Haemonetics Expands Innovative Technology to Grow U.S. Frozen Blood Reserves.

Business Editors/Health/Medical Writers

BRAINTREE, Mass.--(BUSINESS WIRE)--Jan. 7, 2004

FDA Clears Additional Applications for ACP(TM) 215 Cell Washing

Technology

Haemonetics Corporation's ACP 215 system has received FDA clearance for additional blood freezing protocols that make it easier for civilian blood collectors to implement and expand emergency frozen blood reserves for routine and emergency use, the Company announced today.

Frozen blood reserves are an important component of the U.S. healthcare system and ensure that blood is available for patients with rare blood types or during times of shortage, public health crises, or natural disaster. Blood stored in a refrigerated, liquid state must be discarded if not used within 42 days, so continual blood collections are needed to replenish the supply.

Blood can be frozen and stored for up to ten years. However, while the U.S. military and a few civilian blood collectors have maintained frozen blood reserves for some time, technology limitations made it difficult for most civilian blood collectors to manage frozen blood programs.

"The ACP 215 system processes blood in a novel way that allows it to be frozen and then stored for fourteen days after thawing. Other blood processing technologies only allow for 24 hour storage of thawed blood. This significant increase in shelf life was the first step in making it easier for blood collectors to implement, maintain, and manage frozen blood reserves," said Mark Popovsky, M.D., Vice President and Corporate Medical Director for Haemonetics.

"Frozen blood reserves are an excellent way to meet the needs of patients with challenging blood problems. Blood collectors can maintain a frozen inventory of blood for patients who are difficult to cross-match to meet their blood needs," Dr. Popovsky added.

The FDA's Center for Biologics Evaluation ("CBER") issued this 510(k) clearance in a company-record 76 days. This is the third U.S. regulatory clearance for the system which was FDA cleared first in May 2001. At that time, it was approved for use with a blood additive solution most frequently used by military blood collectors. The U.S. military accelerated deployment of the technology following the September 11th tragedy to strengthen its existing frozen blood program.

Haemonetics received its second U.S. clearance for the ACP 215 system in September 2003 when FDA cleared it for use in "cell washing," or removing the plasma proteins from units of red blood cells. Plasma proteins are responsible for adverse patient reactions, so doctors use washed red cells when transfusing patients at risk for allergic or anaphylactic reactions to blood products.

The newly-cleared protocols for the ACP 215 system significantly expand the market for this technology by qualifying its use with the blood storage additive solutions used in 95% of U.S. blood collections.(1) About 15 million units of blood are collected annually for transfusion in the United States. Currently, only about 100,000 units are frozen for future use, due in part to the limitations of past freezing technologies. Industry experts are calling for new strategies to improve blood availability, including increasing collections from targeted donor types and establishment of frozen blood reserves in communities nationwide. Haemonetics' proprietary blood collection and blood freezing systems address this important need.

For a fact sheet and responses to frequently asked questions on the ACP 215 system and blood freezing, please visit Haemonetics website at http://www.haemonetics.com/site/content/investor/mediakit.asp.

Haemonetics will present on January 27th in New York City at the U.S. Bancorp Piper Jaffray Healthcare Conference.

Haemonetics (NYSE: HAE) 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 collection, plasma collection, and blood component safety. To learn more about Haemonetics' products and markets, visit its web site at http://www.haemonetics.com.

This release contains forward looking statements that involve risks and uncertainties, including technological advances in the medical field and standards for transfusion medicine and our ability to successfully implement products that incorporate such advances and standards, product demand, market acceptance, regulatory uncertainties, the effect of economic and political conditions, the impact of competitive products and pricing, blood product reimbursement policies and practices, foreign currency exchange rates, changes in customers' ordering patterns, the effect of communicable diseases and the effect of uncertainties in markets outside the U.S. (including Europe and Asia) in which we operate 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.

(1) Additive Solution 1 ("AS-1") and Additive Solution 3 ("AS-3")