News Release

For Immediate Release -- June 13, 2013

FDA Approves New Drug Application for Whole Blood Collection System

(Fort Detrick, Md.) -- For the first time in more than 15 years, a red blood cell storage solution has been approved by the Food and Drug Administration. Hemerus Medical LLC, in partnership with the U.S. Army Medical Materiel Development Activity, received FDA approval of the New Drug Application for its SOLX® System (LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive).

The SOLX® system is a whole blood collection system that produces Leukoreduced red blood cells and plasma. This system has been approved in the United States by the FDA for six-week red blood cell storage and was previously approved in Europe for eight-week red blood cell storage.

The initial driving force behind this effort was the calculation that an additional two weeks of storage time could save the DoD millions of dollars per year in transportation costs and decreased product loss due to product expiration during military deployments, according to Victor Macdonald, product manager and blood products subject matter expert for Pharmaceutical Systems Project Management Office (PSPMO) at USAMMDA. It was also soon realized that longer storage time only occurred with better quality cells.

"This then was the genesis of a fruitful collaboration between the Army and academia, resulting in a number of peer-reviewed publications that proved the initial concept," said Macdonald. "After years of effort, a partnership was formed with industry for further development of the storage solution and incorporation into a blood collection system with commercial potential."

The need to reduce waste and increase quality is what continues to motivate this research, in an effort to provide medical advances to save our wounded service members, said Andrew Atkinson, product manager for PSPMO at USAMMDA.

"The additive solution has been shown to reduce storage lesions, thus improving the quality of the red blood cells and extending the storage period, potentially improving patient outcomes in transfusion," explained Atkinson, adding that a significant part of the SOLX® System is the additive solution that was co-developed by Walter Reed Army Institute of Research and the University of Cincinnati.

According to Atkinson, the idea for this product evolved from a 1996 meeting between Col. John R. Hess, M.D., M.P.H. from WRAIR, and the late Dr. Tibor Greenwald from the Hoxworth Blood Center, Cincinnati. Hess broached the possibility that changing the formulation of the additive solution used to preserve packed red blood cells might allow refrigerated storage beyond the usual 42 days.

The future for this product includes implementing a Low Rate Initial Production contract where the Army Blood Program Office can purchase the SOLX® product and obtain the subsequent military blood bank Biologic License Application approvals for the plasma and red blood cells, so they can begin using the system.

Partners for this effort include the USAMMDA, WRAIR, University of Cincinnati, and Hemerus Medical LLC, recently acquired by Haemonetics Corporation.

Haemonetics will continue to support this effort as the product's sponsor, and is considered the manufacturer by the FDA.

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