Orthocell Gets Approval for CelGro Trial in Peripheral Nerve Regeneration
Orthocell won ethics approval in Australia for a human study evaluating its CelGro collagen soft tissue repair device for peripheral nerve regeneration.
The study is projected to enroll 20 patients by the end of the year. Researchers will evaluate the safety, tolerability, and effectiveness of CelGro in surgery with patients who have suffered injury to one or more peripheral nerves in the hand and upper limb.
The company has submitted CelGro for regulatory approval in Europe and expects to win CE Mark approval in 2016. It also anticipates applying for regulatory approval in the U.S., Australia and Japan in 2017. — Cynthia Jessup