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West Australia-based regenerative medicine play Orthocell (ASX: OCC) has received regulatory approval from the Health Sciences Authority in Singapore to commence sales of its nerve repair product, Remplir.
It’s the first international approval of the product outside of Australia and New Zealand.
Remplir is a collagen-based wrap similar in composition to human skin which aims to augment nerve repair surgery and is approved for sale in Australia and New Zealand.
The company has been working with distribution partner Device Technologies to roll out Remplir, with 130+ orthopedic and plastic surgeons now reportedly using the product in peripheral nerve repair surgeries.
Orthocell plans to use Singapore as a strategic stepping-stone to approvals in other ASEAN markets including Thailand, Malaysia, Vietnam, Indonesia and Philippines.
The company reports it’s on track to receive regulatory clearance from the US FDA in 1Q CY25 and applications are planned for Canada, Thailand and EU and UK within the next 6-12 months.
Orthocell is targeting a large addressable nerve repair market estimated to be worth in excess of US$3.5 billion according to its own estimations.
The company has posted record revenue for the September quarter of $2.03 million and has grown its share price by an impressive 47% over the last 3 months.
Orthocell has been trading at 51.5 cents at 3pm AEDT.
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