V-Wave has closed a Series C financing extension of up to US$98 million, assuring capital to complete clinical trials for the Ventura interatrial shunt for the treatment of advanced heart failure (HF) and to obtain US Food and Drug Administration (FDA) clearance subject to final data and agency review.
The Ventura Interatrial Shunt is currently being evaluated in the international, multicentre RELIEVE-HF randomised trial in patients with both reduced and preserved ejection fraction who are advanced NYHA Class II, Class III and ambulatory Class IV and already receiving optimal medical therapies. The company is also conducting the RELIEVE-PAH trial from patients suffering from pulmonary arterial hypertension (PAH). The financing was led by Deerfield Management with participation from Aperture Venture Partners, BRM Group, Endeavour Vision, Johnson & Johnson Innovation, Pontifax, Pura Vida Investments, GHS Fund (Quark Venture LP), as well as Triventures and Israel Secondary Fund.
“V-Wave has developed a novel technology that modifies the physiology of HF by reducing left atrial and pulmonary artery pressures in a continuous, real-time manner without any intervention by the patient or a caregiver. Heart failure is not a static disease and patients’ pressures and symptoms vary from day to day or week to week. The Ventura shunt helps reduce excessive rise in left atrial pressure before the patient is aware that this is happening and prior to worsening symptoms. This technology has the potential to become a disruptive, game changer in the management of advanced heart failure,” remarked Andrew ElBardissi, partner at Deerfield Management, the lead investor in the Series C financing.
“The RELIEVE-HF trial is a randomised pivotal controlled clinical trial currently enrolling in the USA and eight other countries. The RELIEVE-HF trial has both a double-blinded randomised cohort and an open label registry. From the latter, we are excited about the early signals related to ease of implantation and procedure safety. With respect to ease of implantation, within the spectrum of structural heart procedures the Ventura Shunt is on the more simple and straightforward side,” said V-Wave CEO Neal Eigler. “Feedback on the product from physicians in the registry is very good with respect to ease of use, deployment and reliability,” added Eigler.
V-Wave chairman, Frank Litvack, added: “With more than 26 million patients suffering HF globally and more than 6 million 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 cancers and is one of the leading drivers of hospital expenditures both domestically and abroad. We are excited about RELIEVE-HF and to seeing our final data once the trial is completed.”