Orthocell has today announced that the Company has submitted a regulatory application to the Health Services Authority of Singapore for approval to market and sell Remplir\u2122 for use in peripheral nerve repair procedures.<\/p>\n
Evaluation of the application by HSA is in progress. HSA is the Singaporean Ministry of Health\u2019s body responsible for regulating the importation, manufacture, export, and supply of medical devices. Once approved, Singapore will be the third country in which Remplir is available for sale, with US application\u00a0 pending.<\/p>\n
Orthocell Managing Director, Paul Anderson, said:<\/p>\n
\u201cWe are delighted to announce our Singapore market regulatory application. This is another significant milestone in our expansion strategy and a testament to our team\u2019s 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<\/em>.\u201d<\/p>\n