Blood storage technology maker Hemerus Medical this week touted its 1st regulatory win, but it’s not the one that will seal the deal on a $27 million buyout by Haemonetics (NYSE:HAE).
The St. Paul, Minn.-based company won CE Mark approval in the European Union for its Solx red blood cell storage system, which was developed in collaboration with the U.S. Army and the University of Cincinnati.
The Solx technology – a red blood cell additive – preserves red blood cells for 56 days, a 2-week bump from the storage period of 42 days for conventional technologies, according to a press release.
It’s an important milestone for the company, but not enough to close the deal on an acquisition by Haemonetics. The $27 million offer is contingent upon Hemerus winning FDA clearance for the Solx product.
Hemerus had previously submitted a U.S. New Drug Application and its EU Medical Device Directive technical file for Solx to the FDA, but the federal watchdog agency recently requested additional information on the technology, pushing back its anticipated FDA win to 2013.
The delay pushes back the acquisition to early 2014, but won’t hinder Haemonetics’ time lines for delivering its 1st whole-blood product suite, which wasn’t slated to include Solx until 2014 anyway, according to a separate press release.
Haemonetics’ blood product suite launch was planned on technology acquired through the $551 million buyout of Pall Corp.’s (NYSE:PLL) blood management business, which the company announced in April.
"The Pall business assets provide us with leading filter technology and manufacturing capability, a broad portfolio of manual collection and processing products, a strong and experienced employee base and relationships with major blood authorities and key customers we have in common," Haemonetics president & CEO Brian Concannon said at the time. "Combined with our internal development initiatives to automate whole blood collection and our suite of blood management software, Haemonetics will represent the broadest product offering to address our customers’ needs in the whole blood market, a market with more than 60 million procedures per year."
Haemonetics has already paid $1 million in cash for Hemerus and will pay the remainder of the $27 million once FDA approval for Solx comes through. Hemerus could collect up to $14 million more based on future Solx sales, according to company statements.
"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," Concannon added in a new statement. "We will proceed with the Haemonetics and Pall elements of that offering while the FDA examination process for the SOLX solution continues."
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