enVVeno Medical Corporation
NVNBW
Other OTC0.01
USD
- -
- -
enVVeno Medical Corporation
NVNBW
(Other OTC)
Recent
price
0.01
P/E
ratio
- -
div
yld
- -
ROIC.AI
Capital Structure
FRC
•
in mil. unless spec.Working Capital
FRC
•
in mil. unless spec.Growth Rates
FRC
•
in mil. unless spec.Quarterly Revenue
FRC
•
in mil. unless spec.Quarterly Earnings Per Share
FRC
•
in mil. unless spec.Quarterly Dividends Per Share
FRC
•
in mil. unless spec.- Similar Companies
- Business
- enVVeno Medical Corporation is a late clinical-stage medical device company specializing in the development of innovative bioprosthetic (tissue-based) solutions for the treatment of venous disease, particularly severe chronic venous insufficiency (CVI). The company's core products include the VenoValve, a first-in-class surgical replacement venous valve designed to restore unidirectional blood flow in the deep veins of the leg, and enVVe, a non-surgical, transcatheter-based replacement venous valve. Both devices function as one-way valves to assist blood propulsion from the legs back to the heart and lungs. enVVeno’s product pipeline targets patients suffering from venous reflux and venous hypertension leading to CVI, addressing a significant unmet medical need with a focus on improving clinical outcomes and quality of life. Founded in 1999 and headquartered in Irvine, California, enVVeno operates primarily in the United States medical device development market and is publicly listed on Nasdaq under the ticker NVNO. The company concentrates on advancing its lead surgical device, the VenoValve, currently under evaluation in the pivotal SAVVE U.S. clinical trial, and is preparing for clinical trials of enVVe, its investigational non-surgical valve replacement device. enVVeno’s solutions target the vascular medicine segment, aiming to set new standards of care for deep venous disease. Recent major company developments include receiving a not-approvable letter from the U.S. Food and Drug Administration (FDA) in 2025 concerning the VenoValve’s premarket approval application, citing insufficient clinical data and safety concerns related to the surgical implantation procedure. Despite this setback, enVVeno continues to engage with the FDA to explore next steps, including potential resubmissions or appeal processes. The company is leveraging insights gained from this regulatory experience to advance the development of enVVe, which is anticipated to offer a less invasive treatment alternative. Additionally, enVVeno has presented clinical data and trial results at major vascular symposiums in recent years, reinforcing its commitment to evidence-based innovation and regulatory progress. enVVeno Medical's products and clinical programs focus exclusively on innovating treatment options for venous insufficiency within the U.S. market, with its bioprosthetic valves representing a differentiated approach compared to conventional therapies such as compression stockings or superficial vein treatments. The company’s strategic emphasis remains on developing safe and effective minimally invasive technologies that address the root cause of deep venous disease, positioning enVVeno as a promising specialist player in the vascular medical device industry. Overall, enVVeno Medical Corporation provides bioprosthetic surgical and transcatheter venous valve replacement devices targeting severe CVI patients, headquartered in Irvine, California, with ongoing clinical development efforts despite regulatory challenges. The company’s product development and regulatory activities represent its core focus within the vascular device industry.