One-glance verdict
Fair value unavailable
Not enough cash-flow history to value this one with our method.
Fundamentals snapshot
NVNO · NCM · Healthcare · Medical Devices
Current price
$6.52
52-week range
$6.26 - $24.36
Market cap
$4.53M
One-glance verdict
Not enough cash-flow history to value this one with our method.
Balance sheet
Net cash $18.06M. Interest coverage shows how many times profit covers the interest bill.
What stands out
What this company does
enVVeno Medical Corporation makes medical devices to treat vein problems, with their main product being a surgical valve replacement called VenoValve, and they are also developing a less invasive valve system. The company's income primarily comes from selling these specialized medical devices, and this matters because it shows how they plan to make money from their innovative treatments for vein conditions.
enVVeno Medical Corporation, originally founded as Hancock Jaffe Laboratories, Inc. in 1999, has evolved significantly in its mission to address venous diseases. The company officially changed its name to enVVeno Medical Corporation in October 2021, signaling a renewed focus on its innovative medical device solutions. This rebranding marked a strategic shift, particularly after facing regulatory hurdles with its initial product. The company's journey has been characterized by a persistent effort to develop advanced treatments for a condition with limited effective options, navigating the complex landscape of medical device development and regulatory approval. Its history is rooted in the pursuit of improving patient care through bioprosthetic tissue-based technologies.
enVVeno Medical Corporation develops and aims to commercialize medical devices designed to treat venous diseases, particularly chronic venous insufficiency. These conditions occur when the valves in the leg veins become damaged, leading to blood pooling and discomfort. The company's core focus is on creating replacement venous valves that restore proper blood flow from the legs back to the heart. Their goal is to significantly improve the quality of life for patients suffering from debilitating venous conditions, offering solutions where few effective treatments currently exist. The company's work is centered on improving the standard of care in the United States for these challenging medical issues.
The enVVe System represents enVVeno Medical's primary focus and future strategy. It is a first-in-class, non-surgical replacement venous valve delivered through a minimally invasive procedure using a catheter. This approach aims to restore one-way blood flow in the deep veins of the leg, addressing the root cause of severe deep venous insufficiency (DVI). Unlike traditional open surgery, the enVVe system is designed to avoid general anesthesia and overnight hospital stays, making it a less burdensome option for patients. The company is actively advancing the enVVe system through clinical trials, including the TAVVE pivotal study, which has received FDA Investigational Device Exemption (IDE) approval. This segment is considered the company's main growth driver and its primary bet for future success in the multi-billion-dollar venous disease market.
The VenoValve was enVVeno Medical's initial lead product, designed as a surgical replacement venous valve for treating severe chronic venous insufficiency (CVI). This device was intended for implantation via an open surgical procedure. However, the company received a 'not approvable' letter from the U.S. Food and Drug Administration (FDA) for its Premarket Approval (PMA) application for the VenoValve. This regulatory setback indicated that the FDA could not approve the application in its current form, citing concerns about the benefit-risk profile and safety issues related to the surgical procedure. While the company has explored options for the VenoValve, including an appeal, its strategic focus has largely shifted to the less invasive enVVe system.
Management at enVVeno Medical is heavily focused on the development and advancement of the enVVe System, a non-surgical, transcatheter-based replacement venous valve. This strategic pivot follows the FDA's decision regarding the VenoValve, with the company accelerating its efforts on the less invasive enVVe approach. Key priorities include successfully executing the TAVVE pivotal study, which is designed to evaluate the enVVe system's safety and efficacy. Management is also focused on building clinical evidence and securing reimbursement pathways to support future commercialization. The company believes the enVVe system has the potential to transform the treatment paradigm for deep chronic venous insufficiency and capture a significant share of a large, underserved market.
Price history
Earnings history
Click any quarter to read the call summary and what the numbers say.
Is it cheap or expensive?
We couldn't calculate a fair value right now.
Is it drowning in debt?
Net cash $18.1M - more cash than debt. Interest coverage -30.2x.
enVVeno Medical Corporation's profit covers its interest bill about 0.0 times over. which is weaker than most peers shown here and 5 peers sit below 1x, which is the danger zone where profit does not fully cover the interest bill.
Total debt $408.00K Interest coverage -30.20x This is the baseline the peer rows are being compared against.
Total debt $90.00K Interest coverage -407.95x Neither company has much profit cushion over interest right now.
Total debt $29.43M Interest coverage -5.45x Neither company has much profit cushion over interest right now.
Total debt $0.00 Interest coverage -9.76x Neither company has much profit cushion over interest right now.
Total debt $1.79M Interest coverage -1,146.57x Neither company has much profit cushion over interest right now.
Total debt $11.41M Interest coverage -8.53x Neither company has much profit cushion over interest right now.
What you should know
The numbers
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What you should know