HeartWare to Acquire Valtech Cardio

September 2, 2015—HeartWare International, Inc. announced that it has entered into a definitive agreement to acquire Valtech Cardio, Ltd., a privately held, Israel-based company developing surgical and transcatheter valve repair and replacement devices for the treatment of mitral valve regurgitation (MR) and tricuspid valve regurgitation. Amir Gross founded Valtech in 2005 and is the company’s CEO.

The company noted that patients with advanced heart failure who receive a ventricular assist device, like HeartWare’s HVAD system, commonly undergo a concomitant, therapeutic mitral or tricuspid valve procedure, so this transaction provides HeartWare with a highly complementary portfolio of technologies for the patient population it serves.

Valtech’s product portfolio includes the Cardioband, Cardinal, CardioValve, and V-Chordal devices.

The Cardioband is an interventional, transfemoral, direct annuloplasty system designed for mitral and tricuspid repair. Cardioband is expected to receive CE Mark approval for mitral valve repair in 2015. A submission for a United States investigational device exemption is planned for 2016. The first human procedures using the Cardioband system, modified for the treatment of tricuspid valve disease, are anticipated in late 2016.

Valtech’s Cardinal is a differentiated, semirigid, adjustable annuloplasty ring system that enables fine-tuning of the ring diameter and leaflet coaptation on a beating heart under real-time echocardiographic guidance to optimize annuloplasty outcomes. The Cardinal device has received CE Mark approval for mitral repair. A commercial launch for mitral repair is anticipated in 2016 and a launch for tricuspid repair in 2017.

CardioValve is a transseptally delivered, low-profile, transcatheter mitral valve replacement system with five degrees of steering maneuverability. The CardioValve platform has an orientation-indifferent structure for reduced implantation complexity. The device was designed to enable transseptal delivery, and can also be delivered transapically. Clinical studies for CardioValve in humans are expected to begin in early 2017.

V-Chordal is a surgical and interventional chord replacement system for MR repair. V-Chordal has been successfully evaluated in a first-in-man clinical trial. The timing for a CE Mark study is being evaluated in relation to the commencement of other Valtech trials.

According to the terms of the agreement, Valtech shareholders will receive an up-front consideration of 4.4 million shares of HeartWare common stock; 800,000 shares of HeartWare common stock, contingent upon CE Mark approval for Cardioband; and 700,000 shares of HeartWare common stock upon the earlier of first-in-man implantations for either Cardioband tricuspid or CardioValve. The transaction also includes warrants to purchase shares contingent on attainment of sales milestones.

The Boards of Directors of HeartWare and Valtech have approved the transaction, which is subject to regulatory approvals, as well as HeartWare stockholder and Valtech shareholder approvals. The closing of the transaction is expected in late 2015.