WALTHAM, Mass., June 23 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. , a company developing proprietary medical devices and cell-based therapies for the many millions of patients each year who experience or at risk for life-threatening episodes of liver failure, announced that the Company’s founder and Chief Scientific Officer, Jacek (Jack) Rozga, M.D., Ph.D., has been invited to give an oral presentation of preclinical and preliminary clinical data for the SEPET(TM) Liver Assist Device at the Annual Conference for the European Society for Artificial Organs. Dr. Rozga’s presentation is entitled, “A Novel Blood Filtration Therapy for Hepatic Failure.” He is scheduled to speak at 11:40 am today, June 23, 2006 at the IDUN Vasaplan Conference Center in Umea, Sweden. His presentation will focus on scientific and medical rationale, preclinical data, and interim clinical trial results for the SEPET(TM) Liver Assist Device.
Arbios has previously announced favorable interim results of a feasibility clinical trial of the SEPET(TM) Liver Assist Device. The objectives of the ongoing clinical feasibility trial are to assess the safety and tolerability of SEPET(TM), as well as its preliminary effectiveness in reversing liver failure and resultant encephalopathy. Encephalopathy associated with liver failure is a life-threatening condition involving brain dysfunction, which is caused by toxins that accumulate in the bloodstream. If liver failure is not reversed, it can lead to the shutdown of multiple organs and death. If a patient is eligible for liver transplantation, treatment with SEPET(TM) may help keep the patient alive until a donor organ becomes available for transplantation. The Company previously announced that all patients treated in the clinical trial had met the prospective clinical effectiveness endpoint of the trial, i.e., at least a 2-stage improvement in encephalopathy, and most had been released from the intensive care unit within 48 hours. The trial has recently been expanded to include all clinical stages of encephalopathy.
The SEPET(TM) Liver Assist Device is a sterile, disposable cartridge containing microporous hollow fibers with unique permeability characteristics. When a patient’s blood is passed through these fibers, blood plasma components of specific molecular weights are expressed through the micropores, thereby cleansing the blood of harmful impurities (i.e., hepatic failure toxins as well as various mediators of inflammation and inhibitors of liver regeneration). These substances would otherwise progressively accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing risk of sepsis development and accelerating damage to the liver and other organs, including the brain, lungs and kidneys, and suppressing the function and regeneration of the liver. SEPET(TM) is designed for use with a standard blood dialysis system available in hospital intensive care units.
Chronic liver disease is the tenth leading cause of death in the U.S., resulting in approximately $10 billion in annual healthcare costs, according to the American Liver Foundation. An estimated one to two million persons worldwide die each year from liver failure. There is currently no satisfactory therapy available to treat patients in liver failure, other than maintenance and monitoring of vital functions and keeping patients stable through provision of intravenous fluids and blood products, administration of antibiotics and support of vital functions, such as respiration.
Arbios Systems, Inc. is a publicly traded medical device and cell-based therapy company based in Massachusetts and in California that is engaged in the discovery, acquisition and development of proprietary liver assist devices and new technologies useful in the diagnosis and treatment of liver failure. Arbios’ products in development include the SEPET(TM) Liver Assist Device, a novel blood purification therapy and the HepatAssist(TM) Cell-Based Liver Support System, a bioartificial liver. For further information on the Company, access the website at http://www.arbios.com.
This press release contains forward-looking statements that involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks or uncertainties related to the goals and results of clinical trials, compliance with regulatory requirements, labeling of the Company’s products, the need for subsequent substantial additional financing to complete clinical development of its products, and Arbios’ ability to successfully market its products and technologies. These statements represent the judgment of Arbios’ management as of this date and are subject to risks and uncertainties that could materially affect the Company. Arbios cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements. Please refer to our Annual Report on Form 10-KSB for the fiscal year ended December 31, 2005 for a description of risks that may affect our results or business conditions. The Company does not undertake any obligation to publicly release the result of any revisions to such forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events except as required by law. SEPET(TM) and HepatAssist-2(TM) are trademarks of Arbios Systems, Inc.
Arbios Systems, Inc.
CONTACT: Arbios, Scott Hayashi, VP and CFO, +1-310-657-4898,shayashi@arbios.com; RX Communications Group, Paula Schwartz, Investors,+1- 917-322-2216, Pat Garrison, Media, +1-917-322-2567
Web site: http://www.arbios.com//
