The Latest Cardiac and Vascular News
The TFA Cannula incorporates a distal balloon feature designed to allow blood flow to the cannulated limb during cardiopulmonary bypass VANCOUVER, BC, July 30, 2026 /CNW/ — Total Flow Medical, a medical device company developing solutions for extracorporeal circulation, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) […]
Maple Grove, Minnesota, July 29, 2026 – VDyne Inc. (“VDyne”), a privately held medical device company developing an innovative transcatheter tricuspid valve replacement (TTVR) system, today announced that the first patient has been enrolled and treated in the TRIVITA US IDE pivotal study of the TriNovaTM system. The randomized controlled […]
BETHESDA, Md. & TORONTO–(BUSINESS WIRE)–CorVista Health and Analytics For Life today announced FDA clearance of the CorVista® System with Pulmonary Capillary Wedge Pressure (PCWP) Add-On. The PCWP Add-On uses an AI-based algorithm to analyze physiological signals from patients with no history of elevated PCWP or prior right heart catheterization presenting with cardiovascular symptoms, such as chest pain, dyspnea, and fatigue, to indicate the likelihood of elevated PCWP. The clearance marks a
Study substantially exceeded enrollment target of 500 patients Topline results anticipated in Q1 2027 THE WOODLANDS, Texas, July 27, 2026 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that randomization of patients has been completed in the pivotal Phase 3 “SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” clinical trial evaluating sotagliflozin in patients with non-obstructive (nHCM) and obstructive (oHCM) hypertrophic cardiomyopathy. The study substantially exceeded its enrollment target of 500 patients across more than 130 sites in 20 countries. The primary efficacy endpoint will assess improvement in symptoms for the entire population (nHCM and oHCM). The final study population included a substantial majority of patients with non-obstructive HCM, providing a robust opportunity to evaluate sotagliflozin in a patient group for whom effective treatment options remain limited, as well as a meaningful cohort of patients with obstructive HCM. Lexicon believes the final study population will enable a thorough assessment of sotagliflozin’s potential across the spectrum of symptomatic HCM. Topline results are anticipated in the first quarter of 2027. “Completion of patient enrollment in SONATA-HCM marks an important milestone for patients living with the symptoms of HCM, a chronic, progressive disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “We believe that sotagliflozin, a dual SGLT1 and SGLT2 inhibitor with a unique mechanism of action as compared to currently available treatments, has the potential to be a differentiated option for symptomatic HCM patients. We look forward to sharing topline results in the first quarter of 2027.” SONATA-HCM is the only ongoing Phase 3 study in both non-obstructive and obstructive HCM and is the largest Phase 3 study including both nHCM and oHCM to date. SONATA-HCM is a randomized, double-blind, placebo-controlled, multinational trial that is evaluating the efficacy of sotagliflozin on symptoms, function, and other patient-reported outcomes, as well as safety, in patients with symptomatic HCM. The primary efficacy endpoint is improvement in symptoms, as measured by change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). Patients with symptomatic HCM on a stable dose of guideline-directed therapy for HCM, including cardiac myosin inhibitors, were permitted to enroll in the study depending on certain criteria. “For patients living with hypertrophic cardiomyopathy, there remains a significant need for additional treatment options that can help address persistent symptoms and improve daily function,” said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM, Presidential Professor, Director of Translational Research of the Penn Cardiovascular Institute, University of Pennsylvania. “Having a well-tolerated medication with a distinct mechanism of action that can complement other therapies would be an important advance for physicians and patients.” “Completing enrollment in SONATA-HCM is a major achievement for the HCM community and reflects the commitment of investigators, study teams and participants,” said Carolyn Y. Ho, M.D., co-principal investigator for SONATA-HCM, Professor of Medicine at Harvard Medical School and Medical Director of the Cardiovascular Genetics Center at Brigham and Women’s Hospital. “We are grateful to the patients involved in this trial, whose partnership is essential to advancing research and hopefully bringing a novel treatment option to people living with HCM.” About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. Sotagliflozin is also currently under investigation for hypertrophic cardiomyopathy (HCM). About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Lexicon has a pipeline of drug candidates in discovery, preclinical, and clinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity and metabolic disorders, and other cardiometabolic indications. For additional information, please visit www.lexpharma.com. Safe Harbor StatementThis press release contains “forward-looking statements,” including statements relating to the research, development and therapeutic and commercial potential of sotagliflozin in hypertrophic cardiomyopathy. In addition, this press release may also contain forward-looking statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Media Inquiries:Dave BelianLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com For Investor Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com
– Phase 2a study of CTEV in coronary artery bypass grafting (CABG) is expected to start this quarter –
The PREVAILS study, now fully enrolled, marks a critical step toward simultaneous regulatory submissions in China and Europe for the next-generation TAVR system HANGZHOU, China, July 23, 2026 /PRNewswire/ — Venus Medtech (Hangzhou) Inc. (02500.HK) today announced that patient enrollment…
WALTHAM, Mass.–(BUSINESS WIRE)–Affinia Therapeutics (“Affinia”), an innovative clinical-stage gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies initially for devastating cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for AFTX-201 for the treatment of BAG3-associated dilated cardiomyopathy (DCM). A potential best-in-class investigational genetic m
SEATTLE & YOKNEAM, Israel–(BUSINESS WIRE)– #DRIVEWIRE–Rapid Medical FDA-cleared DRIVEWIRE 35, first steerable 0.035-inch guidewire for stroke, neurovascular and peripheral access, after 5,000 DW24 cases.
