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Highlights
- Orthocell receives Singapore regulatory approval for Remplir.
- Expansion plans include ASEAN markets and upcoming US FDA approval.
- Record quarterly revenue of $2.03 million reported.
West Australian-based regenerative medicine company Orthocell (ASX:OCC) has secured regulatory approval from Singapore’s Health Sciences Authority for its nerve repair product, Remplir. This marks the product’s first international approval outside Australia and New Zealand, paving the way for global market expansion.
Remplir is a collagen-based wrap designed to support nerve repair surgery and is already used by over 130 orthopedic and plastic surgeons in Australia and New Zealand. Orthocell has been collaborating with its distribution partner to ensure the product reaches a wider audience, and this latest approval in Singapore is expected to be a strategic gateway into other Southeast Asian markets such as Thailand, Malaysia, Vietnam, Indonesia, and the Philippines.
In addition to its plans in ASEAN, Orthocell is targeting approvals in major markets, with US FDA clearance anticipated in the first quarter of 2025. The company also plans to submit applications for regulatory approvals in Canada, Thailand, the EU, and the UK within the next 6-12 months.
Orthocell is addressing a large and growing nerve repair market, which it estimates to be worth over US$3.5 billion globally. The company’s momentum is reflected in its financial performance, reporting record revenue of $2.03 million for the September quarter and a 47% increase in its share price over the past three months.
With its successful entry into Singapore and plans for further international expansion, Orthocell is well-positioned to make significant strides in the global nerve repair market.
