NEWS & EVENTS

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).