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NVNO's Shares Decline on Unfavorable FDA Review Outcome for VenoValve
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Key Takeaways
NVNO stock sank 76.1% after the FDA issued a not-approvable letter for VenoValve.
The FDA flagged insufficient NVNO's SAVVE study data and raised surgical safety concerns.
NVNO eyes an IDE filing for its non-surgical enVVe valve as the next pipeline step.
Shares of enVVeno Medical (NVNO - Free Report) have crashed 76.1% since Aug. 19. The significant decline was due to the FDA’s not-approvable letter in response to its Premarket Approval (“PMA”) application for Veno Valve.
The company submitted the PMA application to the FDA last year, seeking approval for VenoValve as a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). It was filed based on data from a successfully completed pivotal trial, SAVVE. However, the FDA determined that the trial data was not sufficient to determine the favorability of the benefit-to-risk profile for the VenoValve.
The VenoValve is the most advanced pipeline candidate of enVVeno Medical and the FDA’s denial to approve its use significantly hurt NVNO’s prospects.
Price Performance
Shares of enVVeno Medical have lost 66.9% so far this year, primarily due to last week’s crash following an unfavorable FDA outcome, compared with the industry’s decline of 6.7%. The S&P 500 Index has increased 9.8% in the same period.
Image Source: Zacks Investment Research
enVVeno Medical has a significant cash burn of $4-$5 million per quarter. At this pace, the company expects its cash resources to fund the company’s operations through the third quarter of 2026, including pre-commercialization activities for the VenoValve and the initiation of a pivotal study on another pipeline candidate, enVVe. However, the FDA’s not-approvable letter for VenoValve is likely to delay its commercialization, thereby affecting NVNO’s ability to generate a revenue stream. This is likely to keep shares of the company under pressure until it resolves the issues raised by the FDA.
FDA’s Denial
Data from the SAVVE study demonstrated that a high percentage of the patients who previously failed standard of care treatments showed significant clinical improvement after receiving VenoValve.
However, the FDA issued the not-approvable letter for VonoValve’s PMA application citing that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, along with the improvements in pain scores and venous specific quality of life indicators, does not sufficiently help determine favorability of the benefit-to-risk profile of the surgical replacement valve.
Moreover, the FDA also pointed out that clinical improvement may have occurred as a result of the patients being enrolled in a study in the absence of a specific hemodynamic measurement that correlates with patient improvement. The FDA also focused on safety concerns attributed to the VenoValve open surgical procedure, which required re-hospitalizations that are unlikely to occur with a non-surgical replacement valve.
Future Steps
enVVeno Medical is currently reviewing the feedback from the FDA and may meet with the FDA to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision, along with appropriate next steps.
Apart from VenoValve, the company is also developing enVVe as a first-in-class non-surgical transcatheter-based replacement venous valve. The company has successfully completed 6-month pre-clinical GLP study and is on track to submit a IDE filing for enVVe pivotal trial in the upcoming months. A potential FDA approval for the IDE filing can be the next trigger for a recovery in NVNO’s share price.
Some better-ranked stocks in the broader medical space areLeMaitre Vascular, Inc. (LMAT - Free Report) , Encompass Health Corporation (EHC - Free Report) and Envista Holdings Corporation (NVST - Free Report) .
LeMaitre Vascular, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17%. LMAT’s earnings surpassed estimates in two of the trailing four quarters, missed once and met in the other, the average surprise being 3.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
LeMaitre Vascular’s shares have gained 5.2% compared with the industry’s 4.7% growth in the past year.
Encompass Health, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 10.9%. EHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 14%.
Encompass Health’s shares have rallied 34.9% against the industry’s 0.4% decline in the past year.
Envista Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.
Envista Holdings’ shares have gained 9.4% compared with the industry’s 4.7% growth in the past year.
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NVNO's Shares Decline on Unfavorable FDA Review Outcome for VenoValve
Key Takeaways
Shares of enVVeno Medical (NVNO - Free Report) have crashed 76.1% since Aug. 19. The significant decline was due to the FDA’s not-approvable letter in response to its Premarket Approval (“PMA”) application for Veno Valve.
The company submitted the PMA application to the FDA last year, seeking approval for VenoValve as a surgical replacement venous valve for treating severe deep chronic venous insufficiency (CVI). It was filed based on data from a successfully completed pivotal trial, SAVVE. However, the FDA determined that the trial data was not sufficient to determine the favorability of the benefit-to-risk profile for the VenoValve.
The VenoValve is the most advanced pipeline candidate of enVVeno Medical and the FDA’s denial to approve its use significantly hurt NVNO’s prospects.
Price Performance
Shares of enVVeno Medical have lost 66.9% so far this year, primarily due to last week’s crash following an unfavorable FDA outcome, compared with the industry’s decline of 6.7%. The S&P 500 Index has increased 9.8% in the same period.
Image Source: Zacks Investment Research
enVVeno Medical has a significant cash burn of $4-$5 million per quarter. At this pace, the company expects its cash resources to fund the company’s operations through the third quarter of 2026, including pre-commercialization activities for the VenoValve and the initiation of a pivotal study on another pipeline candidate, enVVe. However, the FDA’s not-approvable letter for VenoValve is likely to delay its commercialization, thereby affecting NVNO’s ability to generate a revenue stream. This is likely to keep shares of the company under pressure until it resolves the issues raised by the FDA.
FDA’s Denial
Data from the SAVVE study demonstrated that a high percentage of the patients who previously failed standard of care treatments showed significant clinical improvement after receiving VenoValve.
However, the FDA issued the not-approvable letter for VonoValve’s PMA application citing that the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, along with the improvements in pain scores and venous specific quality of life indicators, does not sufficiently help determine favorability of the benefit-to-risk profile of the surgical replacement valve.
Moreover, the FDA also pointed out that clinical improvement may have occurred as a result of the patients being enrolled in a study in the absence of a specific hemodynamic measurement that correlates with patient improvement. The FDA also focused on safety concerns attributed to the VenoValve open surgical procedure, which required re-hospitalizations that are unlikely to occur with a non-surgical replacement valve.
Future Steps
enVVeno Medical is currently reviewing the feedback from the FDA and may meet with the FDA to discuss requirements for a potential resubmission of the VenoValve or appeal of the decision, along with appropriate next steps.
Apart from VenoValve, the company is also developing enVVe as a first-in-class non-surgical transcatheter-based replacement venous valve. The company has successfully completed 6-month pre-clinical GLP study and is on track to submit a IDE filing for enVVe pivotal trial in the upcoming months. A potential FDA approval for the IDE filing can be the next trigger for a recovery in NVNO’s share price.
enVVeno Medical Corporation Price
enVVeno Medical Corporation price | enVVeno Medical Corporation Quote
NVNO’s Zacks Rank & Key Picks
Currently, NVCR carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space areLeMaitre Vascular, Inc. (LMAT - Free Report) , Encompass Health Corporation (EHC - Free Report) and Envista Holdings Corporation (NVST - Free Report) .
LeMaitre Vascular, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 17%. LMAT’s earnings surpassed estimates in two of the trailing four quarters, missed once and met in the other, the average surprise being 3.2%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
LeMaitre Vascular’s shares have gained 5.2% compared with the industry’s 4.7% growth in the past year.
Encompass Health, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 10.9%. EHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 14%.
Encompass Health’s shares have rallied 34.9% against the industry’s 0.4% decline in the past year.
Envista Holdings, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 16.5%.
Envista Holdings’ shares have gained 9.4% compared with the industry’s 4.7% growth in the past year.