BioProtect Launches an International Multi-Center Clinical Study Following FDA IDE approval
January 9, 2018
FDA has granted Investigational Device Exemption approval (IDE) to conduct a pivotal clinical study examining the use of the ProSpace™ Balloon System to prevent rectal toxicity following prostate cancer radiotherapy TEL AVIV, Israel, January 9, 2018 /PRNewswire/ — BioProtect, the technology leader in biodegradable balloon spacers protecting normal tissue during radiation therapy, announced the launch of its clinical trial following Investigational…
IDE application approved by FDA
November 14, 2017
FDA has granted investigational Device Exemption approval (IDE) to conduct a pivotal clinical study Examining the Use of the ProSpaceTM balloon rectal spacer to prevent GI toxicity following prostate cancer radiotherapy. The company will soon start enrollment for its first large-scale international multi-center clinical study following FDA’s investigational Device Exemption (IDE).