Orthocell Ltd (ASX: OCC) shares are starting the week with a very big bang.
In morning trade, the ASX healthcare share is up 26% to a 52-week high of $1.02.
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Why is the ASX healthcare share soaring today?
Investors have been fighting to get hold of the regenerative medicine company's shares on Monday after it released a major announcement.
According to the release, Orthocell has successfully completed its Remplir 510(k) nerve repair study.
As you might have guessed from the share price reaction, the news was good. Management revealed that the study validates Remplir as safe and effective for use in the surgical repair of peripheral nerves.
The company notes that the U.S. Regulatory Study is a key component of the FDA submission to gain U.S. marketing clearance. As a result, the ASX healthcare share believes it is on schedule to submit its 510(k) application this month.
After which, if everything goes to plan, U.S. FDA clearance is expected in the first quarter of 2025, with commercial distribution to follow soon after.
The study was undertaken in collaboration with a couple of highly regarded research scientists. Pleasingly, the study met all required endpoints and outcomes.
Use of Remplir to repair the severed sciatic nerves resulted in a return of motor function, a return of sensory function, no adverse tissue reactions (providing strong evidence of biocompatibility), and the regeneration of high-quality nerve tissue.
Furthermore, management highlights that the study outcomes reinforce the clinical results, indicating consistent and predictable return of upper arm and hand function following nerve repair with Remplir.
What's the opportunity?
The ASX healthcare share notes that US FDA approval would open the company up to a major addressable market.
It highlights that the U.S. market is estimated to be worth in excess of U.S. $1.6 billion per annum and growing.
Orthocell's CEO, Paul Anderson, said:
We are thrilled with the results from our U.S. 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 U.S. We believe Remplir will redefine the nerve repair market and become an important element in the success of nerve repair surgery.
And with approximately $33 million in cash and no debt, management believes the ASX healthcare share is well-positioned to successfully launch Remplir in Singapore and other key markets including United States, South East Asia, Canada and the EU/UK.
