Regenerative medicine company Orthocell (ASX: OCC) came out of a trading halt this morning with positive interim clinical results for CelGro, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications.
The current trial is being undertaken with leading Australian orthopaedic nerve specialist Dr Alex O’Beirne from St John of God Hospital Murdoch, Jaslyn Cullen from occupational therapy services and Professor Ming Hao Zheng, from the University of Western Australia.
The treatment was hailed as a “breakthrough in soft tissue reconstruction” by the company, that could open the door to significant global commercial potential including bone, tendon, nerve and cartilage surgery, as well as much wider applications in surgical and soft tissue reconstruction.
The most pertinent application is treating peripheral nerve injury patients that have lost the use of their limbs as a result of traumatic injuries following motor vehicle, sporting and work-related incidents.
The addressable market for CelGro is estimated to be significant, given the large number of traumatic injuries occurring globally.
In the US alone, over 20 million people suffer from peripheral nerve injuries at an annual cost of around US$150 billion (A$222 billion). Many of these injuries require surgical nerve reconstruction involving the use of artificial “conduits” or synthetic sheaths that are secured in place with sutures.
However, suturing has multiple disadvantages including undesirable side-effects and suboptimal sensory and functional patient outcomes.
Some of the typical problems encountered by clinicians are that sutures are unable to seal the specific nerve and are thus incapable of preventing leakage of important intraneural fluids from the regenerating nerve.
CelGrow to the rescue
Orthocell says CelGro is a means of enhancing repair of peripheral nerves and stated that following surgery with the assistance of this collagen medical device, patients have regained muscle function in the affected limbs and have either ceased or significantly reduced prescription pain medication, including opioid-based medications.
The currently ongoing study is investigating a total of 20 patients who had an injury that severed the connection between the peripheral nerves in the arm, brachial plexus or spinal cord, causing loss of function or paralysis.
In the trial, CelGro is being used together with microsurgery to repair the damaged nerves and re-establish the connections to target muscles.
For the time being, Orthocell has published an interim review of the first twelve study participants involving 25 nerve transfers augmented with CelGro, 12 months after treatment.
Trial participants all had nerve injuries of varying severity, ranging from peripheral nerve injury to more complex injuries of the brachial plexus and spinal cord, resulting in impaired use of the affected limbs and in the more severe cases, quadriplegia.
The company reported “encouraging” results including the fact that 73% of nerve repairs resulted in “meaningful functional recovery of affected muscles within 12 months”.
One quadriplegic patient with complete paralysis regained sufficient arm and hand function to perform tasks such as brushing teeth, drinking from a cup, and transferring into and out of his wheelchair, despite being classified as a quadriplegic before treatment.
“CelGro facilitates tensionless repair and can prevent regenerating nerves from being compressed or trapped by scar tissue. I am very pleased with these patients’ progress, and their arm and hand function continues to improve,” said Dr Alex O’Beirne, leading Australian orthopaedic nerve specialist and clinical trial lead.
A clinical follow-up of the first twelve participants 12 months after surgery found voluntary muscle movement was restored in 96% of nerve repairs, while 86% of patients who required prescription pain medication, including opioid-based medications, were able to significantly reduce or stop their medication completely. Moreover, 66% of nerve repairs resulted in meaningful functional recovery of muscles.
“Seeing one of our patients progress from no strength in his arm, and no movement in his fingers and thumb, to playing wheelchair rugby is extremely encouraging for our researchers and clinical partners,” said Paul Anderson, managing director of Orthocell.
“We feel we are making a significant breakthrough for the repair of damaged nerves – CelGro is greatly improving quality of life for people with limited treatment options,” he added.
From a commercial perspective, Orthocell now intends to enact its “clear commercialisation strategy” for CelGro and said it intends to “leverage these results and the recent European approval of CelGro for regulatory submission in the US, EU and Australia.”
Given the positive clinical results so far, Mr Anderson confirmed that Orthocell will be “accelerating regulatory applications” in the US, EU and Australia to make this treatment accessible to the more than 700,000 people who experience nerve damage annually.
According to Orthocell, CelGro’s addressable market in peripheral nerve repair is estimated to be worth more than $1.1 billion per annum, with the company eyeing up around 700,000 procedures that could potentially make use of CelGro.
Market growth is expected to be underpinned by surgeons’ preference for quality and functional bio-absorbable membranes, the company said.
News of positive interim results had an immediate impact on Orthocell shares, sending them 19% higher up to $0.47 per share by midday.