enVVeno Medical Corporation develops bioprosthetic venous valve devices for severe deep chronic venous insufficiency in the United States. News about NVNO centers on the company’s enVVe System, a minimally invasive transcatheter replacement venous valve, and its TAVVE pivotal study under FDA investigational device exemption approval.
Recurring updates also cover the VenoValve surgical replacement venous valve, FDA communications tied to device review, clinical-development planning, cash runway and operating losses, Nasdaq listing compliance, shareholder-approved capital-structure actions such as the reverse stock split, and investor communications from this late clinical-stage medical device issuer.
enVVeno Medical (NASDAQ:NVNO) released the third episode of its investor video series, "WTF with Rob Berman," featuring its CEO.
The episode discusses the total addressable market—the potential market size—for severe deep venous insufficiency (DVI). Berman covers the patient population, the market opportunity and what he describes as investors' frequent misunderstandings about market size. The announcement provides no patient-population figures or clinical results.
enVVeno Medical (NVNO) will present its investigational enVVe System at The VEINS 2026 in Las Vegas on October 4, 2026. The presentation will take place at the Blue Sky Breakfast, a gathering of specialists focused on venous and vascular disease, followed by a panel discussion and question-and-answer session.
Earlier this year, the company received FDA Investigational Device Exemption approval, which permits initiation of the TAVVE pivotal trial for enVVe. The company expects enrollment to begin in Q4 2026. The system is a non-surgical replacement venous valve designed to restore one-way blood flow in deep veins and address chronic deep venous insufficiency. Karen B. Garby, an interventional radiologist and Director of Venous Intervention at Comprehensive Integrated Care, will present the system.
enVVeno Medical (NVNO) launched a new CEO-led video series, “WTF Rob Berman,” on September 16, 2026, aimed at giving investors direct, plain‑spoken information about the company.
Hosted by CEO Rob Berman, the series is intended to move beyond scripted corporate messaging and offer candid, fact‑driven discussion of enVVeno’s technology, clinical programs, regulatory and development progress, upcoming milestones, and corporate decision‑making. Episodes will address topics such as the enVVe® System, the path toward the SAVVE pivotal trial, enVVeno’s venous valve replacement approach, and its strategy toward potential commercialization. The company notes severe deep venous insufficiency (DVI) affects an estimated 3 million people in the U.S. and that the enVVe System is being developed as a potential first‑in‑class bioprosthetic venous valve replacement.
enVVeno Medical (NVNO) announced that its pre-recorded presentation from the H.C. Wainwright 28th Annual Global Investment Conference is now available for on-demand viewing starting September 11, 2026, at 7:00 a.m. ET.
The webcast, presented by CEO Robert Berman, covers an overview of the company, its enVVe® System, and recent corporate and clinical developments. The presentation can be accessed via the Events page in the Investors section of enVVeno Medical's website. Management will also be available for one-on-one meetings with registered investors during the conference in New York from September 14-16, 2026.
enVVeno Medical (NASDAQ:NVNO) announced that CEO Robert Berman participated in the Virtual Investor “Why Now” on-demand conference, where he outlined the company’s investment opportunity and the unmet need in treating severe Deep Venous Insufficiency (DVI).
Berman discussed enVVeno’s non-surgical replacement venous valve, enVVe, and the recent FDA IDE approval for a U.S. pivotal study of the device. The TAVVE pivotal trial is expected to start in the fourth quarter of 2026 and enroll about 230 patients across up to 40 U.S. sites, as a key step toward potential regulatory approval of the enVVe System. A video webcast of the presentation is available for on-demand viewing. enVVeno is a late clinical-stage medical device company focused on bioprosthetic solutions for deep venous disease.
enVVeno Medical (NASDAQ: NVNO) announced results from an independent, peer-reviewed health economic analysis in the Journal of Vascular Surgery: Venous and Lymphatic Disorders evaluating prosthetic venous valve replacement for severe deep venous reflux. The modeled five-year analysis found enVVeno’s first-generation VenoValve economically dominant versus compression therapy and wound care, projecting over $32,000 average healthcare savings and about 2.2 fewer venous ulcers per patient, plus improved QALYs and lower overall costs. The study estimated roughly $4,100 savings per rVCSS point of improvement and suggested potential annual system-wide savings of about $5.9 billion with broader venous valve replacement use, supporting the health-economic rationale for the company’s investigational, minimally invasive enVVe system now in the TAVVE pivotal trial.
enVVeno Medical (NASDAQ: NVNO) reported second quarter 2026 results and highlighted FDA Investigational Device Exemption (IDE) approval to begin the TAVVE pivotal trial of its enVVe first-in-class, minimally invasive replacement venous valve for severe deep chronic venous insufficiency (CVI). The pivotal study is expected to start enrolling during the second half of 2026 and ultimately enroll about 230 patients across up to 40 U.S. sites.
The company expanded its intellectual property with a new U.S. patent covering key enVVe components. enVVeno ended June 30, 2026 with approximately $21.5 million in cash and investments, which management believes will fund operations into the third quarter of 2027. Second quarter cash burn was $3.4 million, with an expected increase to $4–5 million per quarter in the second half of 2026 as TAVVE enrollment begins. Net loss was $3.6 million ($5.37 per share), compared to $6.7 million ($11.52 per share) a year earlier.
enVVeno Medical (NASDAQ: NVNO) announced that CEO Robert Berman participated in a Virtual Investor “What This Means” segment to discuss two recent milestones for the company’s enVVe replacement venous valve system. He highlighted the issuance of the first U.S. patent covering the enVVe system, which expands enVVeno Medical’s intellectual property portfolio.
Berman also discussed the company’s progress with what he described as the first FDA-approved pivotal trial for a non-surgical replacement venous valve targeting deep chronic venous insufficiency. According to enVVeno Medical, these milestones are intended to form key elements of its strategy to build shareholder value, strengthen its long-term competitive position, and reinforce barriers to entry around its technology. The company further stated that it views the replacement venous valve space as a large, untapped commercial opportunity and believes enVVe has the potential to transform the treatment paradigm. The Virtual Investor segment is now available online.
enVVeno Medical (NASDAQ:NVNO) received U.S. Patent No. 12,575,932 covering core components of its enVVe transcatheter replacement venous valve system, including valve, support frame, crimping, and delivery systems.
The patent, combined with prior FDA IDE approval for the TAVVE pivotal trial, supports clinical advancement and potential future commercialization targeting deep venous insufficiency.
enVVeno Medical (NASDAQ:NVNO) will present in the Webull Corporate Connect Webinar Series, held virtually June 24‑25, 2026. CEO Rob Berman will speak on June 24, 2026 from 2:00–2:20 PM ET, covering the company’s deep venous disease focus, recent FDA IDE approval for the enVVe® System, and plans for a first U.S. pivotal trial of a non-surgical replacement venous valve.