Israeli startup's personalised cell therapy gets FDA fast-track designation
BioGenCell's BGC101 Receives FDA Fast Track for Critical Limb Ischemia Treatment
BioGenCell, a biotechnology startup based in Netanya, Israel, has announced a significant achievement. The company has received the US Food and Drug Administration's (FDA) Fast Track Designation for its innovative treatment, BGC101. This personalized cell therapy is designed to treat severe Critical Limb Threatening Ischemia (CLTI), a dangerous form of peripheral artery disease that typically affects the legs.
BGC101 works by regenerating damaged tissue using BioGenCell's TRACT platform, providing new hope for patients who have no other treatment options. This recognition by the FDA comes after promising clinical results, marking a major milestone for the company.
BioGenCell has recently completed the enrollment for its Phase 2 trial, which is being conducted across the United States, Europe, and Israel. This progress highlights the potential of BGC101 to make a significant impact on the lives of those suffering from CLTI.
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BioGenCell
BioGenCell is a company that works on developing new medical treatments using biotechnology, which is a field that combines biology and technology.
BGC101
BGC101 is a special treatment developed by BioGenCell. It uses cells from the patient's own body to help heal damaged tissues in their legs.
FDA
The FDA, or Food and Drug Administration, is a government agency in the United States that makes sure medicines and foods are safe for people to use.
Fast Track Designation
Fast Track Designation is a special status given by the FDA to speed up the review process for new treatments that could help people with serious health problems.
Critical Limb Threatening Ischemia (CLTI)
CLTI is a serious condition where not enough blood reaches the legs, causing pain and possibly leading to severe complications like tissue damage.
Peripheral artery disease
Peripheral artery disease is a condition where the blood vessels outside the heart, especially in the legs, become narrow, reducing blood flow.
TRACT platform
The TRACT platform is a technology used by BioGenCell to help repair damaged tissues by using the patient's own cells.
Phase 2 trial
A Phase 2 trial is a stage in medical research where a new treatment is tested on a larger group of people to see if it works and is safe.
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