On the back of outstanding early sales traction for Remplir™ in Australia, New Zealand and Singapore, Orthocell has announced that it is accelerating its global expansion into multiple key jurisdictions. 

Orthocell has recently submitted its US FDA 510(k) regulatory application for clearance to commercially distribute Remplir into the US$1.6 billion U.S. market, with approval expected in March / April 2025

A further five applications across Canada, Thailand, the United Kingdom, the European Union and Brazil are in progress for 2025. Expansion into these markets will significantly increase the revenue opportunity for the Company to circa US$3.2 billion, where the Company is targeting a 20% market share.

Click to read the ASX release.