Orthocell leaps closer to FDA approval after pivotal nerve-repair product study success

Orthocell US FDA 510(k) regulatory study of peripheral nerve-repair product Remplir meets all endpoints
Company due to submit 510(k) application in December with US FDA approval expected in Q1 CY25
Study found use of Remplir results in high quality of nerve repair. Results reinforce previously published clinical results

Special Report: Regenerative medicine company Orthocell (ASX:OCC) has started the last month of 2024 on a high and is up ~13% on Monday after announcing the US FDA 510(k) regulatory study of its peripheral nerve-repair product Remplir has met all endpoints.

The regulatory study validated Remplir as a safe and effective biological medical device for use in the surgical repair of peripheral nerves and will form a key component of the FDA submission to gain marketing clearance in the US $1.6 billion market.

The findings will also assist the company to further successfully execute its proven strategy to engage high-quality distribution partners.

Orthocell said it remained on schedule to submit its 510(k) application in December CY24, with US FDA clearance expected in Q1 CY25 and commencement of sales soon thereafter.

The study was undertaken with Professor Bill Walsh – the Director of Surgical and Orthopaedic Research Laboratories at the Prince of Wales Hospital in Sydney and University of New South Wales – along with the University of Western Australia’s Winthrop Professor of Orthopaedic Research, Minghao Zheng.

The study was conducted using an established rat sciatic nerve injury model. Repair of surgically transected (severed) nerves was evaluated in 72 rats across three treatment groups including:

repair using suture only (control group);
repair with Remplir; and
repair with the predicate product (comparator).

Nerve regeneration was measured at four, 12 and 24-weeks post-treatment. The key outcome measures included restoration of motor and sensory function and the performance of Remplir in facilitating high-quality nerve regeneration.

All study endpoints achieved

The study demonstrated that Remplir is safe and effective for use in surgical repair of peripheral nerves, with outcomes comparable to the FDA-cleared control device.

Orthocell said the nerve-repair process following nerve injury involves a complex interplay between specialised cells and the surrounding tissue.

Histological evaluation of the nerve tissue by an experienced, independent pathologist revealed that use of Remplir supported healing and nerve regeneration after injury that was consistent with normal nerve-repair processes.

Use of Remplir to repair the severed sciatic nerve resulted in:

return of motor function – demonstrated by the return of function of the extensor muscle comparable to the opposite untreated leg by 12 weeks post-treatment;
return of sensory function – demonstrated by a withdrawal response to mechanical stimulus in the treated leg returning to normal (comparable to the opposite untreated leg) by 12 weeks post-treatment;
no adverse tissue reactions providing strong evidence of biocompatibility;
remodelling and integration into host nerve tissue by 12 weeks post-treatment; and
regeneration of high-quality nerve tissue as demonstrated by the number of myelinated (mature) axons that were detected downstream of the repair site.

The study outcomes reinforce the clinical study results indicating consistent and predictable return of upper arm and hand function following nerve repair with Remplir, which were published in the peer-reviewed Journal of Reconstructive Microsurgery Open.

The published results showed 85% (23 of 27) of nerve repairs with Remplir, at 24 months post treatment, resulted in functional recovery of muscles controlled by the repaired nerve.

Simplifying the repair process

Professor Zheng said that the use of Remplir did not induce inflammation or scarring, which are known to impede nerve regeneration.

“This outstanding local tissue response, combined with its optimal handling qualities, will be a key advantage for Remplir in nerve-repair surgery,” he noted.

“Use of Remplir will help surgeons to simplify the repair process, facilitate high-quality nerve regeneration, and ultimately provide consistent and predictable outcomes to patients and support their return of function goals.”

Redefining the global nerve-repair market

Remplir is already approved in the Australian, New Zealand and Singapore markets with rapidly growing sales and an increasing number of surgeons using and endorsing its unique repair qualities in clinical practice.

CEO and managing director Paul Anderson said considering the study results, published clinical data and the rapid product adoption in existing markets, Remplir could rapidly become an important element in nerve-repair surgery to return function to paralysed upper limbs.

Remplir has also been flagged as having potential for treating complex spinal cord or traumatic nerve injuries.

“We believe Remplir will redefine the nerve-repair market and become an important element in the success of nerve-repair surgery,” he said.

With ~$33m in cash and no debt, Orthocell said it was well positioned to successfully launch Remplir in Singapore and other key markets including the US, South East Asia, Canada and the EU/UK.

The OCC share price is up ~125% YTD.

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.