Orthocell Limited (ASX:OCC) has reached the 300-case milestone for its collagen medical device CelGro® under Australia’s Therapeutic Goods Administration (TGA) Special Access Scheme approval.
Approvals were granted by the TGA for use of CelGro® in nerve, tendon, cartilage and dental maxillofacial bone repair.
The SAS product use also provides real-world evidence for the safety and efficacy of CelGro®, further validating data collected in clinical trials.
Preparing for first Australia/US approvals
Orthocell managing director Paul Anderson, said: “This is an important milestone demonstrating Key Opinion Leaders’ (KOLs) continued uptake and use of CelGro® via the SAS.
“The data collected from these CelGro® cases provide important real-world evidence adding to the effectiveness established in clinical studies as we prepare for first Australian and US approval.”
The regenerative medicine company said under SAS approval, doctors could prescribe use of therapeutic goods prior to regulatory approval if they could justify that the product had significant advantages for their patient over existing approved products or where there were no approved products currently available.
Real-world evidence, as compared to evidence from a clinical trial, is increasingly recognised as a valuable source of data to show performance and safety of a medicine or medical device.
Patients in a clinical trial are carefully selected to ensure that outcomes of the trial are comparable across the group, but real-world evidence represents the every-day use of the product in a much wider patient population.
Orthocell is continuing to collect real-world evidence for CelGro® in diverse clinical applications, such as nerve, tendon, cartilage and dental maxillofacial bone repair.
Perspective of a patient
The company presents the perspective of showed Adrian, a patient who fractured vertebrae in his neck following a mountain bike accident in 2017.
Adrian had tetraplegia and his hands, torso and legs were paralysed, with some movement in his elbows and upper arms.
His complex and challenging surgery involved CelGro® nerve transfer surgery to return function to target muscles.
Adrian and his surgeon talk about their experiences, the nerve transfer procedure and his recovery here.
CelGro® is a collagen medical device platform for soft tissue regeneration and repair applications, manufactured at Orthocell’s Good Manufacturing Practices (GMP)-licensed facility in WA.
Orthocell has market authorisation (CE Mark) for CelGro® in the EU for dental bone and soft tissue applications.
CelGro® has been shown to improve tissue growth and repair in clinical studies using CelGro® to augment repair of the rotator cuff tendon within the shoulder, to guide bone regeneration in the jaw and to assist in the re-joining of severed or damaged peripheral nerves.