Orthocell secures third global approval in April for Remplir, adds Canada to growing list

Orthocell has received its third regulatory approval for April after getting the green light to sell its flagship nerve repair product Remplir into Canada.

Orthocell has received approval for Remplir in Canada, its third international market nod in April. Pic via Getty Images.

• Orthocell receives Canadian approval for Remplir, its flagship nerve repair product

• Remplir also granted regulatory approvals in Thailand and US markets during April

• Application to enter US$75 million Canadian nerve repair market lodged in February and received earlier than expected

Special Report:  Orthocell has scored a hat-trick in April, securing its third regulatory approval of the month with the green light to sell its flagship product Remplir into Canada’s US$75 million nerve-repair market.

Perth-based regenerative medicine company Orthocell (ASX:OCC) has announced it has received a medical device licence (MDL) by Health Canada to allow sales of Remplir in the North American country.

Orthocell has now received three international approvals this month for Remplir, a collagen wrap used in nerve repair surgery to assist surgeons in improving outcomes in repair and regeneration of damaged nerves

On Monday the company announced it had been granted a licence by the Food and Drug Administration of Thailand for Remplir into the significant and growing US$84m Thai nerve repair market.

On April 4 Orthocell announced it had received US Food and Drug Administration (FDA) 510(k) clearance for Remplir, paving the way for its commercial distribution in the world’s largest nerve repair market, estimated at US$1.6 billion (~A$2bn)

The approvals rapidly expand the total addressable market for Remplir and add to pre-existing approvals in Australia, New Zealand and Singapore.

Orthocell said the MDL application was lodged with Health Canada in February and approval received earlier than expected – a testament to the quality of the product and strong clinical data.

Negotiations for Canadian distributors

Orthocell said negotiations were underway to appoint distribution partners in Canada to drive market penetration, with first sales expected in the H2 CY25.

The company intends to appoint non-exclusive, local specialist distributors to drive sales in Canada.

Orthocell CEO and managing director Paul Anderson said use of external distributors continues to be the most efficient process to drive sales in each new market.

He said the strategy enables internal resources and sales and marketing spend to remain focused on the larger, more strategically important US market.

“The most efficient way for us to engage with markets outside the US is to use local distributors with existing customer relationships and sales channels,” he said.

“We’re in discussions with parties that we believe will be the right partners for us in Canada.

“Using this strategy, we’re expecting the recently approved jurisdictions for Remplir to start contributing revenue during the second half of calendar year 2025.”

Rapidly growing global footprint

Anderson said the company was building a significant portfolio of jurisdictions in which Remplir is approved for sale and was delighted to add Canada to the growing list.

Regulatory-approved markets for Remplir now equate to a significant total addressable market of US$1.8 bn with applications for the EU and UK on track to be submitted in the next six to 12 months.

The global addressable nerve repair market is estimated to be worth more than US$3.5bn with ~2 million peripheral nerve repairs performed annually across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand.

“Each new regulatory approval is an important addition to the overall value of our product portfolio and our company,” Anderson said.

“We have a focused and effective strategy to grow sales in the key markets around the world, with the bulk of our internal sales, marketing and medical education resources focused on the US, by far the largest addressable market for us.”

With a strong balance sheet of $31.7m cash at bank as of March 31 and no debt, the company said it was well funded to continue its rapid growth plans.

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.