Cameron Health, Inc., a San Clemente, California-based developer a subcutaneous implantable defibrillator, has completed a $107m equity financing.
Investors include Alloy Ventures and Delphi Ventures.
The company intends to use the funds to expand the commercialization of its S-ICD System outside the US, submit the US Premarket Approval study to the FDA, and expand critical infrastructure and manufacturing capabilities in preparation for the US commercial launch, expected in late 2013.
The S-ICD System is a subcutaneous implantable defibrillator, designed to provide life-sustaining therapy to patients at risk of sudden cardiac arrest (SCA). It has been implanted in approximately 800 patients worldwide.
Led by President and CEO Kevin Hykes, Cameron Health secured CE mark in Europe and initiated a limited commercial launch outside the US. The company recently completed enrollment in a 330-patient pivotal FDA study involving 33 centers around the world and it expects to file for FDA approval in early 2012.