Hemerus Medical’s SOLX red blood cell additive receives world's first CE Marking

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 storage. 

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. as well." 

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 of Hemerus' 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."