Orthocell Posts Record Full-Year Revenue, Takes Remplir and Striate into New Global Markets
Regenerative medicine company Orthocell (ASX: OCC) has reported a record revenue of $9.19 million for the 12 months to the end of June 2025, underscoring market penetration and sales growth of its flagship nerve repair product Remplir in Australia.
The figure was up 35.8% on the previous financial year — boosted by $2.73m revenue in the June quarter alone — and marks Orthocell’s fifth consecutive quarter of record results.
The company has recorded a 9.5% compound quarterly growth rate over the past three years.
US Nerve Market Entry
Orthocell has been awaiting US Food and Drug Administration 510(k) (pre-market) clearance for Remplir, ahead of its commercial distribution into the US$1.6 billion US nerve repair market.
The company expects the launch to provide a step change in revenue through a network of 14 specialist nerve distributors with direct-to-surgeon and hospital clients across 25 states.
To support US sales, Orthocell has finalised logistics and sales pathways and confirmed an annual medical device manufacturing capacity for 100,000 units, with capability for further modularised, low-capital manufacturing expansion.
Regulatory Approvals
Orthocell has expanded regulatory approvals for Remplir in the strategically-important markets of Hong Kong, Thailand and Canada.
The company received the approvals ahead of expectations and believes they demonstrate the quality of the product, support clinical data, and enhance Remplir’s growing global recognition.
Specialist external distributors will service the new markets while Orthocell’s internal resources remain focused on the US market roll-out.
Accelerating Progress
Chief executive officer Paul Anderson said the company had been accelerating its progress in the US market.
“The key to accessing the US market is striking the right balance between internal resources and external specialist distributors who hold direct relationships with the surgeons and hospitals that are ultimately our customers,” he said.
“We have seen excellent take up of Remplir in our existing markets including Australia, which is an endorsement of our market access model that we expect to replicate on a much larger scale in the US.”
Striate Global Rollout
Orthocell continued the global rollout of its Striate resorbable collagen membrane through distribution partner BioHorizons and received the go-ahead for sales of Striate+ dental guided bone regeneration product sales into Brazil’s US$65m market.
The company expects to commence its first sales of Striate+ in Brazil in the first half of 2026, regarding it as a major market opportunity and a key part of the wider US$735m global target market for Striate+ that includes Europe, Australia, New Zealand, Canada, and Singapore.
Orthocell held a cash balance of $28.6m at the end of the June quarter, keeping it well-funded to advance its US expansion plans and the lodgement of international regulatory applications.
Mr Anderson said continued revenue growth from Remplir sales in the Australian market highlighted a “best-in-class” product dynamic and the significant revenue potential of global markets.