V-Wave Ltd., a cardiovascular device company developing proprietary, minimally invasive interatrial shunt devices for treating patients with severe symptomatic heart failure (HF) and pulmonary arterial hypertension (PAH), announced that it has successfully closed all remaining tranches of the Series C extension totaling $98M. The financing assures capital to complete the clinical trial for the VenturaÒ Interatrial Shunt for the treatment of advanced heart failure and submit a PMA subject to final data for Agency review. It further funds continued development of the V-Wave Ventura Shunt product pipeline including its proprietary adjustable size Magical™ shunt.
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The Ventura Shunt is currently being evaluated in an international, multicenter RELIEVE-HF randomized trial in patients with both reduced and preserved ejection fraction who are advanced NYHA Class II, Class III and ambulatory Class IV and on guideline directed medical therapies. The financing was led by Deerfield Management with participation from Aperture Venture Partners, BRM Group, Endeavour Vision, Johnson & Johnson Innovation – JJDC Inc., Pontifax, Pura Vida Investments, GHS Fund (Quark Venture LP), as well as Triventures and Israel Secondary Fund.
“The RELIEVE-HF trial is a randomized double-blind pivotal controlled clinical trial currently enrolling in the U.S. and 10 other countries comprising approximately 500 subjects. A parallel open label arm of the study with the first subjects implanted at sites (n=97 patients) has completed enrollment and is expected to complete the 1-year follow-up in 2022. The open label arm, demonstrated the ease and success of the implantation procedure, as well as safety, shunt durability, patency and improvement in quality-of-life metrics.” said V-Wave CEO Dr. Neal Eigler MD.
V-Wave shunt has been designated by FDA as a Breakthrough device technology and is uniquely designed to reduce left atrial pressure while minimizing thromboembolic events that have historically seen atrial septal defects. Episodic elevations of left atrial pressure cause worsening symptoms of difficulty breathing often resulting in the need for acute hospitalization. The Ventura shunt alters the physiology of HF thereby reducing left atrial pressures and working in concert with all other approved HF therapies, whether drug or device. Once implanted with the Ventura shunt, the patient requires no additional caregiver intervention. “We are excited about the advancement of the next generation precision shunt which will tailor the degree of shunting at the time of implant and will continue over time in correlating to the severity of heart failure. We believe this technology may be a game changer in the management of advanced heart failure in patients with either reduced or preserved ejection fraction” remarked Dr. Andrew ElBardissi, Partner at Deerfield Management, the lead investor in the Series C financing.
V-Wave Chairman Dr. Frank Litvack added, “With more than 60 million patients suffering from HF globally and more than 6 million HF patients in the US, there is a huge unmet clinical and economic need for simple, cost-effective new therapies. Advanced heart failure has a prognosis worse than many other disease states, including cancers. HF is one of the leading drivers of hospital expenditures both domestically and abroad. We are looking forward to completion of RELIEVE HF.”