to raise any additional funding it will need to continue to pursue the clinical development of TN-401 and its other product candidates, as well as Tenaya’s general business plans; Tenaya’s reliance on third parties; Tenaya’s manufacturing, commercialization and marketing capabilities and strategy; the loss of key scientific or management personnel; competition in the industry in which Tenaya operates; Tenaya’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Tenaya’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, and future documents that Tenaya files from time to time with the Securities and Exchange Commission. These forward-looking statements are made as of the date of this press release, and Tenaya assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Tenaya ContactsMichelle CorralVP, Corporate Communications and Investor RelationsIR@tenayathera.com InvestorsAnne-Marie FieldsPrecision AQannemarie.fields@precisionaq.com MediaWendy RyanTen Bridges Communicationswendy@tenbridgecommunications.com
IMDS Launches NHanceIT™ Microcatheter in the U.S. to Advance Complex PCI
RODEN, Netherlands–(BUSINESS WIRE)–Interventional Medical Device Solutions (IMDS), a specialty catheter company developing purpose-built solutions for complex PCI, CHIP, and CTO procedures, today announced the U.S. launch of NHanceIT™, an over-the-wire, single-lumen microcatheter built on proprietary Skeleton Backbone™ technology. Engineered to improve lesion crossing in challenging coronary anatomy, NHanceIT is part of the IMDS portfolio designed to address distinct procedural challenges thr
New Study Links HFSA OMT-HF Education to Changes in Heart Failure Prescribing
New research builds on earlier findings showing HFSA’s OMT-HF program improves clinician confidence in delivering guideline directed medical therapy WASHINGTON, Sept. 10, 2026 /PRNewswire/ — New research published in the Journal of Cardiac Failure provides additional evidence that…
Medicana Uses Robot-Assisted Technology to Perform Heart Surgery Through Small Ports
Medicana Health Group’s Prof. Suat Büket, MD explains how selected bypass and heart-valve procedures can be completed without dividing the breastbone while maintaining the same surgical objective Photo: Robotic heart surgery at Medicana Health Group via FL Comms ISTANBUL, Sept. 09, 2026 (GLOBE NEWSWIRE) — For selected heart patients, complex surgery can now be performed through several small openings between the ribs rather than by dividing the breastbone. Robot-assisted cardiac surgery combines a surgeon-controlled console with high-definition three-dimensional imaging, tremor filtration and highly articulated instruments, offering a minimally invasive route to procedures that have traditionally required a full sternotomy. Prof. Suat Büket, MD, a cardiovascular surgeon at Medicana Health Group, said the most important point is often misunderstood: the robot does not perform the operation independently. “The surgeon remains in control at every stage. The system translates the surgeon’s hand movements into precise movements inside the chest. Its value lies in giving us a magnified three-dimensional view and a range of motion that is difficult to achieve with conventional instruments through a small opening,” said Prof. Büket. Photo: Prof. Suat Büket, MD via FL Comms Several small ports instead of a divided breastbone In conventional open-heart surgery, access to the heart often requires a midline incision and division of the sternum. The bone is then rejoined at the end of the operation and must heal over the following weeks, during which patients may face movement restrictions. Wound and bone-healing complications can be particularly challenging for patients with certain risk factors. In robot-assisted cardiac surgery, the surgical team can access the chest through three or four ports between the ribs, each approximately one centimetre, depending on the planned operation. A camera and the robotic instruments are introduced through these openings. The surgeon operates from a console in the operating theatre while the bedside team supports the procedure. Technology expands the surgeon’s view and reach The system’s high-definition camera provides a three-dimensional, magnified view of the operative field. Wristed instruments can bend and rotate beyond the range of the human hand, while computer-assisted tremor filtration supports steady movement. These features are designed to help the surgeon work precisely in confined anatomical spaces; they do not replace clinical judgement or the surgical team. The robot is a surgical instrument — not an autonomous decision-maker. Patient selection, operative planning and every surgical movement remain the responsibility of the trained clinical team. The surgical objective does not change Prof. Büket stressed that a minimally invasive approach should not mean a reduced operation. When robot-assisted surgery is clinically appropriate, the aim is to complete the same planned cardiac repair or revascularisation that would otherwise be performed through an open approach. “If the plan is to perform bypass grafting or repair or replace a heart valve, the objective remains the same. The difference is the route we use to reach the heart. A smaller incision must never mean an incomplete procedure,” he said. Recovery benefits depend on the right patient Avoiding sternotomy may reduce the burden of bone healing and allow some patients to return to everyday movement sooner. Smaller incisions may also reduce wound-related concerns and can offer cosmetic and psychosocial benefits. However, not every patient is a candidate. The decision depends on the planned procedure, anatomy, previous operations, vascular access and the findings of pre-operative tests. “Robotic cardiac surgery is not automatically the best option simply because the incisions are smaller,” Prof. Büket said. “The safest and most effective approach is selected after a complete assessment. Technology adds value when it is matched to the right patient, the right procedure and an experienced team.” From precision tools to connected operating rooms Robot-assisted surgery also points toward a more connected future for operating theatres. Research into remote surgical support and telesurgery continues, but current practice still depends on a trained surgical team, specialist infrastructure and direct clinical oversight. For Prof. Büket, the immediate priority is not distance but precision: using the technology available today to reduce surgical trauma without compromising the completeness or safety of the operation. About Medicana Health Group Founded in 1992, Medicana Health Group is one of Türkiye’s leading privately owned healthcare providers, operating 19 hospitals in Türkiye, the United Kingdom, and Bosnia and Herzegovina. Serving more than 5 million patients annually, including a significant international patient base, Medicana delivers multidisciplinary care across a broad range of specialties with a strong focus on clinical excellence and patient-centered service. In addition to healthcare, the Group invests in education through Medicana Education Group and Fenerbahçe University. With approximately 15,000 employees, Medicana continues to expand its international footprint while advancing sustainability through renewable energy investments and supporting Turkish sports through long-term health sponsorships. Media contact Uğur AlkaparGlobal Media Relations DirectorFL Communicationsugur@flcommunications.co.uk This press release is intended for general informational purposes. Treatment decisions must be made by qualified clinicians following an individual patient assessment. Photos accompanying this announcement are available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7b10f86c-bc1f-41a5-a99e-3a5afb79b174 https://www.globenewswire.com/NewsRoom/AttachmentNg/92e8455e-008d-4a4a-9c60-1b85de881324



