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BioProtect Receives FDA Clearance for Biodegradable Balloon

Monday, August 28, 2023

BioProtect has received FDA clearance for its BioProtect Balloon Implant™ System. The balloon is an innovative medical device designed to enhance the safety and effectiveness of prostate cancer radiation therapy.

This biodegradable balloon serves as a spacer that offers enhanced protection to the rectum during radiation treatment, reducing the risk of damage to healthy tissues and minimising potential side effects.

The balloon is designed with a pre-formed contour that conforms to the anatomy of the patient, and its position can be adjusted as needed to ensure optimal protection. Furthermore, its high visibility under various imaging modalities allows clinicians to accurately monitor its placement and the overall treatment progress.

The primary challenges in prostate cancer radiation therapy is effectively shielding nearby healthy organs and tissues from the harmful effects of radiation while targeting the cancerous tissue. The BioProtect Balloon addresses this challenge by providing enhanced protection to healthy organs surrounding the prostate.

The balloon's unique design and features enable it to support dose escalation and hypofractionation in radiation therapy. Dose escalation involves delivering higher doses of radiation to the tumour, which can enhance the effectiveness of treatment.