– New national campaign encourages recognition of ATTR-CM, often mistaken for other heart conditions, where earlier diagnosis and treatment may help improve outcomes1 PALO ALTO, Calif., April 28, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (the “Company,” “we” or “BridgeBio”), a biopharmaceutical company focused on developing medicines for genetic conditions, has teamed up with award-winning actor Morgan Freeman and Howard “H” White, a longtime basketball apparel marketing executive, cultural connector, and heart health advocate, to bring greater attention to ATTR-CM, a progressive heart disease that can be underrecognized and often mistaken for other forms of heart failure.1,2 Don’t Pass On Your Heart Health encourages people to take persistent symptoms seriously, recognizing that earlier action can help support better long-term outcomes. Although ATTR-CM has historically been diagnosed more often in men, research suggests the need for broader awareness across men and women over 55.3 “In clinical practice, ATTR-CM is often hiding in plain sight. Many people come in with symptoms like shortness of breath, fatigue, carpal tunnel, nerve pain, or leg swelling that are commonly attributed to other forms of heart failure or aging,” said Albert J. Hicks, III, M.D., MPH, Section Chief of Heart Failure & Cardiac Transplant at University of Maryland Medical Center. “What’s critical is recognizing when those symptoms may point to an underlying condition that requires further evaluation. Increasing awareness among both clinicians and patients can help prompt earlier recognition, which is an important step toward improving long-term outcomes.” “We continue to see a disproportionate impact of ATTR-CM in Black communities, where people may face delays in diagnosis and access to care,” said Richard Allen Williams, M.D., FACC, Founder and past President of the Association of Black Cardiologists. “Improving awareness is critical, but so is ensuring people feel empowered to speak up, ask questions, and advocate for themselves when something doesn’t feel right.” Howard “H” White is known for shaping athlete-driven movements in global sports culture. Over a four-decade marketing career, he is an author, philanthropist and is widely recognized for building connections between sports, community, and culture, including founding youth-focused initiatives that empower the next generation. Howard experienced symptoms not typically associated with heart failure or heart disease, including carpal tunnel syndrome and an enlarged heart. As his condition progressed, he developed shortness of breath, leg swelling, and fatigue, and by the time he recognized the seriousness of his symptoms, his disease had significantly advanced. He is now committed to ensuring others do not go through the same experience, encouraging anyone experiencing these symptoms to speak with their doctor early so it does not progress to that point. His commitment to advancing awareness and care also includes founding the Howard “H” White Center for Cardiac Amyloidosis at Providence St. Vincent Medical Center, which focuses on improving diagnosis, treatment, and education around amyloid heart disease. “For years, people have been living with cardiac amyloidosis without knowing it,” said Howard “H” White. “I didn’t recognize it until simple things – like walking up the stairs – left me out of breath. I had been told my enlarged heart was from sports. The truth was, amyloid was making my heart bigger and weaker. By the time I found out, my condition had already progressed significantly. Today, earlier detection is possible. My message is simple: know the signs, ask questions, and see your doctor so you don’t have to follow my path.” Transthyretin (TTR) is a protein that circulates in the blood, where it transports thyroxine and vitamin A and supports critical functions, including cognition, cardiovascular health, muscle integrity, metabolism, vision, and bone strength. ATTR-CM occurs when misfolded TTR protein, also known as amyloid, builds up in the heart over time. As deposits accumulate, the heart can become thicker and stiffer, making it harder to pump blood effectively. Because symptoms may resemble those of more common forms of heart failure, or be dismissed as “normal aging,” ATTR-CM is frequently overlooked or identified later in the disease journey.3 ATTR-CM includes both wild-type disease associated with aging and hereditary (variant) forms caused by genetic changes in the transthyretin (TTR) gene.1 Certain variants are more commonly carried by people of African ancestry, and approximately 1 in 25 Black/African American individuals in the United States carry the V142I (also known as V122I) variant associated with ATTR-CM.2 As a result, Black men and women over 55 may face elevated risk and delayed diagnosis, with research showing that people with this variant can experience more severe disease and poorer outcomes, including worse survival and higher rates of heart failure.2,4,5 Recent clinical findings highlight why recognizing ATTR-CM earlier can make a meaningful difference. In the Phase 3 ATTRibute-CM study evaluating Attruby®, the treatment showed consistent benefit in people with both wild-type and hereditary forms of the disease.6,7 Changes linked to stabilizing the TTR protein were seen as early as four weeks after starting treatment and were sustained over time.8 Over the course of the study, Attruby helped adults with ATTR-CM live longer and have fewer hospitalizations due to heart issues. 