Orthocell has announced the submission of its U.S. FDA 510(k) regulatory application for clearance to commercially distribute Remplir\u2122 into the US$1.6 billion 1 U.S. nerve repair market. The Regulatory Submission formally kicks off the U.S. FDA 90 calendar day review process with US clearance anticipated in late March or early April 2025 and commercial distribution to commence soon thereafter.<\/p>\n
Orthocell CEO and MD, Paul Anderson, said:<\/p>\n
\u201cWe are thrilled to submit our U.S. 510(k) regulatory application following successful pre-submission meetings with the FDA and completion of our pivotal Regulatory Study. We believe Remplir is redefining the nerve repair market and leading the way in successful nerve repair surgery. With a strong balance sheet, and U.S. sales and medical affairs team leads in place, we are now resolutely focused on preparing for launch and to commence selling Remplir in the largest healthcare market in the world.\u201d<\/em><\/p>\n