Orthocell Ltd (ASX:OCC, OTC:ORHHF) has maintained rapid market penetration with its market-leading regenerative medical devices demonstrated by revenue of A$2.21 million in the December ‘24 quarter, a third consecutive quarter of record figures.
Revenue during the period was 9% higher than the previous record of A$2.03 million achieved in the September quarter, which the company says is an impressive result given the December quarter traditionally is seasonally lower.
Sustained growth
The A$2.21 million in revenue was also 46% above the previous corresponding December 2023 quarter of A$1.51 million, showing significant and sustained growth for the company which has two products in market – Striate+™ for dental bone regeneration and Remplir™ for peripheral nerve repair.
This revenue growth is evidence that Orthocell’s products are achieving traction with new and existing surgeons in their respective markets, underpinned by the excellent performance of these novel devices in clinical practice.
New markets
And the success shows no signs of abating with multiple new international markets nearing regulatory approvals as Orthocell pushes ahead with global commercialisation plans targeting a market opportunity worth circa US$4.5 billion in key markets.
Of particular focus is the near-term FDA approval of Remplir in the US which is expected by March/April 2025 and will open up the significant US$1.6 billion USA nerve repair market opportunity.
Increasing traction
“We are delighted with the continued growth in demand and record quarterly revenue for our market-leading products Striate+ and Remplir,” Orthocell CEO and MD Paul Anderson said.
“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.
“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.”
Opportunities
The global market opportunity for the two products in nine key jurisdictions - USA, EU, UK, AUS/NZ, SGP, CAN, BRZ, JAP, THA - is estimated to be approximately US$4.5 billion.
Expansion into other markets would see an increase in these projections, demonstrating significant growth potential for the company in the immediate future.
Striate+ is distributed globally by BioHorizons Implant Systems Inc, one of the largest global dental implant companies.
Remplir is distributed by Device Technologies (DVT), a respected name in the provision of medical devices and healthcare solutions across Australia, New Zealand and Singapore.
Orthocell has been working with its distributor partners to drive uptake of Striate+ and Remplir in key regulatory markets.
Striate+ is available for sale in the US, Europe, UK, Australia, New Zealand and Canada, while Remplir is available for sale in Australia, New Zealand and Singapore.
The significant revenue growth Orthocell has achieved is set to increase with additional approvals in other markets.
Engagement strategy
The company has a regulatory and clinician engagement strategy in place for both products to expand access into other geographical regions.
Importantly, the company remains well funded to continue its aggressive growth plans with circa $31 million in cash and an R&D rebate of approximately $3 million expected in the current quarter.