Orthocell Ltd (ASX:OCC) has wrapped up its Remplir™ (previously CelGro®) nerve reconstruction study, and the results are promising.
Participants in the clinical trial suffered traumatic nerve injuries following motor vehicle, sporting or work-related incidents, resulting in partial or total loss of use of their arms and, in more severe cases, their legs and torso (quadriplegia).
They experienced significant pain and were unable to perform basic activities of daily living – such as eating, bathing and dressing – play sport or work. Without surgery, they would not have regained normal use of their injured arm and hand.
The trial participants received one or more nerve reconstructions augmented with Remplir™ 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.
Restores arm and hand function
Orthocell welcomed the final data read-out at 24 months post-treatment for all patients in the trial, which showed that nerve reconstruction with Remplir – following injury to the spinal cord, brachial plexus and other peripheral arm/hand nerves – consistently restores arm and hand function.
The results also demonstrate that not only were functional gains maintained between 12 and 24 months post-treatment but also that patients continued to improve over that time.
At 12 months, 76% of all reconstructed nerves resulted in functional recovery of muscles controlled by the repaired nerve, improving to 85% at 24 months post-treatment.
In the quadriplegic patient cohort, 76% of reconstructed nerves also resulted in functional recovery of muscles controlled by the repaired nerve at 12 months, improving to 92% at 24 months post-treatment.
“Life-altering” repair for participant
Trial participant Damien Hall injured his hand skateboarding, seriously damaging a motor nerve and leaving him with a permanently closed fist.
“The treatment I received to repair my nerve damage has been completely life-altering. I had lost full function of my hand, making the simplest of tasks impossible – from tying my own shoelaces to changing my baby’s nappy,” he said.
“After being in the trial, I have made a full recovery and am now able to complete tasks unassisted and pain-free giving me back my freedom and independence.
“The treatment has also allowed me to return to the sport I love of rock climbing, where I am performing at the same level prior to my injury including competition climbing.”
Quadriplegic patient outcomes
More than half of the nerve repairs augmented with Remplir were performed in five quadriplegic patients. The results for this challenging condition have been very encouraging. Patients demonstrated faster and better results in muscle function restoration compared to published studies of nerve transfer surgery using the standard method.
In particular, 76% of the quadriplegic nerve transfers resulted in the best-case clinical outcome for target muscles at 12 months post-treatment, improving to 92% at 24 months post-treatment.
A muscle power assessment (MRC Scale) 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.
These results have seen shares increase by as much as 9.1% intraday to A$0.42 and since the market close on May 10, securities have risen from A$0.235.
Regulatory approval
In March, Orthocell received Australian regulatory approval for Remplir for use in peripheral nerve reconstruction procedures.
The company is now in advanced discussions with potential marketing and distribution partners in Australia and progressing its regulatory strategy to achieve US market approval.
Global addressable market
The company believes Remplir to be an important step forward for improving nerve reconstruction surgery.
Its ease of use, along with consistent and predictable high-quality outcomes, which are achieved in a shorter timeframe compared to competing treatments, will empower surgeons to improve the lives of patients with these complex injuries.
Remplir’s global addressable market in peripheral nerve reconstruction is estimated to be worth more than US$7.5 billion per annum, with approximately 3 million procedures that could use Remplir conducted each year.