9 At 30 months, treatment was associated with a 50% reduction in the cumulative frequency of cardiovascular-related hospitalizations compared to placebo, and people taking Attruby also reported a better health-related quality of life compared to those not taking Attruby.6,7,10 The majority of side effects, like diarrhea and abdominal pain, were mild and went away on its own, allowing people to stay on Attruby.9 “ATTR-CM is a condition where earlier awareness can make a meaningful difference, yet many people are still diagnosed only after symptoms have progressed,” said Jonathan Fox, M.D., Ph.D., Chief Medical Officer at BridgeBio Cardiovascular. “This is particularly important for individuals carrying genetic variants, such as p.Val142Ile (also known as V122I), who often experience delays in diagnosis and limited awareness, which can contribute to poorer outcomes over time. Improving recognition of the disease, especially at a stage when intervention may help stabilize disease progression, is an important step toward better long-term outcomes.” To support people in taking the next step for their heart health, BridgeBio has launched a new educational hub on Attruby.com offering clear information about ATTR-CM including Howard “H” White’s testimonial video, practical resources, and a downloadable Doctor Discussion Guide to help individuals and families recognize potential warning signs and prepare for informed conversations with healthcare providers. BridgeBio continues research to better understand outcomes in both wild-type and variant ATTR-CM, helping to advance knowledge of how the disease affects different populations. To hear more from Howard “H” White on the importance of recognizing ATTR-CM earlier, visit: attruby.com/howard-h-white About Attruby® (acoramidis) INDICATIONAttruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.7 IMPORTANT SAFETY INFORMATION Adverse ReactionsDiarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).7 About BridgeBio Pharma, Inc.BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok. BridgeBio Pharma, Inc. Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential benefits of earlier awareness, recognition, diagnosis and treatment of ATTR-CM, the potential ability of intervention to help stabilize disease progression or improve long-term outcomes, and the Company’s ongoing and future research regarding outcomes in wild-type and variant ATTR-CM. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to those risks set forth in the Risk Factors section of the Company’s most recent Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. BridgeBio Contact:Bubba Murarka, Executive Vice Presidentcontact@bridgebio.com (650)789-8220 References: Attruby.com, “What Is ATTR-CM?” Disease overview and symptom information. Accessed January 27, 2026.Attruby.com, “Signs & Symptoms” section. Accessed January 27, 2026.Buxbaum JN, Ruberg FL, Tripp KP, et al. The amyloidogenic V122I transthyretin variant in elderly Black Americans. N Engl J Med. 2014;370(23):2135–2142. Accessed January 27, 2026.Khedraki R, et al. Race, genotype, and prognosis in transthyretin amyloid cardiomyopathy. Am J Cardiol. 2024;216:97–104. doi:10.1016/j.amjcard.2024.02.019. Accessed March 24, 2026.Damrauer SM, Chaudhary K, Cho JH, et al. Association of the TTR V122I Variant With Heart Failure Among Individuals of African or Hispanic/Latino Ancestry. JAMA. 2019;322(22):2191–2202. doi:10.1001/jama.2019.17935. Accessed March 24, 2026Gillmore JD, Judge DP, Cappelli F, et al. Efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy. N Engl J Med. 2024;390(2):132-142.doi:10.1056/NEJMoa2305434.Attruby® (acoramidis) Prescribing Information. BridgeBio Pharma, Inc. Accessed January 27, 2026.Maurer M, Sarswat N, Grogan M, et al. Acoramidis improves serum TTR levels in patients with wild-type or variant transthyretin amyloid cardiomyopathy–results from ATTRibute-CM. Poster presented at: Annual Congress of the Heart Failure Association of the European Society of Cardiology; May 17-20, 2025; Belgrade, Serbia. Accessed March 24, 2026.BridgeBio Pharma, Inc. (2024). Acoramidis Significantly Reduces All-cause Mortality in the Overall ATTR-CM Variant and V142I (V122I) Populations press release. Accessed February 3, 2026.BridgeBio Pharma, Inc. (2025). Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) Through Month 42 of the ATTRibute-CM Open-Label Extension. August 30, 2025. Available at: investor.bridgebio.com. Accessed March 30, 2026.
