Remplir™ RWE study delivers 90% success rate
Orthocell has announced compelling new data from its ongoing Remplir™ Real World Evidence (RWE) study, demonstrating strong and consistent clinical outcomes across a broad range of peripheral nerve repair procedures. The latest results show an overall treatment success rate of 89.7%, based on performance data from 66 participants undergoing 78 nerve repair procedures. This expanding dataset reinforces Remplir’s clinical utility and supports the […]
Orthocell successfully completes US FDA 510(k) regulatory study for Remplir™
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.
Commencement of Nerve Repair Study
Orthocell (ASX:OCC) has announced the commencement of a nerve repair study aimed at supporting product marketing initiatives and international regulatory and reimbursement strategies for its nerve repair device, Remplir. The comparator study aims to evaluate the safety, mechanism of action and product performance of Remplir™, when used as a nerve wrap in peripheral nerve repair, […]