AUST article:

Hope for quadriplegics as ‘miracle treatment’ gets green light from regulator

In a major step forward for treating victims of paralysis, Australian regenerative medicine company Orthocell has won regulatory approval for a groundbreaking nerve repair device.

The news heralds an opportunity for thousands of quadriplegic patients to receive potentially life-changing treatment with the device, Remplir, deemed primarily effective for restoring the use of arms and hands in patients.

Clinical trials of Remplir (formerly known as CelGro) found 82.6 per cent of recipients regained use of the muscles controlled by the repaired nerve after 24 months of treatment. Templar is a collagen membrane that mimics the outer layer of the peripheral nerve.

Surgeons join a damaged nerve with a healthy one – taken from another part of the body – using minimal tension, and wrap the device around the area to create a ‘healing chamber’ that allows the nerve endings to reform organically, eventually restoring muscle function.

The process involves minimal suturing (stitching), negating the need to manually rejoin nerve endings in the correct alignment and orientation. “Traditionally nerves have been repaired using a needle and a thread which damages the nerve,” Orthocell managing director Paul Anderson said “Remplir enables surgeons to minimise the use of sutures. “It helps the nerve to heal in a faster and better way, and surgeons are saying it handles magnificently … they’re seeing more predictable outcomes.”

Adrian Walsh, who was part of the Remplir trials after a mountain bike accident in 2017 that left him a quadriplegic, says the news is a flicker of light at the end of the tunnel for patients. “Getting that tiny bit of extra movement is a big deal … making muscles work that previously didn’t work is a huge step forward,” he said.

Since his accident and subsequent treatment, Mr Walsh has taken up wheelchair rugby, is able to drive his children to and from school, and is secretary for the Peel Districts Mountain Bike Club in Western Australia. “It takes a long time to see improvements – nerves grow at about a millimetre a day,” cautions Mr Walsh. “After the surgery though, I could move my fingers on my right hand which was previously“Now I can grab stuff more easily with both hands … the little gains have had a big impact.”

Mr Anderson expects Remplir to be readily accessible to the 11,500 Australians treated annually for peripheral nerve repairs “in the next few years”. “Approval from the Therapeutic Goods Administration opens up the possibility for us to apply for reimbursement from private health insurance,” he said. “We’re very confident we can get that this year … which will make Remplir very accessible to patients in both the public and private health care systems.”

Orthocell has an Australian reimbursement application planned for submission this year, which will define the minimum benefit value paid by private insurers.

Orthocell chief scientific officer Minghao Zheng called the device a “paradigm shift” for nerve treatment. “Remplir … is easy to use and results in (a) consistent and predictable return of muscle function to paralysed limbs,” he said.

Remplir is the only Australian-made device for nerve repair to gain regulatory approval. Mr Anderson confirmed that the device could also be used as treatment for lower-body injuries. “We started the development of this product with upper limbs, as that’s where a majority of these injuries occur, ” he said.