Regenerative medicine company Orthocell (ASX:OCC) has announced the successful completion of its Remplir 510(k) nerve repair study.
The company said the study validates Remplir as safe and effective for surgical repair of peripheral nerves. It said the study is critical to an FDA submission to gain US marketing clearance. It remains on schedule to submit its 510(k) application this month.
Orthocell CEO and managing director Paul Anderson said, “We are thrilled with the results from our US 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.”
Orthocell undertook with research scientist Professor Bill Walsh, the director of surgical and orthopaedic research laboratories at the Prince of Wales Hospital in Sydney and the University of New South Wales, and Professor Minghao Zheng, the Winthrop Professor of Orthopaedic Research at the University of Western Australia.
Orthocell said all study endpoints were achieved, demonstrating that Remplir is safe and effective for use in the surgical repair of peripheral nerves, with outcomes comparable to the FDA-cleared control device
Professor Zheng said, “Use of Remplir did not induce inflammation or scarring, which are known to impede nerve regeneration. This outstanding local tissue response, combined with its optimal handling qualities, will be a key advantage for Remplir in nerve repair surgery. Use of Remplir will help surgeons to simplify the repair process, facilitate high quality nerve regeneration, and ultimately provide consistent and predictable outcomes to patients and support their return of function goals.”