Rockeby appoints Italian distributor

Rockeby Biomed (ASX:RBY) has appointed Italian company Named as its first distributor in the European market.

The move comes a couple of weeks after the company announced that it had received ISO 13485:2003 and ISO 9001:200 certification and CE Mark approval for CanDia5, its point-of-care test for vulvo-vaginal candidiasis (VVC).

"This marketing agreement opens the door for Rockeby into Europe, and we anticipate recording the first European revenues from the sales of CanDia5 in the fourth quarter of this current financial year. CanDia5 will be introduced in March 2005 at the 12th World Congress on Human Reproduction in Venice, Italy," said CEO Sze-Wee Tan.

Tan emphasised the agreement as a stepping stone into the rest of the European market, with discussions underway for other lead markets in Europe including the UK, Germany, France and Spain.

Details of the two-year agreement were not disclosed, but Tan said it included minimum monthly targets and an initial order of the product.

Named is a privately-owned Italian company specialising in sales, marketing and distribution of natural medicines, diagnostics and medical devices to the Italian primary care, hospital and specialist medical community, with a focus and reputation in the area of female healthcare.

According to Rockeby VP of marketing Nick Plumeridge, the company expects the coverage of key physicians in the Italian market to be very strong.

Rockeby is waiting to hear from the US FDA about its 510(k) applications for CanDia5 and SysCan3, a clinical laboratory test for systemic candidiasis, which were lodged in September last year.