AngioDynamics' (ANGO) New FDA Recognition to Boost Treatment
AngioDynamics, Inc. ANGO recently announced the receipt of the FDA’s Breakthrough Device designation for its AngioVac System for the proposed indications for use to include the non-surgical removal of vegetation from the right heart. Following the FDA’s grant of the Breakthrough Device designation, AngioDynamics will engage with the FDA to achieve the new expanded indication for the non-surgical removal of the vegetation.
The latest FDA recognition is expected to significantly solidify AngioDynamics’ foothold in the niche space and strengthen its Med Tech segment globally.
Significance of the Designation
The AngioVac System uses a venous drainage cannula to remove thrombi (a blood clot formed within the vascular system of the body) or emboli during extracorporeal bypass for up to six hours.
The FDA Breakthrough Device designation is designed to help patients gain timely access to medical devices that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions for which no approved or cleared alternatives currently exist.
Per management, the FDA’s recognition of the AngioVac System reflects its potential to provide a novel and innovative treatment pathway for the non-surgical removal of vegetation from the right heart. Management believes that the recognition will likely be a significant step toward advancing patient care.
Industry Prospects
Per a report by Allied Market Research, the global thrombectomy devices market was valued at $1.3 billion in 2020 and is anticipated to reach $2.6 billion by 2030 at a CAGR of 7.4%. Factors like the increase in the incidence of cardiovascular diseases and growth in demand for minimally invasive procedures are likely to drive the market.
Given the market potential, the latest regulatory recognition raises optimism about AngioDynamics.
Recent Developments
This month, AngioDynamics announced the completion of enrolment and final treatment in its Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE).
In July, AngioDynamics reported fourth-quarter fiscal 2023 results, wherein it registered a solid uptick in the overall top line. Robust domestic and international revenues were also seen. The company continued gaining from its Med Tech business and robust sales of Auryon and NanoKnife were encouraging. Continued positive physician feedback for both the F22 and F18 versions of AlphaVac was also received.
Price Performance
Shares of AngioDynamics have lost 63.6% in the past year compared with the industry’s 3.8% decline. The S&P 500 has witnessed 4.2% growth in the said time frame.
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Zacks Rank & Stocks to Consider
Currently, AngioDynamics carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the broader medical space are Cardinal Health, Inc. CAH, HealthEquity, Inc. HQY and McKesson Corporation MCK.
Cardinal Health, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 13.5%. CAH’s earnings surpassed estimates in all the trailing four quarters, with an average surprise of 16%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardinal Health has gained 31.1% compared with the industry’s 11.2% rise over the past year.
HealthEquity, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 22%. HQY’s earnings surpassed estimates in three of the trailing four quarters and missed once, with an average of 9.1%.
HealthEquity has gained 13.3% against the industry’s 15.2% decline over the past year.
McKesson, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 10.7%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 8.1%.
McKesson has gained 17.3% compared with the industry’s 11.2% rise over the past year.
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