Regenerative medicine company Orthocell Ltd (ASX:OCC, OTC:ORHHF) has chalked up record revenue of A$2.03 million for the September 2024 quarter, marking a second consecutive quarter of record growth.
Two market-leading products
The figures are a 7.82% increase on the A$1.88 million achieved in the June quarter, driven by growing demand for its market-leading flagship assets, Striate+™ and Remplir™.
Striate+, used for dental bone regeneration, is currently sold in key global markets, including the US, Canada, Europe, the UK, Australia and New Zealand.
Remplir, a product designed for peripheral nerve repair, is available in Australia and New Zealand, with further international expansion planned.
As a result of their strong clinical performance, both products are seeing increasing uptake among surgeons.
Orthocell is targeting new regulatory approvals to expand into additional markets.
US nerve repair market
A key milestone is the expected near-term US Food and Drug Administration (FDA) approval of Remplir, which would open up the US nerve repair market, estimated to be worth more than US$1.6 billion.
Final data for the FDA approval process is due in the fourth quarter of this year with formal submission and potential approval anticipated in the first three months of 2025.
The global market opportunity for Striate+ and Remplir is estimated to exceed US$4 billion across nine major jurisdictions.
Orthocell has strategic distribution partnerships with BioHorizons Implant Systems for Striate+ and Device Technologies for Remplir, which have helped drive significant revenue growth.
With around A$18.4 million in cash, Orthocell is well-positioned to continue its aggressive growth strategy, focusing on global expansion and securing pivotal US product registrations for Remplir.
The company’s ongoing regulatory and clinician engagement efforts are expected to further accelerate its market presence.
Growth in demand
Orthocell CEO and MD Paul Anderson said: “We are delighted with the continued growth in demand and record quarterly revenue for our market-leading products Striate+ and Remplir.
“These sales results demonstrate increasing market traction, which is 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 a US$4 billion global market.”