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Orthocell (ASX:OCC), has risen more than 7% today after clearing the latest hurdle to distributing its nerve repair product in the U.S. The stock’s bull run over the last two months has seen its share price more than double as investors eye the lucrative $1.6 billion nerve repair market in the States.
There were times during the day it touched as much as +12%, though the Healthcare stock has given some of its green rise back through afternoon trade.
The Perth-based regenerative medicine company completed a critical U.S. FDA 510(k) regulatory study for its nerve repair product, Remplir. The study confirmed Remplir as possessing strong efficacy and safe for use in the surgical repair of peripheral nerves, meeting all FDA requirements.
This milestone clears the decks for a marketing application later this month, with FDA approval expected in the first quarter of 2025.
A 510(k) study aims to validate a device is significantly comparable in safety and efficacy to similar FDA-approved devices. These studies produce critical data required for an application and form a prerequisite to any product marketed in the U.S.
Remplir, in use in Australia, New Zealand, and Singapore, is designed to facilitate high-quality nerve regeneration. It’s a collagen nerve wrap that provides compression-free protection, generating an ideal microenvironment to aid healing. Clinical data demonstrated 85% of nerve reconstructions using Remplir resulted in functional recovery of muscles controlled by the repaired nerve.
The company engaged with three globally respected researchers, including Professors Bill Walsh of UNSW and Minghao Zheng of the University of Western Australia. The study focussed on evaluating nerve regeneration in 72 rats using Remplir, a comparator product, and a control group.
Eventual results showed Remplir’s efficacy in restoring motor and sensory functions and an absence of inflammation or scarring.
Orthocell CEO Paul Anderson said: “These results validate the superior outcomes of Remplir and provide critical data for FDA clearance. We are excited about bringing this transformative product to the world’s largest healthcare market.”
Orthocell has been 87 cents per share just before close Sydney time.
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