BioProtect Notes Completion of Patient Enrollment for its IDE Pivotal Study of the ProSpace™ Balloon Spacer

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Jun 15, 2021, 09:30 ET

TZUR IGAL, Israel, June 15, 2021 /PRNewswire/ -- BioProtect Ltd., a private commercial-stage medical device company, announced today that the company has enrolled all the planned patients in the ongoing IDE ProSpace™ trial, with a total of 222 patients recruited and randomized.

This study is a prospective, multi-center, randomized, double-arm, single-blind, concurrently controlled study to assess the safety and efficacy of the ProSpace™ Balloon Spacer in prostate cancer subjects. The efficacy endpoint of this IDE study is designed to demonstrate that the ProSpace™ Balloon Spacer, when used in prostate cancer patients undergoing radiotherapy using IMRT, reduces the radiation dose delivered to the anterior rectum.

Gil Rosen, CEO of the Company, said: "It is certainly rewarding for the BioProtect team to see the conclusion of the enrollment phase of the ProSpace™ trial, given that the COVID-19 pandemic, presented unique challenges for everyone who was involved in clinical trials during this period. I thank our team, and study sites' teams for their dedication and quality work. We look forward to seeing a more complete picture of efficacy and safety of the ProSpace™ Balloon Spacer in patients as the data becomes available."

About BioProtect

BioProtect Ltd., a proprietary technology platform company, designs, manufactures, and commercializes innovative bioabsorbable spacers. BioProtect's vision is to provide safer and improved clinical outcomes for patients undergoing radiation therapy. Last year the company raised a round of finance of $25M USD from a group of international investors.

About ProSpace™ Balloon Spacer

BioProtect's first product, commercially available in Europe and other territories outside the USA, is the ProSpace™ Balloon Spacer. Placed between the rectum and the prostate, the biodegradable spacer is injected with saline under trans-rectal ultrasound guidance. In spacing the rectum away from the prostate, it is intended to reduce the amount of radiation the patient's rectum is exposed to.

Company contact:
Michal Shavit,
[email protected]

For more information, visit www.bioprotect.com

SOURCE BioProtect