Xcorporeal, Inc. Announces the XCR-6 Dialysis Platform for Self-Directed Kidney Hemodialysis

  
    
  
  
    
      Xcorporeal, Inc. (AMEX:XCR) announced today the XCR-6 Dialysis Platform 
      for self-directed kidney hemodialysis. The XCR-6 will be the smallest, 
      lightest, and easiest to use dialysis machine ever conceived, using 
      Xcorporeal’s proprietary closed loop, 
      regenerated dialysate technology platform. The Company is currently 
      preparing for unattended/home use clinical trials of the XCR-6 in 
      anticipation of commercialization in the near future.
    
    
      The XCR-6 was developed through extensive research and represents a 
      significant improvement compared with equipment currently utilized by 
      patients suffering from chronic renal failure. The technology will, for 
      the first time, allow dialysis providers to "bring the therapy to the 
      patient" because the XCR-6 uses an extremely small amount of tap water; 
      requires no special plumbing or water processing plants; runs on 
      standard household electricity; is the size and weight of a small 
      household appliance; is easy to learn and use as all tubing is 
      integrated into a single proprietary cassette that snaps into place with 
      one hand and retains all fluids within the disposable cassette, 
      facilitating clean up. The Company estimates that the home hemodialysis 
      market represents a multi-billion dollar revenue opportunity.
    
    
      “We are extremely excited to announce the 
      XCR-6,” said Kelly McCrann, Chairman and Chief 
      Executive Officer of Xcorporeal. “The XCR-6 
      represents the culmination of years of research and development 
      activities in an attempt to change the lives of patients living with 
      kidney dialysis on a daily basis. With its compact size, allowing it to 
      fit into an airline carry-on compartment, the days of patients requiring 
      Center visits for dialysis are numbered. Our ability to deliver a 
      simple, robust, portable, cost-effective solution will finally remove 
      the barriers to home-based hemodialysis services.”
    
    
      Unlike conventional, single pass dialysis machines that require 50 
      liters or more of dialysate generated by a large water purification 
      plant, Xcorporeal’s unique approach requires 
      only 6 liters of dialysate, generated from readily available tap water, 
      and then recirculated in a closed loop to attain the same toxin 
      clearance rates as conventional single pass machines.
    
    
      About Xcorporeal
    
    
      Xcorporeal, Inc. is a medical device company developing an innovative extra-corporeal 
      platform technology to be used in devices to replace the function of 
      various human organs. The platform leads to three initial products: a 
      Portable Artificial Kidney (PAK) for hospital based Renal Replacement 
      Therapy, the XCR-6 for home hemodialysis, and a Wearable Artificial 
      Kidney (WAK) for continuous ambulatory hemodialysis.
    
    
      For the hospital market, Xcorporeal is developing a portable, 
      multi-functional renal replacement device that will offer cost-effective 
      therapy for those patients suffering from Acute Renal Failure, which 
      causes a rapid decline in kidney function. In the U.S., the disease 
      affects more than 200,000 patients annually with a mortality rate 
      approaching 50%, according to a study published in the Clinical Journal 
      of American Society of Nephrology in 2006. The Company has completed a 
      functional prototype of the product, which is currently undergoing bench 
      testing, and anticipates submitting 510(k) filings, for the device and 
      attendant disposable components, with the Food and Drug Administration 
      (FDA) during 2009.
    
    
      The Company also plans to commercialize the XCR-6, a home hemodialysis 
      device, for the chronic End Stage Renal Disease (ESRD) market, comprised 
      of patients in whom the kidneys have ceased to function. The Company’s 
      devices are intended to combine the best attributes of currently 
      marketed home hemodialysis machines to offer patients convenient, 
      durable and truly portable treatments at home. The Company believes its 
      devices will provide a cost-effective alternative to current home 
      treatment modalities, due to their ability to offer hemodialysis without 
      the need for large quantities of dialysate fluid or purified water. The 
      Company has also completed a functional prototype of the XCR-6, which is 
      currently undergoing bench testing, and anticipates submitting a 510(k) 
      with the FDA during 2010.
    
    
      The Company’s WAK is also a device for the 
      chronic treatment of ESRD. The Company has successfully demonstrated a 
      prototype system that weighs less than 6 kg., is battery operated, and 
      can be worn by an ambulatory patient. This miniature, wearable device is 
      intended to enable continuous (up to 24 hours × 
      7 days per week) renal replacement therapy at home. Increasing dialysis 
      time has previously been shown to reduce morbidity and improve quality 
      of life of ESRD patients. The WAK has been featured in articles written 
      by the Los Angeles Times, The Lancet, Kidney International, and various 
      other medical periodicals.
    
    
      Additional Company information may be found on the Internet at: www.xcorporeal.com.
    
    
      Forward-Looking Statements
    
    
      Except for statements of historical fact, the matters discussed in this 
      press release are forward looking and made pursuant to the Safe Harbor 
      provisions of the Private Securities Litigation Reform Act of 1995. 
      These forward-looking statements reflect numerous assumptions and 
      involve a variety of risks and uncertainties, many of which are beyond 
      the company's control that may cause actual results to differ materially 
      from stated expectations. These risk factors include, among others, 
      limited operating history, difficulty in developing, exploiting and 
      protecting proprietary technologies, the risk that our technology may 
      not be effective, uncertainty as to the outcome of arbitration and legal 
      proceedings, intense competition and substantial regulation in the 
      medical device industry; and additional risks factors as discussed in 
      the reports filed by the Company with the Securities and Exchange 
      Commission, which are available on its website at http://www.sec.gov.