Remplir Approved to Commence Sales in US$75m Canadian Market
| Stock | Orthocell Ltd (OCC.ASX) |
|---|---|
| Release Time | 30 Apr 2025, 9:08 a.m. |
| Price Sensitive | Yes |
Orthocell Receives Regulatory Approval to Sell Remplir in $75m Canadian Market
- Orthocell granted Medical Device Licence by Health Canada to sell Remplir in Canada
- Canadian nerve repair market estimated at US$75 million
- Remplir now approved in markets with total addressable market of US$1.8 billion
- Orthocell expects step change in revenue once sales traction achieved in new markets
Orthocell Limited (ASX:OCC) has received a Medical Device Licence (MDL) from Health Canada for its flagship nerve repair product Remplir. This adds the US$75 million Canadian nerve repair market to the existing list of jurisdictions where Remplir is approved for sale, taking the total addressable market (TAM) for approved jurisdictions to US$1.8 billion. The regulatory submission was lodged in February 2025 and approval was received earlier than expected, a testament to the quality of the product and clinical data. Orthocell intends to appoint non-exclusive, local specialist distributors to drive sales in Canada, with negotiations underway. The Company believes using external distributors is the most efficient process to drive sales in each new market, allowing internal resources and sales and marketing spend to remain focused on the larger, more strategically important US market. Remplir is a collagen wrap used in nerve repair surgery to assist surgeons in improving outcomes. In addition to the approved markets, regulatory applications for the EU and UK are on track to be submitted in the next 6-12 months. Orthocell has a strong balance sheet with A$31.7 million cash at bank as at 31 March 2025 and no debt, and is well-funded to continue broadening its commercial footprint and growing revenues in existing and new markets.
Orthocell expects a step change in revenue once sales traction is achieved in the recently approved markets of the US, Thailand and Canada.
Orthocell is targeting a large global addressable nerve repair market estimated to be worth in excess of US$3.5 billion with an estimated ~2.0M peripheral nerve repairs performed across Australia/New Zealand, Singapore, USA, EU/UK, Canada, Brazil, Japan and Thailand.