Israel-based regenerative medicine specialist BioGenCell announced on Thursday that it has received Fast Track Designation from the US Food and Drug Administration (FDA) for its lead candidate, BGC101, for the treatment of severe Critical Limb Threatening Ischemia (CLTI).

BGC101 aims to prevent amputations, hinder disease progression and relieve pain for severe CLTI patients -- offering hope to no-option patients. It leverages BioGenCell's proprietary TRACT platform to develop personalised therapies using immune and stem cells from the patient's own blood.

Fast Track Designation allows accelerated clinical development of therapies that deal with serious conditions with unmet needs. In certain cases, like BioGenCell's, it also already enables compassionate-use access for eligible patients.

"Achieving Fast Track Designation is a significant milestone for BioGenCell and for patients in critical need," said Dr. David Raab, BioGenCell chairman.

Dr. Yael Porat, BioGenCell's founder and CEO, added: "This recognition underscores the promise of our personalised cell therapy, supported by preliminary clinical results and a clear mechanism of action."