Orthocell Ltd (ASX:OCC, OTC:ORHHF) has seven regulatory applications in progress or planned, targeting approval in significant markets. Striate+™, used for guided bone and tissue regeneration, is gaining traction in the US, Europe/UK, Australia and Canada. Orthocell aims to obtain approval in Brazil and Singapore within 6-12 months. Remplir™, designed for peripheral nerve repair, is already approved in Australia, with regulatory clearance in Singapore and the US expected within 6-9 months. Applications for Canada, Thailand and the EU/UK are also planned within the next year.
The global market opportunity for Striate+™ and Remplir™ is estimated to exceed US$3 billion. With Striate+™ achieving a 98.6% success rate in clinical studies, Orthocell, in partnership with BioHorizons Implant Systems Inc, is focusing on market expansion. Striate+™ is anticipated to secure significant market share in existing and new markets. For Remplir™, the product has gained positive feedback from surgeons in Australia and New Zealand, and Orthocell is on track to expand into the US and Singapore, with further expansion planned in ASEAN markets and Canada.
Orthocell’s strong balance sheet of $20.6 million positions the company well for expanding its commercial footprint and growing product adoption and revenues.