Navigation Links
Unilife Corporation Secures FDA 510k Clearance for the Unitract™ 1mL Tuberculin Syringe
Date:9/1/2010

LEWISBERRY, Pa., Sept. 1 /PRNewswire-FirstCall/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS, ASX: UNS), today announced that its Unitract™ Tuberculin (TB) Syringe has received  510(k) market clearance from the U.S. Food and Drug Administration (FDA).  

The Unitract™ TB syringe is a variant of the Unitract™ 1mL Insulin Syringe for which Unilife secured FDA clearance earlier this year. Unlike insulin syringes which are primarily used by people with diabetes, TB syringes are used for the administration of a range of therapeutic drugs and vaccines within acute-care hospitals and other healthcare facilities.

The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication. Production of the Unitract™ 1mL syringe is occurring at Unilife's FDA-registered manufacturing facility in Lewisberry, Pennsylvania.

Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "U.S. FDA 510k market clearance for our Unitract™ TB syringe marks an important step in our company's efforts to bring a complete line of safety syringes to market, as it is our second product to receive this clearance.  With TB syringes most commonly used within acute-care hospitals and other healthcare facilities, FDA clearance of our Unitract™ TB syringe significantly broadens our capacity to market our unique products across the U.S. and other key international markets."

Unilife has also recently secured its EC certification to apply the CE Mark to its Unitract™ 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.

The Company also expects to complete studies required to attain a five-year shelf life expiration date for its full range of Unitract™ 1mL syringes in September. The inclusion of a five-year expiry date on medical device packaging is considered to be the gold-standard within the industry, and should help to finalize discussions with a number of interested U.S. healthcare distributors in the near future.

About Unilife CorporationUnilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission. 

General: UNIS-G Investor Contacts (US):Investor Contacts (Australia)Todd Fromer / Garth Russell

Stuart Fine

Jeff CarterKCSA Strategic Communications

Carpe DM Inc

Unilife CorporationPhone + 1 212-682-6300

Phone + 1 908 469 1788

Phone + 61 2 8346 6500
'/>"/>

SOURCE Unilife Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Unilife Corporation Commences Trading on the NASDAQ Global Market Under the Ticker Symbol UNIS
2. Unilife Corporation Schedules Fiscal 2010 Fourth Quarter and Year End Conference Call for Monday, August 30, 2010
3. Unilife Corporation Announces Preliminary Financial Results for Fourth Quarter and Fiscal Year 2010
4. Genaera Corporation Presents Interim Phase 1 Data for Obesity Compound Trodusquemine (MSI-1436) at IBC Conference
5. CEL-SCI Corporation Releases Letter to Shareholders
6. Alfacell Corporation to Present at UBS Global Life Sciences Conference
7. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
8. Genaera Corporation Presents Preclinical Trodusquemine (MSI-1436) Data at the North American Association for the Study of Obesity Annual Meeting
9. Genaera Corporation Presents Phase 1 Data for Trodusquemine (MSI-1436) at the North American Association for the Study of Obesity Annual Meeting
10. The Quigley Corporation Reports Third Quarter Results, Increases Investment in Pharmaceutical R&D for Diabetic Neuropathy
11. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):