enVVeno Medical hires VP to lead VenoValve marketing

IRVINE, CA - enVVeno Medical Corporation (NASDAQ:NVNO), a late-stage medical device company, has announced the appointment of Sandy Prietto as Vice President of Marketing. Ms. Prietto brings extensive experience in medical device marketing, having previously spearheaded product launches at Endologix (OTC:ELGXQ) and Edwards Lifesciences (NYSE:EW).

Robert Berman, CEO of enVVeno Medical, expressed confidence in Prietto's ability to drive the commercialization of the VenoValve, a surgical replacement venous valve for patients with severe Chronic Venous Insufficiency (CVI). Prietto's track record includes the successful introduction of the DETOUR System at Endologix, which received breakthrough device designation from the FDA.

The company is preparing for several key milestones in the fourth quarter of 2024, including the completion of the Pre-Market Approval (PMA) submission to the FDA for the VenoValve, anticipated one-year data from the VenoValve U.S. pivotal study, and the commencement of a Good Laboratory Practice (GLP) pre-clinical study for enVVe, a non-surgical replacement venous valve.

CVI, often caused by blood clots in the leg veins, leads to symptoms such as leg swelling, pain, and venous ulcers. The VenoValve and enVVe are designed to act as one-way valves to assist blood flow back to the heart and lungs. The VenoValve is currently under evaluation in the SAVVE U.S. pivotal study, and testing is underway for the enVVe pivotal trial.

enVVeno has reported $39.1 million in cash and investments as of the end of the second quarter, which is expected to fund operations through the end of 2025. The company's advancements are aimed at improving care for the estimated 2.5 million new U.S. patients each year who could benefit from the VenoValve.

This news is based on a press release statement and should be considered in light of risks and uncertainties, including those disclosed in the company's filings with the Securities and Exchange Commission.

In other recent news, enVVeno Medical Corporation has made significant strides in the FDA premarket approval process for its VenoValve product. The company has successfully submitted and received approval for four out of five required modules, with the final module expected to be filed in Q4 2024. The VenoValve product, currently under evaluation, aims to alleviate the debilitating effects of Chronic Venous Insufficiency (CVI).

On another note, recent trials of the VenoValve product have shown promising results for venous ulcer healing. In a study involving twenty-one patients, 91% experienced complete healing or improvement in their ulcers within a year. This development is a part of enVVeno Medical's ongoing efforts in venous disease treatment.

In addition, enVVeno Medical has appointed Andrew Cormack as Chief Commercial Officer, a strategic move indicating the company's transition from clinical-stage to a commercial entity. The company's financial position remains robust, with sufficient capital to support operations through the anticipated FDA decision on the VenoValve and until the end of 2025. These are recent milestones in enVVeno Medical Corporation's journey.

InvestingPro Insights

As enVVeno Medical Corporation (NASDAQ:NVNO) gears up for significant milestones in the development and potential commercialization of its medical devices, it is worth noting the company's financial health and market performance. According to InvestingPro data, enVVeno Medical has a market capitalization of $70.12 million, reflecting the scale of the business in the eyes of investors.

One of the InvestingPro Tips highlights that enVVeno Medical holds more cash than debt on its balance sheet, which is a positive sign for financial stability. This is particularly relevant as the company is preparing for the PMA submission to the FDA and the completion of pivotal studies. However, another tip indicates that the company is quickly burning through cash and has weak gross profit margins, which could be a concern for sustaining long-term operations without additional funding or revenue streams.

Furthermore, the InvestingPro Fair Value estimate for enVVeno Medical is at $4.39, which is below the previous close price of $5.26. This suggests that the stock may be overvalued compared to the fair value estimate. Nevertheless, the company's potential for growth must be weighed against these financial metrics, especially with upcoming clinical trial results and the FDA's review process on the horizon.

For readers interested in a deeper analysis, there are additional InvestingPro Tips available at: https://www.investing.com/pro/NVNO. These tips can provide further insights into enVVeno Medical's financial health and market expectations.

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