Orthocell Ltd (ASX:OCC, OTC:ORHHF) has taken steps toward its goal of global expansion for its market-leading peripheral nerve repair product Remplir, submitting a regulatory application with the Singapore authorities to bring the treatment to Singaporean markets.
Singapore would be the third market for Remplir, which is already sold in Australia and will soon be sold in the US, should the company’s pending application be approved.
Approval would open ASEAN markets
“We are delighted to announce our Singapore market regulatory application,” Orthocell managing director Paul Anderson said.
“This is another significant milestone in our expansion strategy and a testament to our team’s efforts to gain approval of Remplir for nerve repair in key global markets.
“Singapore is an important market and a stepping stone to the very large and attractive ASEAN targets.
“Once approved, it will be the third country in which Remplir is available for sale, with US regulatory application, a key focus of the company, on track for submission Q4 CY24.”
OCC says its Remplir US 510k regulatory study is on track for completion and data read out in the third quarter of this year, with formal submission of the application expected to occur in the fourth quarter, with formal approval to follow shortly after.
The treatment is already finding a market in Australia via OCC’s exclusive distributor Device Technologies – more than 100 orthopaedic and plastic surgeons are now using the technology in peripheral nerve repair surgeries, from facial to upper and lower limb nerves.