The study is slated to enroll 20 patients at St. John of God Hospital at the end of the calendar year. Researchers will evaluate the safety, tolerability, and effectiveness of CelGro in surgery with patients who have suffered injury to 1 or more peripheral nerves in the hand and upper limb.
The Perth, Australia-based company’s device functions as a scaffold for orthopedic and reconstructive surgical procedures. Researchers are also studying the device’s ability to augment repair of the rotator cuff tendon, to promote bone regeneration, and guide cartilage repair in the hip joint, Orthocell said.
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.
“This is an exciting new phase in the development of CelGro and its use as an augment to improve nerve repair,” managing director Paul Anderson said in prepared remarks. “It further validates CelGro as a unique platform technology for soft tissue repair.”
“This is an exciting development that has the potential to improve patient outcomes by allowing for a suture-less repair to the damaged nerve, to guide nerve regeneration and accelerate the healing process,” study principal investigator Dr. Alex O’Beirne added.