Hemerus Medical Receives CE Marking for World's First 56 Day Red Blood Cell
Storage Solution - SOLX®
ST. PAUL, Minn., Sept. 17, 2012
ST. PAUL, Minn., Sept. 17, 2012 /PRNewswire/ --Hemerus Medical, LLC, a
Minnesota-based company that develops innovative technologies for the
collection, processing, preservation, and storage of blood products announced
that it has received the world's first CE Marking for a 56 day red blood cell
storage solution – the SOLX^® red blood cell additive (AS-7). The current
conventional red blood cell storage solutions have only provided 42 days of
Dr. Majid Zia, CTO and inventor of the LEUKOSEP^® and LEUP^® technologies,
explained, "The ability to provide extended storage for red blood cells can
reduce red blood cell outdating, provide better logistics and mitigate
shortages in emergency or natural disaster situations. SOLX^® was developed
to reduce storage lesions and improve the quality of red blood cells through
the current standard 42 day storage period. This is extremely important as
enhanced red cell quality is of great interest in potentially improving
patient outcomes in transfusions."
SOLX^® was the result of a collaborative effort between the US Army, the
University of Cincinnati and Hemerus. The SOLX^® storage solution research
was initially funded by the US Army, and invented by Dr. John Hess of the
University of Maryland, and the late Dr. Tibor Greenwalt of the University of
Cincinnati. Hemerus furthered this research through its development of a
whole blood leukoreduction collection set and performed clinical trials, which
were also partially funded by the US Army. Hemerus holds the exclusive
worldwide license to the intellectual property.
Michael Spearman, CEO, commented: "SOLX^® represents the next generation in
red blood cell storage solutions. It is the first new development in storage
solutions in 25 years and has the ability to change the worldwide market. We
are very pleased to see this first regulatory approval for SOLX^®. This means
that SOLX^® can now be marketed throughout most of the world. We are looking
forward to also receiving the FDA approval so it will be available in the U.S.
Hemerus had previously reported submission of a New Drug Application for its
SOLX^® whole blood collection system to the FDA. Hemerus has received a
request from FDA for resubmission with additional information and expects U.S.
approval in 2013.
Hemerus has a definitive agreement in place to be acquired by Haemonetics
Corporation. Under terms of the definitive agreement, Haemonetics will pay
Hemerus up to $27 million in several stages, each of which is contingent upon
successful regulatory approvals of SOLX^® most of which should be received in
year 2013. Additionally, a royalty agreement for up to $14 million will be in
force for future sales of SOLX^® based products.
As reported by Haemonetics Corporation President and CEO Brian Concannon: "The
addition ofHemerus' SOLX^®collection system is intended to complement the
portfolio of whole blood collection, filtration and processing product lines
we recently acquired from Pall Corporation. We will proceed with the
Haemonetics and Pall elements of that offering while the FDA examination
process for the SOLX^® solution continues. We are pleased that CE Marking has
been granted which gives credibility to the value of this new science."
Hemerus Medical, LLC develops and manufactures innovative technologies for the
collection, processing, preservation and storage of blood products. Hemerus
was formed in 2001 as a spin-off of Porous Media Corporation utilizing the
advanced blood filtration and processing technologies developed there. To
learn more about Hemerus, visit our web site at www.hemerus.com.
Haemonetics is a global healthcare company dedicated to providing innovative
blood management solutions for their customers (http://www.haemonetics.com).
LEUKOSEP^®, LEUP^®, and SOLX^® are registered trademarks of Hemerus Medical,
SOLX^® is not currently approved for sale.
Michael Spearman, CEO
Tel. (651) 635-0070
SOURCE Hemerus Medical, LLC
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