Cameron to spend US$107 million on FDA trial and manufacture of implantable cardiac defibrillator

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Cameron Health plans to use US$107 million from a recent round of venture capital to complete a US IDE clinical trial, boost overseas sales and expand manufacturing of the S-ICD system in the USA. The company now has raised nearly US$200 million in financing, with the latest round led by Palo Alto’s Alloy Ventures and Delphi Ventures of Menlo Park.

The S-ICD system is the only implantable defibrillator that does not require electrical wires in the heart. This system is implanted using a completely subcutaneous procedure that leaves the heart and blood vessels untouched and intact. By placing the electrode just under the skin, the S-ICD system eliminates potentially serious short- and long-term risks associated with placing electrical wires inside the heart or blood vessels. When sudden cardiac arrest is detected, the electrode delivers a shock to the heart similar to external defibrillator paddles used by paramedics. Even without directly touching the heart, the shock can reset the heart’s normal rhythm.

S-ICD system IDE clinical study is a prospective, non-randomised, multicentre clinical study without a control group conducted in the United States, Europe, and New Zealand. Patients meeting eligibility criteria for implanting an S-ICD system will be enrolled in this clinical study, implanted with an S-ICD system, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. After the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure.

“Cameron is getting ready to start a 335-patient trial and intends to submit data to the FDA in early 2012,” Kevin Hykes, chief executive, Cameron Health, said. “It is the most rigorous type of trial as the patients, on average, are to be followed six months to a year. The device literally protects people from death,” Hykes stated.

The device maker now has no US revenue. The S-ICD is currently an investigational device in the USA. The company expects full-year sales of US$10 million to US$12 million in Europe, where the device is approved.

For more information on the S-ICD system IDE clinical study visit: https://www.clinicaltrials.gov/ct2/show/study/NCT01064076?term=S-ICD+Study&rank=1&show_locs=Y#locn