Our Solution

Predictable, Reproducible, Pre-Formed, Adjustable, and Safe Space.

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The Problem

Rectal toxicity stems from the rectum’s proximity to the prostate. It is a highly prevalent complication during prostate cancer radiation therapy. Despite technological advancements and careful and precise treatment planning, prostate movement within or between sessions leave parts of the rectal wall exposed to high radiation doses, which may result in rectal toxicity or proctitis.

The Solution

Hypofractionation and dose escalation are leading treatments for prostate radiation. There is a growing need for a solution to protect the rectum from the high-dose radiation field, significantly reduce rectal toxicity, and pave the way to safer and more cost-effective radiation therapy techniques.

48mm length
18mm height
Up to 17ml inflation volume
6 months to substantial absorption
35mm width

BioProtect Balloon Implant™ System

The BioProtect Balloon spacer provides up to 18mm of separation between the rectal wall and the treated area before commencing radiation therapy.

During the minimally invasive procedure, the balloon is introduced under ultrasound guidance (TRUS), using a transperineal technique, with local or general anesthesia. Once the balloon is placed between the prostate and the rectum, it is filled with sterile saline and positioned to gain its final configuration.

The balloon provides reproducible separation between the prostate and rectum. It is visible under all imaging modalities, including CT, MRI, and ultrasound. By creating a space, it reduces the radiation dose delivered to the anterior rectum resulting in safe radiation therapy.

Provides optimal organ separation through optimal positioning
Saline filled biodegradable balloon, minimally invasive implanted under TRUS guidance
Provides safe distance between prostate and rectum
6 months to substantial absorption
Visible under any imaging modality (CT, Ultrasound, MRI)

The Procedure