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NVNO Completes Application for VenoValve's PMA, Shares Likely to Gain
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enVVeno Medical's (NVNO - Free Report) submission of the final module for VenoValve’s Premarket Approval (PMA) application to the FDA represents a crucial milestone in addressing unmet needs in the treatment of Chronic Venous Insufficiency (CVI). As a breakthrough-designated device, VenoValve aims to treat severe CVI by restoring proper blood flow and alleviating debilitating symptoms like leg swelling, pain, and venous ulcers.
With approximately 2.5 million candidates for the device annually in the U.S., FDA approval could position enVVeno at the forefront of transforming the standard of care for venous disease.
NVNO's Likely Stock Trend Following the News
Subsequent to the news, the share price of NVNO dropped 5.5% to $3.41 yesterday.
Although the shares are southbound, the latest development is likely to boost the company’s bioprosthetic (tissue-based) solutions business. The company is gaining positive market acceptance for its progress with the treatment of CVI. The latest development is the fifth and final module of the FDA application containing favorable clinical data. The previous four modules had already been reviewed and approved by the FDA. Accordingly, the latest submission is a significant step forward in gaining the FDA nod for VenoValve. We thereby expect market sentiment toward NVNO stock to turn out to be positive surrounding this news.
NVNO boasts a market capitalization of 59.8 million. The company is estimated to report 31.9% earnings growth in 2024.
Positioning enVVeno for Growth in the Bioprosthetic Market
VenoValve’s PMA approval by the FDA has the potential to significantly expand enVVeno’s portfolio of bioprosthetic solutions. The device leverages advanced tissue-based technology to replicate the function of damaged venous valves, addressing a void in current treatment options. This innovation aligns with enVVeno’s broader mission of developing surgical and non-surgical solutions for venous disease, exemplified by the upcoming transcatheter-based enVVe valve. Together, these products highlight the company’s commitment to serving both patients and physicians with versatile and effective treatment modalities.
Image Source: Zacks Investment Research
VenoValve’s pending approval could catalyze enVVeno’s growth in the medical device market, fostering new revenue streams and elevating its competitive position. Concurrently, the planned pivotal trial for the enVVe valve in mid-2025 underscores enVVeno’s focus on innovation and market expansion.
As the company awaits FDA feedback, VenoValve’s progress reflects a broader strategy to revolutionize care for venous disease while driving enVVeno’s business growth in the bioprosthetic sector.
Market Prospect in Favor of enVVeno
According to a Data Bridge Market Research report, the global venous disease treatment market size was valued at $6.17 billion in 2023 and is projected to reach $10.85 billion by 2031, at a CAGR of 7.30%. The market is witnessing rapid expansion, driven by the rising prevalence of diabetes and advancements in technology. Insulin pumps have emerged as a vital component in diabetes care, offering precision in insulin delivery and improving glycemic control for patients. The increasing adoption of continuous glucose monitoring systems further complements insulin pump usage, enabling real-time data integration and personalized treatment plans.
Key trends shaping the market include the shift toward compact, user-friendly devices and the integration of artificial intelligence for predictive insulin dosing. Companies are also focusing on improving accessibility through cost-effective solutions, broadening market reach in developing regions.
Telemedicine and remote monitoring are significantly influencing the market landscape, particularly post-pandemic, as patients seek more convenient and efficient care options. Moreover, regulatory approvals for hybrid closed-loop systems are accelerating innovation, setting new standards for automated insulin delivery systems.
NVNO's Stock Price Performance
Shares of NVNO have dipped 11% in a year against the industry’s 15% growth.
Haemonetics has an earnings yield of 5.02% compared with the industry’s 1.18%. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 19.39%. Its shares have gained 1.8% compared with the industry’s 23.1% growth in the past year. Estimates for Haemonetics’ 2025 EPS have moved north by 0.4% to $4.59 in the past 30 days.
Estimates for Penumbra’s 2024 EPS have moved north by 8.1% to $2.79 in the past 30 days. Shares of the company have surged 60.6% in the past year compared with the industry’s growth of 32.7%. PEN’s earnings surpassed estimates in three of the trailing four quarters and missed in one of the same. It delivered an earnings surprise of 10.54%.
Estimates for ResMed’s fiscal 2025 EPS have risen 2.7% in the past 30 days. Shares of the company have surged 86.3% in the past year compared with the industry’s 32.1% growth. RMD’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 6.4%. In the last reported quarter, it delivered an earnings surprise of 8.4%.
