Integrum (publ) announced that the US Department of Defense has decided to fully fund a clinical study of OPRA(TM) Implant System on up to 30 patients with transtibial (below-knee) amputations. As previously announced, the study will be performed by the Walter Reed National Military Medical Center in Bethesda, Maryland. Integrum will supply OPRA(TM) Implant Systems to Walter Reed on commercial terms. The OPRA(TM) Implant System clinical study on the below-knee amputation level recently received FDA approval, and recruitment to the study will start as soon as the protocol is approved by the Investigational Research Board (IRB).

Once the study is finalized, Integrum will be able to use the data in any future regulatory process.