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enVVeno (NVNO) Plans to Expedite enVVe Development for CVI
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enVVeno Medical Corporation (NVNO - Free Report) is poised to advance in the field of venous disease treatment with its innovative enVVe transcatheter-based replacement venous valve. The company's recent announcement to expedite the development of enVVe is a significant milestone in this regard as currently millions of patients worldwide are battling chronic venous insufficiency (CVI).
Severe CVI is a debilitating disease that primarily occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg. Symptoms of severe CVI include leg swelling, pain, edema and recurrent open sores known as venous ulcers. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence.
More on enVVe
enVVe is a non-surgical, replacement venous valve, made from specially formulated biocompatible nickel and titanium alloy, which self-expands once deployed, and has a delivery profile of only 13 Fr when crimped. It is delivered via a minimally invasive procedure requiring no general anesthesia or overnight hospital stay. This valve is designed to accommodate the natural dilation and contraction of the vein and will be available in three sizes to ensure a proper fit across a broad range of vein sizes.
According to the company, leveraging insights from VenoValve, the company’s successful pre-clinical testing for enVVe coupled with FDA feedback, enVVeno is poised to be a leading player in both surgical and non-surgical replacement venous valves. enVVeno noted that its strong capital position is now sufficient to begin the enVVe pivotal study.
Consequently, the company has decided to expedite enVVe’s development and immediately begin preparations for the enVVe pivotal trial.
Image Source: Zacks Investment Research
In a recent release, enVVeno announced completion of enrollment for the SAVVE U.S. pivotal trial for the VenoValve, with top-line safety data expected in the fourth quarter of 2023. The top-line efficacy data is expected in the second quarter of 2024. enVVeno expects to have sufficient data to be eligible to file a PMA seeking FDA approval for VenoValve in the third quarter of 2024.
Market Prospects
Going by a 2022 Bloomberg report, the global venous disease treatment market was valued at $5.9 billion in 2021 and is expected to exhibit a CAGR of 6.8% from 2022 to 2031. By 2031, the market for varicose vein treatment alone is projected to exceed $ 11.3 billion.
Several factors are fueling this growth, including an aging global population, advancements in treatment technologies and the rise of specialized medical fields that require more venous therapy. Furthermore, increased awareness of venous disorders and their treatments is contributing to market expansion. Access to treatment is also increasing, thanks to the proliferation of private rehabilitation facilities.
Share Price Performance
Shares of NVNO have plunged 18.8% over the past year against the industry’s 3.1% growth.
Zacks Rank and Key Picks
enVVeno currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Quanterix (QTRX - Free Report) and Align Technology (ALGN - Free Report) , each carrying a Zacks Rank #2 (Buy).
DaVita has gained 25.5% against the industry’s 8.9% decline over the past year.
Estimates for Quanterix’s 2023 loss per share have remained constant at 97 cents in the past 30 days. Shares of the company have surged 141.5% in the past year compared with the industry’s fall of 5.6%.
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 27% in the past year compared with the industry’s rise of 14.3%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.
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enVVeno (NVNO) Plans to Expedite enVVe Development for CVI
enVVeno Medical Corporation (NVNO - Free Report) is poised to advance in the field of venous disease treatment with its innovative enVVe transcatheter-based replacement venous valve. The company's recent announcement to expedite the development of enVVe is a significant milestone in this regard as currently millions of patients worldwide are battling chronic venous insufficiency (CVI).
Severe CVI is a debilitating disease that primarily occurs when valves inside the veins of the leg fail, causing blood to flow in the wrong direction (reflux) and increased pressure within the veins of the leg. Symptoms of severe CVI include leg swelling, pain, edema and recurrent open sores known as venous ulcers. There are currently no effective treatments for severe CVI of the deep vein system caused by valvular incompetence.
More on enVVe
enVVe is a non-surgical, replacement venous valve, made from specially formulated biocompatible nickel and titanium alloy, which self-expands once deployed, and has a delivery profile of only 13 Fr when crimped. It is delivered via a minimally invasive procedure requiring no general anesthesia or overnight hospital stay. This valve is designed to accommodate the natural dilation and contraction of the vein and will be available in three sizes to ensure a proper fit across a broad range of vein sizes.
According to the company, leveraging insights from VenoValve, the company’s successful pre-clinical testing for enVVe coupled with FDA feedback, enVVeno is poised to be a leading player in both surgical and non-surgical replacement venous valves. enVVeno noted that its strong capital position is now sufficient to begin the enVVe pivotal study.
Consequently, the company has decided to expedite enVVe’s development and immediately begin preparations for the enVVe pivotal trial.
Image Source: Zacks Investment Research
In a recent release, enVVeno announced completion of enrollment for the SAVVE U.S. pivotal trial for the VenoValve, with top-line safety data expected in the fourth quarter of 2023. The top-line efficacy data is expected in the second quarter of 2024. enVVeno expects to have sufficient data to be eligible to file a PMA seeking FDA approval for VenoValve in the third quarter of 2024.
Market Prospects
Going by a 2022 Bloomberg report, the global venous disease treatment market was valued at $5.9 billion in 2021 and is expected to exhibit a CAGR of 6.8% from 2022 to 2031. By 2031, the market for varicose vein treatment alone is projected to exceed $ 11.3 billion.
Several factors are fueling this growth, including an aging global population, advancements in treatment technologies and the rise of specialized medical fields that require more venous therapy. Furthermore, increased awareness of venous disorders and their treatments is contributing to market expansion. Access to treatment is also increasing, thanks to the proliferation of private rehabilitation facilities.
Share Price Performance
Shares of NVNO have plunged 18.8% over the past year against the industry’s 3.1% growth.
Zacks Rank and Key Picks
enVVeno currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Quanterix (QTRX - Free Report) and Align Technology (ALGN - Free Report) , each carrying a Zacks Rank #2 (Buy).
DaVita has an estimated long-term growth rate of 12.7%. DVA’s earnings surpassed estimates in three of the trailing four quarters and missed once, with an average surprise of 21.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
DaVita has gained 25.5% against the industry’s 8.9% decline over the past year.
Estimates for Quanterix’s 2023 loss per share have remained constant at 97 cents in the past 30 days. Shares of the company have surged 141.5% in the past year compared with the industry’s fall of 5.6%.
QTRX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 30.39%. In the last reported quarter, it posted an earnings surprise of 55.56%.
Estimates for Align Technology’s 2023 earnings have moved up from $8.77 to $8.78 per share in the past 30 days. Shares of the company have increased 27% in the past year compared with the industry’s rise of 14.3%.
ALGN’s earnings beat estimates in three of the trailing four quarters and missed in one. In the last reported quarter, it posted an earnings surprise of 9.90%.