HeartWare International has entered into a definitive agreement to acquire Valtech Cardio, a company that specialising in the development of innovative surgical and transcatheter valve repair and replacement devices for the treatment of mitral valve regurgitation (MR) and tricuspid valve regurgitation (TR).
The vast majority of patients with MR and TR also suffer from advanced heart failure, and the progression of heart failure can accelerate considerably as a result of valvular dysfunction. 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. This transaction provides HeartWare with a highly complementary portfolio of technologies to broaden the treatments it offers heart failure patients and enhance patient outcomes.
Left untreated, severe MR can eventually lead to a meaningful deterioration in cardiac function and death. Approximately 4.2 million patients are affected by mitral valve disease in the USA alone, which represents a several-billion-dollar market opportunity. TR is estimated to affect 1.6 million patients in the USA and complements the mitral patient population, as a significant percentage of patients suffer from both MR and TR.
“We have been actively monitoring the mitral space for several years, given the overlap of patient population and referral channel with our ventricular assist device business,” said Doug Godshall, president and chief executive officer of HeartWare. “We have concluded that Valtech’s platforms represent the most innovative and comprehensive portfolio of interventional and surgical products for mitral and tricuspid repair and replacement in development today. Valtech provides HeartWare with commercial-stage products for mitral repair, as well as a robust technology pipeline, an advanced research and development centre and an impressive, experienced team with a proven track record. This combination represents an attractive opportunity for value creation for HeartWare shareholders, customers, employees and patients by expanding HeartWare’s footprint in the high-growth structural heart market.”
Since incorporation in 2005, Valtech has developed a portfolio of technologies for the treatment of mitral and tricuspid valve disease, including the Cardioband device—the first interventional, transfemoral, direct annuloplasty system designed for mitral and tricuspid repair. To date, Cardioband has been used to treat more than 50 patients and is expected to receive CE mark approval for mitral valve repair in 2015. Following regulatory approval, Cardioband is expected to be commercially launched on a limited basis in Europe in late 2015. A US Investigational Device Exemption is planned for submission in 2016. The first human procedures using the Cardioband system, modified for the treatment of tricuspid valve disease, are anticipated in late 2016.
“Valtech’s robust portfolio of repair and replacement technologies provides us with the most comprehensive product suite to treat the mitral and tricuspid populations. We believe it will be critical to offer patients and physicians a multifaceted approach in the treatment of MR and TR, with both repair and replacement options,” added Godshall. “The mitral repair market is already a well-established and rapidly growing market with a significant, unmet, immediate clinical need. The Cardioband transfemoral annuloplasty system represents a more reproducible and predictable platform for mitral valve repair than existing solutions. We believe Cardioband will be a natural and clear selection as a first-line treatment for the broadest spectrum of MR patients, since it offers a safer option and, even in early clinical use, has already demonstrated a strong efficacy profile.”
“By joining HeartWare, we can more quickly and fully realise the potential of our pipeline technologies and further influence the underpenetrated markets that we serve,” said Amir Gross, founder and chief executive officer of Valtech. HeartWare’s existing market development experience and commercial infrastructure provide a compelling platform from which to launch multiple products worldwide, including a near-term launch of Cardioband in international markets following anticipated CE mark approval this year. Together, we can offer clinical heart failure teams a compelling portfolio of surgical and interventional technologies to serve the advanced heart failure population.”