IRVINE, CA - enVVeno Medical Corporation (NASDAQ:NVNO), a medical device firm, today announced encouraging results from its SAVVE U.S. pivotal trial, indicating significant healing in patients with venous ulcers using its VenoValve product. The findings will be presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago.
The trial evaluated twenty-one patients with venous ulcers, totalling thirty ulcers. At the one-year mark, 91% of these patients showed complete healing or improvement in their ulcers. Notably, patients with ulcers of one year or less duration prior to receiving the VenoValve all experienced full healing, with two-thirds achieving this within 90 days post-surgery. Ulcers persisting for over a year before treatment also showed significant healing or improvement (89%), with an average reduction in total ulcer size of 85%.
The VenoValve, a surgical device designed to treat severe Chronic Venous Insufficiency (CVI), has shown potential in a patient population that has not responded to conventional treatments, including wound care, compression therapy, ablation, or stenting. The SAVVE study's results suggest earlier intervention with VenoValve, within a year of ulcer occurrence, could lead to better outcomes.
The trial's positive interim data is supported by advanced image analysis using an FDA-registered scientific calibrant and artificial intelligence to track wound healing over time.
CVI, often caused by deep vein thromboses, can lead to leg swelling, pain, edema, and venous ulcers. The VenoValve is being evaluated in a non-blinded, single arm, multi-center study of seventy-five CVI patients across 21 U.S. sites. The FDA has requested a minimum of one year of data on all patients before considering the company's application for approval, which is expected to be filed in the fourth quarter of 2024.
enVVeno Medical, with a focus on bioprosthetic solutions for venous disease, is also developing a non-surgical, transcatheter-based venous valve, enVVe®, for deep venous CVI treatment. The company reported having sufficient capital to support operations through the anticipated FDA decision on the VenoValve and until the end of 2025.
This report is based on a press release statement from enVVeno Medical Corporation.
In other recent news, enVVeno Medical Corporation has reported significant clinical improvements in patients with Chronic Venous Insufficiency (CVI) from its VenoValve U.S. pivotal trial. The study revealed that 94% of patients experienced clinical improvement, with 72% showing a Clinical Meaningful Benefit. The company is on track to file for FDA approval in Q4 2024, with the expectation to complete data collection by September 2024.
In an associated development, enVVeno Medical has announced the appointment of Andrew Cormack as its Chief Commercial Officer. This strategic move aims to guide the company's transition from a clinical-stage company to a commercial entity, focusing on the product launch strategy for the VenoValve.
Furthermore, the company presented new efficacy data from the VenoValve trial at the 2024 Charing Cross International Symposium in London. The presentation highlighted the VenoValve's long-term benefits for severe CVI patients. The data will be released publicly post-symposium, providing access to the presentation slides on the company's website.
Lastly, the company's financial position appears stable, with $46.4 million in cash and investments as of December 31, 2023, which is expected to fund operations through the FDA decision on the VenoValve and the end of 2025. These are recent developments in enVVeno Medical Corporation's ongoing efforts to provide innovative solutions for venous disease treatment.
InvestingPro Insights
As enVVeno Medical Corporation (NASDAQ:NVNO) showcases promising trial results for its VenoValve product, investors and industry watchers may be keen on understanding the financial health and market performance of the company. According to InvestingPro, NVNO holds more cash than debt on its balance sheet, which aligns with the company's reported capital sufficiency through the anticipated FDA decision and beyond. However, it's important to note that the company is quickly burning through cash and has weak gross profit margins, as per InvestingPro Tips. These factors are critical to consider when assessing the company's long-term viability and potential need for additional financing.
On the market front, NVNO's market capitalization stands at a modest $62.25 million, reflecting its status as a smaller player in the medical device sector. The stock has experienced a high return over the last year of 71.06%, possibly reflecting investor optimism about the company's technology and trial outcomes. Despite these gains, the company's P/E ratio is negative at -2.81, indicating that it is not currently profitable—analysts do not anticipate profitability this year either. This is further underscored by the company's negative operating income of -$23.94 million over the last twelve months as of Q1 2024.
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