Orthocell Limited (ASX:OCC) Submits FDA Application for Remplir™
Regulatory Submission
Orthocell Limited (ASX:OCC) has submitted its U.S. FDA 510(k) regulatory application for Remplir™, aimed at the US$1.6 billion nerve repair market. The submission initiates a 90-calendar day review process, with clearance anticipated in late March or early April 2025. This regulatory advancement follows successful completion of the Remplir regulatory study, which met all necessary endpoints.
Commercial Launch Preparations
The company has made significant progress in commercial launch preparations by appointing U.S. sales and medical affairs executives. Orthocell is commencing discussions with potential distributors and engaging a panel of U.S. Key Opinion Leaders (KOLs) to drive the market launch post-clearance.
CEO Comments
Paul Anderson, CEO and Managing Director of Orthocell, expressed enthusiasm about the U.S. regulatory application submission. “We 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,” Anderson stated. He added, “We believe Remplir is redefining the nerve repair market and leading the way in successful nerve repair surgery.” This innovative approach aims to improve outcomes for patients with peripheral nerve injuries.
Remplir’s Market Potential
Remplir™ is currently available in Australia, New Zealand, and Singapore, achieving rapid sales growth and endorsement from a growing number of surgeons. The successful U.S. regulatory clearance will enable Orthocell to tap into a significantly expanding market. Remplir™ is designed to support nerve regeneration through its unique properties that promote integration into nerve tissue.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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