Perth-based regenerative medicine company Orthocell will ramp up its US expansion after delivering a 45 per cent revenue increase for the year, giving it a $44 million war chest with zero debt or royalties.
The Murdoch-based medtech posted its full-year results on Monday, revealing $13.2 million in revenue, with gross profit lifting 86 per cent to $6.7 million.
That included a 35.7 per cent increase in Q4 revenue compared to the same period in the previous financial year.
The result was largely attributed to sales growth for its remplir and striate+ products.
Remplir, the company's flagship product, is a breakthrough collagen-based nerve wrap designed to facilitate surgical repair of peripheral nerve injuries.
The biological scaffold uses a proprietary manufacturing process to mimic the human nerve's outer layer, providing a compression-free environment that promotes high-quality tissue regeneration and faster functional recovery.
Since gaining regulatory approval in Australia in 2022, it has gained global traction for its ability to reduce the need for damaging sutures in complex procedures ranging from trauma reconstruction to robotic prostate surgeries.
Striate is a collagen membrane used to support guided bone regeneration in dental implant procedures.
Both products are manufactured at the company's Perth facility.
The results, combined with a $30 million raise during the year, left capacity to execute the company's commercial, manufacturing, regulatory and product development plans, according to chair John Van Der Wielen.
"Orthocell's strategy remains clear: to build a global regenerative medicine company based on proprietary Australian technology, high-quality manufacturing and products that address meaningful clinical needs," Mr Van Der Wielen said.
"By owning its manufacturing capability, Orthocell maintains control over product quality, margins and supply continuity—an increasingly important advantage as hospitals globally place greater value on supply chain security.
"We enter FY27 with confidence, maintaining a clear focus on the United States nerve repair market as our largest commercial opportunity, while building disciplined presence in selected international markets."
The company's chief executive and managing director Paul Anderson said growth in the US and Australian markets, with over 1000 procedures using remplir being completed in the June quarter in Australia alone, had driven the results.
"FY26 was remplir's first full year of commercial availability in the United States following first sales in June 2025," he said.
"During this US market access phase, our focus was to establish the infrastructure needed to support high-quality, sustainable adoption.
"By year-end, we had expanded our specialist distributor network across more than 20 states... and achieved use across 70 hospitals and 76 surgeons, with quarterly US unit sales increasing to 119."
He said a hallmark of any strong platform technology was its ability to expand organically into new clinical uses.
"By year-end, more than 250 nerve-sparing prostage procedures using remplir had been completed by 39 surgeons across Australia," he said.
"In FY27, our priorities are clear: deepen adoption in the United States nerve repair market, our largest commercial opportunity; grow established markets; prepare selectively for further international launches; and advance product opportunities that can broaden the portfolio over time.
"The foundations are in place, but our work is not complete. Growth will depend on disciplined execution and the progressive conversion of market access into routine clinical use, and we will continue to report transparently on our progress."
Aside from its US expansion, the company will also progress a planned $5.5 million expansion of its Perth manufacturing facility through the year ahead.
The company boasts several high-profile WA figures on its board, including former WA governor Kim Beazley and former HBF chief executive and Crown Perth chair, Mr Van Der Wielen.
