• Orthocell has successfully completed a pivotal FDA regulatory study for Remplir™, validating its safety and efficacy in peripheral nerve repair.
• The study demonstrated that Remplir™ facilitated effective nerve regeneration, restoring motor and sensory functions comparable to an FDA-cleared control device.
• Orthocell plans to submit its marketing application this month, with FDA clearance anticipated in the first quarter of the New Year, targeting the $1.6 billion US nerve repair market.
• Clinical data showed that 85% of nerve repairs using Remplir™ achieved functional recovery, supporting its adoption in Australia, New Zealand, and Singapore.