HeartWare International, an innovator of less invasive, miniaturized circulatory support technologies for the treatment of advanced heart failure, has acquired CircuLite, developer of the SYNERGY Circulatory Support System, designed to treat less sick, ambulatory, chronic heart failure patients who are not yet inotrope-dependent.
HeartWare has acquired CircuLite for $30 million—$18 million in HeartWare common stock and cash of approximately $12 million to settle CircuLite's debt and transaction expenses, plus milestones not to exceed $320 million in the aggregate over a 10-year period.
"CircuLite has pioneered the partial-assist approach and demonstrated that this technique can significantly enhance the quality of life for this group of patients, which is believed to be a substantially larger population than the end-stage heart failure patients that HeartWare currently treats with full-support Ventricular Assist Devices (VADs),” said Doug Godshall, president and CEO at HeartWare. “CircuLite's next generation endovascular system offers an interventional approach to circulatory support. While our HVAD and MVAD Systems offer minimally invasive treatment to end-stage heart failure patients, the SYNERGY platform offers even less invasive and ultimately interventional options to earlier-stage heart failure patients."
The SYNERGY Surgical System, which received CE Marking in the E.U. in 2012, is designed for long-term support and is intended to reduce the heart's workload while improving blood flow to vital organs. Approximately the size and weight of a AA battery, the system is implanted through a right, mini-thoracotomy procedure and does not require a sternotomy or cardiopulmonary bypass. With this approach, the inflow cannula is placed in the left atrium, and the outflow graft is attached to the subclavian artery. CircuLite's proprietary micro-pump is then placed in a pacemaker-like pocket and attached to the inflow cannula and outflow graft, which connects to a wearable, external controller and battery pack.
"The SYNERGY system is a novel entrant in the partial-support space for treating patients with earlier stage heart failure," said Dr. Martin Strueber, of the University Heart Center Leipzig in Leipzig, Germany. "To date, there is no viable option for those patients who have used biventricular pacemakers without success and who are not yet sick enough for a VAD or cardiac transplantation.”