Boston Scientific has announced its intention to acquire Cameron Health, a privately held company based in San Clemente, Calif., which has developed the only commercially available subcutaneous implantable cardioverter-defibrillator–the S-ICD system.
Unlike conventional implantable cardioverter-defibrillators (ICDs), which require thin, insulated leads to pass through the venous system and into the heart, the S-ICD system sits just below the skin and leaves the heart and blood vessels untouched.
The S-ICD system has received CE Mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide.
Cameron received expedited review status and submitted its pre-market approval (PMA) application to the FDA in December 2011. The Natick, Mass.-based Boston Scientific anticipates FDA approval for the S-ICD system in the first half of 2013.
The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD system, plus up to an additional $1.05 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval.
The company expects to fund these payments through the cash flow of its business. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.
The S-ICD system is restricted under federal law for investigational use only and is not for sale in the U.S.