BioProtect Balloon Spacer Study Published in International Journal of Radiation Oncology, Biology, Physics and Featured at ASTRO 2024, Demonstrates Significant Rectal Protection

On September 27, 2024 BioProtect Ltd, a private MedTech company focused on providing innovative, biodegradable spacing solutions, reported the publication of its pivotal study’s successful outcomes in the International Journal of Radiation Oncology, demonstrating a high level of efficacy and safety for its biodegradable balloon spacer (Press release, BioProtect, SEP 27, 2024, View Source [SID1234646903]).

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"The randomized, 220-patient, multi-center, prospective, clinical study demonstrated a significant dose reduction to the rectum in 97.9% of the patients, while maintaining very low rates of rectal toxicity compared to the control arm, meeting both study’s primary endpoints," said Daniel Song, MD, Professor of Radiation Oncology, Johns Hopkins University, who is the study’s principal investigator. Dr. Song will present the pivotal study data alongside other leading experts at the upcoming American Society for Radiation Oncology (ASTRO) Annual Meeting in Washington, D.C. in late September.

"This recent data further solidifies our confidence in supporting the U.S. commercialization of the BioProtect Balloon spacer, which received FDA clearance in August 2023 for enhancing rectal protection during radiation therapy for prostate cancer patients," said BioProtect’s CEO, Itay Barnea. "Following its FDA clearance, the device has been successfully implanted in over 2,000 U.S. patients since launch. Our close, ongoing collaboration with the clinical community ensures that more patients and physicians can benefit from its superior characteristics as we continue to expand its adoption in cancer treatment centers nationwide."