Orthocell's Regulatory Approval in Singapore

Orthocell Limited (ASX:OCC) has received a significant boost with the Health Sciences Authority (HSA) in Singapore granting regulatory approval for its leading nerve repair product, RemplirTM. This marks the first major international approval for Remplir outside of Australia and New Zealand, where the product is already being sold. The company is now poised to commence sales in Singapore, a strategic regulatory jurisdiction, with the market launch anticipated for Q1 CY25.

Orthocell CEO and MD, Paul Anderson, on Singapore Approval

Orthocell CEO and MD, Paul Anderson, expressed his delight at the Singaporean regulatory approval for Remplir, emphasizing its significance as a validation of the company's high-quality product and manufacturing processes. He highlighted the approval's potential to increase revenue and build confidence in the anticipated US FDA clearance in Q1 2025. Anderson also emphasized the company's focus on growing revenue in existing markets and adding new jurisdictions, citing the confidence in Remplir as a best-in-class product and the growing revenues driven by surgeons achieving consistent and predictable outcomes using Remplir.

Orthocell's Expansion and Market Outlook

Orthocell's receipt of regulatory approval for Remplir in Singapore represents a significant milestone, opening doors to a strategic market and potential gateway to other substantial ASEAN markets. The company's advanced discussions with an international medical device distributor and the anticipated market launch in Q1 CY25 indicate a proactive approach to capitalize on this approval. With the global market opportunity for Remplir estimated to exceed US$3.5 billion, Orthocell is well-positioned to tap into this lucrative market. The company's ongoing regulatory program for other jurisdictions, including the key US market, along with Canada, UK, Europe, and other ASEAN markets, reflects a robust expansion strategy. The positive feedback and strong adoption of Remplir in Australia and New Zealand, coupled with the anticipation of US FDA regulatory clearance, bode well for Orthocell's future growth and revenue prospects.