Press Releases
ARBIOS SYSTEMS STRENGTHENS ITS PROPRIETARY POSITION FOR BLOOD FILTRATION THERAPIES IN CRITICAL CARE MEDICINE
In-Licensed Patents Provide Competitive Protection in Liver Failure, Multi-Organ Failure and Sepsis
WALTHAM, MASSACHUSETTS – MARCH 30, 2006 -- Arbios Systems, Inc. (OTC: ABOS), a company developing proprietary medical devices and cell-based therapies for the millions of patients each year who experience or are at risk for life-threatening episodes of liver failure, today announced the in-licensing of a patent portfolio of issued U.S. patents as well as pending U.S. and foreign applications and other intellectual property. The exclusive license includes five issued U.S. patents with broad claims for methods of treating liver failure, multi-organ failure, multi-organ dysfunction syndrome, sepsis, septic shock, systemic inflammatory response syndrome, and related inflammatory disorders by selective blood filtration.
Walter C. Ogier, President and Chief Executive Officer of Arbios Systems Inc., commented, "The in-license of this important patent portfolio represents a significant development for Arbios and our SEPET™ product candidate. We now have the protection of issued and pending patents for our lead SEPET™ Liver Assist Device development program. This intellectual property provides further protection for our planned extension of our SEPET™ technology into other areas of critical care medicine, including major opportunities for the treatment of multi-organ failure, sepsis, and related indications in critical care medicine."
The in-licensed U.S. patents relate to the use of blood filtration devices that remove, from the blood of patients with the above disease conditions, a broad spectrum of inflammatory and other disease mediators ranging from small molecules through intermediate size blood proteins with molecular weights up to the size of beneficial immunoglobulins. Such devices are capable of removing known "bad actor" compounds associated with liver failure, multi-organ failure and sepsis while preserving critical immunoglobulins, clotting factors, lipids, and other beneficial large proteins in the circulating blood of afflicted patients. The patents also relate to the combined use of replacement fluids, including human serum albumin, or combined uses of secondary selective plasma adsorption devices and/or certain classes of anti-inflammatory therapeutic drugs.
Arbios will be obligated to pay royalties on net sales of products covered by the license. The Company will also owe maintenance and milestone fees and have certain other obligations under the license. In connection with the license, Arbios issued the licensor a warrant to purchase 225,000 shares of the Arbios common stock at an exercise price of $1.50 with a 6-year term. In addition, Arbios entered into consulting arrangements with certain inventors of the patents subject to the license agreement, to assist the Company with the continued prosecution of the patents as well as provide strategic and consulting services.
About SEPET™ Liver Assist Device
The SEPET™ 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, lungs and other organs, including the brain and kidneys, and suppressing the function and regeneration of the liver. SEPET™ is designed for use with standard blood dialysis systems available in hospital intensive care units.
About Liver Disease
According to the American Liver Foundation, chronic liver disease is the tenth leading cause of death in the U.S., resulting in approximately $10 billion in annual healthcare costs. The World Health Organization estimates that 20 million people worldwide have cirrhosis of the liver and/or liver cancer, arising predominantly among the estimated 500 million persons (nearly 10% of the world population) who are afflicted with persistent hepatitis B or hepatitis C viral infections. Liver failure may also result from excessive alcohol consumption, aggressive forms of fatty liver disease or other chronic liver disorders. It can also be caused by ingestion of common medications, such as acetaminophen, contaminated herbal medicines, or toxic mushrooms. An estimated one to two million persons worldwide die each year from liver failure, with more than 50,000 deaths per year in the United States. Liver failure typically develops slowly, and its progression usually goes unnoticed until it becomes life-threatening. It occurs in persons of all ages but is most common (representing the fifth leading cause of death) among 25 to 65 year olds.
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. While a patient's liver may regenerate on its own to varying degrees, a chronic liver failure patient often continues to lose more and more liver cell mass and function as the disease progresses and ultimately needs to undergo liver transplant surgery. A shortage of livers and other factors make such therapy unavailable to the large majority of liver failure patients worldwide.
Arbios Systems, Inc. is developing proprietary medical devices and cell-based therapies to enhance the survival of millions of patients each year who experience, or are at risk for, life-threatening episodes of liver failure. The Arbios product candidate portfolio includes the SEPET™ Liver Assist Device, a novel blood purification therapy that provides enhanced "liver dialysis," and the HepatAssist™ Cell-Based Liver Support System, a bioartificial liver that combines blood detoxification with liver cell therapy to replace whole liver function in patients with the most severe forms of liver failure. For more information on the Company, please visit 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, future markets and demand for the Company's 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™ and HepatAssist™ are trademarks of Arbios Systems, Inc.
