Orthocell has received regulatory approval from the Health Sciences Authority (HSA) in Singapore, allowing the Company to commence sales of its market leading nerve repair product, Remplir™
This marks the first major international approval of Remplir outside of Australia and New Zealand.
Singapore is a strategic regulatory jurisdiction, both as a destination for sophisticated medical treatments in the region and as a regulatory gateway to other substantial ASEAN markets. Orthocell is also in advanced discussions with an experienced international medical device distributor ahead of the Singapore market launch anticipated for Q1 CY25.
Orthocell CEO and MD, Paul Anderson, said:
“We are delighted to receive Singaporean regulatory approval for Remplir in this important regional gateway market. This approval is further validation of Orthocell’s, high-quality product, manufacturing processes and expanding global footprint. This approval strengthens our position to increase revenue and builds further confidence in our US FDA clearance anticipated in Q1 2025.”