Orthocell Ltd has completed a pivotal US Food and Drug Administration (FDA) 510(k) regulatory study for its nerve repair device, Remplir™, marking a significant step towards its US market launch. The study, designed to validate the safety and efficacy of Remplir™ in the surgical repair of peripheral nerves, met all required endpoints, paving the way for a marketing application submission this month.
Validating Remplir's Efficacy
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. Key observations included the restoration of muscle function to levels comparable with the untreated limb within 12 weeks and the restoration of normal sensory responses within the same timeframe. Histological analysis further revealed that Remplir™ supported normal nerve healing processes without inducing inflammation or scarring, creating an optimal environment for regeneration.
Professor Minghao Zheng, Orthocell CSO, highlighted that "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."
Clinical Outcomes and Market 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.
Orthocell CEO Paul Anderson stated, "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."
Targeting the US Nerve Repair Market
Upon approval, Orthocell plans to enter the lucrative US$1.6 billion nerve repair market. 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. With cash reserves of approximately A$33 million, Orthocell is well-positioned 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.
