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Pall and Kawasumi in Agreement to Market Pall's Enhanced Bacterial Detection System for Safer Blood Transfusions in Japan.


EAST HILLS, N.Y. -- Pall Corporation (NYSE NYSE

See: New York Stock Exchange
:PLL PLL - phase-locked loop ) announced today that it has finalized an agreement for Kawasumi Laboratories, Inc. to become the exclusive provider of the Pall eBDS (enhanced Bacterial Detection System) in Japan. Bacterial contamination of platelets is the number one infectious cause of morbidity and mortality Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
 from a blood transfusion blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. . Bacteria contaminate anywhere from one in 2,000 to one in 5,000 platelets collected worldwide. The number of platelet collections in Japan is about 780,000 annually.

This agreement is the latest in a ten-year long relationship between the two companies. Kawasumi, a leading provider of medical devices and pharmaceuticals for blood banking, uses only Pall leukocyte leukocyte (l`kəsīt'): see blood.
leukocyte
 or white blood cell or white corpuscle
 (white blood cell) reduction filters in its blood collection and transfusion systems and is Pall's exclusive route to market for these filters in such systems in Japan.

Under the new agreement, Pall is also receiving milestone payments to correspond with providing Kawasumi scientific and technical support to help it bring the technology to market in Japan. Kawasumi will submit the product to the Japanese regulatory authority (MoHLW), whose approval process often mirrors that of the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
).

The FDA cleared the Pall eBDS for marketing in January 2004. The eBDS is also approved by Health Canada, the Canadian regulatory authority, and is CE marked for use throughout Europe. More than 30 U.S. blood centers, one of Canada's largest hospitals, plus four blood centers throughout Europe and the Middle East have already incorporated the Pall eBDS as part of their routine standard of practice. As of March 1, 2004, a new standard set by the American Association of Blood Banks requires U.S. blood centers to test all platelet components for the presence of bacteria prior to transfusion. The eBDS was designed to provide the most comprehensive, reliable and sensitive detection system to help blood centers meet the new standard while assuring conformance to good manufacturing practices.

"We have kept Kawasumi closely informed of our progress throughout the development of the eBDS since Japan is a nation that is highly focused on blood product safety and quality," said Roberto Perez, President of Pall Life Sciences. "We are highly confident that this will be a mutually beneficial relationship for both companies as well as for all blood transfusion patients in Japan."

"The eBDS will be another step forward for us to ensure the safest blood possible for all transfusion patients in Japan," said Choichiro Tsuji, Corporate Office and Executive General Manager of Kawasumi. "We are pleased to continue to build upon our long-standing relationship and work with Pall."

The eBDS can detect bacteria in all platelets, whether derived from single donor (apheresis apheresis (əfĕr`əsĭs), or hemapheresis (hē'məfĕr`əsĭs), any procedure in which blood is drawn from a donor or patient and a component (platelets, plasma, or white blood ) or random donor (whole blood) collection procedures. It allows blood banks to accurately detect the lowest levels of bacterial contamination so that viable and valuable platelets are not discarded or wasted. It does this with minimal platelets loss. The eBDS is automated, requires little training to operate and is easy to incorporate into standard blood center practice. A rapid read system provides Pass/Fail results in approximately 30 seconds thus improving availability of blood for transfusion by allowing faster access to platelets found to be bacteria free prior to becoming outdated. In Japan, platelets have a shelf life of only three days.

Platelets, a blood component required for clotting, are a highly valued life saving resource most often given to immunocompromised immunocompromised /im·mu·no·com·pro·mised/ (-kom´pro-mizd) having the immune response attenuated by administration of immunosuppressive drugs, by irradiation, by malnutrition, or by certain disease processes (e.g., cancer).  patients for the treatment of cancer, leukemia and other blood disorders blood disorders,
n.pl hematologic dyscrasias that affect the component cells and plasma elements of the blood. They are generally divided into two broad groups: those in which an increase in bulk occurs (e.g.
.

The eBDS is part of the Pall Medical Bacteria Risk Management Program, which includes products to address contamination at every stage of blood collection and processing. Other steps in this program include the Company's Sample Diversion Pouch, which diverts the usually contaminated initial volume of donor blood during collection and filtration technologies for leukocyte reduction leukocyte reduction Leukocyte depletion, leukodepletion Transfusion medicine Any technique that ↓ WBCs in transfused blood products–eg, RBCs, platelets; LR to < 5 x 108 virtually eliminates nonhemolytic (immunologic) transfusion reactions.  of both red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.

Mentioned in: Bone Marrow Transplantation

red blood cells 
 and platelets.

Pall is the world leader in leukocyte reduction filtration technologies. It is committed to developing new technologies that safeguard public health and improve transfusion safety including extensive research and development on the removal of prions and other pathogens that can contaminate blood.

About Kawasumi Laboratories, Inc.

Kawasumi Laboratories, Inc., founded in 1954, is a global manufacturer of medical devices and pharmaceuticals for hemodialysis, blood banking, cardiovascular, intravenous infusion and other fields. Headquartered in Tokyo, Japan, the company is listed on the Second Section of the Tokyo Stock Exchange Tokyo Stock Exchange

Main stock market of Japan, located in Tokyo. It opened in 1878 to provide a market for the trading of government bonds newly issued to former samurai.
 (Code number 7703) and reported worldwide sales of approximately 30 billion yen for the fiscal year ended March 31, 2004.

About Pall Corporation

Pall Corporation is the leader in the rapidly growing fields 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 transfusion medicine Blood banking A subspecialty of clinical pathology or internal medicine which is involved in Pt management through administration of blood cells and blood products including fresh-frozen plasma and cryoprecipitate; TM specialists are versant in , semiconductors, municipal drinking water drinking water

supply of water available to animals for drinking supplied via nipples, in troughs, dams, ponds and larger natural water sources; an insufficient supply leads to dehydration; it can be the source of infection, e.g. leptospirosis, salmonellosis, or of poisoning, e.g.
, aerospace and broad industrial markets. Total revenues are $1.77 billion. The Company headquarters are in East Hills, New York East Hills is a village in Nassau County, New York on the North Shore of Long Island. It is considered part of the Greater Roslyn area, which is anchored by the Village of Roslyn. As of the United States 2000 Census, the village population was 6,842.  with operations in more than 30 countries. Further information is available at www.pall.com.

This release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These statements are based on current Company expectations and are subject to risk and uncertainties, which could cause actual results to differ materially. Such risks and uncertainties include, but are not limited to: fluctuations in foreign currency exchange rates; regulatory approval and market acceptance of new technologies; changes in product mix and product pricing and in interest rates and cost of raw materials; the Company's success in enforcing its patents and protecting its proprietary products and manufacturing techniques and its ability to achieve the savings anticipated from its cost reduction initiatives; global and regional economic conditions and legislative, regulatory and political developments; and domestic and international competition in the Company's global markets. Additional information regarding these and other factors is available on the Web at www.pall.com and is included in the Company's reports filed with the U.S. Securities and Exchange Commission. Copies of such reports can be obtained, without charge, at www.sec.gov.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Oct 7, 2004
Words:1008
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