Orthocell Ltd (ASX:OCC, OTC:ORHHF) has wrapped up a pivotal US Food and Drug Administration (FDA) 510(k) regulatory study for its nerve repair device, Remplir™, that validates its safety and efficacy in the surgical repair of peripheral nerves.
In so doing, the company has cleared one of the final barriers in the journey towards US market clearance.
Closer to market launch
Orthocell CEO and MD Paul Anderson said: “We are thrilled with the results from our US regulatory study, validating the superior Remplir clinical outcomes, previously published in a highly regarded, peer-reviewed journal.
“The study results provide key data for the FDA submission to gain market clearance and start selling Remplir in the US.
“We believe Remplir will redefine the nerve repair market and become an important element in the success of nerve repair surgery.”
The study, a critical element of Orthocell’s FDA submission, met all required endpoints, providing the key data necessary for the upcoming 510(k) marketing submission.
The company remains on track to submit its application this month and FDA clearance is expected very soon – in the first quarter of the New Year.
Upon approval, Orthocell plans to enter the lucrative US$1.6 billion nerve repair market.
Study reinforces clinical outcomes
The study, conducted using a rat sciatic nerve injury model, demonstrated that repairs using Remplir facilitated effective nerve regeneration with outcomes comparable to an FDA-cleared control device.
Scientists observed:
- Return of motor function - Muscle function restored to levels comparable with the untreated limb within 12 weeks.
- Restoration of sensory function - Normal sensory responses by 12 weeks post-treatment.
- Biocompatibility - No adverse tissue reactions, with evidence of integration into host nerve tissue by 12 weeks.
- High-quality nerve regeneration - Increased presence of mature myelinated axons downstream of the repair site.
Histological analysis revealed that Remplir supported normal nerve healing processes without inducing inflammation or scarring, creating an optimal environment for regeneration.
“Use of Remplir did not induce inflammation or scarring, which are known to impede nerve regeneration," Orthocell CSO Professor Minghao Zheng said.
“This outstanding local tissue response, combined with its optimal handling qualities, will be a key advantage for Remplir in nerve repair surgery."
Clinical adoption and global strategy
These results bolster previously published clinical outcomes showing that 85% of nerve repairs using Remplir achieved functional recovery.
Already approved in Australia, New Zealand and Singapore, Remplir has gained rapid adoption, with growing endorsements from surgeons for its unique repair capabilities.
“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,” Zheng said.
Orthocell’s cash reserves of some A$33 million position the company well for a commercial launch in the US and expansion into Canada, the UK, Europe and Southeast Asia.
In anticipation of its launch in that country, Orthocell has appointed US sales and medical affairs executives to drive market entry.
Orthocell plans to leverage these pivotal results to establish high-quality distribution partnerships and be ready to execute its US launch strategy upon FDA clearance.