{"id":9193,"date":"2025-11-15T09:15:16","date_gmt":"2025-11-15T06:15:16","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=9193"},"modified":"2025-11-15T09:15:16","modified_gmt":"2025-11-15T06:15:16","slug":"repairon-biovat-hf-key-interim-results-aha-2025","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/repairon-biovat-hf-key-interim-results-aha-2025\/","title":{"rendered":"Repairon BioVAT\u2013HF: Key Interim Results (AHA 2025)"},"content":{"rendered":"<div>Repairon BioVAT\u2013HF: Key Interim Results (AHA 2025)<\/div>\n<div><\/div>\n<div>Source: (AHA) Scientific Sessions, Nov 10, 2025<\/div>\n<div>Key notes :<\/div>\n<div><span> 1. Study Design<\/span><\/div>\n<div><span> \u2022 First-in-patient Phase 1\u20132 trial (BIOVAT-HF-DZHK20).<\/span><\/div>\n<div><span> \u2022 Human iPSC-derived engineered heart muscle (EHM) patches transplanted onto the LV of patients with advanced HFrEF.<\/span><\/div>\n<div><span> \u2022 Open-label; dose escalation followed by treatment of 16 patients at maximal safe dose.<\/span><\/div>\n<div><span> 2. Safety Outcomes<\/span><\/div>\n<div><span> \u2022 Well tolerated with no unexpected safety signals.<\/span><\/div>\n<div><span> \u2022 Acceptable rates of MACE, arrhythmias, and immune rejection.<\/span><\/div>\n<div><span> 3. 3-Month Efficacy (Interim)<\/span><\/div>\n<div><span> \u2022 Heart wall thickness \u2191 4.5 mm<\/span><\/div>\n<div><span> \u2022 LVEF \u2191 3.9%<\/span><\/div>\n<div><span> \u2022 KCCQ-23 Overall Summary Score \u2191 6.7 points<\/span><\/div>\n<div><span> 4. Long-Term Follow-Up (up to 36 months)<\/span><\/div>\n<div><span> \u2022 Sustained wall thickness gain: +2.7 mm<\/span><\/div>\n<div><span> \u2022 LVEF improvement: +6.9%<\/span><\/div>\n<div><span> \u2022 Quality of life improvement: +17 points<\/span><\/div>\n<div><span> 5. Clinical Significance<\/span><\/div>\n<div><span> \u2022 Demonstrates biological ventricular assist tissue (BioVAT) can augment myocardial structure and function.<\/span><\/div>\n<div><span> \u2022 Potential new option for patients refractory to guideline-directed therapies.<\/span><\/div>\n<div><span> 6. Supporting Evidence<\/span><\/div>\n<div><span> \u2022 Builds on decades of research including:<\/span><\/div>\n<div><span> \u2022 Preclinical data in Rhesus macaques<\/span><\/div>\n<div><span> \u2022 First-in-human cardiac remuscularization published in Nature (Jebran et al., 2025)<\/span><\/div>\n<div><span> 7. Next Steps<\/span><\/div>\n<div><span> \u2022 Transition toward pivotal Phase III trial.<\/span><\/div>\n<div><span> \u2022 Expansion of clinical sites in and outside Germany.<\/span><\/div>\n<div><span> 8. Unmet Clinical Need<\/span><\/div>\n<div><span> \u2022 Advanced HF: high mortality (\u224850% within 1 year).<\/span><\/div>\n<div><span> \u2022 Current options limited to LVADs or heart transplantation.<\/span><\/div>\n<div><span> 9. About Repairon GmbH<\/span><\/div>\n<div><span> \u2022 Germany-based biotech (founded 2014).<\/span><\/div>\n<div><span> \u2022 Specializes in reparative engineered heart muscle therapies.<\/span><\/div>\n<div><\/div>\n<div><a href=\"https:\/\/www.nature.com\/articles\/s41586-024-08463-0?utm_source=chatgpt.com#citeas\">https:\/\/www.nature.com\/articles\/s41586-024-08463-0?utm_source=chatgpt.com#citeas<\/a><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Repairon BioVAT\u2013HF: Key Interim Results (AHA 2025) Source: (AHA) Scientific Sessions, Nov 10, 2025 Key notes : 1. Study Design \u2022 First-in-patient Phase 1\u20132 trial (BIOVAT-HF-DZHK20). \u2022 Human iPSC-derived engineered heart muscle (EHM) patches transplanted onto the LV of patients with advanced HFrEF. \u2022 Open-label; dose escalation followed by treatment of 16 patients at maximal [&hellip;]<\/p>\n","protected":false},"author":145,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-9193","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9193","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/145"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=9193"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9193\/revisions"}],"predecessor-version":[{"id":9194,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/9193\/revisions\/9194"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=9193"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=9193"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=9193"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}