Following publication of BioProtect's pivotal randomized trial in the International Journal of Radiation Oncology, Biology, Physics (Red Journal) and presentation of the long-term quality-of-life follow-up analysis at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, BioProtect is sharing new evidence demonstrating sustained preservation of bowel, urinary, and sexual quality of life through 48 months of follow-up.

The pivotal, multicenter, randomized trial previously demonstrated significant rectal dose reduction and low toxicity rates compared with control, meeting its primary efficacy and safety endpoints. The newly presented data from the 164-patient cohort, confirm that these anatomic and dosimetric advantages translate into clinically meaningful, sustained preservation of quality of life. Importantly, this represents the only rectal spacing study to demonstrate a statistically significant improvement in patient-reported sexual function, further underscoring the long-term benefit of consistent and reproducible spacing.

"These long-term results reinforce what we have seen clinically, that rectal spacing can have a meaningful and lasting effect on patients' day-to-day lives following radiation," said Daniel Song, MD, Professor of Radiation Oncology at Johns Hopkins University and the study's principal investigator.

Shawn Zimberg, MD, National Director of Radiation Oncology Services at Solaris Health and study co-investigator, added, "What stands out in this follow-up is the consistency of the quality-of-life results. Seeing these benefits persist for four years speaks to the durability of protection that the BioProtect Balloon Spacer provides in real-world treatment settings."