Orthocell gains approval in key Hong Kong market for flagship nerve repair product

Orthocell has been given the green light to sell its flagship nerve-repair product Remplir in the strategically important Hong Kong market.

Orthocell adds Hong Kong to its growing portfolio of approvals for Remplir. Pic via Getty Images.

• Orthocell receives regulatory approval to start sales of Remplir in the strategically important Hong Kong market

• Approval received well-ahead of initial expectations of Q4 2025 following submission in April

• Hong Kong approval adds to growing global regulatory approvals for Orthocell’s flagship nerve-repair product

 

Special Report: Orthocell has been given the green light to sell its flagship nerve-repair product Remplir in the strategically important Hong Kong market, adding to a growing global footprint after a hat-trick of approvals was granted in April.

Perth-based regenerative medicine company Orthocell (ASX:OCC) has received a licence from the Hong Kong Department of Health’s Medical Device Division for Remplir, a collagen wrap used to assist surgeons in improving outcomes in repair and regeneration of damaged nerves.

Orthocell said the licence, originally expected to be granted in Q4 2025, was received about one month following the regulatory submission on April 10, demonstrating the quality of Remplir, clinical data and its growing global recognition.

The company can now start sales of Remplir into the Hong Kong nerve repair market, considered a strategically valuable APEC addition to the product’s global footprint.

Orthocell said Hong Kong was recognised as a leader in medical services across Asia.

Growing global footprint

Orthocell has built a significant portfolio of Remplir regulatory approvals globally.

It is approved in Australia, New Zealand and Singapore. In April, Remplir was granted regulatory approval in Thailand, Canada and the US, the world’s largest healthcare market.

Orthocell is ultimately targeting a total addressable market (TAM) in selected jurisdictions of more than US$3.5 billion.

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

The product is manufactured at its certified Good Manufacturing Practice (GMP) facility at Murdoch University in Perth using its proprietary SMRT manufacturing technology.

The SMRT tech was first developed in conjunction with Orthocell’s chief scientific officer Professor Minghao Zheng and the University of Western Australia.

Orthocell intends to appoint a local on-the-ground specialist distributor to drive sales of Remplir in Hong Kong.

The company has built significant experience working with local distributors in multiple jurisdictions across Remplir and Striate+, its other product.

Striate+ is a trademarked collagen membrane designed to support dental guided bone and tissue regeneration procedures.

Focus on converting ‘approvals into sales’

Orthocell CEO and managing director Paul Anderson said the company was delighted to receive approval for Remplir in Hong Kong just one month after lodging its application.

“The Hong Kong authorities have the right to take up to 12 months to assess submissions, so to turn it around so quickly is a testament to our product quality and clinical data.

“We are now building a strategically valuable portfolio of approvals for Remplir spanning the Asia Pacific region and North America.

Anderson said each additional country approval added to the overall strategic value of its product portfolio.

“We’ve experienced rapid growth in 2025 in the number of countries in which Remplir is approved and our focus is moving towards converting those approvals into sales,” he said.

“We’ll continue to be smart in how we go about driving sales in these markets.

“Our strategy is to focus the bulk of our internal resources on our largest potential market, the US, while using specialist in-country distributors in other markets.”

Orthocell has a strong balance sheet with $31.7 million cash as of March 31, 2025 with no debt.

The company said it was well-funded to continue to broaden its commercial footprint and grow revenues in existing and new markets.

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.

Originally published as Orthocell gains approval in key Hong Kong market for flagship nerve repair product