FDA Grants Clearance to Market Pall BDS to Detect Bacteria Contaminated Platelets: The #1 Infectious Blood Transfusion Risk.

Business Editors/Health & Medical Writers

EAST HILLS, N.Y.--(BUSINESS WIRE)--Oct. 23, 2002

Pall Corporation (NYSE: PLL) announced today that the U.S. Food and Drug Administration (FDA) granted clearance to market the Pall(R) BDS, a new system to detect bacterial contamination of platelets.

Bacterial contamination of platelets is the leading cause of morbidity and mortality from a transfusion-transmitted infection. It is estimated that as many as one in 4,000 transfusions lead to a severe septic reaction and as many as one in 12,000 transfusions can lead to death due to bacterial contamination.

"Bacteria are the most common infectious agents transmitted by blood and are a far greater threat to patient health than viruses such as HIV and hepatitis," said Roslyn Yomtovian, M.D., Director, Blood Bank-Transfusion Medicine Service and Associate Professor, Department of Pathology at the University Hospitals of Cleveland. "The Pall BDS gives us a novel approach to address the long-standing problem of bacterial contamination of platelets; a problem that has been eluding us for years."

The launch of the Pall BDS comes at a time when the nation's leading blood safety experts have called for immediate action from the blood banking community to initiate a program to detect the presence of bacteria in platelets. The risk of receiving a bacterially contaminated platelet is 50- to 250-fold higher than the combined risk of transfusion-related infections from HIV, hepatitis B and C, and human T cell leukemia (HTLV I/II) viruses. The bacterial contamination rate is estimated to range from one in 2,000 to one in 3,000 per platelet unit.

Studies conducted with the strains of bacteria reported to cause 98 percent of the fatalities due to bacterial contaminated platelets in the U.S. have shown that the Pall BDS accurately detects both gram- positive and gram-negative bacteria. The Pall BDS accurately detected bacterial contamination of both apheresis (single donor) platelets and random donor platelets, which comprise all platelets transfused in the U.S.

"By combining our filtration expertise and scientific knowledge of blood Pall was able to develop this novel detection system that can be easily incorporated into the blood banking process with minimal cost, time and technician training," said Sam Wortham, President of the Pall Medical Group. "This is certainly good news for patients and their doctors. This new technology better safeguards public health and improves the standard of care for a blood transfusion."

The Pall BDS is the company's first entry into the diagnostic testing market. It uses changes in oxygen concentration as a result of bacterial growth to provide a practical and reliable detection method. Since the vast majority of bacteria that cause clinically significant problems in patients are either aerobes or facultative anaerobes (bacteria that consume oxygen), changes in the level of oxygen in a platelet sample indicate the presence of bacteria. A specially designed filter in the system allows bacteria, if present, to enter the sample while preventing platelets and other cellular components from contaminating the sample. Following incubation of the sample, oxygen levels are easily measured in the analyzer to obtain a result, which appears as a simple "pass" or "fail" reading. This provides the ability to detect and discard contaminated platelets while also eliminating the need for specialized training or capital equipment expenditures.

Platelets are the blood component most vulnerable to bacterial contamination because they must be stored at room temperature, which facilitates bacterial growth. Detection is complicated by the fact that there are numerous strains of bacteria with varying growth rates and time needed for some strains to proliferate to the point where they can be detected. A reliable method must be able to detect the most common and lethal bacteria that contaminate platelets prior to platelet outdating, which is only five days in the U.S. Since platelets are a highly valuable resource, the method must also be able to detect bacteria without false positive results so that viable platelets are not discarded and wasted.

Approximately 2.1 million platelets are transfused each year in the U.S., primarily as a life-saving therapy for people with cancer and leukemia or bleeding problems.

In addition to the launch in the U.S., the Pall BDS is available in Canada and in several countries throughout Europe. Pall Corporation is involved in extensive research and development in many areas of blood safety. It is the worldwide leader for leukocyte (white blood cell) reduction filtration technologies for both red blood cells and platelets, and was just recently granted FDA approval to market the new RC2D Leukocyte Reduction Filter that processes blood faster and with greater plasma recovery.

About Pall Corporation

Pall Corporation is the global leader in the rapidly growing field of filtration, separations and purification. Pall's business is organized around two broad markets: Life Sciences and Industrial. The Company provides leading-edge products to meet the demanding needs of customers in biotechnology, pharmaceuticals, transfusion medicine, semiconductors, municipal drinking water and aerospace. Total revenue for Pall Corporation is $1.3 billion. The Company is headquartered in East Hills, New York, and has operations in more than 30 countries. Further information can be found on its web site (www.pall.com).

    Editors Note:

    --  In addition to Dr. Yomtovian, several of the nation's blood
        safety opinion leaders and Pall Corp. executives are available
        for in-person or telephone interviews

    --  A complete press kit including photos of the Pall BDS,
        bacteria that contaminate platelets, and abstracts of studies
        are available online at http://www.pall.com/pressroom/BDS or
        by calling Patrice Radowitz at [phone].

    --  B-roll of the Pall BDS, patient receiving a blood transfusion,
        physician sound bite, etc., can be accessed by satellite:

            Wednesday, October 23 at 1:15 - 1:30 pm EST and at 3:00 -
            3:15 pm EST at: Telstar 6 (C-Band), Transponder 9, Dual
            Audio 6.2/6.8.

            Thursday, October 24, 1:45 - 2:00pm EST at: Telstar 6
            (C-Band), Transponder 9, Dual Audio 6.2/6.8.

            Friday, October 25, 2:00 - 2:15 pm EST at: Telstar 6
            (C-Band), Transponder 9, Dual Audio 6.2/6.8.

            If technical difficulties are experienced, please call
            312-942-1199 ext. 101.

    --  Beta copies of b-roll are also available by calling Patrice
        Radowitz at [phone].