02 Dec 2013, BioSpectrum Bureau , BioSpectrum
Singapore: HeartWare International, a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing 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.
According to the terms of the merger agreement, HeartWare has acquired all of the issued and outstanding equity interests of CircuLite for consideration of $30 million, consisting of approximately $18 million in HeartWare common stock and cash of approximately $12 million to settle CircuLite's debt and transaction expenses, plus certain contingent success payments due upon satisfaction of regulatory and commercial milestones not to exceed $320 million in the aggregate over a 10-year period.
"The partial-support system developed by CircuLite represents the industry's most intriguing platform for the treatment of patients with earlier stage heart failure," said Mr Doug Godshall, president and CEO, HeartWare. "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 our full-support Ventricular Assist Devices (VADs).
CircuLite's next generation endovascular system, which will be implanted collaboratively by cardiologists and surgeons in a hybrid cath lab setting, offers an extremely compelling 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 European Union in 2012, is designed for long-term support and is intended to reduce the heart's workload while improving blood flow to vital organs.
The system is currently undergoing an upgrade to resolve issues that arose post commercial release. Surgical system sales are expected to resume in a controlled fashion following regulatory approval to re-launch the system in Europe and will focus on building experience at a small number of centers of excellence, refining training techniques and implementing additional system upgrades in advance of a full rollout.
"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."
Dr Strueber also said, "Having implanted Synergy systems and witnessed the marked benefits to my patients and increased referrals I received for both full and partial mechanical support, I look forward to technological advancements to the system and a restored availability for patients. Longer-term, the endovascular approach, which we have explored extensively in Leipzig in partnership with our cardiology colleagues, is truly exciting and holds considerable promise."
"We are confident that HeartWare's technical, regulatory, sales and marketing capabilities will have a profound impact on enabling the Synergy system to reach its full potential," said Dr Daniel Burkhoff, chief medical officer at CircuLite. "There is considerable opportunity for the current Synergy system, and through continued investment and innovation, we believe we could expand the circulatory support market with the launch of a groundbreaking, endovascular treatment for patients with earlier stage heart failure."
"The team at CircuLite created the Synergy endovascular system in collaboration with several leading cardiologists and received approval to commence a feasibility study earlier this year. We look forward to commencing an investigation of this elegant device, as we believe it has the potential to vastly expand the mechanical support market by bringing cardiologists into the implant procedure for the first time," Mr Godshall added.