Key points from article :
Orthocell Ltd is nearing the U.S. launch of its nerve repair device, Remplir™, following the completion of a key regulatory study for FDA 510(k) clearance. The study validated the device's safety and efficacy in repairing peripheral nerves, demonstrating promising results comparable to an already FDA-approved control device. Orthocell plans to submit its FDA application this month, with clearance anticipated in early 2024. Upon approval, the company will enter the U.S. nerve repair market, valued at approximately $1.6 billion.
The preclinical study, which utilized a rat sciatic nerve injury model, confirmed Remplir’s ability to support effective nerve regeneration. Results showed restored motor and sensory function within 12 weeks, with no adverse tissue reactions or scarring. The device promoted high-quality nerve regeneration, including the development of mature myelinated axons, creating an ideal environment for nerve healing.
Already approved in Australia, New Zealand, and Singapore, Remplir has gained traction among surgeons for its reliable outcomes and ease of use. Orthocell’s $33 million cash reserve supports plans for commercial expansion into the U.S., Canada, Europe, and Southeast Asia. The company has also appointed sales and medical executives to lead its U.S. entry and aims to establish strong distribution partnerships post-FDA clearance.
