The Phase I study will include up to three European hospitals and will enroll chronic heart failure patients who are awaiting heart transplantation and whose heart function is in a state of decline. Patients will be surgically implanted with the device. The trial will evaluate the safety of the device for up to six months. CircuLite developed this trial to evaluate Synergy in a surgical, bridge-to-transplant setting in order to collect initial data to establish clinical proof-of-concept; however, the further development of the device will be focused on non-surgical, endovascular implantation for use as a long-term therapy.

"The current trial design is an important first-step for our Synergy device, but our eventual plan is to utilize a minimally invasive procedure and for patients to be implanted with the device sooner, before they have reached the later stages of chronic heart failure. This treatment paradigm would ensure that patients could benefit as much as possible from this long-term therapy," said Daniel Burkhoff, M.D., Ph.D., CircuLite's Medical Director and Adjunct Associate Professor of Medicine at Columbia University Medical School.


About Synergy™

The Synergy Pocket Circulatory Device is a small implantable blood pump designed to provide long-term, partial circulatory support to patients with chronic heart failure. The key component of the Synergy device is the proprietary and patented micro-pump technology acquired after eight years of development at the Helmholtz Institute in Aachen, Germany, one of the world's leading centers for blood pump technology development, in collaboration with Katholieke Universiteit in Leuven, Belgium. The device is designed to be small enough to be implanted subcutaneously in the "pacemaker pocket" through a minimally invasive procedure. Synergy is designed to supplement the heart's native pumping function, potentially increasing blood flow and allowing the heart to rest and potentially recover, possibly improving the quality of life of chronic heart failure patients. The CircuLite technology may provide a new treatment option for millions of chronic heart failure patients worldwide who continue to be significantly symptomatic despite appropriate, optimal medical therapy.

About CircuLite™

CircuLite is developing a miniature blood pump, designed to be placed superficially like a pacemaker, for the long-term treatment of chronic heart failure. The Synergy Pocket Circulatory Assist device is designed to rest a failing heart by supplementing its natural function. By providing long-term circulatory assist on a minimally invasive platform, CircuLite's Synergy has the potential to transform the management of chronic heart failure and improve the quality of life for millions of patients and their families. For more information on CircuLite and the Synergy Pocket Circulatory Assist device, visit our website at www.CircuLite.net.

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