BioProtect has received the US Food and Drug Administration (FDA) clearance for the BioProtect Balloon Implant System for its use in rectal protection during prostate cancer radiation therapy.

The Israel-based medical devices manufacturer has designed the implantable, biodegradable balloon to provide optimal, consistent, and repeatable protection to the rectum during the treatment.

Available commercially in Europe, the new generation spacer is intended to offer a defined, enclosed distance to minimise radiation exposure to the rectum.

The balloon is said to provide reproducible separation between the prostate and rectum, which is visible in all imaging modalities like MRI, CT, and ultrasound. This also enables safe radiation therapy, the medical devices manufacturer stated on its website.

Princeton Radiation Oncology MD Edward Soffen said: “The BioProtect Balloon offers me the opportunity to optimise 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.”

The biodegradable BioProtect Balloon spacer is introduced through a swift and minimally invasive procedure by employing a distinct insertion device with a blunted tip. This method is said to ensure the secure placement of the balloon in its ideal position.

BioProtect CEO Itay Barnea said: “We believe that our balloon has the potential to revolutionise rectal protection from toxicity during prostate cancer radiation therapy.

“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.”

BioProtect is backed by Triventures, KB Investment, Almeda Ventures, Peregrine Ventures, Consensus Business Group of Vincent Tchenguiz, and other venture capital companies.

The company has also announced the appointment of Ken Knudson as general manager and chief commercial officer to drive its expansion into the US market.