Orthocell files FDA application to sell nerve-repair product in the US

Orthocell submits key US FDA regulatory application to sell its Remplir nerve-repair device
Market clearance expected in late March or early April 2025
Preparations for commercial launch in the US already well advanced

Special Report: Orthocell has submitted a key US Food and Drug Administration regulatory application for clearance to commercially distribute its peripheral nerve-repair device Remplir into the US$1.6bn US market.

The submission of the 510(k) application follows the successful completion of the regulatory study which found that Remplir met all endpoints and provided the key data to support such a clearance.

Based on the expected 90-day calendar review process and allowing for festive period closure, Orthocell (ASX:OCC) expects to secure market clearance in late March or early April 2025.

The company’s commercial launch preparations are also well advanced with the recent appointments of US sales and medical affairs executives to drive the market launch and sales immediately post clearance.

Remplir is already approved and selling 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.

“We are thrilled to submit our US 510(k) regulatory application following successful pre-submission meetings with the FDA and completion of our pivotal regulatory study,” managing director Paul Anderson said.

“We believe Remplir is redefining the nerve-repair market and leading the way in successful nerve-repair surgery.

“With a strong balance sheet, and US sales and medical affairs team leads in place, we are now resolutely focused on preparing for launch and to commence selling Remplir in the largest healthcare market in the world.”

The US$1.6bn US market makes up a large percentage of the US$3.5bn global nerve-repair market that OCC is targeting.

Around two million peripheral nerve repairs are estimated to be performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand each year.

Safe and effective

In early December, OCC announced the regulatory study had validated Remplir as a safe and effective biological medical device for use in the surgical repair of peripheral nerves.

It 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.

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.

Further demonstrating its effectiveness, published results showed that 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.

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.

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.