Orthocell Ltd (ASX: OCC) has announced the successful completion of its Remplir 510(k) nerve repair study, sending its shares soaring. The study validates Remplir as a safe and effective solution for surgical repair of peripheral nerves, paving the way for a U.S. FDA submission this month and potential clearance in the first quarter of 2025. This development could open access to a U.S. market estimated at over US$1.6 billion per annum.
The U.S. Regulatory Study, a key component of the FDA submission, achieved all required endpoints and outcomes. Severed sciatic nerves treated with Remplir showed a return of both motor and sensory function. The study also demonstrated no adverse tissue reactions, indicating strong biocompatibility, and the regeneration of high-quality nerve tissue.
Key Study Outcomes
The outcomes of the study reinforce previous clinical results, indicating consistent and predictable return of upper arm and hand function following nerve repair with Remplir. These results are crucial for Orthocell's FDA submission and potential market clearance.
Paul Anderson, Orthocell's CEO, stated, "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."
Market Opportunity
U.S. FDA approval would grant Orthocell access to a significant addressable market. The company highlights that the U.S. market for nerve repair is estimated to be worth in excess of U.S. $1.6 billion per annum and is growing. With $33 million in cash and no debt, Orthocell believes it is well-positioned to successfully launch Remplir in Singapore and other key markets including United States, South East Asia, Canada and the EU/UK.
