BioProtect announces clinical study of ProSpace biodegradable spacer device to prevent rectal toxicity following prostate cancer radiotherapy.
M2 EQUITYBITES-January 11, 2018-BioProtect announces clinical study of ProSpace biodegradable spacer device to prevent rectal toxicity following prostate cancer radiotherapy
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Balloon spacers company BioProtect reported on Wednesday the start of its international multi-centre clinical trial of the ProSpace biodegradable spacer device that provides significant reduction of rectal radiation exposure.
This trial follows the approval granted by the US FDA's Investigational Device Exemption (IDE) in November 2017.
The company said the 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 ProSpace is approved for sale in Europe under CE regulations, stated the company.
Additionally, 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 the balloon device is estimated to exceed USD1.2bn annually, concluded the company.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jan 11, 2018|
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