Orthocell Seeks Remplir Approval in Thailand

Regenerative medicine company Orthocell (ASX:OCC) has submitted an application to the Thai Food and Drug Administration (Thai FDA) for its leading nerve repair product, Remplir.

The company said the Thai nerve repair market is currently valued at US$84 million.

The submission is via an expedited registration pathway for medical devices already approved by the Health Sciences Authority in Singapore.

Orthocell said it is evaluating other potential markets in the area, including Taiwan, Vietnam, Indonesia and the Philippines.

Remplir is a collagen wrap used in nerve repair surgery to assist surgeons in improving outcomes in the repair and regeneration of damaged nerves. It has been approved for sale in Australia, New Zealand, and Singapore, and it is pending approval in the US, Canada, and Thailand.

Orthocell said there are approximately 180 orthopaedic and plastic surgeons now using Remplir in peripheral nerve repair surgeries across Australia, New Zealand and Singapore.

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