enVVeno Medical Corporation (NVNO)

Significant stock events in the past six months include the FDA's refusal to approve the VenoValve PMA application in August 2025, causing a 71% stock plunge due to concerns about data sufficiency, benefit-risk profile, bias, and safety. enVVeno Medical filed a request for a supervisory appeal in September 2025 and completed an in-person appeal meeting in October 2025. In October 2025, the company received a Nasdaq delisting notice. Positive interim two-year follow-up data from the VenoValve pivotal study were presented in July 2025. The company reported its third-quarter 2025 financial results on October 31, 2025, noting a decrease in net loss and sufficient cash to fund operations through Q2 2027. The stock price experienced a significant decline of 88.89% between January 10, 2025, and January 9, 2026, and decreased by 91.70% over the past six months.

Information regarding demand seasonality for enVVeno Medical Corp.'s products and services is not publicly available.

enVVeno Medical Corp. is a clinical-stage medical device company focused on developing bioprosthetic solutions for venous disease, operating in the Healthcare sector, specifically in the Medical Specialties and Medical Instruments industries. Its primary products are the VenoValve, a surgical replacement venous valve in a U.S. pivotal study for severe deep chronic venous insufficiency (CVI), and enVVe, a non-surgical, transcatheter-based replacement venous valve system.

enVVeno Medical Corp. operates in the United States and is headquartered in Irvine, California.

enVVeno Medical Corp.'s brand reputation has been negatively impacted by the FDA's refusal to approve VenoValve in August 2025, raising concerns about the device's benefit-risk profile and safety. The subsequent appeal process is critical for the company's reputation. Conversely, positive interim two-year data from the VenoValve pivotal study in July 2025, demonstrating sustained clinical improvement, could have positively influenced its scientific and medical community reputation. The company's continued engagement with vascular specialists and academic institutions also contributes to its reputation.

enVVeno Medical Corp. has a diverse ownership structure, with institutional shareholders owning approximately 29.51% to 34.71% of the stock, insiders holding around 54.40%, and retail investors accounting for about 16.09% to 70.36%. Major institutional owners include Perceptive Advisors LLC, Kingdon Capital Management, L.L.C., Vanguard Group Inc., CM Management, LLC, Geode Capital Management, Llc, and JPMorgan Chase & Co. The largest individual shareholder is Yury Zhivilo, owning 4.48 million shares, representing 22.15% of the company. Browston Trading Ltd is also a significant insider owner.