Research & Development
BioProtect to conduct pivotal clinical study of the ProSpace Balloon System to prevent rectal toxicity following prostate cancer radiotherapy
10 January 2018 -

Implantable balloon solutions company BioProtect revealed on Tuesday the start of its clinical trial of the ProSpace biodegradable spacer in aid of patients undergoing the prostate cancer radiotherapy following the US FDA's Investigational Device Exemption (IDE) approval in November 2017.

BioProtect said this prospective, randomised study will demonstrate the safety and efficacy of the ProSpace biodegradable spacer to protect the rectum and lower GI tract during radiation therapy for prostate cancer compared to patients without any spacers.

According to the company, the ProSpace is a novel, biodegradable polymer balloon spacer designed to safely and temporarily separate the rectum from the prostate during prostate cancer radiation therapy. Rectal radiation exposure is a major limiting factor in prostate radiation oncology and a cause for acute and chronic rectal toxicity, manifested in rectal pain and bleeding. The ProSpace is designed for transperineal implantation, possibly during markers implantation.

In conjunction, the company's ProSpace is approved for sale in Europe under CE regulations.

Additionally, the company believes ProSpace could be used to spare the rectum in hundreds of thousands of patients who are undergoing prostate cancer radiotherapy every year. The potential global market for the ProSpace is estimated to exceed USD1.2bn annually.