Oncology device developer BioProtect said today it won FDA investigational device exemption approval to launch a pivotal clinical study of its ProSpace balloon system designed to prevent rectal toxicity following prostate cancer radiotherapy.
The ProSpace balloon system is a novel balloon spacer designed to temporarily separate the rectum from the prostate during prostate cancer radiation therapy to reduce rectal radiation exposure.
The Israel-based company said it plans to launch a prospective, randomized study to explore the safety and effectiveness of the ProSpace spacer to protect the rectum and lower GI tract during radiation therapy for patients with prostate cancer as compared to patients being treated without 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. 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. Launching the study is a significant milestone towards obtaining Marketing Approval in the US,” CEO Israel Birenbaum said in a press release.
Last April, BioProtect said it raised $3.5 million to support the development of its BioProtect system, which has already received CE Mark approval in the European Union.