Coronary/Structural Heart
Anteris Technologies Secures CMS Reimbursement Supporting U.S. Site Activation for PARADIGM Trial
MINNEAPOLIS and BRISBANE, Australia, April 28, 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, today announced it has secured U.S. Medicare reimbursement eligibility for the global pivotal PARADIGM Trial under a Centers for Medicare & Medicaid Services (CMS) national coverage policy. Eligible procedures performed at participating U.S. study sites are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32. The CMS framework operates under a Coverage with Evidence Development (CED) model, enabling reimbursement with clinical evidence generation in the PARADIGM Trial. This milestone is expected to facilitate U.S. site activation, accelerating operational momentum across participating centers. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® Transcatheter Heart Valve (“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. For further information, please refer to ClinicalTrials.gov NCT07194265. 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® THV, was designed in collaboration 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 regarding the expectation that achievement of the milestone will facilitate U.S. site activation, accelerating operational momentum across participating centers, and the PARADIGM Trial. 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, 2025 that was filed with the Securities and Exchange Commission 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: Global Investor Relations Investor Relations (US)investors@anteristech.commchatterjee@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 Website www.anteristech.comX@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech
Tenaya Therapeutics Announces Late-Breaking Oral Presentation of New Clinical Data from RIDGE™-1 Phase 1b/2 Clinical Trial of TN-401 Gene Therapy in Adults with PKP2-Associated ARVC at ASGCT 2026
Readout to Include One-Year Cohort 1 Results and Early Cohort 2 Data; Webcast Conference Call Planned to Review RIDGE-1 Data at ASGCT Additional Presentations at ASGCT Showcase Tenaya’s Work with Patients to Advance Gene Therapy and Early-Stage Pipeline Innovations in Cardiac Gene Editing SOUTH SAN FRANCISCO, Calif., April 27, 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 the acceptance of multiple abstracts for presentation at the American Society of Gene and Cell Therapy (ASGCT) Annual Meeting, taking place May 11-15, 2026, in Boston, Massachusetts. Of note, new clinical data from both dose cohorts of the RIDGE-1 Phase 1b/2 trial of TN-401 will be featured as a late-breaking oral presentation. TN-401 is being developed for the potential treatment of adults with arrhythmogenic right ventricular cardiomyopathy (ARVC), a form of arrhythmogenic cardiomyopathy (ACM) that primarily impacts the right ventricle, caused by mutations in the plakophilin-2 (PKP2) gene. PKP2 gene mutations result in insufficient levels of critical proteins needed to maintain the structural integrity and cell-to-cell electrical signaling of heart muscle cells. TN-401 gene replacement therapy is designed to address the underlying cause of disease by delivering a functional PKP2 gene into heart muscle cells using an adeno associated virus serotype 9 (AAV9) capsid. The ASGCT presentation will include new safety, biopsy and efficacy data from patients treated at both the 3E13 vg/kg and 6E13 vg/kg dose levels. Details of the TN-401 clinical data presentation are as follows: Presentation Date & Time: Friday, May 15, 2026, from 8:00 am – 9:00 am EDT Abstract Title: Interim Data from RIDGE-1: A Phase 1b/2 Interventional Study to Evaluate Safety and Efficacy of TN-401, an AAV9 Investigational Gene Replacement Therapy, in Adults with PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy Location: Westin Seaport Commonwealth Ballroom ABC (Concourse Level)Presenting Author: John Giudicessi, M.D., Departments of Cardiovascular Medicine and Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic, Rochester, New York Two other Tenaya abstracts have been accepted for poster presentations during ASGCT 2026. The first poster will detail results of a survey exploring parental perceptions of gene therapy treatment for children with cardiomyopathies conducted in partnership with DDC Clinic and the patient advocacy group, Children’s Cardiomyopathy