Haemonetics Corp. (HAE) issued an update on the status of its previously announced agreement to acquire Hemerus Medical, LLC , a Minnesota-based company that develops innovative technologies for the collection of whole blood and for the processing and storage of blood components. Hemerus' US New Drug Application and EU Medical Device Directive technical file for the SOLX whole blood collection system had been submitted to the FDA and TUV SUD notified body, respectively.
The company announced that it has learned that Hemerus has received a request from the FDA for resubmission of their application with additional information. As a result, the timing of the closing of the acquisition, which is contingent upon receipt of FDA approval, is still pending and now is expected to occur early in fiscal 2014.
In addition, the company said it has also learned that Hemerus has received CE Marking (Conformite Europeenne) in the European Union to market SOLX with the world's first 56-day red blood cell storage indication.
Haemonetics said it plans include delivery of its first whole blood automation software package, an automated whole blood collection device and continued development of acquired Pall whole blood products. We believe SOLX remains an important part of the strategy for rapid market adoption of the whole blood product suite.
The FDA request for resubmission has minimal effect on our pipeline development since the inclusion of the SOLX solution in these products was contemplated for fiscal 2014 and beyond.
Haemonetics noted that it paid $1 million cash in its first fiscal 2013 quarter and, upon receipt of the aforementioned FDA approvals for the product, will pay the remainder of the $27 million purchase price for Hemerus Medical. Additionally, Haemonetics has agreed to pay a royalty of up to $14 million on future sales of SOLX-based products.
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