FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining theuse of the ProSpace[TM] Balloon System to prevent rectal toxicity following prostate cancer radiotherapy.
BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its clinical trial following Investigational Device Exemption (IDE) approval granted by the FDA in November 2017.
The trial is a prospective, randomized study to demonstrate the safety and efficacy of the ProSpace biodegradable spacer to protect the rectum and lower GI tract during radiation therapy for prostate cancer compared to patients without any spacers.
“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,” said Israel Birenbaum, BioProtect CEO.
“Clinical studies outside the USA have shown that the ProSpace balloon spacer is a safer device providing significant reduction of rectal radiation exposure compared to currently available treatments,” he said. “Launching the study is a significant milestone towards obtaining Marketing Approval in the U.S.”
About the ProSpace Balloon System: The ProSpace is a novel, biodegradable polymer balloon spacer designed to safely and temporarily separate the rectum from the prostate during prostate cancer radiation therapy. Rectal radiation exposure is a major limiting factor in prostate radiation oncology and a cause for acute and chronic rectal toxicity, manifested in rectal pain and bleeding. The ProSpace is designed for transperineal implantation, possibly during markers implantation.
ProSpace is approved for sale in Europe under CE regulations. The company believes it could be used to spare the rectum in hundreds of thousands of patients who are undergoing prostate cancer radiotherapy every year. The potential global market for the ProSpace is estimated to exceed $1.2 Billion annually.