Haemonetics Submits Applications to FDA for Blood-Washing Product; New Device Will Ease Pressure On Worldwide Blood Supplies.
BRAINTREE, Mass.--(BW HealthWire)--March 22, 2000
Haemonetics Corporation (NYSE:HAE) announced today that it has completed its submission to the Food and Drug Administration ("FDA") for approval to market a cell washing system that will expedite the availability of blood in disaster areas and conflict zones during times of urgent need. The system can also help to reduce the amount of blood that must be discarded by blood centers.
At a meeting today of investment analysts in Las Vegas, NV, James L. Peterson, Haemonetics President and CEO told the audience, "Our blood-washing system could make as much as 5% more blood available with no increase in blood collections. This is powerful technology."
The new system is an automated device, used in combination with a single-use disposable and a red blood cell nutrient solution, which can extend the shelf life of thawed red blood cells to 14 days. With current technology, thawed red blood cells not used within 24 hours must be discarded because of the risk that bacteria growth in them could harm a patient undergoing a transfusion.
Red blood cells are the blood components most frequently needed by patients, and it is customary for blood management agencies to stockpile frozen quantities of these cells to ensure their availability in times of need. In preparation for frozen storage, the cells are specially treated after they have been collected from the blood donor. Later, when they are needed for transfusion, they are thawed and then washed in order to remove the treatment solution.
Haemonetics' new system increases the shelf life of the washed blood by removing the treatment solution in a functionally closed system that is sterile and protected from outside air. The highly automated device enables one operator to monitor up to eight cell-washing procedures at one time.
Extending Shelf Life Helps Get Blood to Disaster Areas
Peterson commented, "No one can predict natural disasters, and emergencies can break out anywhere with little or no notice. Blood management agencies maintain blood depots all over the world, where they store frozen red cells for emergency use. The ability to distribute these red cells over a period of 14 days, versus the current 24 hours, will greatly facilitate distribution logistics and expand the market opportunity for frozen cells from the disaster support category to a mainstream management strategy for the total blood system."
Less Discarded Blood Means More Blood Available for Transfusion
There is a small amount of red blood cell freezing currently done in blood banks, also. Red cells that are not frozen must be used within 42 days of collection, or they must be discarded. The most recent US statistics showed that 5% of the red blood cells collected annually were thrown away because they were not used before their expiration date.(1)
Mary O'Neill, M.D., Medical Director, American Red Cross Blood Services - New England Region, said, "This technology, in extending the shelf-life of a thawed frozen red cell, should provide significant advantages in our ability to manage the blood inventory."
"This is a particular advantage when managing the frozen inventory of type O blood and rare blood types. Since the thawed products would be transfusible for a longer period, they could meet more needs of hospitals, and we could maintain a larger frozen inventory."
The new Haemonetics system, when used in conjunction with the Company's device that collects two units of red blood cells from a single donor, will enable blood centers to collect additional blood at times of peak donation. The centers can then freeze the excess blood for future use in times of short supply. Haemonetics cell washing system will help blood banks to better manage the logistics of existing blood inventories because of the extended storage time, especially as shortages become more frequent.
Haemonetics submitted the third and final module of its 510(k) and New Drug Application ("NDA") to the FDA on February 29, 2000. Modules 1 and 2 were submitted on January 11, and 21 of this year, respectively. Haemonetics plans to commercialize the new cell washer beginning next year.
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 release contains forward looking statements that involve risks and uncertainties, including technological advances in the medical field, product demand, 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.
(1) National Blood Data Resource Center Report on Blood Collection and Transfusion in the United States in 1997.
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|Date:||Mar 22, 2000|
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