Orthocell has been granted a licence by the Food and Drug Administration of Thailand to commence sales of Remplirâ„¢ into the significant and growing US$84 million Thai nerve repair market.
Thai approval was secured ahead of schedule, following regulatory submission in February 2025. The submission leveraged an expedited registration pathway available for medical devices already approved by the Health Sciences Authority (HSA) in Singapore.
The Company plans to partner with an exclusive distributor in Thailand, with first sales expected in the second half of 2025.
Remplir is now approved in the US, Australia, New Zealand, Singapore and Thailand, which equates to a significant market opportunity of $1.7 billion and with further jurisdictions planned and pending.