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BioProtect Ltd.. (8/28/23). "Press Release: BioProtect Receives FDA’s Clearance for Its Biodegradable Balloon for Rectal Protection during Prostate Cancer Radiation Therapy". Tzur Yigal.

Region Region United States (USA)
Organisations Organisation BioProtect Ltd.
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product BioProtect Balloon Implant™ System
  Product 2 MedTech (medical technology)
Persons Person Barnea, Itay (BioProtect 202309 CEO)
  Person 2 Knudson, Ken (BioProtect 202308– General Manager US + CCO before Bard + Augmenix + Boston Scientific)

Israeli medical devices manufacturer BioProtect Ltd. announced today that their BioProtect Balloon Implant™ 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.

BioProtect is based in Israel and is backed by Triventures, Almeda ventures, KB investment, Peregrine Ventures, Consensus Business Group of Vincent Tchenguiz and other leading VCs. To drive the company's penetration into the US market, the company has announced the appointment of Ken Knudson as General Manager and Chief Commercial Officer. Knudson, who will lead BioProtect's activity in the US, has a proven commercial track record in Urology and medical devices in general, including prior positions at Bard, Augmenix and Boston Scientific.

For more information about BioProtect and their products, please visit

Record changed: 2024-01-06


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