Researchers are evaluating 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 company said that an interim review at 20 days post operation for the 1st 2 patients to receive CelGro showed that the device is safe.
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 2 patients previously suffered traumatic peripheral nerve injury which cost them the ability to bend their elbows, according to Orthocell. The data from the company’s interim review demonstrated that the device was well tolerated, with no inflammatory reactions or complications.
“This initial assessment is very positive and represents an important step forward in the development of CelGro in the very important area of human nerve regeneration,” managing director Paul Anderson said in prepared remarks. “CelGro allows for suture-less reconnection of the damaged nerve while guiding nerve regeneration and accelerating the healing process.”
The company has submitted CelGro for regulatory approval in Europe and expects to win CE Mark approval in the 1st quarter of this year. It also submitted a 510(k) application to the FDA for regulatory approval in the U.S., and plans to apply for approval in Japan and Australia this year.