Israeli firm gets FDA approval for rectum shield that blocks radiation

BioProtect Ltd., an Israeli medical devices manufacturer, has recently received FDA clearance for their innovative BioProtect Balloon Implant System, a biodegradable product that shields the rectum from unnecessary radiation during prostate cancer treatment.

When implanted and inflated, the device creates a consistent, reliable, and reproducible space between the prostate and rectum while also acting as a shield, reducing the amount of stray radiation absorbed by the latter during radiation therapy.

Prostate cancer ranks as the second most prevalent cancer among American men, with over a quarter of a million new cases diagnosed in 2023, as per the American Cancer Society. By providing reliable protection to the rectum, BioProtect offers a major paradigm shift in the way the condition can be treated.

“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.”

Micrograph of prostate cancer with Gleason score 6 (3+3) (credit: Diagnostic Pathology 11/Jennifer Gordetsky and Jonathan Epstein)

New device will help ‘optimize treatment for all men with prostate cancer’

Dr. Edward Soffen of Princeton Radiation Oncology emphasized the advantages of the device’s adaptability. “The BioProtect Balloon offers me the opportunity to optimize treatment for almost all men with prostate cancer, even those with high-risk disease,” he said. “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, techniques make it a promising option.”

BioProtect’s roots in Israel are reinforced by backing from notable investors, including Triventures, Almeda Ventures, KB, Peregrine Ventures, and the Consensus Business Group led by Vincent Tchenguiz. To establish a foothold in the US market, the company has appointed Ken Knudson as General Manager and Chief Commercial Officer. Knudson’s extensive experience, garnered from roles at Bard, Augmenix, and Boston Scientific, positions BioProtect for a dynamic presence in the US market.

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