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FDA clears Stemco's Aldecount 510(k) submission

March 17, 2004: STEMCO Biomedical Inc. announced today that it has gained FDA clearance to market for the ALDECOUNT™ product through the 510(k) process. This is a milestone for StemCo Biomedical and continues to validate the technology on which the company has been founded. ALDECOUNT the second product for STEMCO Biomedical is based on the successful ALDEFLUOR™ research use only product which was launched last year. ALDECOUNT enumerates functional side scatter low aldehyde dehydrogenase bright cells which have been shown to possess properties of hematopoietic stem cells. Data published in British Journal of Hematology show that the dose of these cells transplanted into cancer patients correlates with the speed of recovery of blood cells. Dr. M.Fox of Arkansas was quoted at the recent American Society of Hematology as saying "HPCs expressing high levels of the enzyme aldehyde dehydrogenase (ALDH) are believed to be pluripotent and generally express CD34 on their surface. A commercial assay has now been developed for this intracellular enzyme (ALDECOUNT™, StemCo Biomedical, Inc., Durham, NC). As this assay detects both CD34+ and CD34- cells and appears to differentiate viable from non viable cells, its use may eventually lead to a major change in how HPCs are enumerated in transplant grafts.”

ALDECOUNT will revolutionize the way hematopoietic stem cells are enumerated during aphaeresis and subsequent transplantation therapy.

About STEMCO Biomedical.
StemCo Biomedical, Inc. was founded in 1999 and is located in the Research Triangle Park area of NC. The Company is engaged in the development, manufacture and distribution of a series of medical products designed to improve therapeutic transplantation of adult hematopoetic stem and progenitor cells derived from bone marrow, peripheral blood, or umbilical cord blood. Addressing a market of more than $1 billion annually, the Company will have a series of products--the first launched in 2002 (ALDEFLUOR) --to identify, sort and custom-engineer stem cell grafts based upon cellular expression of ALDH, resulting in what may be better, more effective stem cell transplants in the future.

For further information please contact:

Noel R Brown
Director of Marketing
STEMCO Biomedical, Inc.
2810 Meridian Parkway, Suite 148
Durham NC 27713 USA
Tel 919 484 2571 x 224
Fax 919 484 8792

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