Unilife Completes Unitract 1ml Syringe Ageing Studies

Published: 21-Dec-2009

To commence commercial release and sale within Europe in Q1, 2010

Unilife Medical Solutions (Unilife) has commenced final preparations for the commercial release and sale of its Unitract 1ml syringes, following the completion of device ageing studies for product manufactured at its manufacturing facility in Pennsylvania.

The company expects to be in a position to shortly announce the appointment of a number of agreements for the sale and distribution of its Unitract 1ml syringes by pharmaceutical companies and other healthcare distributors, which are active across a number of international markets including North America and Asia.

Following the successful completion this week of a Medical Device Directive (MDD) audit for CE Mark registration of US-manufactured product, Unilife also expects to be in a position to commence Unitract 1ml syringe sales within Europe during the first quarter of 2010. Final negotiations regarding the placement of initial orders for the Unitract 1ml syringes with interested distributors in Europe are also now taking place.

Bernhard Opitz, senior vice president of operations at Unilife, said: “The operational resources of Unilife remain very much focused upon the on-time completion of the industrialisation program for the Unifill syringe. Also, I am pleased that we are now moving into a position where we can commence the commercial release of our Unitract 1ml Syringes. The company is building its product inventory at its Lewisberry facility in Pennsylvania to fulfil initial orders from a number of interested parties.”

Mark Iampietro, vice-president of quality and regulatory affairs at Unilife, said: “The completion of device ageing studies for the Unitract™ range of 1mL syringes manufactured at our Lewisberry facility in Pennsylvania is a positive sign. It reflects the significant work which has been undertaken this year to build a Quality Management System that is fully compliant to international medical device and pharmaceutical regulations. We are now in a strong position to commence the commercial release of our Unitract 1ml syringes within the US, Europe and other international markets.”

Mark Hassett, director of sales and marketing at Unilife, said: “The Unitract range of 1ml syringes is to our knowledge the world’s first product with an automatic retraction mechanism enabling operators to control the speed of needle withdrawal directly from the body into the barrel of the syringe. Our products are well positioned to protect those at risk of infection from HIV and hepatitis C via potential transmission routes such as needlestick injuries and splatter. We are excited by the level of interest we have received from healthcare workers, patients who selfadminister prescription medication, distributors and pharmaceutical companies. We look forward to strengthening our relationships with these, and other industry leaders, as we roll out our Unitract 1ml Syringes across key international markets throughout 2010.”

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