Shares have been as much as 27% higher to 47.5 cents on strong volume of almost 7 million and since the market close on November 2 have increased from 33 cents.
In consultation with key stakeholders, the regenerative medicine company has decided that the clinical results have met the study objectives and has closed recruitment.
The company is now progressing regulatory applications in Australia and will start the US regulatory study shortly.
Higher quality outcomes
Orthocell managing director Paul Anderson said: “Our goal in this study is to return function to paralysed limbs.
“I am delighted by the 24-month follow-up results reinforcing the initial patient outcomes previously reported demonstrating higher quality outcomes, improved predictability and consistency of return of muscle function following CelGro® nerve regeneration treatment.”
Leading Australian orthopaedic nerve specialist and clinical trial lead Dr Alex O’Beirne added: “Nerve transfer surgery to return arm or hand function is a relatively new technique that can be complex and challenging.
“Using CelGro® has improved the success rate and efficiency of the surgery.
“Seeing patients regain enough independence so that they can be involved in family life and return to work, is very rewarding.”
24-month clinical data
Under the study, patients received one or several nerve repairs augmented with CelGro® in one or both upper limbs.
Recovery after treatment was assessed by grading the strength of target muscles closest to the site of nerve repair.
Assessments were performed before treatment and at 12 and 24 months after treatment.
Results from 10 participants (19 nerves) 24 months after treatment with CelGro® showed upper limb function was restored in 17 of 19 (89%) nerve repairs.
These results follow the clinical data of the same ten participants 12 months after surgery announced on 9 October 2019.
Patients ceased, or significantly reduced, prescription pain medication (including opioid-based medications), and in many cases returned to work and participation in recreational activities.
Quadriplegic patient outcomes
A review of the quadriplegic patient cohort contributing 12 and 24-month data after treatment, involving nine nerve transfers augmented with CelGro® showed:
➢ Quadriplegic patients regained voluntary muscle movement of previously impaired or paralysed upper limbs within 12 months (MRC Grade 2 or better) of treatment;
➢ Number of nerve repairs resulting in the best case clinical outcome (MRC Grade 3 or 4) increased from 7 of 9 (78%) repairs at 12 months to 8 of 9 (89%) repairs at 24 months post-treatment; and
➢ MRC Grade 3 or 4 means quadriplegic patients regain a level of independence enabling them to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of a wheelchair without assistance.
Met study objectives
Anderson said: “Following these positive results validating the interim data, our team is progressing regulatory applications in Australia and will commence the US regulatory study shortly to make this treatment accessible to the millions of people who experience nerve damage annually.”
CelGro®’s global addressable market in peripheral nerve repair is estimated to be worth more than US$7.5 billion per annum, with around 3 million procedures that could use CelGro® completed each year.