FBLG News & Events

FibroBiologics announced the expansion of its wound care platform into the treatment of patients with acute and chronic burn injuries. Building on its investigational fibroblast spheroid-based programs in chronic wound healing, FibroBiologics is applying the same core technology to address the significant unmet medical needs in burn care. In preclinical burn models, treatment with proprietary fibroblast spheroids was associated with nearly a four-fold increase in tissue-level IL-10, a cytokine known to support tissue repair and wound healing in skin. Additionally, CYWC628 drove a significant reduction in IL-1B, a key driver of inflammation in burn wounds, further supporting the potential of the platform to promote better, faster healing in patients with severe burns. "These new burn data reinforce our conviction that fibroblast spheroids can reshape how serious wounds are treated," said Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics. "By combining strong signals of tissue repair with meaningful reductions in inflammatory markers, CYWC628 positions us to address a large, underserved market in burn care and create significant benefit for patients. We believe that a targeted, cell-based approach has the potential to improve healing outcomes, reduce complications, and ultimately change the standard of care for burn patients worldwide."

FibroBiologics announced that onboarding of the clinical sites has been completed for its Phase 1/2 clinical trial evaluating the safety and efficacy of CYWC628 for the treatment of refractory diabetic foot ulcers. The clinical trial is a prospective, multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of FibroBiologics' investigational topically administered allogeneic fibroblast spheroid-based therapy, CYWC628, for the treatment of refractory DFUs. Participants will receive up to 12 weeks of treatment using either standard of care plus a low or high dose of CYWC628, or SoC alone. FibroBiologics has completed site onboarding as outlined in the protocol for the clinical trial but will activate additional sites if needed to support recruitment objectives.

FibroBiologics announced the issuance of a new U.S. patent entitled "Fibroblast Cell Therapy for Treatment of Osteoporosis." "This patent is more than a milestone, it's a bold step forward in our mission to rethink what's possible in regenerative medicine," said Pete O'Heeron, Founder and Chief Executive Officer of FibroBiologics. "Osteoporosis impacts millions of lives across the globe, often quietly and profoundly. We see fibroblasts not just as cells, but as catalysts for change, with the potential to transform the way we treat bone degeneration by tackling both inflammation and the rebuilding process at its core. That's the kind of innovation that truly excites us."