Organogenesis' ReNu knee OA therapy accepted for FDA review

Tempo Therapeutics has closed an oversubscribed $14.5 million financing round led by Galaxy Sirius Partners, with participation from Johnson & Johnson through Johnson & Johnson Innovation - JJDC, Inc., Gideon Strategic Partners, Mesa Verde Venture Partners, YK Bioventures and other new and existing investors. The financing follows publication of the company's first-in-human clinical study of its Microporous Annealed Particle (MAP) technology and submission of a De Novo application to the U.S. Food and Drug Administration for its lead product. Proceeds will support the lead surgical reconstruction program through potential regulatory clearance and commercialization, while also generating clinical data to evaluate additional applications of the MAP platform, including aesthetic dermatology. The published randomized, controlled, multicenter study evaluated MAP treatment in 40 patients with full-thickness wounds following Mohs surgery for non-melanoma skin cancer, met its primary safety endpoint with no serious adverse device effects, infections or delayed wound healing, and showed MAP-treated wounds reached a favorable Wound Bed Score approximately 14 days earlier than controls, with significantly improved physician-assessed scar quality at approximately six months. In conjunction with the financing, Eric Richman was appointed Interim Chief Executive Officer and Steven Sands, Co-Principal of Galaxy Sirius Partners, was appointed Chairman of the Board, while Co-Founder Westbrook Weaver, Ph.D., moves from CEO to Chief Technology Officer.

CytoSorbents Corporation announced new real-world data showing a significant 37% relative reduction in severe bleeding with its CytoSorb device in urgent coronary artery bypass grafting patients on the blood thinner ticagrelor, alongside progress in FDA pre-submission meetings for its DrugSorb-ATR system. The patient-level matched analysis, presented at the European Society of Cardiology Congress 2026, compared 198 CytoSorb-treated patients from the STAR-T Registry with 389 matched controls, finding severe bleeding in 21.8% versus 34.5%, with a number needed to treat of eight to prevent one event. The findings also showed significant reductions in 24-hour chest tube drainage and red blood cell transfusions, with no serious device-related adverse events. CytoSorbents expects this analysis to be a core component of a new De Novo submission for DrugSorb-ATR, increasing the treated patient pool roughly five-fold to about 250 patients. Recent FDA pre-submission meetings provided constructive feedback on separate applications for ticagrelor and direct oral anticoagulant removal, with a planned new De Novo submission for the ticagrelor indication in early 2027.