Orthocell sets new benchmark in nerve repair

  • A new study shows Orthocell’s Remplir product results in superior generation of nerve tissue and earlier return of muscle function
  • The product allows surgeons to reduce the number of sutures required to reconnect severed nerves
  • Existing cash reserves of $30m sees the company fully funded for a Remplir global roll-out

 

Special Report: Interim results from a study on structural nerve repair show that Orthocell’s Remplir product enables faster functional recovery and superior nerve tissue regeneration compared to standard suture-only methods.

Orthocell (ASX:OCC) commissioned the Suturing Study to support the US roll-out of Remplir, in collaboration with its chief scientific officer, Professor Minghao Zheng, and the University of Western Australia.

Worldwide, sutures are the primary method used in peripheral nerve repair, accounting for nearly 90% of the 700,000 nerve repair procedures conducted each year in the US.

But despite over 50 years’ experience with this surgical technique, outcomes from peripheral nerve repair procedures remain inconsistent and unpredictable.

An emerging body of evidence suggests that adverse tissue reaction to suture material may be a significant contributing factor in poor clinical outcomes after peripheral nerve repair.

Animal studies have shown that sutures can trigger inflammation, resulting in scar tissue that blocks nerve repair and limits mobility.

Remplir enables surgeons to use fewer sutures when reconnecting nerve ends, resulting in more consistent and predictable clinical outcomes.

 

Watch: Captain Valerio speak about Remplir

 

 

Study and results

Orthocell’s study was conducted using an established rat sciatic nerve injury model.

Nerve repair was assessed in 48 rats assigned to four groups – (i) repair using one suture, (ii) repair using three sutures, (iii) repair using six sutures, and (iv) repair using one suture augmented with Remplir.

Nerve function and regeneration were evaluated up to 12 weeks post-treatment.

Earlier restoration of nerve function and regeneration of high-quality nerve tissue were observed in the Remplir group compared to suture-only repair.

There was no evidence of adverse reaction to Remplir, consistent with Remplir’s established history of superior biocompatibility in thousands of procedures already undertaken.

However, histological evaluation of nerve tissue in the suture-only groups showed consistently severe inflammation and foreign body response adjacent to the suture material.

Remplir appeared to reduce inflammation caused by suture material, helping to minimise scarring that can impair nerve healing, movement and function.

 

‘Cornerstone of US medical educational efforts’

OCC CEO and managing director Paul Anderson said the results provide evidence that supports the positive outcomes of previous animal and human studies of Remplir.

“We are delighted with the results from our Suturing Study, validating the superior Remplir clinical outcomes previously published in a highly regarded, peer reviewed journal,” he said.

“These study results provide key data to support the US product sales roll out and rapid market adoption and will be a cornerstone of our US medical education efforts.

“We believe Remplir will redefine the nerve repair market and vastly improve the success of often complex nerve repair surgery.”

 

What’s next?  

Based on these study findings, published clinical data, and swift adoption in current markets, Orthocell is confident that Remplir can transform the global nerve repair market and quickly establish itself as the new gold standard for restoring function in paralysed limbs.

Interim study results will be presented at an upcoming key medical conference with final study results to be released and prepared for publication.

With ~$30m in cash and no debt, Orthocell is well positioned to successfully complete first US sales and drive rapid product adoption to deliver a step change in revenue in FY26.

The company is also accelerating the launch of Remplir in Canada and remains on schedule to submit its EU/UK application in Q4 CY25.

 

This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Related Topics

Explore more

Explore more

Investor Guide: Health & Biotech FY2025 featuring Tim Boreham

Read The Guide