Orthocell Ltd (ASX:OCC), a regenerative medicine company, has been granted new patents in Canada and Hong Kong for its novel CelGro® collagen medical device platform for soft tissue regeneration applications.
The patents titled ‘Suture-less repair of soft tissue’ have now been granted in Australia, New Zealand, China, Japan, Hong Kong and Canada, with further applications progressing in the US and EU.
Promisingly, the patents cover the method of using CelGro® to repair a defect in soft tissue, such as tendons, ligaments and nerves, avoiding the use of damaging sutures.
“Patents an important addition”
Orthocell managing director Paul Anderson said: “These patents are an important addition to our global intellectual property portfolio, further strengthening our position in regenerative medicine product development and novel surgical techniques for soft tissue repair.
“Suture-less or tensionless repair is of particular importance in the optimal repair of damaged nerves and is a key part of the repair process undertaken in the CelGro® nerve regeneration clinical study.
“This comes at a perfect time for the company as we move our exciting pipeline products in nerve, tendon and ligament repair through the registration process in the US, EU and AUS.”
Superior nerve repair
Suture-less repair of soft tissue refers to the method of repairing damaged soft tissue without the use of damaging sutures/stitches.
This method has the potential to greatly improve the efficiency and efficacy of surgical procedures by simplifying techniques, reducing surgery time and reducing the risk of additional trauma to soft tissue caused by the use of stitches.
Orthocell’s pre-clinical studies have shown at a microscopic level that CelGro® produces superior nerve repair and return of muscle function in severed peripheral nerves when compared to the traditional (direct suture) repair method.
Promisingly, CelGro® has also facilitated a 30% greater transmission of electrical impulses and corresponding muscle function.
Human nerve regeneration study
Orthocell has now completed patient treatments in its CelGro® nerve regeneration clinical study involving 19 patients and 33 nerve repairs.
Positive clinical data shows nerve repair with CelGro® following injury to the spinal cord, brachial plexus and other peripheral arm/hand nerves consistently restore arm and hand function.
Forward plan
Orthocell has now engaged Experien Group as its US regulatory advisory team to evaluate opportunities for expedited approval of CelGro® for nerve regeneration.
The evaluation has been completed and Experien is now developing the US FDA submission to confirm the most appropriate US regulatory pathway, which includes potential for inclusion in expedited programs and clarity regarding the reimbursement value of the product.