STAT still low end with FDA news just in. Likely mover fyi
EAST WINDSOR, N.J., Feb. 22 /PRNewswire/ -- i-STAT Corporation (Nasdaq: STAT - news), a leading manufacturer of point-of-care diagnostic systems for blood analysis, announced today it has received Food and Drug Administration clearance to market its celite©ACT activated clotting time
test(1).
The activated clotting time test is used extensively in cardiovascular surgery, cardiac catheterization labs
(angiography and angioplasty) and other critical care settings to monitor patients on heparin therapy.
William P. Moffitt, president and chief executive officer, said, ``With the introduction of coagulation
testing on the i-STAT© System, we have enhanced the value of our products for our customers and expanded our market opportunity. At the same time, we have further solidified our position as a leader in the point-of-care testing market, the fastest growing segment of the in vitro diagnostic product market. The activated clotting time test is a natural addition to the test menu of the i-STAT System in that it is used extensively by many of our existing customers. Nearly all of the 16,000 i-STAT analyzers in
customers' hands around the world will be able to run the new celiteACT cartridge,' he added.
``With the introduction of celiteACT, we have become the first company in history to provide the capability for testing electrolytes, metabolites, blood gases and coagulation in a single instrument, thus combining a broad array of critical care tests into a simple-to-use, hand-held format for testing right at the patient's bedside. Consolidating point-of-care testing onto a single platform will allow our customers to simplify operating systems and reduce the costs associated with training and maintenance. We believe that we will continue to demonstrate the scope and value of our technology as we expand the test menu
and develop further system functionality for our customers,' stated Michael P. Zelin, senior vice president of research and development.
i-STAT Corporation develops, manufactures and markets diagnostic products for blood analysis that provide healthcare professionals critical diagnostic information accurately and immediately at the point of patient care. Through the use of advanced semiconductor manufacturing technology, established
principles of electrochemistry and state-of-the-art computer electronics and software, i-STAT developed
the world's first hand-held automated blood analyzer capable of performing a panel of commonly ordered
blood tests on two or three drops of blood in just two minutes at the patient's side.
Certain statements in this press release may relate to future events and expectations and as such
constitute ``forward-looking statements,' within the meaning of the Private Securities Litigation Reform
Act of 1995. The words ``believes,' ``anticipates,' ``plans,' ``expects,' and similar expressions are
intended to identify forward-looking statements. Such forward-looking statements involve known and
unknown risks, uncertainties, and other factors which may cause the actual results, performance or
achievements of the Company to be materially different from any future results, performance or
achievements expressed or implied by such forward-looking statements and to vary significantly from
reporting period to reporting period. Such factors include, among others, competition from existing
manufacturers and marketers of blood analysis products who have greater resources than the Company,
economic conditions affecting the Company's target markets, the uncertainty of new product
development initiatives, the ability to attract and retain key scientific, technological and management
personnel, dependence upon limited sources for product manufacturing components, upon a single
manufacturing facility and upon innovative and highly technical manufacturing techniques, market
resistance to new products and point of care blood diagnosis, inconsistency in customer order patterns
(including those affected by Y2K issues), domestic and international regulatory constraints, uncertainties
of international trade, pending and potential disputes concerning ownership of intellectual property,
availability of capital upon favorable terms and dependence upon and contractual relationships with
strategic partners, particularly Abbott Laboratories. See additional discussion under ``Factors That May
Affect Future Results' in the Company's Annual Report on Form 10-K for the year ended December 31,
1998, and other factors detailed from time to time in the Company's other filings with the Securities and
Exchange Commission.
(1) Celite is a registered trademark of Celite Corporation for its diatomaceous earth products.
SOURCE: i-STAT Corporation |
