IRVINE, CA - enVVeno Medical Corporation (NASDAQ:NVNO), a medical device company focused on venous disease treatment, announced it will present new efficacy data from its VenoValve U.S. pivotal trial at the upcoming 2024 Charing Cross International Symposium in London.
The results, highlighting long-term benefits for patients with severe Chronic Venous Insufficiency (CVI), will be shared on Wednesday, April 24, 2024, by Dr. David Dexter of Sentara Hospital and Eastern Virginia Medical School.
The data encompasses an 11-month weighted average from the Surgical Anti-reflux Venous Valve Endoprosthesis (SAVVE) study, which evaluated the VenoValve's performance in patients who showed no improvement after three months of conventional treatment.
The revised Venous Clinical Severity Score (rVCSS), an objective system for assessing venous diseases, was used to measure outcomes. Improvements of 3 or more points in the rVCSS were indicative of a clinically meaningful benefit, which will be detailed in the presentation.
The SAVVE study's findings are considered crucial as the U.S. Food and Drug Administration (FDA) weighs the risks and benefits of new technologies, especially those addressing unmet medical needs like severe CVI. The condition, characterized by leg pain, swelling, and venous ulcers, severely affects daily activities and can contribute to mental health issues. enVVeno estimates that annually, approximately 2.5 million new patients in the U.S. could be candidates for the VenoValve.
The Charing Cross Symposium, in its 46th year, is a leading event in the vascular field and is expected to draw over 4,000 attendees. Following the symposium, enVVeno will release the data publicly and provide access to the presentation slides on its website.
enVVeno Medical Corporation, based in Irvine, California, is advancing bioprosthetic solutions for venous disease treatment. Its lead product, the VenoValve, is a surgical replacement venous valve being evaluated in the SAVVE U.S. pivotal study. The company is also developing a non-surgical, transcatheter-based replacement venous valve called enVVe.
The information in this article is based on a press release statement.
InvestingPro Insights
As enVVeno Medical Corporation (NASDAQ:NVNO) prepares to unveil new data on its VenoValve product, investors and stakeholders are closely watching the company's financial health and market performance. Despite the clinical advancements, enVVeno's financial metrics reflect certain challenges. The company's market capitalization stands at a modest $65.52 million, and the P/E ratio, both current and adjusted for the last twelve months as of Q4 2023, remains negative at -2.55 and -2.64 respectively, indicating that the company is not currently profitable.
From an operational standpoint, enVVeno reported an operating income of -$25.24 million over the same period, with a corresponding EBITDA of -$25.02 million. These figures underscore the company's current financial strain as it continues to invest in research and development for its innovative medical devices. The InvestingPro Tips for enVVeno highlight a mixed picture: while the company holds more cash than debt and has liquid assets exceeding short-term obligations, it is rapidly burning through cash and suffers from weak gross profit margins. Moreover, analysts do not expect the company to be profitable this year, and it has not been profitable over the last twelve months. On a positive note, enVVeno has experienced a strong return over the last three months, with a 28.54% price total return, signaling investor confidence in the company's future prospects despite short-term challenges.
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