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Classified in: Health
Subject: FDA

V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension

CAESAREA, Israel, Sept. 12, 2019 /PRNewswire/ -- V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation ? the first was for its interatrial shunt for Heart Failure (HF), and the second, for Pulmonary Arterial Hypertension (PAH). V-Wave is testing a minimally invasive, implanted interatrial shunt device for PAH in a global approved IDE Early Feasibility Study, RELIEVE-PAH.

V-Wave Ltd. is an Israel-based company that has developed a proprietary, minimally invasive implanted interatrial shunt device for treating patients with severe symptomatic heart failure with either preserved or reduced ejection fraction. V-Wave is enrolling patients in its global, randomized, controlled, double-blinded, 500 patient pivotal study, the RELIEVE-HF study, which will evaluate the safety and effectiveness of V-Wave's novel therapy. The study is funded by a $70M C-Round financing. (PRNewsfoto/V-Wave Ltd.)

PAH is a disease that affects approximately 20,000 patients in the USA and is a severely debilitating, progressive, life shortening disorder that predominantly afflicts women, with an average age of about 50 at the time of diagnosis. "It causes high blood pressure in the pulmonary arteries, which results in failure of the right ventricle of the heart," noted cardiologist and V-Wave Chief Medical Officer, William T. Abraham, MD. "Patients are currently treated with multiple medications that improve symptoms and outcomes for a while, but often, symptoms worsen and patients need more invasive medications that have significant side effects and cost more than $150,000 a year. Balloon atrial septostomy is an alternative treatment that creates a flow of blood (a shunt) from the right to the left atrium, which improves right ventricular function. Septostomy is a guideline indicated therapy for PAH that has been shown to improve symptoms and exercise capacity, but its adoption has been limited by frequent septostomy closure and inadequate control over the shunt diameter. V-Wave is testing an investigational therapeutic implantable device that is placed in the heart through a catheter inserted through a vein in the groin. The goal of the implant is to create a well-controlled, durable shunt that will yield more reliable results and prolong the benefits found with septostomy. The FDA has agreed to initial human testing of the V-Wave shunt in patients who remain severely symptomatic despite multiple medications."

CEO Neal Eigler, MD, stated that, "These two distinct breakthrough designations illustrate V-Wave's dedication to innovation and improving outcomes for two debilitating diseases ? HF and PAH. Through the Breakthrough device program, the FDA may grant sponsors earlier market approval based on intermediate and surrogate endpoints that correlate with patient improvement. Sponsors would then gather longer term, more traditional clinical endpoint data during the early post-market phase. We are thrilled to be able to work even more closely with the FDA to accelerate the introduction of potentially clinically impactful PAH therapies in the USA. Given the small patient population and the severity of the disease, Breakthrough Designation may provide an opportunity for expedited access of this novel therapeutic approach to highly symptomatic and compromised PAH patients who need better treatment options as quickly as possible."

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.

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 Interatrial Shunt System is under clinical investigation and is not available for sale in the United States or other countries.


Murtaza Mogri, PhD

SOURCE V-Wave Ltd.

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