Orthocell garners regulatory approval to kick off sales of Remplir™ in important Hong Kong market

Orthocell Ltd continues to make inroads into key markets, having just secured a licence from the Hong Kong Department of Health’s Medical Device Division for its flagship nerve repair product Remplir™.

Remplir is a collagen wrap used in nerve repair surgery to assist surgeons to improve outcomes in the repair and regeneration of damaged nerves.

Strategically important market

The licence means the company can now kick off sales of Remplir in the strategically valuable Hong Kong nerve repair market, a hub in the APEC region and a recognised leader in medical services across Asia.

The approval was originally expected to roll in later this year, in the fourth quarter, but was in fact granted just one month after the company submitted the application on April 10.

The company says this speaks to the quality of the product and the clinical data that supports it, and growing global recognition of the brand.

Orthocell’s recent spate of Remplir regulatory approvals in the region has grown its portfolio, with Australia, New Zealand, Singapore and Thailand already on board, and approvals also in place in the US and Canada.

The markets in which Remplir is approved now represent a total addressable market (TAM) of some US$1.8 billion – a sizeable chunk of the US$3.5 billion TAM the company is chasing.

The company plans to submit further regulatory applications, for the EU and the UK, within the next six to 12 months.

Distributor sought

Next up, Orthocell will appoint a local on-the-ground specialist distributor to drive sales in Hong Kong.

To this end, the company will be well served by the valuable experience it has clocked up working with local distributors across both its Remplir and Striate+ products in multiple global jurisdictions.

Incremental markets outside of the US, including Hong Kong, are expected to be serviced using external specialist distributors, and will need only minimal additional internal resources.

Internal resources remain focused on the Remplir rollout in the US$1.6 Billion US market, with representatives on the ground making good progress towards imminent first US sales.

The company has existing cash reserves of $31.7 million (as at March 31), which will see it comfortably through the Remplir global roll out.

Valuable portfolio

“We are delighted to receive approval for Remplir in Hong Kong just one month after lodging our application,” Orthocell CEO and MD Paul Anderson said.

“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.

“We believe each additional country adds to the overall strategic value of our 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.

“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.”