FDA Clears Biodegradable Balloon for Rectal Protection During Prostate Radiotherapy

BioProtect Ltd. has received US FDA clearance for BioProtect Balloon Implant System, a biodegradable balloon spacer designed to provide optimal, consistent, and reproducible protection to the rectum during prostate cancer radiation therapy.

"We believe that our balloon has the potential to revolutionize rectal protection from toxicity during prostate cancer radiation therapy," said Itay Barnea, CEO of BioProtect. "Not only does it provide better protection to healthy organs, it also supports dose escalation and hypofractionation, which are leading trends in prostate cancer radiation therapy."

"The BioProtect Balloon offers me the opportunity to optimize treatment for almost all men with prostate cancer, even those with high-risk disease. The fact that it provides additional space with a pre-formed contour, the ability to adjust its position, and high visibility with all imaging modalities would make it the choice for my patients," says Edward Soffen, MD, of Princeton Radiation Oncology.