Foundation. Presentation Session Date & Time: Tuesday, May 12, 2026, from 5:00 pm – 6:30 pm EDT Abstract Title: Perceptions and attitudes towards gene replacement therapy in parents of children with cardiomyopathy (#1372)Location: MCEC Exhibit and Poster HallPresenting Author: Kimberly Cohee, Executive Director, Patient Advocacy at Tenaya The second poster accepted for presentation builds on research previously presented for TN-501, a gene editing therapeutic candidate intended for the treatment of PLN-R14del-associated dilated cardiomyopathy (DCM). TN-501 is uniquely designed to specifically inactivate the pathogenic phosolamban (PLN) R14del allele while preserving healthy function. Presentation Session Date & Time: Thursday, May 14, 2026, from 5:00 pm – 6:30 pm EDTAbstract Title: Development of TN-501, an AAV-Delivered Gene Editing Therapy for PLN-R14del Cardiomyopathy (#3432) Location: MCEC Exhibit and Poster HallPresenting Author: Huanyu Zhou, PhD, Associate Director, Gene Therapy at Tenaya Therapeutics The posters presented at ASGCT will be available in the “Our Science” section of the company’s website at the time of the live presentation. Conference Call and WebcastTenaya management plans to host a webcast conference call to discuss the TN-401 data being presented at the upcoming ASGCT Annual Meeting 2026. Details will be posted to the “Events & Presentations” page in the investor section of the Tenaya website at www.tenayatherapeutics.com. 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 impulses in the heart become unstable, resulting in irregular heart rhythms that can be fatal. ARVC symptoms include arrhythmias, palpitations, lightheadedness, dizziness and fainting. It is typically diagnosed before age 40, and sudden cardiac arrest due to life-threatening ventricular arrhythmias 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. Tenaya’s development of TN-401 is supported in part by a grant from the California Institute for Regenerative Medicines (CIRM). The RIDGE-1 Phase 1b/2 clinical trial 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 will seek to enroll up to fifteen adults who have been diagnosed with PKP2-associated ARVC, have an ICD and have high counts of premature ventricular contractions (PVCs) during screening, indicating electrical instability and increased risk of fatal arrhythmias. To learn more about gene therapy for ARVC and the RIDGE-1 clinical trial, please visit ARVCstudies.com or ClinicalTrials.gov (NCT06228924). 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) and TN-401, a gene therapy for PKP2-associated arrhythmogenic right ventricular cardiomyopathy (ARVC) and TN-301, a clinical-stage small molecule HDAC6 inhibitor for the potential treatment of heart failure and related cardio/muscular disease, such as Duchenne’s muscular dystrophy. Tenaya has employed a suite of integrated internal capabilities, including modality agnostic target validation, capsid engineering and manufacturing, to generate a portfolio of novel medicines based on genetic insights, including multiple early-stage programs in preclinical development aimed at the treatment of both rare genetic disorders and more prevalent heart conditions. Tenaya is also leveraging this expertise through a research collaboration with Alnylam Pharmaceuticals to discover novel human genetic targets for the potential development of disease-modifying treatments for cardiovascular diseases. For more information, visit www.tenayatherapeutics.com. Forward-Looking StatementsThis 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 “planned,” “potential,” “will,” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include, among other things, the therapeutic potential of TN-401 as a treatment for ARVC caused by mutations in the PKP2 gene; the timing and content of the RIDGE-1 data presentation and related conference call, as well as Tenaya’s other ASGCT poster presentations; and TN-501 as a potential treatment for PLN R14del-associated DCM. 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 times; the timing and progress of RIDGE-1 and Tenaya’s other ongoing clinical trials; the potential failure of Tenaya’s product candidates to demonstrate safety and/or efficacy in clinical testing; the potential for any 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 its business and product development 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 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 Bridge Communicationswendy@tenbridgecommunications.com
