Orthocell has today reached another significant milestone with the successful completion of its Remplir™ 510(k) nerve repair regulatory study, validating Remplir as a safe and effective biological medical device for use in the surgical repair of peripheral nerves.
Key findings from the study:
- Met all primary study endpoints, validating Remplir’s safety and efficacy
- Confirmed previous clinical findings where 85% of nerve reconstructions achieved functional muscle recovery in the treated area
Orthocell CEO and MD, 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.”
The study’s successful completion marks a significant step toward entering the US$1.6 billion United States nerve repair market.
The U.S. Regulatory Study is a key component of the FDA submission to gain U.S. marketing clearance and the Company remains on schedule to submit its 510(k) application in December CY24, with U.S. FDA clearance expected in Q1 CY25 and commercial distribution soon thereafter
Click to read the ASX Release. 
