Osteopore receives approval to make its products commercially available to doctors and hospitals across Australia
Osteopore Limited (ASX: OSX) a medical device company commercialising a range of 3-D printed bioresorbable scaffolds for regenerative bone healing has received regulatory approval from the Australian Therapeutics Goods Administration (TGA) for its craniofacial products: Osteomesh, Osteoplug, and Osteoplug-C.
According to Osteopore’s CEO Goh Khoon Seng, receiving TGA approval for Osteoplug and Osteomesh opens up a key market in its global expansion of Osteopore.
Osteopore has already received regulatory clearance and approval in international markets including United States FDA and European CE Mark clearance, together with Singapore and other East Asian regulatory clearances, enabling wider commercial access to its products from medical professionals.
Osteopore’s products have been previously successfully used in Australia for customised implants used under Special Access Scheme. Its scaffold technology was used in 2017 to enable the successful regeneration of a patient’s tibia, which led to a successful recovery and significant media coverage for its breakthrough in medical technology innovation.
Read the press release here.