Regenerative medicine company Orthocell (ASX:OCC) has announced positive initial safety and tolerability results for its CelGro collagen-based medical device, in a clinical study examining its use to augment the repair of nerve damage.
The first two patients treated in the trial had previously suffered traumatic peripheral nerve injury resulting in the inability to bend their elbow and significantly impacting basic activities of daily living.
An interim review at 20 days post operation for the first two patients to receive CelGro nerve regeneration treatment demonstrated it was safe and well tolerated with no inflammatory reactions or complications.
According to Orthocell managing director Paul Anderson, "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. CelGro allows for suture-less reconnection of the damaged nerve while guiding nerve regeneration and accelerating the healing process."
Peripheral nerve injury is most commonly caused by accidents or other trauma and in the US alone, over 20 million people are affected each year, at a cost of approximately $150 billion in annual health care dollars.
CelGro is a biological medical device used in a variety of orthopaedic and general reconstructive surgical applications.
The company is undertaking a wide range of clinical studies using CelGro to augment tendon, nerve and cartilage repair as well as to guide and promote bone regeneration. It has submitted CelGro for first regulatory approval in Europe and says it expects to receive notice of approval of its CE Mark application in Q1 2017.
Orthocell has also submitted a 510(k) application for FDA regulatory clearance of CelGro in the US.