E-Z-EM Launches EZ CHEM Point-of-Care Blood Analyzer.LAKE SUCCESS, N.Y. -- E-Z-EM, Inc. (Nasdaq:EZEM) announced the formal launch of the Company's new EZ CHEM CHEM Chemistry CHEM Chemical CHEM Chemist CHEM Chemistry Mission CHEM Centre des Hautes Études Militaires (French) CHEM Center for Healthcare Environmental Management CHEM Charge-Energy-Mass (spectrometer) (TM) blood analyzer, a convenient point-of-care device for conducting blood assays in patients prior to certain imaging procedures. Nova Biomedical--the Company's development partner for EZ CHEM--submitted a 510(k) application for the base technology, under the product name StatSensor(TM), to the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in January 2007. Nova received FDA clearance for StatSensor in May 2007. Nova has since completed all remaining regulatory and engineering requirements for EZ CHEM, including the preparation and filing of all necessary documentation, and the product is now cleared for sale in the US. The Company expects to begin shipping initial units to select clinical sites in the coming weeks. EZ CHEM performs a simple test for assessing kidney function right in the imaging suite, and produces results in as little as 30 seconds. The device analyzes a finger prick sample of blood for levels of creatinine--an important indicator of a patient's renal function. Such blood values are often required to determine a patient's kidney function before IV contrast agents are administered. Evaluating a patient's kidney function can help determine their ability to safely receive IV contrast prior to CT and MR imaging procedures--an important precaution especially for patients with risk factors such as diabetes, known kidney impairment, and advanced age. Currently, such blood tests must be sent to a lab before the patient can undergo a CT or MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. procedure, a time-consuming step that can cause delays in busy radiology departments. Commenting on the announcement, Brad S. Schreck, the Company's Senior Vice President-Global Sales, Marketing and Engineering, said, "EZ CHEM provides the ability to quickly and accurately assess kidney function where it is needed most, at the point-of-care. Screening for patients with renal insufficiency has been in focus recently, as certain contrast agents, particularly those used in MRI, have been associated with Nephrogenic nephrogenic /neph·ro·gen·ic/ (-jen´ik) producing kidney tissue. nephrogenic producing kidney tissue. Systemic Fibrosis (NSF NSF - National Science Foundation )-a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction and potentially severe condition that currently has no clear and widely successful treatment. We believe EZ CHEM will help reduce the risks associated with the use of IV contrasts for certain patients while improving productivity in the imaging suites, all through a simple, reimbursable test. We have been pleased to work with Nova Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. during the development phase and are excited to begin offering EZ CHEM to the radiology and gastroenterology marketplace." About E-Z-EM, Inc. E-Z-EM is a leading manufacturer of contrast agents for gastrointestinal radiology. The Company is the developer of VoLumen([R]), the next generation, low-density barium sulfate suspension Barium sulfate suspension is barium sulfate (powder) turned into a liquid form by suspending it in a quick-flowing drink to aid in CT scans of the gastrointestinal region. Use for use as an oral contrast in Multidetector CT (MDCT MDCT Modified Discrete Cosine Transform MDCT Multi-detector Computed Tomography MDCT Multiple Description Correlating Transform MDCT Motorsport Dual Clutch Transmission ) and Positron Emission Tomography positron emission tomography: see PET scan. positron emission tomography (PET) Imaging technique used in diagnosis and biomedical research. (PET/CT PET/CT Positron Emission Tomography and Computed Tomography ) studies. The Company also offers Empower([R])--the only family of CT injectors on the market with patented EDA (1) (Electronic Design Automation) Using the computer to design, lay out, verify and simulate the performance of electronic circuits on a chip or printed circuit board. [TM] technology that can help detect contrast extravasation--and offers a complete product set for the virtual colonoscopy practitioner. This product line consists of virtual colonoscopy hardware, software, nutritional prep kits and bowel cleaners, tagging agents and a carbon dioxide colon insufflation insufflation /in·suf·fla·tion/ (-sah-fla´shun) 1. the act of blowing a powder, vapor, or gas into a body cavity. 2. finely powdered or liquid drugs carried into the respiratory passages by such devices as aerosols. system. The Company is also the exclusive worldwide manufacturer and marketer of RSDL (Reverse Spiral Dual Layer) A technique used with dual-layer DVD discs that allows the end of the first layer to seamlessly connect to the second layer. The first layer is recorded from the inside out, and the second layer is recorded from the outside in. [TM] for first-responder organizations and military services. RSDL is a patented, broad-spectrum liquid chemical warfare (CW) agent decontaminant, that neutralizes or removes chemical agents from skin on contact, leaving a non-toxic residue that can be rinsed off with water. About Nova Biomedical Corporation Nova Biomedical is the world technology leader in the development of fast whole blood analyzers to support the care of critically ill patients. Compared to any competitive alternative, Nova analyzers have the most extensive stat test menus and deliver these tests in the shortest time at the lowest costs. Their pioneering technologies provide the right test menu needed by clinicians at the right cost for administrators. Whether testing is performed in the central laboratory, emergency department, surgery, critical care area, or respiratory care, Nova can help improve patient outcomes while reducing the cost of care. The statements made in this document contain certain forward-looking statements. Words such as "expects," "intends," "anticipates," "plans," "believes," "seeks," "estimates" or variations of such words and similar expressions, are intended to identify such forward-looking statements. The forward-looking statements contained in this release may involve numerous risks and uncertainties, known and unknown, beyond the Company's control. Such risks and uncertainties include: the ability of the Company to develop its products; successful launch, market acceptance and future sales of EZ CHEM, market acceptance and sales of VoLumen([R]); future actions by the FDA or other regulatory agencies, overall economic conditions, general market conditions, price increases of raw materials and components, foreign currency exchange rate fluctuations as well as the risk factors listed from time to time in the SEC filings of E-Z-EM, Inc., including but not limited to its Annual Report on Form 10-K for the fiscal year ended June 2, 2007. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements, and investors are cautioned not to place undue reliance on the forward-looking statements included in this release. |
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