FDA Grants ‘Fast Track’ Approval for Artery Disease Treatment Developed in Israel

(Shutterstock) (Shutterstock)

BioGenCell’s technology uses immune and stem cells from the patient’s own blood.

By Shula Rosen

The US Food and Drug Administration (FDA) granted Fast Track approval to a treatment that can protect patients with severe artery disease from disease progression and limb amputation.

Israeli company BioGenCell developed BGC101 to treat Critical Limb-Threatening Ischemia (CLTI), a microvascular disease that often requires amputation.

BioGenCell’s technology uses immune and stem cells from the patient’s own blood. The treatment is rapid, scalable, and personalized to each patient.

The FDA reserves Fast Track Designation and allows accelerated development of treatments for severe conditions and to address unmet needs.

CLTI is the often-lethal last state of peripheral artery disease, during which patients may face amputation and high risk of death. The disease often arises from diabetes and atherosclerosis. Many patients are ineligible for revascularization or the re-introduction of blood and require alternative treatments.

According to its website, BioGenCell “is dedicated to changing the lives of patients suffering from degenerative microvascular diseases,” using “revolutionary cell therapy treatments.”

The company has developed the TRACT Solution: Tissue Regenerative Activated Cell Therapy, which can be performed in just one day.

The blood is collected from the patient, processed with the patient’s own immune and stem cells, and then used to treat the patient.

Vascular diseases, peripheral vascular disease, heart disease, stroke, and blindness account for 25% of global deaths, and current treatments are costly.

Many patients, particularly those in the late and severe stages, do not respond to traditional treatments, but clinical trials have shown promise for BioGenCell’s BGC101.

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

“This recognition underscores the promise of our personalized cell therapy, supported by preliminary clinical results and a clear mechanism of action,” said Dr. Yael Porat, BioGenCell’s founder and CEO.