Highlights
- Orthocell achieved record revenue of A$2.03 million in Q3 2024.
- Demand for key products Striate+ and Remplir continues to drive growth.
- US FDA approval for Remplir could unlock a $1.6 billion nerve repair market.
Orthocell Ltd (ASX:OCC), a leader in regenerative medicine, reported record revenue of A$2.03 million for the September 2024 quarter, marking its second consecutive quarter of record-breaking growth. This reflects a 7.82% increase from the A$1.88 million earned in the June quarter, driven by increasing demand for its innovative products Striate+™ and Remplir™.
Innovative Products Driving Revenue
Orthocell's flagship products, Striate+ and Remplir, have been key contributors to its revenue growth. Striate+, a dental bone regeneration solution, is available in global markets, including the US, Canada, Europe, the UK, Australia, and New Zealand. The product’s strong clinical outcomes have made it popular among surgeons.
Similarly, Remplir, which focuses on peripheral nerve repair, is seeing growing adoption in Australia and New Zealand. Orthocell is preparing to expand Remplir into international markets, with plans for additional regulatory approvals in key regions.
Expanding into the US Nerve Repair Market
A significant milestone for Orthocell is the anticipated US Food and Drug Administration (FDA) approval for Remplir. This approval would allow the company to enter the US nerve repair market, estimated to be worth over US$1.6 billion. Final data for the FDA submission is expected by the end of 2024, with formal approval anticipated in early 2025.
In total, the global market potential for Striate+ and Remplir is estimated to exceed US$4 billion across multiple jurisdictions.
Strategic Partnerships and Growth
Orthocell’s distribution partnerships with BioHorizons Implant Systems for Striate+ and Device Technologies for Remplir have been instrumental in driving revenue growth. These partnerships, along with Orthocell’s solid cash position of A$18.4 million, place the company in a strong position for further expansion and success in obtaining crucial US product registrations.
CEO Paul Anderson expressed optimism about the company's trajectory, highlighting the consistent demand for Striate+ and Remplir, and the company’s potential to capture significant market share in the coming years. Orthocell continues to engage with regulators and clinicians worldwide, with a focus on expanding its market presence and driving future growth.
Orthocell’s recent performance, coupled with its global expansion efforts and innovative product offerings, positions it for further success in the regenerative medicine market.