Israeli company V-Wave Ltd., which has developed a proprietary, minimally invasive implanted interatrial shunt device for treating patients with severe symptomatic heart failure (HF), announced today that it has closed a Series C financing of $70 million led by Deerfield Management along with participation from new investors - healthcare funds Endeavour Vision, Quark Venture and Aperture Venture Partners. All of V-Wave’s existing major investors are also participating in this round, including strategic investors Johnson & Johnson Innovation (JJDC Inc.) and Edwards Lifesciences, along with BRM Group, Pontifax, Pura Vida Investments, TriVentures, BioStar Ventures, and Israel Secondary Fund.
Having received approval from the FDA to initiate a pivotal IDE study, V-Wave also announced the upcoming launch of its global, randomized, controlled, double-blinded multicenter clinical trial - the RELIEVE-HF study - evaluating the safety and effectiveness of its novel device therapy in HF patients with Class III or ambulatory Class IV symptoms with preserved or reduced ejection fraction already receiving optimal therapies.
With more than 26 million people suffering from chronic heart failure globally, heart failure is the leading cause of hospitalizations in many countries; in the US, it is Medicare’s largest expense for acute hospitalization. Heart failure patients experience repeated hospitalizations, a poor quality of life, and a greatly reduced life expectancy.
Few companies in the world, and certainly in Israel, dare these days to embark on the adventure of developing an implanted medical device that has to be registered on the long PMA track. As the amount V-Wave has raised indicates, the road to the market on this track is expensive and long, while exits are few and, in comparison with drug development, not large. Nevertheless, when a product represents a breakthrough and a substantial solution for a condition that is costly to treat, the picture is likely to change. The involvement of two medical equipment companies in V-Wave indicates that this may be the case here.
“V-Wave has developed a novel technology that addresses the underlying cause of heart failure decompensations,” remarked Dr. Andrew ElBardissi, Principal at Deerfield Management. “This technology has the potential to be the standard of care for a large segment of HF patients that continue to worsen despite the use of approved drugs and devices. In addition to improving outcomes for patients, this has the potential to significantly reduce the cost burden of heart failure.”
“V-Wave’s interatrial shunt provides clinicians a new tool to control elevated left atrial pressure, the primary cause of breathing difficulty and hospitalization due to worsening HF,” noted Dr. William T. Abraham, Professor and Chief of Cardiovascular Medicine at the Ohio State University Wexner Medical Center. “The company’s feasibility study results, presented in March 2018 as a late breaking clinical trial at the American College of Cardiology showed that shunting was safe and that morbidity and mortality were low compared to a matched population receiving optimal care. The upcoming pivotal trial in at least 400 randomized patients should provide sound assurance of the efficacy of this approach in patients that have a poor prognosis and few options.” V-Wave CEO Dr. Neal Eigler said, “As an interventional cardiologist focused on HF for the past two decades, I am excited that with this funding, we can pursue the science that will bring us a giant step closer to commercial release of an easy to implant device that can provide the hope for immediate and longer-term symptom relief, increased exercise capacity, decreased need for acute hospital admission, and reduced mortality with an improved quality of life for hundreds of thousands of suffering patients.”
Adv. Itamar Mei-Zahav, a partner at international law firm ZAG-S&W, represented V-Wave.
Published by Globes [online], Israel business news - www.globes-online.com - on April 26, 2018
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