Osteopore granted key regulatory approval in Hong Kong

Today’s announcement of product registration in Hong Kong may fast track Osteopore’s access to China’s large craniofacial market.

Osteopore (ASX:OSX) has been green lit by Hong Kong’s Medical Device Control System (MDACS), offering the bone healing specialist the perfect staging ground into Greater China.

A pilot program launched late last year is helping cut through some of China’s reddest tape with Ostepore’s Hong Kong approved products now placed for expedited access to HK’s prosperous Greater Bay Area, an 11% contributor to the world’s second largest economy.

To qualify, Osteopore’s world-leading regenerative tissue implants must be used by public hospitals in Hong Kong or Macau, meet urgent clinical needs, and contribute to clinical advancements.

Typically, access to the mainland via China’s National Medical Product Administration (NMPA), requires local data from clinical trials, a process which is slow – at least a few years – and expensive.

Ostepore’s MDACS registration springs that door ajar.

Osteopore granted patent in China

Only last month Osteopore secured a patent in China for its ‘smart’ 3D biometric scaffolds, which promote faster bone growth.

The tech was co-developed with the Nanyang Technological University (NTU Singapore) and was already granted a European patent earlier this year.

Patent in hand, Osteopore is forging deeper ties with the Chinese medical research and surgical communities, offering pathways to more collaborative R&D, plus lucrative commercial opportunities in a region that accounts for almost one fifth of the entire global craniofacial market.

Osteopore’s ‘smart’ 3D biomimetic scaffolds are made from polycaprolactone and magnesium composite material, which is expected to promote faster bone growth and healing. The company has also been granted a European patent for the scaffolds.

Osteopore chief technology officer Dr Jing Lim is confident the first generation polycaprolactone biomimetic scaffolds meet MDACS qualification. As surgeons gain experience in their application, Osteopore plans to collaborate with these surgeons in conducting clinical trials with scaffolds made from the latest generation materials.

“Based on the information available, we are confident of meeting the qualification criteria since our products and technology contribute to clinical advancements and are already adopted by leading public hospitals, helping trauma patients regrow their craniofacial bones,” Osteopore Chief Technology Officer Dr Jing Lim said.

CEO Khoon Seng Goh said the company hit a key strategic milestone today with HK regulatory approval.

“While we recognise that this is a modest step in our Chinese business development 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,” he said.

Osteopore’s Chairman, Mark Leong added that Osteopore is laying the groundwork for accessing the lucrative Chinese market.

“The path of entering into the Chinese market can be an arduous journey but it is a big market that cannot be disregarded and is potentially very rewarding. We are encouraged that we have executed the necessary foundational steps beginning with the Memorandum of Co-operation and securing first orders with Boao Yijing Care Centre, followed by our Suzhou business registration, the patent grant in China for our ‘smart’ 3D biomimetic scaffolds and most recently the product registration in Hong Kong” he said.

Osteopore ended the September quarter with almost $6m cash on hand, giving it the flexibility to continue its growth strategy, regardless of the pandemic’s considerable disruption to healthcare systems and elective surgeries.

The company is confident of a turnaround in surgical activity and with a strong pipeline of sales Osteopore is starting to see a robust improvement in gross margins, which jumped by almost 75% in the September quarter, up from 52.7% in Q3 2020.

This article was developed in collaboration with Osteopore, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.