CAESAREA, Israel and AGOURA HILLS, Calif., Sept. 22, 2020 /PRNewswire/ -- 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 today that it has closed a Series C extension of up to $98M. The financing assures capital to complete clinical trials for the Ventura® Interatrial Shunt for the treatment of advanced heart failure and to obtain FDA clearance subject to final data and agency review. The Ventura Interatrial Shunt is currently being evaluated in the 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 already receiving optimal medical therapies. The company is also conducting the RELIEVE-PAH trial from patients suffering from PAH. 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.
"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 Dr. Andrew ElBardissi, Partner at Deerfield Management, the lead investor in the Series C financing.
"The RELIEVE-HF trial is a randomized pivotal controlled clinical trial currently enrolling in the U.S. and 8 other countries. The RELIEVE-HF trial has both a double-blinded randomized 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 Dr. Neal Eigler MD. "Feedback on the product from physicians in the registry is very good with respect to ease of use, deployment and reliability," added Dr. Eigler.
V-Wave Chairman Dr. 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."
About V-Wave Ltd.
V-Wave is a privately held medical device company with offices in Israel and the U.S. For more information, please visit www.vwavemedical.com
Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. For more information, please visit www.deerfield.com
About Endeavour Vision
Endeavour Vision a global investor in exceptional medtech companies, led by extraordinary teams, working on big ideas with the potential to meaningfully improve the standard of care. For more information, please visit www.endeavourvision.com.
About Quark Venture
Quark Venture Inc. headquartered in Vancouver, Canada, and is focused on equity financing of innovative biotechnology and health sciences companies with breakthrough technology platforms and projects. For more information, please visit www.quarkventure.com.
About Aperture Venture Partners
Aperture Venture Partners is a healthcare-focused investment firm committed to working with exceptional entrepreneurs to build innovative companies in the medical device, pharmaceutical, healthcare IT/services and diagnostic sectors. For more information, please visit www.aperturevp.com.
About Pura Vida Investments
Pura Vida is a hedge fund focused on both public and private companies in the healthcare industry. The fund invests across all sectors and stages of healthcare. For further information please visit www.puravidainvestments.com
This press release contains certain forward-looking statements that involve risks and uncertainties, including statements related to clinical development and potential regulatory approval of V-Wave's products. All forward-looking statements and other information included in this press release are based on information available to V-Wave as of the date hereof, and the Company assumes no obligation to update any such forward-looking statements or information. The company's actual results could differ materially from those described in the company's forward-looking statements.
CAUTION: The V-Wave Ventura Interatrial Shunt System is not available for sale in the United States or other countries.
Nigel Tinberg, Director of Marketing
Email: [email protected]
Telephone: +1 818 629 2164
SOURCE V-Wave Ltd.