Global expansion is the name of the game for Orthocell Ltd (ASX:OCC, OTC:ORHHF), with a raft of regulatory approvals pending in new markets around the world for its medical devices Striate+™ and Remplir™.
Large addressable markets
The company has submitted or is planning seven new regulatory applications to push into several key markets, following record revenues in the 2024 financial year.
Orthocell is moving into large addressable markets, with an estimated 5.5 million dental membranes used annually in dental-guided bone and tissue regeneration and implant procedures across its existing and targeted markets.
Striate+™, a collagen barrier membrane for dental bone and tissue regeneration, has already gained significant traction in the United States, Europe/UK and Australia.
The device was recently approved in Canada, and the company is now targeting regulatory approvals in Brazil and Singapore, expected within six to 12 months.
Global distribution
Orthocell's exclusive global distribution partner, global dental implant company BioHorizons Implant Systems Inc, is driving these regulatory efforts with the aim of penetrating multiple new large markets.
Following a successful US product launch in November 2022, BioHorizons has focused on supplying key opinion leader accounts and major customers.
The product has seen strong sales traction in existing markets, which the company sheets home to BioHorizons' comprehensive marketing and medical education programs.
The company also observed an impressive 98.6% success rate in the Striate+™ post-market clinical study.
In parallel, Orthocell is accelerating the market expansion of Remplir™, a product designed for peripheral nerve repair.
The product is gaining traction at home in Australia and regulatory approval is anticipated in Singapore within six months.
What’s more, the critical US Food and Drug Administration (FDA) approval for Remplir is expected within nine months, and further regulatory applications are planned for Canada, Thailand and the EU/UK in the coming months.
US$3 billion market
The global market opportunity for Striate+™ and Remplir™ is estimated to exceed US$3 billion (circa A$4.5 billion).
Orthocell is targeting a 20% market share for both products, which, if achieved, would significantly boost the company's revenue and commercial footprint.
The company is in a strong financial position to expand, with a balance sheet of $20.6 million and a record revenue of $6.72 million in the 2024 financial year – up 30% year-on-year.