Orthocell (ASX: OCC), a regenerative medicine company focused on developing and commercialising novel collagen scaffold products for the repair of soft tissue injuries, has announced record revenue of $9.19 million for the year ending June 2025. This figure represents a 35.8% increase compared to the previous financial year, bolstered by $2.73 million in revenue generated in the June quarter alone. Orthocell’s flagship nerve repair product, Remplir, is driving the company’s growth in the Australian market. The company is awaiting US FDA 510(k) clearance for Remplir before beginning commercial distribution into the US.
Orthocell anticipates that entry into the US$1.6 billion US nerve repair market will significantly boost revenue. The company has established a network of 14 specialist nerve distributors to reach surgeons and hospitals across 25 states. To support US sales, Orthocell has finalised logistics and sales pathways and secured an annual medical device manufacturing capacity of 100,000 units, with the potential for further expansion.
In addition to its US expansion plans, Orthocell has secured regulatory approvals for Remplir in Hong Kong, Thailand, and Canada. The company believes these approvals demonstrate the product’s quality and enhance its global recognition. Orthocell is also continuing the global rollout of its Striate resorbable collagen membrane through its distribution partner, BioHorizons, and has received approval for sales of Striate+ in Brazil’s US$65 million market.
Orthocell held a cash balance of $28.6 million at the end of the June quarter, positioning it well to pursue its US expansion plans and international regulatory applications. The company expects to commence its first sales of Striate+ in Brazil in the first half of 2026, viewing it as a major market opportunity and a key part of the wider US$735m global target market for Striate+.
