SOURCE: Unilife Medical Solutions Ltd.

Unilife Medical Solutions Ltd.

August 12, 2009 13:18 ET

Unilife Commences US Production of Unitract 1mL Syringes

LEWISBERRY, PA--(Marketwire - August 12, 2009) - Unilife Medical Solutions Limited ("Unilife" or "the Company") (ASX: UNI) (PINKSHEETS: UNIFF) today announced that it has commenced US production of the Unitract™ 1mL Insulin Syringe ("Unitract 1mL Syringes") at its FDA-registered manufacturing facility in Pennsylvania.

This significant milestone follows the successful transfer of the automated assembly system for the Unitract 1mL Syringes into its designated clean room in accordance with previously announced schedules.

Prior to transferring the automated assembly system into the clean room, it was required to pass a series of operational tests designed to validate its performance in areas such as running speeds and product quality. These tests were successfully completed, with the automated assembly system now rated at up to 90% of efficiency. Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of approximately 40 million units per annum.

In parallel to completing the transfer of the 1mL assembly system into the clean room, Unilife also installed and tested other related manufacturing systems including an automated barrel printer and an automated packaging system.

The start of US production will enable Unilife to complete required product ageing studies and build inventory to fulfil current and anticipated orders for its Unitract 1mL Syringes. The Unitract 1mL Insulin Syringe has received key regulatory certifications for use within the US, Canada, Europe and Australia.

Commercial release of the Unitract 1mL Syringes is expected to occur during the fourth quarter of 2009 once product ageing studies have been completed. Unilife is currently in discussions with a number of interested pharmaceutical and healthcare companies located in the US, Europe and Asia regarding the Unitract 1mL Syringes. Unilife will also promote the products at key US and European industry events.

Unilife's CEO Alan Shortall said, "I encourage shareholders to visit Unilife's website to view a video of the production of the Unitract 1mL Syringes inside its designated clean room. This automated assembly system has been fully designed, developed, built and qualified by Unilife using our own internal resources and world-class operational team. The technical challenges Unilife has overcome to commence high-volume production of the Unitract 1mL Syringes has turned our in-house operational capabilities into a key commercial strength.

"The lessons we have learned during the successful completion of fully automated production for the Unitract 1mL Syringes are now serving as a gateway to the creation of additional substantial opportunities such as the Unilife Ready-to-Fill Syringe."

Unilife's Senior Vice President of Operations, Bernhard Opitz said, "Unilife has taken several significant steps this year to reach this moment where US production of our Unitract 1mL Syringes has commenced. The continued strengthening of our world-class operational team and its technical expertise in the development of innovative safety medical devices has contributed to us reaching this milestone. We look forward to further increasing the efficiency of the automated assembly system in anticipation of the scheduled commercial release of the product later this year."

A production video of the Unitract 1mL Syringes is available for viewing at:

About Unilife

Unilife Medical Solutions Ltd is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.

Unitract 1mL Syringes

The Unitract 1mL Syringes are a patent-protected range of safety syringes designed to protect those at risk of needlestick injury and other unsafe injection practices. A proprietary passive (automatic) needle retraction mechanism allows operators to control the speed of needle withdrawal into the barrel, where it is locked in place to prevent re-use or product tampering. Product variants include the Unitract 1mL Insulin and Tuberculin (TB) Syringes suitable for use within healthcare and pharmaceutical markets, and a Safe Syringe designed for use within harm reduction markets.

Contact Information

  • Shareholder / Analyst Enquiries:

    Jeff Carter
    Phone: + 61 2 8346 6500

    United States
    Stuart Fine
    Phone: + 1 908 469 1788

    Media Enquiries:

    Michael Mullane
    Phone: +61 2 8284 9990

    United States
    Sharon O'Shea
    Phone: + 1 610 659 9091