LIÈGE, Belgium–(BUSINESS WIRE)–CryoTherapeutics, a medical device company developing minimally invasive localized cryotherapy for the treatment of coronary artery disease, today announced the successful treatment of the first patient in its ICECAP clinical trial. The milestone marks an important step in evaluating whether localized cryotherapy can help stabilize vulnerable coronary plaques before they lead to myocardial infarction. During ICECAP screening, the first patient with stable angina
Hennigsdorf/Berlin, July 16, 2026 – 4TEEN4 Pharmaceuticals GmbH today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to invobenitug (formerly known as procizumab), for the treatment of cardiogenic shock (CS). Invobenitug is 4TEEN4’s lead investigational monoclonal antibody targeting circulating dipeptidyl peptidase 3 (cDPP3). It is currently being evaluated in PROCARD 2a (NCT06832722), a multicenter, randomized, placebo-controlled, double-blind Phase 1b/2a trial assessing its safety, tolerability, pharmacokinetics, and exploratory efficacy in patients with CS and elevated cDPP3 concentrations. “Fast Track designation represents an important milestone for 4TEEN4 as we continue to advance invobenitug through clinical development,” said Dr. Andreas Bergmann, CEO of 4TEEN4 Pharmaceuticals. “The designation recognizes both the significant unmet medical need in cardiogenic shock and the potential of invobenitug as a targeted therapeutic approach. Building on encouraging preclinical findings and favorable safety and tolerability data from our Phase 1 study in healthy volunteers, we look forward to collaborating closely with the FDA as we advance the program.” Cardiogenic shock is a rapidly progressive, life-threatening syndrome that occurs when the body is unable to maintain sufficient circulation to support essential organ function. cDPP3, a key driver of shock, degrades angiotensin II, inducing dysregulation of the renin-angiotensin-aldosterone system (RAAS) that can lead to organ failure and death. By inhibiting cDPP3, invobenitug is intended to restore RAAS signaling, stabilize cardiovascular function and improve outcomes in patients with shock. “Cardiogenic shock remains one of the most challenging conditions in acute cardiovascular medicine, with mortality rates exceeding 50% and no approved therapies that target the underlying biology,” commented Alexandre Mebazaa, MD, PhD, Professor of Medicine at Université Paris Cité in France and Principal Investigator for the ongoing PROCARD 2a study. “Rather than simply treating the downstream consequences of shock, our goal is to intervene at its biological root by neutralizing cDPP3 in patients most likely to benefit. This designation marks an important step towards establishing one of the first targeted therapeutic approaches for cardiogenic shock.” Fast Track Designation is intended to facilitate the development and expedite the regulatory review of investigational therapies for serious conditions that have the potential to address an unmet medical need. The designation provides opportunities for more frequent interactions with the FDA throughout development, as well as potential eligibility for Rolling Review, Accelerated Approval, and Priority Review, where applicable. About Cardiogenic ShockCardiogenic shock is a severe and life-threatening condition in which the circulatory system fails to deliver sufficient oxygen to meet the body’s metabolic demands, leading to organ dysfunction and high mortality. It can result from a variety of causes, including sepsis, trauma, burns, major surgery, and cardiac events, and accounts for approximately one in three admissions to intensive care units.1 Cardiogenic shock is the second most common form of circulatory failure. It is most often triggered by acute myocardial infarction or acute decompensated heart failure. Despite advances in supportive care, cardiogenic shock remains a major unmet medical need associated with substantial morbidity and mortality rates exceeding 50%.2,3 No approved pharmacologic therapy specifically targets the molecular mechanisms of cardiogenic shock. About Invobenitug Invobenitug (formerly known as procizumab) is a humanized monoclonal antibody designed to selectively target circulating dipeptidyl peptidase 3 (cDPP3). Under physiological conditions, DPP3 is an intracellular enzyme. However, when released into the circulation, typically as a result of cellular injury, it degrades angiotensin peptides, resulting in dysregulation of the renin-angiotensin-aldosterone system (RAAS). The loss of RAAS control can lead to shock, broad organ failure, and ultimately death. By inhibiting cDPP3 activity, invobenitug restores RAAS balance and stabilizes cardiovascular function. The therapeutic potential of invobenitug has been demonstrated in preclinical and clinical settings, where it effectively normalized cardiovascular parameters, reversed organ dysfunction, and increased survival. Invobenitug also exhibited a favorable safety and tolerability profile in a completed Phase 1 study in healthy volunteers. Invobenitug is currently being evaluated in the Phase 1b/2a PROCARD 2a clinical trial. About 4TEEN44TEEN4 is a clinical-stage biotechnology company developing invobenitug (formerly known as procizumab) as a potential biomarker-guided therapy for patients with cardiogenic shock associated with elevated cDPP3. 4TEEN4’s mission is to reverse life-threatening shock and restore organ function with invobenitug. This highly specific, first-in-class antibody blocks circulating DPP3, the key pathological driver of mortality in shock. Based on highly encouraging results across preclinical models and initial use in patients, invobenitug is now in a Phase 1b/2a study evaluating its potential as a treatment for shock caused by acute cardiovascular and septic events. By targeting the root cause, 4TEEN4 aims to move shock treatment beyond supportive care and improve survival in critically ill patients. Investor & Media Contact:Trophic CommunicationsAnja Heuer or Joe Rayne+49 151 106 199 05 4TEEN4@trophic.eu 1 Van Lier, D. & Pickkers, P. Circulating biomarkers to assess cardiovascular function in critically ill. Curr. Opin. Crit. Care 27, 261–268 (2021).2 van Diepen, S. et al. Contemporary Management of Cardiogenic Shock: A Scientific Statement from the American Heart Association. Circulation 136, e232-e268 (2017).3 Arrigo, M. et al. Current and future trial design in refractory cardiogenic shock. Eur. J. Heart Fail. 25, 609–615 (2023).
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4TEEN4 Fast Track Designation
