BETA
Israeli medical device manufacturer, now part of Olympus, developing biodegradable balloon spacers for prostate cancer radiotherapy.
BioProtect is an Israeli medical device manufacturer established in 2004 and now part of Olympus. Olympus completed its acquisition on June 1, 2026. The company’s biodegradable balloon spacer is intended to create temporary separation between the prostate and rectum during prostate radiotherapy.
The BioProtect Balloon Implant System is placed between the prostate and anterior rectal wall and inflated to create a defined spacing geometry. It is designed to reduce radiation exposure to the rectum and then biodegrade after the treatment period. The product is also marketed as the BioProtect Balloon Spacer.
BioProtect received U.S. FDA clearance in August 2023 and commercially launched later that year. Olympus reported approximately US$14.5 million in BioProtect revenue for 2025 and a workforce of 130 in its May 2026 acquisition announcement. BioProtect previously closed a US$28 million financing in September 2023 to support U.S. commercialization.
FDA cleared the BioProtect Balloon Implant System under K222972 on August 25, 2023 as a Class II device. Its intended use is to temporarily position the anterior rectal wall away from the prostate during prostate cancer radiotherapy, thereby reducing the radiation dose delivered to the anterior rectum. [6][1][2]
The FDA submission describes a biodegradable inflatable implant used with a delivery system. Current commercial branding uses Balloon Spacer, while the authorization retains Balloon Implant System. The clearance applies to the labeled spacing use and does not establish that the implant itself treats prostate cancer. [6][1][2]
Latest recorded source review: 2026-11-06.
Scope: selected product families.
Documented commercial product families.
Single-use biodegradable balloon implant and delivery components designed to temporarily separate the prostate from the anterior rectal wall during prostate cancer radiotherapy. The inflated balloon provides a defined spacing geometry and is absorbed after the treatment period. [2][6]
FDA 510(k) cleared · K222972Olympus confirmed completion of the BioProtect acquisition. [8]
Olympus announced an agreement to acquire BioProtect for US$270 million. The purchase price is distinct from company funding. [5]
MVM Partners led the financing to support U.S. commercialization of the balloon implant system. [9]
FDA issued K222972 for temporary spacing of the anterior rectal wall from the prostate during radiotherapy. [6]
Olympus’ acquisition announcement records BioProtect’s establishment in 2004. [5]
Accessed 11/06/2026