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NVNO Completes Application for VenoValve's PMA, Shares Likely to Gain
enVVeno Medical's (NVNO - Free Report) submission of the final module for VenoValve’s Premarket Approval (PMA) application to the FDA represents a crucial milestone in addressing unmet needs in the treatment of Chronic Venous Insufficiency (CVI). As a breakthrough-designated device, VenoValve aims to treat severe CVI by restoring proper blood flow and alleviating debilitating symptoms like leg swelling, pain, and venous ulcers.
With approximately 2.5 million candidates for the device annually in the U.S., FDA approval could position enVVeno at the forefront of transforming the standard of care for venous disease.
NVNO's Likely Stock Trend Following the News
Subsequent to the news, the share price of NVNO dropped 5.5% to $3.41 yesterday.
Although the shares are southbound, the latest development is likely to boost the company’s bioprosthetic (tissue-based) solutions business. The company is gaining positive market acceptance for its progress with the treatment of CVI. The latest development is the fifth and final module of the FDA application containing favorable clinical data. The previous four modules had already been reviewed and approved by the FDA. Accordingly, the latest submission is a significant step forward in gaining the FDA nod for VenoValve. We thereby expect market sentiment toward NVNO stock to turn out to be positive surrounding this news.
NVNO boasts a market capitalization of 59.8 million. The company is estimated to report 31.9% earnings growth in 2024.
Positioning enVVeno for Growth in the Bioprosthetic Market
VenoValve’s PMA approval by the FDA has the potential to significantly expand enVVeno’s portfolio of bioprosthetic solutions. The device leverages advanced tissue-based technology to replicate the function of damaged venous valves, addressing a void in current treatment options. This innovation aligns with enVVeno’s broader mission of developing surgical and non-surgical solutions for venous disease, exemplified by the upcoming transcatheter-based enVVe valve. Together, these products highlight the company’s commitment to serving both patients and physicians with versatile and effective treatment modalities.
Image Source: Zacks Investment Research
VenoValve’s pending approval could catalyze enVVeno’s growth in the medical device market, fostering new revenue streams and elevating its competitive position. Concurrently, the planned pivotal trial for the enVVe valve in mid-2025 underscores enVVeno’s focus on innovation and market expansion.
As the company awaits FDA feedback, VenoValve’s progress reflects a broader strategy to revolutionize care for venous disease while driving enVVeno’s business growth in the bioprosthetic sector.
Market Prospect in Favor of enVVeno
According to a Data Bridge Market Research report, the global venous disease treatment market size was valued at $6.17 billion in 2023 and is projected to reach $10.85 billion by 2031, at a CAGR of 7.30%. The market is witnessing rapid expansion, driven by the rising prevalence of diabetes and advancements in technology. Insulin pumps have emerged as a vital component in diabetes care, offering precision in insulin delivery and improving glycemic control for patients. The increasing adoption of continuous glucose monitoring systems further complements insulin pump usage, enabling real-time data integration and personalized treatment plans.
Key trends shaping the market include the shift toward compact, user-friendly devices and the integration of artificial intelligence for predictive insulin dosing. Companies are also focusing on improving accessibility through cost-effective solutions, broadening market reach in developing regions.
Telemedicine and remote monitoring are significantly influencing the market landscape, particularly post-pandemic, as patients seek more convenient and efficient care options. Moreover, regulatory approvals for hybrid closed-loop systems are accelerating innovation, setting new standards for automated insulin delivery systems.
NVNO's Stock Price Performance
Shares of NVNO have dipped 11% in a year against the industry’s 15% growth.
enVVeno's Zacks Rank and Key Picks
enVVeno currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Haemonetics (HAE - Free Report) , Penumbra (PEN - Free Report) , and ResMed (RMD - Free Report) . While ResMed sports a Zacks Rank #1 (Strong Buy) at present, Haemonetics and Penumbra carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Haemonetics has an earnings yield of 5.02% compared with the industry’s 1.18%. Its earnings surpassed the Zacks Consensus Estimate in each of the trailing four quarters, the average surprise being 19.39%. Its shares have gained 1.8% compared with the industry’s 23.1% growth in the past year. Estimates for Haemonetics’ 2025 EPS have moved north by 0.4% to $4.59 in the past 30 days.
Estimates for Penumbra’s 2024 EPS have moved north by 8.1% to $2.79 in the past 30 days. Shares of the company have surged 60.6% in the past year compared with the industry’s growth of 32.7%. PEN’s earnings surpassed estimates in three of the trailing four quarters and missed in one of the same. It delivered an earnings surprise of 10.54%.
Estimates for ResMed’s fiscal 2025 EPS have risen 2.7% in the past 30 days. Shares of the company have surged 86.3% in the past year compared with the industry’s 32.1% growth. RMD’s earnings surpassed estimates in each of the trailing four quarters, the average beat being 6.4%. In the last reported quarter, it delivered an earnings surprise of 8.4%.