Orthocell achieves third consecutive quarter of record revenue

Orthocell achieves third consecutive quarter of record revenue, reporting $2.21 million in Q2 FY25
Growth attributed to increase in sales of its Striate+ and Remplir products
Regulatory approval of Remplir in US expected in March/April 2025, opening a US$1.6 billion nerve repair opportunity

Special Report: Regenerative medicine company Orthocell has reported its third consecutive quarter of record revenue, reporting $2.21 million in Q2 FY25, up 9% on the previous record of $2.03m in Q1 FY25 and 46% on pcp.

Perth-based Orthocell (ASX:OCC) has attributed the increase to growth in sales of its Striate+ and Remplir products and said the result is significant given Q2 is traditionally seasonally lower.

Striate+ is Orthocell’s trademarked, collagen membrane designed to support dental guided bone and tissue regeneration procedures. It is currently sold in the US, Canada, Europe, UK, Australia and New Zealand.

Remplir is Orthocell’s trademarked collagen wrap used for peripheral nerve repair. The product has unique features such as reducing damaging sutures, creating an optimal healing environment and facilitating free gliding during the critical healing period.

Remplir is currently sold in Australia and New Zealand, and in December recorded its first sales in Singapore.

Orthocell said the sustained increase in revenue was evidence that its products were achieving traction with new and existing surgeons in their respective markets, underpinned by excellent performance of these novel devices in clinical practice.

Targeting US approval for Remplir in global growth strategy

In December Orthocell announced the US FDA 510(k) regulatory study of its peripheral nerve-repair product Remplir had met all endpoints.

The study forms a key component of the FDA submission to gain regulatory approval for Remplir in the US, which is expected by March/April 2025, opening a US$1.6 billion nerve repair opportunity in the world’s biggest healthcare market.

Orthocell said multiple new international markets were nearing regulatory approvals as the company pushed ahead with its global commercialisation plans.

The company estimates the global market opportunity for Striate+ and Remplir in nine key jurisdictions – including the US, Europe, UK, Australia/New Zealand, Singapore, Canada, Brazil, Japan and Thailand – to be US$4.5 billion.

Orthocell said expansion into other markets would see an increase in these projections, demonstrating significant growth potential in the immediate future.

Striate+ is distributed by BioHorizons Implant Systems Inc, one of the largest global dental implant companies.

Remplir is distributed by Device Technologies, a respected name in the provision of medical devices and healthcare solutions across Australia, New Zealand and Singapore.

Orthocell said it had been working with its distributor partners to drive uptake of Striate+ and Remplir in key regulatory markets and remained well-funded to continue its aggressive growth plans, with ~$31 million in cash and an R&D rebate of ~$3 million expected in Q3 FY25.

‘Potential for exponential growth’

Orthocell CEO and managing director Paul Anderson said the company was delighted with continued demand and record quarterly revenue for its Striate+ and Remplir.

“The majority of revenue growth is in existing markets, demonstrating increasing market traction, driven by the consistent and predictable outcomes surgeons can achieve using our products,” he said.

“We are excited by the potential for exponential growth and believe we are on track to become a key player in the US$4.5 billion global market we are targeting.

“The near-term US FDA approval which we expect in March/April 2025 will be a very significant catalyst of value for the company, opening up the substantial US$1.6 billion US nerve repair market.”

This article was developed in collaboration with Orthocell, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.