FDA Mandate to Shrink U.S. Blood Supply; Haemonetics' Technology Will Help Blood Banks Avoid Critical Shortages

FDA Mandate to Shrink U.S. Blood Supply; Haemonetics' Technology Will Help Blood Banks Avoid Critical Shortages

Business Wire - August 17, 1999

BRAINTREE, Mass.--(BW HealthWire)--Aug. 17, 1999--Today, the Food and Drug Administration as well as Health Canada issued guidance to each nation's blood collection agencies which prohibits them from collecting blood from anyone who has visited the United Kingdom for an extended period of time since 1980. Haemonetics Corporation (NYSE:HAE) is in a unique position, with its proprietary blood collection technology, to help the nation's bloodbanks recover from the critical blood shortages this guidance is expected to create.

The Impact on US Patients

This guidance may reduce by as much as 2.2%, or 286,000 units, the amount of blood donated in the U.S. each year. Additionally in May, the National Blood Data Resource Center ("NBDRC"), predicted that the United States' need for blood would exceed its supply by 249,000 units next year.

In effect, there is a potential blood shortage of more than 500,000 units which may pose a problem as great as any other we face in the year 2000. This is particularly alarming given statistics shown by a 1998 Nationwide Blood Collection and Utilization Survey conducted by NBDRC which showed that as early as 1997, because of blood shortages, 9% of hospitals had to cancel surgical procedures and 25% were unable to meet their non-surgical blood needs on one or more days.

Dr. Peter Tomasulo, Corporate Medical Director and Senior Vice President for Haemonetics Corporation, said, "A sudden shortfall in donations of this magnitude (530,000 units annually), if uncompensated, would mean that every day as many as 400 patients nationwide could be affected by insufficient blood. Surgical procedures and other treatment might have to be delayed."

One Solution

The FDA has approved technology from Haemonetics that allows blood centers to safely collect twice as many red blood cells from one donor as they can collect with traditional manual techniques. By using this technique, known as apheresis, blood banks will be better able to meet blood supply needs, even if the donor population continues to shrink every year because of tighter FDA guidelines.

Apheresis is not new. It was pioneered by Haemonetics in the 1970s for collecting platelets and then plasma. What is new is the ability to use apheresis to collect red blood cells, the most frequently needed blood component. More than 40 million red cell units are transfused annually worldwide.

Dr. Harvey Klein, Chief of Transfusion Medicine at the National Institutes of Health, said, "This FDA directive has the purpose of reducing the risk of transmitting new variant Creutzfeldt-Jakob Disease ("nvCJD"). The donor deferral is being recommended even though there is no scientific proof that CJD is transmitted by blood because to await definitive proof might expose US patients to avoidable risks."

"Mandates such as these are intended to assure a safe blood supply, but they often reduce blood availability which creates different patient risks. Haemonetics' two-unit red cell apheresis technology is becoming more important to increase the availability of life-saving blood. In fact, by using apheresis technology for the collection of red cells, blood centers could significantly increase the number of red cell units collected from their existing donor base," he added.

The FDA guidance specifically states that blood centers must defer blood donations from any person who has visited or resided in the United Kingdom for a cumulative period of six months or more since 1980. The guidance was given as a result of a recommendation by the Transmissable Spongiform Encephalopathies Advisory Committee, whose intention was to reduce the theoretical risk of transmitting new variant Creutzeldt-Jakob disease (a derivative of mad cow disease) through blood transfusion.

Apheresis is an automated blood collection technique using a closed circuit disposable collection system. Donated blood is centrifuged immediately into its component parts (platelets, plasma, and red cells) allowing one or more transfusable doses of the desired component(s) to be separated into blood collection bags. The unused portion of the blood is then returned to the donor. Unlike traditional manual collection processes, the blood collected through apheresis requires no further processing before transfusion to a patient, making apheresis an efficient and cost-effective procedure for blood centers.

Aside from its protocols permitting multi-component collection from a single donor, Haemonetics is also addressing this blood shortage by making apheresis donations more convenient to the donor. Haemonetics is pioneering bringing apheresis donation more conveniently to the donor on mobile drives where 70% of the US blood supply is collected.

Haemonetics is a global company engaged in the design, manufacture and worldwide marketing of automated blood processing systems. These systems address important medical markets: surgical blood salvage, blood component collections and plasma collections. Over sixty percent of the Company's business is outside the US. To learn more about Haemonetics' products and markets, visit the Company's web site at http://www.haemonetics.com.

This news release contains forward looking statements that involve risks and uncertainties, including technological advances in the medical field, product demand and market acceptance, regulatory uncertainties, the effect of economic conditions, the impact of competitive products and pricing, foreign currency exchange rates and other risks detailed in the Company's filings with the Securities and Exchange Commission. The forward looking statements are based on estimates and assumptions made by management of the Company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results and experience could differ materially from the forward looking statements.

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CONTACT: Haemonetics Corporation Lisa Lopez (781) 356-9517 investor@haemonetics.com
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