E-Z-EM Receives FDA 510(k) Clearance for EmpowerMR Injector System

  
    
  
  
    
      E-Z-EM, Inc. (NASDAQ:EZEM) today announced that the Company has 
      received 510(k) clearance from the Food and Drug Administration (FDA) 
      for its EmpowerMRTM injector system—the 
      Company’s first product for the magnetic 
      resonance (MR) imaging market. Building on the Company’s 
      successful Empower family of CT injector systems, EmpowerMR has the same 
      easy-to-use interface and robust safety features as the other products 
      in the Empower injector line. EmpowerMR also employs several innovative 
      features designed to cope with the problem of electrical interference in 
      the magnetic field of the MR scanner.
    
    
      Magnetic resonance imaging systems operate by detecting minute variances 
      in the alignment of molecules within certain tissues of the human body. 
      To detect these variances, MR systems create powerful magnetic fields, 
      and require the use of non-magnetic materials and components in the 
      immediate surroundings of the scanner. Electromechanical devices like 
      injector systems can create both electric and magnetic fields that cause 
      electrical interference with the scanner during the imaging process, 
      leading to image distortion or artifacts.
    
    
      To minimize this problem, EmpowerMR employs a unique, patent-pending 
      hydraulic control system instead of the shielded electrical control 
      components used by most other MR injectors systems. EmpowerMR has no 
      shielded iron core motors, piezoelectric motors or electrically active 
      motor control circuitry adjacent to the scanner, which significantly 
      minimizes the prospect of electrical interference with the scanner’s 
      magnetic field. EmpowerMR provides for utilization in MR field strengths 
      up to 7 Tesla. EmpowerMR is also not battery operated, and links to its 
      electrical supply by a single pass-through cable that does not require 
      special shielding. As there is no motor in the MR suite, EmpowerMR does 
      not generate audible noise. EmpowerMR’s 
      hydraulic control also means the system can deliver consistent flow 
      rates, volumetric and pressure performance on demand—features 
      which may help improve productivity in the MR suite.
    
    
      According to recent data from IMV Limited, a medical technology market 
      analysis firm, there are approximately 6,000 MR scanners in the United 
      States and approximately 15,000 worldwide. Currently, approximately 20% 
      of MR procedures involve the use of injected contrast.
    
    
      Commenting on the announcement, Anthony A. Lombardo, President and Chief 
      Executive Officer, “EmpowerMR is a natural 
      addition to our family of injector products, and offers the same feature 
      set and interface that made our Empower line an award winner. With its 
      unique hydraulic control systems, we believe it is one of the most 
      innovative injector systems available to the imaging market, and when 
      coupled with our IRiSMRTM data management 
      software, EmpowerMR will provide superior injection data management 
      capability as well. We look forward to formally launching EmpowerMR in 
      the coming weeks and for the product to be a contributor to sales in our 
      next fiscal year.”
    
    
      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®—the 
      next generation low density barium sulfate suspension for use as an oral 
      contrast in Multidetector CT (MDCT) and Positron Emission Tomography 
      (PET/CT) studies. The Company also offers Empower®?the 
      only family of CT injectors on the market with patented EDA™ 
      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 system. The Company is also the exclusive 
      world-wide manufacturer and marketer of RSDL for first-responder 
      organizations and military services. RSDL is a patented, broad spectrum 
      liquid decontaminant, that neutralizes and/or removes chemical warfare 
      agents and T-2 toxins from skin.
    
    
      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 Empower MR injector systems, market acceptance and 
      sales of VoLumen®; 
      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 3, 2006 and its 10-Q for the quarter ended 
      March 3, 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.