Australia-based regenerative medicine company Orthocell has announced positive results from the clinical trial of its medical device CelGro in repair of nerve damage.
Developed for use in different orthopaedic and general reconstructive surgical applications, CelGro is a bio-compatible and bio-absorbable collagen-based scaffold that can be used either alone or in combination with autologous cells or growth factors for tissue reconstruction and repair.
Equipped with the firm’s patented CelGro technology, it can also be used for orthopaedics, general, gynaecology and ENT surgeries.
The primary aim of the clinical trial was to assess the ability of the CelGro to augment the repair of nerve damage.
The results indicated that the first two patients, with inability to bend their elbow due to traumatic peripheral nerve injury, have showed safety and tolerability with no inflammatory reactions or complications after 20 days of nerve regeneration treatment with the device.
Orthocell managing director Paul Anderson said: “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.
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“CelGro allows for suture-less reconnection of the damaged nerve while guiding nerve regeneration and accelerating the healing process.”
Orthocell is conducting multiple clinical studies to evaluate the ability of the CelGro to enhance tendon, nerve and cartilage repair as well as bone regeneration.
It is expected that the device will receive approval for its European CE mark application in the first quarter of this year.
The firm has also submitted a 510(k) clearance application to the US Food and Drug Administration (FDA), with plans to apply for regulatory approvals in Australia and Japan in the coming months.