Summary
- Regenerative medicine company Orthocell Limited released positive results in its CelGro® nerve repair study.
- The Company revealed that patient enrolment for the CelGro® nerve repair study is now complete.
- Following these positive findings validating the interim data, Orthocell is progressing regulatory applications in Australia and will initiate the US regulatory study soon.
ASX-listed regenerative medicine player Orthocell Limited (ASX:OCC) announced the completion of patient enrolment for the CelGro® nerve regeneration trial. The Company highlighted that new clinical data, 24 months after the treatment, demonstrates that nerve repair with CelGro® resulted in predictable and consistent restoration in the functioning of the upper limb (arm and hand).
This news was well-received by the market, with the share price of OCC surging by 14.666% to A$0.430 (at AEDT 2:20 PM). The Company’s market capitalisation stood at A$69.29 million.
Let us dive deep and discuss Orthocell’s nerve repair trial in detail-
About Orthocell Limited
A world-leading regenerative medicine player, Orthocell Limited, is engaged in providing innovative products for restoring function, mobility as well as performance. The Company’s product portfolio includes CelGro®, a collagen medical device facilitating tissue repair and healing in several orthopaedic, reconstructive, and surgical applications.
Positive Findings in nerve repair study of CelGro®
On 20 November 2020, Orthocell disclosed that the enrolment of patients for the CelGro® nerve regeneration trial was complete. The trial includes repair of 35 nerves in 19 patients (to date).
Positive long-term clinical information demonstrated that nerve repair with CelGro® leads to predictable and consistent restoration of upper limb function.
Results from ten participants (19 nerves) of the study after 24 months of CelGro® treatment demonstrated that the upper limb function was restored in 89% of the patients (17 out of 19). Moreover, these findings follow the clinical data of the same ten participants 12 months post-surgery, announced on 9 October 2019.
Patients in the clinical trial experienced traumatic nerve injuries after work-related, motor vehicle, and/or sporting incidents. Further, this resulted in partial or total loss of movement of arms and, in more severe cases, movement of legs and torso (quadriplegia).
Further, patients suffered from substantial pain and were not able to perform their daily living basic activities (bathing, dressing, eating, and toileting), working or playing sport. These patients would not have regained normal use of their injured upper limb without surgery.
It is noteworthy to mention that CelGro® is an essential step forward for improving nerve repair. Its ease of use, consistent and predictable high-quality results will encourage doctors for improving the lives of patients having these complex injuries.
Orthocell Managing Director Paul Anderson commented-
Trial participant Adrian Walsh, post-treatment of 24 months said-
Upcoming Milestones
The regenerative medicine company disclosed that in consultation with its major stakeholders, Orthocell has decided that the clinical results have met the objectives of the study and has thus closed the recruitment of patients.
Mr Anderson added that after these positive findings validated the interim outcomes, the team is continuing regulatory applications in Australia. He also added that the Company would start the US regulatory study shortly to make the treatment available to the millions of people experiencing nerve damage yearly.
