(MENAFN - ProactiveInvestors - Australia) NuSep (ASX: NSP) has received Australian Therapeutic Goods Administration (TGA) accreditation to manufacture in-vitro diagnostics medical devices (IVDs) used in the field of coagulation.
The company is one of the first IVD manufacturers in Australia to have achieved this accreditation under the recently introduced requirement for ISO 13485 compliance.
Significantly, this now paves the way for NuSep to expand its in-vitro diagnostics product range offering, enabling the company to capture a share of the highly profitable 5 million diagnostic market.
The TGA certification will help NuSep, which is now preparing the membrane manufacturing process, to supply PrIME Biologics with cartridges to manufacture therapeutic plasma products and SpermGen with IVF cartridges.
NuSep is in the process of spinning out its therapeutic plasma fractionation business, PrIME Biologics, to realise the asset's S60 million (A47 million) value.
PrIME Biologics is using NuSep's PrIME Technology in its therapeutic plasma manufacturing process and is concentrating on opening up the Asian therapeutic plasma market, particularly the untapped Currently Unprocessable Plasma (CUP) market.
The move allows NuSep to focus on the development of new PrIME Technology applications while also creating two new highly profitable revenue streams for the company.
NuSep will now seek registration of its in-vitro diagnostics products with the European Union to allow the sale of these products in Europe.
This registration is expected to be completed in early 2013 with NuSep currently in discussions with European distributors for the sale of its coagulation products in Europe.