Orthocell Ltd (ASX:OCC, OTC:ORHHF) has welcomed the regulatory green light from Singapore’s Health Sciences Authority (HSA) for its market-leading product, Remplir™, to be used in peripheral nerve repair.
This is the first major international regulatory approval for Remplir outside of the product’s existing markets, Australia and New Zealand.
Strategic for ASEAN markets
The company sees Singapore as a milestone jurisdiction being both a destination for sophisticated medical treatments in the region and a regulatory gateway to other substantial ASEAN markets.
Singapore is known for its state-of-the-art medical facilities, high standards and efficiency, and its regulatory approval is a stepping stone to approvals in other regional markets such as Thailand, Malaysia, Vietnam, Indonesia and the Philippines.
Orthocell will kick off sales of Remplir early next year in the key region, which will complement the excellent revenue growth it is seeing in its existing markets.
The biotech company is in advanced discussions with an experienced international medical device distributor ahead of the Singapore launch, which will fast-track first sales in the region.
Huge addressable market
The global market opportunity for Remplir is estimated to exceed US$3.5 billion.
The company continues to accelerate its regulatory program for other jurisdictions, including the vital US market, estimated to be worth in excess of $1.6 billion, along with Canada, UK, Europe and other ASEAN markets.
Orthocell is on track to receive US Food and Drug Administration (FDA) regulatory clearance in the first quarter of the 2025 calendar year, with applications planned for Canada, Thailand, the EU and the UK within the next 6-12 months.
Remplir is gaining significant traction with new and existing surgeons in Australia and New Zealand with record quarterly revenue reported for the September 24 quarter.
Orthocell CEO and managing director 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.
“We are completely focused on growing revenue in our existing markets, as well as adding new jurisdictions, because we have absolute confidence in Remplir as a best-in-class product.
“We are seeing surgeons achieve consistent and predictable outcomes using Remplir, which is translating to growing revenues.”
About Remplir
Remplir is a collagen wrap to augment nerve repair surgery. It is approved for sale in Australia and New Zealand and distributed by Device Technologies (DVT), a respected name in the provision of medical devices.
Uptake of the product by medical professionals has been driven by qualities that enable the reduction of damaging sutures, creation of an optimal healing microenvironment and facilitation of free gliding within the repair site during the critical healing period.
Orthocell has been working with DVT to introduce Remplir, with 130+ orthopaedic and plastic surgeons across Australia and New Zealand now using Remplir in peripheral nerve repair surgeries.
The company says the feedback from surgeons is ‘extremely encouraging’ and product adoption has been strong.