Financing Enables Cameron Health to Complete FDA Submission in the United States (US) and Expand International Commercialization of the S-ICD® System
SAN CLEMENTE, Calif.--(BUSINESS WIRE)-- Cameron Health, Inc., developer of the world’s only completely subcutaneous implantable defibrillator, announced today that it has completed a $107 million equity financing round led by Alloy Ventures and Delphi Ventures.
Since Cameron Health’s last equity financing round in 2008, the company has secured CE mark in Europe, initiated a limited commercial launch outside the US, and published a seminal article in the New England Journal of Medicine. Cameron Health has 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. The S-ICD System has been implanted in approximately 800 patients worldwide.
The financing enables Cameron Health to expand the commercialization of the 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 of the S-ICD System, estimated in late 2013.
“While this financing facilitates a number of key clinical, regulatory, commercial and operational initiatives for Cameron Health, the most important benefit is that it allows us to expand access to the S-ICD System to more patients who are at risk of sudden cardiac arrest,” said Kevin Hykes, President and CEO of Cameron Health.
The S-ICD System is the first and only totally subcutaneous implantable defibrillator, designed to provide life-sustaining therapy to patients at risk of sudden cardiac arrest (SCA). The technology is unique in that implantation of the system is entirely subcutaneous, eliminating the need for electrical wires (leads) to be placed in the heart. The S-ICD System detects highly accelerated and disorganized heart rhythms and provides therapy through delivery of an electrical shock to restore the heart’s normal rhythm. Left unaddressed, these disorganized heart rhythms are often fatal.
“We are excited by the positive momentum of this important new technology. The growing wealth of clinical data combined with the experienced leadership team at Cameron Health provide a strong foundation for future growth of the S-ICD System,” said Doug Kelly, General Partner of Alloy Ventures.
“We are extremely encouraged by the potential benefits of this new technology,” said David Douglass, General Partner of Delphi Ventures. “We believe Cameron Health has developed an innovative implantable defibrillator that can potentially redefine the clinical treatment of SCA.”
About Cameron Health, Inc.
Cameron Health, Inc. (www.cameronhealth.com), headquartered in San Clemente, California, is a pioneer in the development, manufacture and distribution of the next generation of implantable defibrillators.
Cameron Health, Inc.
Ward Dykstra, 949-940-4001
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Health Cardiology Medical Devices FDA