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AngioDynamics' (ANGO) AlphaVac Gets FDA Nod for PE Treatment
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AngioDynamics, Inc. (ANGO - Free Report) recently announced the FDA 510(k) clearance for its AlphaVac F1885 System for the treatment of pulmonary embolism (PE).
The application of the AlphaVac F1885 System in the non-surgical excision of thrombi or emboli from the venous vasculature is increased by the enhanced FDA indication, which permits the system to be used for PE therapy. By lowering the thrombus burden and enhancing right ventricular function, the indication broadens the range of therapy alternatives available to PE patients.
Price Performance
In the past six months, ANGO’s shares have lost 10.5% against the industry’s rise of 20.6%. The S&P 500 has gained 19.8% in the same time frame.
Image Source: Zacks Investment Research
More on AlphaVac F1885 System
The AlphaVac F1885 System is currently approved for use as an emergent first-line device for treating PE and removing thromboemboli from the venous system. The system consists of an obturator, a waste bag assembly, an ergonomic handle, and an 18F cannula angled at an angle of 85 degrees. To offer safety and efficacy information for a clearing unique to PE, the APEX-AV Study was developed.
More on the APEX-AV Study
In December 2023, AngioDynamics announced that patient enrollment in the single-arm Investigational Device Exemption study, Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV), was completed. The study involved the enrollment of 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to evaluate the AlphaVac F1885 System for the treatment of PE.
APEX-AV study's primary efficacy endpoint was the RV/LV ratio decrease from baseline to 48 hours after surgery. The rate of Major Adverse Events within the first 48 hours, which included occurrences like severe bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury, was the main safety goal. After the index procedure, patients were monitored for 30 days.
The results of the APEX-AV research demonstrated a quick clearing of the clot burden in the pulmonary arteries and a notable improvement in RV function.
The 510(k) clearance of the AlphaVac System is likely to represent an important achievement toward the treatment of PE and further boosting AngioDynamics’ revenues.
Industry Prospects
Per a report by Data Bridge Market Research, the global pulmonary embolism market size, which was valued at $1.65 billion in 2022, is expected to reach more than $3.12 billion by 2030 at a growth rate of 8.3%.
The global pulmonary embolism market is driven by an increase in the prevalence of cancer. Another significant factor influencing the growth rate of the pulmonary embolism market is the rising healthcare expenditure, which helps in improving its infrastructure.
Notable Developments
AngioDynamics recently announced that it has entered into a settlement agreement with Becton, Dickinson and Company, popularly known as BD, to resolve all outstanding patent litigation with C.R. Bard, Inc., an affiliate of BD.
AngioDynamics is likely to benefit from the settlement of this prolonged legal dispute to a successful resolution as it will lower the company’s ongoing legal expenses and terminate more than 10-year distraction.
In February, the company announced the completion of the sale of its PICC and Midline product portfolios to Spectrum Vascular for $45 million in cash.
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Cencora, Inc. (COR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 58.3% compared with the industry’s 18.9% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 14.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 51.9% compared with the industry’s 3.2% rise in the past year.
Cencora, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 9.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 6.7%.
Cencora’s shares have surged 51.5% compared with the industry’s 3.6% rise in the past year.
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AngioDynamics' (ANGO) AlphaVac Gets FDA Nod for PE Treatment
AngioDynamics, Inc. (ANGO - Free Report) recently announced the FDA 510(k) clearance for its AlphaVac F1885 System for the treatment of pulmonary embolism (PE).
The application of the AlphaVac F1885 System in the non-surgical excision of thrombi or emboli from the venous vasculature is increased by the enhanced FDA indication, which permits the system to be used for PE therapy. By lowering the thrombus burden and enhancing right ventricular function, the indication broadens the range of therapy alternatives available to PE patients.
Price Performance
In the past six months, ANGO’s shares have lost 10.5% against the industry’s rise of 20.6%. The S&P 500 has gained 19.8% in the same time frame.
Image Source: Zacks Investment Research
More on AlphaVac F1885 System
The AlphaVac F1885 System is currently approved for use as an emergent first-line device for treating PE and removing thromboemboli from the venous system. The system consists of an obturator, a waste bag assembly, an ergonomic handle, and an 18F cannula angled at an angle of 85 degrees. To offer safety and efficacy information for a clearing unique to PE, the APEX-AV Study was developed.
More on the APEX-AV Study
In December 2023, AngioDynamics announced that patient enrollment in the single-arm Investigational Device Exemption study, Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV), was completed. The study involved the enrollment of 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to evaluate the AlphaVac F1885 System for the treatment of PE.
APEX-AV study's primary efficacy endpoint was the RV/LV ratio decrease from baseline to 48 hours after surgery. The rate of Major Adverse Events within the first 48 hours, which included occurrences like severe bleeding and serious device-related clinical deterioration, pulmonary vascular injury, and cardiac injury, was the main safety goal. After the index procedure, patients were monitored for 30 days.
The results of the APEX-AV research demonstrated a quick clearing of the clot burden in the pulmonary arteries and a notable improvement in RV function.
The 510(k) clearance of the AlphaVac System is likely to represent an important achievement toward the treatment of PE and further boosting AngioDynamics’ revenues.
Industry Prospects
Per a report by Data Bridge Market Research, the global pulmonary embolism market size, which was valued at $1.65 billion in 2022, is expected to reach more than $3.12 billion by 2030 at a growth rate of 8.3%.
The global pulmonary embolism market is driven by an increase in the prevalence of cancer. Another significant factor influencing the growth rate of the pulmonary embolism market is the rising healthcare expenditure, which helps in improving its infrastructure.
Notable Developments
AngioDynamics recently announced that it has entered into a settlement agreement with Becton, Dickinson and Company, popularly known as BD, to resolve all outstanding patent litigation with C.R. Bard, Inc., an affiliate of BD.
AngioDynamics is likely to benefit from the settlement of this prolonged legal dispute to a successful resolution as it will lower the company’s ongoing legal expenses and terminate more than 10-year distraction.
In February, the company announced the completion of the sale of its PICC and Midline product portfolios to Spectrum Vascular for $45 million in cash.
AngioDynamics, Inc. Price
AngioDynamics, Inc. price | AngioDynamics, Inc. Quote
Zacks Rank & Stocks to Consider
ANGO carries a Zacks Rank #4 (Sell) at present.
Some better-ranked stocks in the broader medical space are DaVita Inc. (DVA - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Cencora, Inc. (COR - Free Report) .
DaVita, sporting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 12.1%. DVA’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 35.6%. You can see the complete list of today’s Zacks #1 Rank stocks here.
DaVita’s shares have gained 58.3% compared with the industry’s 18.9% rise in the past year.
Cardinal Health, flaunting a Zacks Rank of 1 at present, has an estimated long-term growth rate of 14.2%. CAH’s earnings surpassed estimates in each of the trailing four quarters, with the average being 15.6%.
Cardinal Health has gained 51.9% compared with the industry’s 3.2% rise in the past year.
Cencora, carrying a Zacks Rank of 2 (Buy) at present, has an estimated long-term growth rate of 9.8%. COR’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 6.7%.
Cencora’s shares have surged 51.5% compared with the industry’s 3.6% rise in the past year.