Orthocell has today released interim results from a new Remplir™ Real World Evidence study, demonstrating an overall treatment success rate of 81.1% following nerve repair procedures.
Key findings:
- 81.2% of muscles innervated by repaired nerves achieved functional motor recovery.
- 89.5% of nerve decompression procedures resulted in significant improvement or complete relief of symptoms.
- No post-treatment complications or adverse reactions to Remplir were reported in any patient.
- Results consistent with previously published clinical trial outcomes.
The data confirms the superior and predictable outcomes that Remplir delivers and is testament to why over 200 surgeons across more than 165 hospitals (and growing) are now using the product.
Study data will be an important addition to Orthocell’s medical education efforts in US sales roll out and provide supporting evidence for the EU + UK regulatory submission expected in Q4 CY25.
Orthocell CEO and MD, Paul Anderson, said:
“We are delighted with the interim results from our Remplir RWE Study, validating the superior Remplir clinical outcomes, previously published in a highly regarded, peer reviewed journal. This performance is why more than 200 surgeons across more than 165 hospitals are now using Remplir and these numbers continue to grow.
“This data is incredibly valuable from a commercial and regulatory perspective as it demonstrates the performance of Remplir across a heterogenous patient population in the real world, as distinct from a tightly controlled clinical trial environment.
“It is imperative that we continue to collect performance data to drive the rapid market adoption in the US and support the EU & UK regulatory applications.”