Anaxiom Announces Early Clinical Results from First-in-Human Experience of Novel Minimally Invasive Obesity Device; Advances Toward U.S. Early Feasibility Study
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Anaxiom Corporation, a clinical-stage medical device company developing a novel, non-surgical treatment for obesity, today announced the successful completion of a 12-patient OUS clinical study. Early results demonstrate device safety and promising weight loss supporting advancement toward a U.S. Early Feasibility Study. Promising Early Clinical Experience The […]
Late-Breaking Data from PRESERVE Trial Evaluates XVIVO’s HOPE Preservation Approach in Heart Transplantation
Preliminary results suggest potential to support extended preservation time and donor heart utilization TORONTO–(BUSINESS WIRE)–XVIVO, a global medtech company in the organ transplant industry, today announced late-breaking preliminary data from the PRESERVE Trial (NCT05881278) evaluating hypothermic oxygenated perfusion (HOPE) using the XVIVO Heart Assist Transport™. The trial met its pre-specified […]
Atrium Therapeutics Earns $15 Million Milestone Payment from Bristol Myers Squibb Under Global Cardiovascular Collaboration
SAN DIEGO, April 23, 2026 /PRNewswire/ — Atrium Therapeutics, Inc. (Nasdaq: RNA) (the “Company”), a biopharmaceutical company dedicated to delivering RNA therapeutics directly to the heart, announced today it has earned a $15 million development milestone payment from Bristol Myers…
New HFSA Scientific Statement Provides Practical Guidance for Managing Heart Failure with Mildly Reduced Ejection Fraction
New guidance reframes HFmrEF as a distinct, clinically meaningful condition requiring consistent recognition and management WASHINGTON, April 22, 2026 /PRNewswire/ — A new Scientific Statement from the Heart Failure Society of America (HFSA) challenges longstanding ambiguity in the…
BioCardia and Japan PMDA Align on Acceptability of CardiAMP Clinical Data to Support Regulatory Approval in Ischemic Heart Failure
SUNNYVALE, Calif., April 20, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today reported a positive outcome in its formal clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA). PMDA has determined that the clinical safety and efficacy evidence for the CardiAMP® Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Good alignment was achieved in the meeting on the acceptability of the foreign clinical data that has been developed in the United States, the indications for use in patients, the approach for introduction of the therapy in Japan, and the need for continued post marketing studies in Japan. The Company will await the minutes from PMDA to provide detailed feedback and timeline for potential filing. “We are thankful for PMDA’s engagement and for the unanimous support of the world class cardiologists from Japan and the United States attending the meeting,” said BioCardia Chief Executive Dr. Peter Altman. “We are on track to have the first minimally invasive biologic therapy in ischemic heart failure approved in Japan.” About CardiAMP Autologous Cell TherapyGranted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Forward Looking Statements:This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of CardiAMP Cell Therapy by PMDA. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact:Miranda Peto, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact:David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
Conavi Medical Announces FDA 510(k) Clearance of its Next-Generation Hybrid IVUS-OCT System for Intravascular Imaging
– First co-registered and co-aligned IVUS-OCT Platform for Intravascular Imaging – Company Positioned for U.S. Commercial Launch in a Growing Intravascular Imaging Market Estimated at Over $1 Billion
Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of Directors
Milestones underscore clinical progress and strengthen commercial foundation LOS GATOS, Calif., April 8, 2026 /PRNewswire/ — Supira Medical, Inc. (Supira), a clinical-stage company focused on transforming the percutaneous ventricular assist device (pVAD) market, today announced FDA approval to initiate the SUPPORT II Pivotal Trial. The trial is designed to support a future PMA submission and […]



