Proactive’s Tylah Tully breaks down ‘Just the Facts’ of the latest news from Orthocell Ltd (ASX:OCC, OTC:ORHHF).
The company has achieved a key milestone in the commercialisation of its peripheral nerve repair device, Remplir™, with first sales in Singapore. This follows regulatory approval granted in October and was achieved ahead of the planned market launch.
The sales were facilitated by the company’s exclusive distribution partner, Device Technologies Asia (DT Asia), which is actively promoting the product, educating medical professionals, and building networks among plastic and orthopaedic surgeons. Remplir is now available in Singapore, Australia, and New Zealand, receiving endorsements from surgeons for its unique repair capabilities.
Singapore has been identified as a strategic market for its role in advanced medical treatments and as a regulatory gateway to the ASEAN region, which is part of the global nerve repair market valued at over US$3.5 billion. Orthocell has $33 million in cash reserves and no debt, enabling further expansion into other markets, including the US, Southeast Asia, Canada, and the EU/UK.
The company is on track to submit its US FDA 510(K) application this quarter, aiming for regulatory clearance and commercial distribution shortly thereafter. Additional sales and revenue growth are anticipated in the coming year.