BioProtect receives FDA’s clearance for its biodegradable balloon for rectal protection during prostate cancer radiation therapy

TZUR IGAL, Israel, August 28, 2023 – Israeli medical devices manufacturer BioProtect Ltd. announced today that their BioProtect Balloon ImplantTM System has been cleared by the FDA. The biodegradable balloon is a new generation spacer designed to provide optimal, consistent, and reproducible protection to the rectum during prostate cancer radiation therapy.

According to the American Cancer Society, prostate cancer is the second most common cancer among men in the United States, with 288,300 new cases diagnosed in 2023.

“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.
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