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IRVINE, CA - enVVeno Medical (TASE:PMCN) Corporation (NASDAQ:NVNO), an Irvine-based medical device company, has announced the submission of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the VenoValve, a device intended to treat severe deep venous Chronic Venous Insufficiency (CVI). The company reported that four out of five modules of the PMA application have been approved by the FDA, with the final module, containing clinical data from the SAVVE pivotal trial and proposed labeling for the device, currently under review.
The VenoValve has been designated as a breakthrough device, which affords it priority review status. The device is designed to address the debilitating effects of CVI, a condition often resulting from blood clots in the leg veins, leading to symptoms such as leg swelling, pain, edema, and venous ulcers. According to enVVeno Medical, approximately 2.5 million people in the U.S. could be potential candidates for the VenoValve each year.
In addition to the VenoValve, enVVeno is developing a next-generation, non-surgical transcatheter-based replacement venous valve, enVVe, which is expected to enter a pivotal trial by mid-2025. This development could potentially cater to an even larger patient and physician market.
The definitive data supporting the VenoValve PMA application will be presented today at the 51st Annual VEITH Symposium in New York City. Following the symposium, a live video conference call with the Principal Investigators (PIs) presenting the trial data is scheduled for 2:00 PM Eastern Time.
enVVeno Medical specializes in the advancement of bioprosthetic solutions for venous disease treatment. Its lead product, the VenoValve, is currently under evaluation in the SAVVE U.S. pivotal study, with the company performing final testing necessary for the enVVe pivotal trial approval.
The company's CEO, Robert Berman, expressed optimism about the final phase of the PMA review process and anticipates further interactions with the FDA. While the timeline for the PMA process's completion is uncertain, enVVeno expects to potentially have a decision in the second half of 2025.
This news is based on a press release statement from enVVeno Medical Corporation.
In other recent news, enVVeno Medical Corporation has announced a public stock offering, with the proceeds intended to support the development of its leading products, VenoValve and enVVe. The offering is managed by Titan Partners Group, a division of American Capital Partners (WA:CPAP). The company has also made significant strides in the premarket approval process for VenoValve with the U.S. Food and Drug Administration (FDA), successfully submitting and receiving approval for four out of the five required modules.
The VenoValve is currently under evaluation in a pivotal study, showing promising results for venous ulcer healing. In a recent trial involving twenty-one patients, 91% experienced complete healing or improvement in their ulcers within a year. Furthermore, enVVeno Medical has recently appointed Sandy Prietto as Vice President of Marketing and Andrew Cormack as Chief Commercial Officer, indicating a strategic shift towards commercialization.
The company's financial position remains strong, with $39.1 million in cash and investments reported at the end of a recent quarter, expected to fund operations through the end of 2025. These are recent developments in enVVeno Medical Corporation's ongoing efforts to improve care for patients who could benefit from the VenoValve.
InvestingPro Insights
As enVVeno Medical Corporation (NASDAQ:NVNO) progresses with its VenoValve PMA application, investors might find value in examining the company's financial metrics and market position. According to InvestingPro data, NVNO's market capitalization stands at $58.04 million, reflecting its current valuation in the medical device sector.
The company's financial health presents a mixed picture. With an adjusted operating income of -$23.41 million for the last twelve months as of Q3 2024, NVNO is currently operating at a loss, which is not uncommon for biotech companies in the development stage. This is further reflected in the negative P/E ratio of -2.54, indicating that the company is not yet profitable.
However, there are signs of potential upside. An InvestingPro Tip suggests that NVNO's stock price is trading below its fair value based on analyst price targets. The fair value estimate from analysts stands at $18, significantly higher than the current trading price. This could indicate that the market has not fully priced in the potential success of the VenoValve and other pipeline products.
Another InvestingPro Tip points out that NVNO has seen strong EBITDA growth, with a 7.94% increase in the last twelve months as of Q3 2024. This growth could be a positive indicator as the company moves closer to potential commercialization of its products.
It's worth noting that InvestingPro offers 9 additional tips for NVNO, providing a more comprehensive analysis for investors interested in delving deeper into the company's prospects.
As enVVeno awaits the FDA's decision on the VenoValve, expected in the second half of 2025, investors should keep an eye on the company's burn rate and its ability to fund operations through the regulatory process and potential commercialization phase. The upcoming presentation at the VEITH Symposium and the subsequent video conference call with Principal Investigators could provide valuable insights into the VenoValve's clinical performance and market potential, potentially influencing the company's valuation in the near term.
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