HemaSure Receives U.S. FDA Clearance for Its r\LS Red Blood Cell Filtration System for Marketing
PR Newswire - June 01, 1999 08:21
Product for the Removal of Leukocytes from Donated Blood Receives 510(k) Clearance
Strong Global Trend Shows Increased Demand for Leukocyte-Reduced
Donated Blood to Protect Patients from Harmful Viruses
and Transfusion Reactions
MARLBOROUGH, Mass., June 1 /PRNewswire/ -- HemaSure Inc. (OTC Bulletin Board: HMSR), a developer and supplier of blood filtration technologies, today announced that its r\LS Red Blood Cell Filtration System has received 510(k) clearance for marketing in the United States by the U.S. Food and Drug Administration (FDA). HemaSure intends to launch the r\LS System in the U.S. as soon as practical both directly to the American Red Cross and through its distributor, COBE BCT, Inc. (COBE). The product has been launched by COBE outside of the U.S. with a focus on Europe, where it has already received the CE Mark. The r\LS System is designed to reduce leukocytes (white blood cells) in donated blood. Leukocytes can transmit a number of bacteria and viruses and cause reactions in blood transfusion patients. The Company believes that the cost-effectiveness of the r\LS, coupled with the efficiencies gained by leukoreducing blood in large quantities at donor centers, should increase the use of this method, and in turn, of leukoreduction procedures in general.
"FDA clearance of the r\LS is a major milestone achievement in our strategy to position HemaSure to capitalize on the rapidly increasing global demand for leukoreduced blood," stated Jack McGuire, President and Chief Executive Officer of HemaSure Inc. "During the past two years, we have taken actions to sharply focus HemaSure on developing and delivering a red blood cell filter that meets our customers' unique requirements. This approval, together with significant distribution and development agreements, brings HemaSure one step closer to its ultimate objective of profitability and value creation for our shareholders."
HemaSure's development and distribution agreement with COBE, a leading manufacturer of automated blood component collection systems and a business unit of $2 billion Gambro AB, gives COBE distribution rights for HemaSure's products worldwide, excluding sales to the American Red Cross (ARC). COBE is an excellent marketing partner for the r\LS, since their sales force already calls on the same potential users of the r\LS for their own products. The arrangement also gives HemaSure access to COBE's strong international distribution network, including sales offices in more than 100 locations worldwide. The product development agreement covers the development of filtration devices that may be used in connection with COBE's automated blood component collection equipment.
In August 1998, the Company renewed its strategic alliance with American Red Cross Biomedical Services, a unit of the ARC. Under this five-year initial agreement, the two organizations can co-develop enhanced versions of HemaSure's leukoreduction filters and collaborate on other filtration opportunities. The ARC represents nearly 50 percent of the blood donated in the U.S. The r\LS is the first product developed under this alliance.
"We are especially excited by the 510(k) clearance in light of clear market trends toward the universal leukoreduction of donated blood domestically and throughout the world. In the United States, where currently approximately 20 percent of donated blood is leukoreduced, 100 percent leukoreduction has been recommended by the FDA's Blood Products Advisory Committee. The FDA has also recently recommended that the filtration be performed pre-storage, which is our focused market. Additionally, several countries outside of the U.S. are currently providing or have committed to provide only leukoreduced blood components. We stand ready to assist our customers in meeting these increasing demands and believe that the quality and cost effectiveness of our r\LS product should enable us to participate internationally in this explosive market."
Concluded McGuire, "The FDA clearance of the r\LS serves as an important platform for HemaSure to achieve other critical goals for our company: the achievement of profitability and the development of a family of filtration products based on our core technology. We look forward to these new opportunities."
HemaSure Inc., based in Marlborough, Massachusetts, develops and delivers innovative filtration technologies designed to set standards of safety for processing blood components worldwide.
Any statements contained herein that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Potential factors could cause actual results to differ materially from those expressed or implied by such statements. These statements include, but are not limited to, those relating to the launch of the Company's r\LS System in the United States and internationally, and the Company's potential future profitability. Information on the potential factors that could affect the Company's actual results of operations are included in its filings with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 1998.
SOURCE HemaSure, Inc.
/CONTACT: James B. Murphy, Senior Vice President, Finance and
Administration, of HemaSure Inc., 508-490-9500/
(HMSR)
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Can't believe the stock is actually selling off on this phenomenal news. Looking to add to the position here.
I know a stock needs to maintain a bid price of at least $3 to move up from the BB to the Nasdaq Small Caps. Does anyone know how long this must be maintained in order to qualify? |
