Israeli startup's personalised cell therapy gets FDA fast-track designation

Dec 22, 2024

Jerusalem [Israel], December 22 (ANI/TPS): Netanya-based biotechnology startup BioGenCell announced it has received the US Food and Drug Administration's Fast Track Designation for BGC101, a personalized cell therapy for severe Critical Limb Threatening Ischemia (CLTI).
CLTI is a life-threatening form of peripheral artery disease, usually occurring in the legs.
Using its TRACT platform, BGC101 regenerates damaged tissue, offering hope to patients with no other treatment options. The milestone follows promising clinical results. BioGenCell recently completed Phase 2 trial enrollment across the US, Europe, and Israel. (ANI/TPS)