Osteopore gains China product approval

Bone reconstruction technology company Osteopore has broken into the China market with its regenerative bone scaffold implants used to speed healing in craniofacial surgery.

The Singapore and Australian company has won approval from the Hong Kong regulatory authority, allowing it to market its bioresorbable polymer implants in the Greater Bay Area, a region covering 11 per cent of the China market.

Its products have been registered with Hong Kong’s Medical Device Control System – which is voluntary – for a pilot program in Hong Kong which gives wider access into the immediate region.

The company said in a statement: “The program allows for expedited partial access to the lucrative Chinese market, a process that could take at least a few years.”

The pilot program is for products purchased by Hong Kong and Macau public hospitals that meet urgent clinical needs and contribute to clinical advancements.

This also necessitates clinical data from clinical trials in patients.

Osteopore, which 3D prints its scaffolds to suit individual patients, was recently granted a Chinese patent for ‘smart’ scaffolds that promote faster bone growth.

China accounts for 18 per cent of the global craniofacial market.

CEO Khoon Seng Goh said the move was a modest step in its China strategy.

“It presents the company with a very real opportunity to engage with key surgeons, helping them to apply our technology in craniofacial procedures, laying the foundation for clinical collaboration and sales growth into the future.”

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