V-Wave said today it raised $70 million in a closed Series C round of financing, with funds slated to support the launch of a pivotal trial of its investigational interatrial shunt device designed for patients with advanced heart failure.
The interatrial shunt is designed to be implanted trans-venously and placed in the atrial septum, where a valve regulates left to right shunting of blood to reduce the chance of paradoxical embolus, the Israel-based company said. The device is also designed to regulate left atrial pressure by shunting excess blood away from the left ventricle.
The Series C round was led by Deerfield Management and joined by newly invested Endeavour Vision, Quark Venture and Aperture Venture Partners.
V-Wave said that all its existing major investors also joined the round, including Johnson & Johnson (NYSE:JNJ) Innovation, Edwards Lifesciences (NYSE:EW), BRM Group, Pontifax, Pura Vida Investments, TriVentures, BioStar Ventures and Israel Secondary Fund.
“V-Wave has developed a novel technology that addresses the underlying cause of heart failure decompensations. 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,” Deerfield Management principal Dr. Andrew ElBardissi said in a prepared statement.
V-Wave said that with the funding and previously obtained FDA IDE approval, it plans to launch a global, randomized, controlled, double-blinded clinical trial. In the trial, investigators will look to evaluate the safety and effectivenss of the interarterial shunt in heart failure patients with Class III or ambulatory Class IV symptoms with preserved or reduced ejection fraction who are already receiving optimal therapies.
“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. 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,” Dr. William Abraham of the Ohio State University Wexner Medical Center said in a press release.
“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,” V-Wave CEO Dr. Neal Eigler said in a press release.
Last month, V-Wave released results from the 1st-in-human implantation of its investigational shunt, touting a 100% success rate for implantation and no device-related adverse events.
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