BioProtect Launches Clinical Trial post IDE approval by FDA

Biodegradable balloon spacers, BioProtect announces the launch of Clinical Trial followed by the FDA approval for Investigational Device Exemption in November , 2017 that seeks to evaluate the use of Prospace^(TM) Balloon system forbidding rectal toxicity post prostate cancer radiotherapy.

Israel Birenbaum, BioProtect CEO said “We are addressing a major downside of prostate cancer radiotherapy which is complications of bowel function and rectal toxicity associated with radiation exposure to the rectum adjacent to the prostate. This challenge is clinically relevant in all radiation modalities.”