Four-year follow-up demonstrates preserved bowel, urinary, and sexual outcomes with consistent, reproducible spacing
BETHLEHEM, Pa., Nov. 7, 2025 /PRNewswire/ — 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.¹
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.² 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.¹ 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.”
“At BioProtect, we’re focused on empowering physicians with solutions that deliver consistent performance and impact,” said Itay Barnea, CEO of BioProtect. “These results highlight how precision in spacing leads to lasting protection for patients, helping them move forward with confidence and quality of life after prostate cancer treatment.”
The BioProtect Balloon Spacer is the first and only preformed, biodegradable balloon implant designed to create a consistent and reproducible space between the prostate and rectum during radiation therapy. The spacer provides visible, controllable separation and is resorbed within six months.³ Cleared by the U.S. FDA in 2023, the BioProtect Balloon Spacer has now been used successfully in thousands of patients across the United States and Europe.
About BioProtect
BioProtect is redefining the standard of care in prostate cancer radiation therapy through precision spacing innovations that protect healthy tissue and preserve quality of life. The company’s flagship product, the BioProtect Balloon Spacer, is the first non-gel spacing technology, engineered to deliver consistent, visible, and reproducible separation during treatment.
With a mission to empower healthcare providers and patients, BioProtect continues to advance the science of spacing to enable safer and more effective radiation therapy.
For more information, please visit: www.BioProtect.com
References
- Song D, et al. Long-term toxicity and patient-reported quality of life after prostate IMRT with or without biodegradable balloon rectal spacer: analysis of a pivotal randomized trial.Int J Radiat Oncol Biol Phys. 2025; S0360-3016(25)01710-9. Link
- Song D, et al. Prospective, randomized controlled pivotal trial of biodegradable balloon rectal spacer for prostate radiation therapy.Int J Radiat Oncol Biol Phys. 2024; 120(5):1410–1420. Link
- U.S. Food and Drug Administration. 510(k) Summary: BioProtect Balloon Implant System. K222972. August 2023. Link
Media Contact:
Itay Barnea, CEO
[email protected]
SOURCE BioProtect
