Medical devices company Unilife Corporation (UNIS) recently obtained 510 (k) clearance from the U.S. Food & Drug Administration (FDA) for its Unitract Tuberculin (TB) Syringe, a variant of the Unitract 1mL Insulin Syringe for which the company received FDA clearance earlier in 2010. 
While insulin syringes are mainly used by diabetic patients, TB syringes, on the other hand, are used to deliver a wide range of therapeutic drugs as well as vaccines within acute-care hospitals and other settings.
The Unitract range of 1mL syringes may be considered unique in the sense that they allow care givers to control the speed of automatic needle retraction. These syringes are designed to preempt the spread of blood-based diseases such as HIV and hepatitis C.
Unilife is producing its Unitract 1mL syringe at its manufacturing plant in Lewisberry, Pennsylvania. According to the company, the 510 (k) clearance for the Unitract TB syringe enables it to market a composite line of safety syringes, as this is its second product to be cleared by the FDA.
The company intends to sell the syringes to healthcare providers, pharma companies as well as patients who self-administer medicine doses. It has recently finalized EC certification to apply for the CE Mark approval for its Unitract 1mL syringes, which will allow it to sale this product-line in the European Union and Australia.
Unilife is conducting studies (expected to complete in September 2010) to attain a five-year shelf life for its Unitract 1mL syringe. A five-year expiry period on packaging is deemed to be the “gold-standard” within the medical device industry, and is expected to lead to higher business with healthcare distributors.
Unilife reported revenues of $2.7 million in fourth-quarter fiscal 2010 (ending June 30), down 65% year over year. Adjusted loss for the quarter was 11 cents per share, compared with a gain of 8 cents a share a year-ago. The weak results are mainly due to a relative drop in sales from the company’s industrialization agreement with Sanofi-Aventis (SNY) in 2010.
Re-domiciled in the U.S. in January 2010, Unilife is a medical device company that designs, manufactures and sells retractable syringes. Its patented syringes provide integrated safety, which is designed to protect patients from needlestick injuries.
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