- Trial Phase
- Approved/Commercialized
- Time to Market
- Already on the market. Initial FDA 510(k) clearance June 2021. PE-specific clearance April 2024. CE Mark Europe May 2024.
- Why 4/10
- AlphaVac is already FDA-cleared and commercially marketed (initial 510k 2021, PE-specific clearance Apr 2024, expanded VTE clearance Nov 2025). The next binary catalyst would be the RECOVER-AV trial readout, but first patient enrolled June 2025 with no published completion date — likely 12+ months out. As an approved device with no imminent regulatory decision, per the rubric the score is capped at 4-5.
AlphaVac is an approved, revenue-generating product in a $1.87B+ thrombectomy device market growing ~7% CAGR. The key catalyst to watch is enrollment progress and eventual data from the RECOVER-AV long-term outcomes trial. The bigger near-term stock driver for ANGO is actually the NanoKnife oncology platform and its Medicare coverage catalyst (effective July 5, 2026), not AlphaVac. AlphaVac contributes to the Med Tech segment narrative but is not a standalone binary.
Price Chart
Executive Summary
AlphaVac is AngioDynamics' mechanical thrombectomy device for removing blood clots from large veins, including pulmonary embolism (PE). Already FDA-cleared (initial 2021, PE-specific April 2024, expanded VTE Nov 2025) and CE-marked in Europe (May 2024). The APEX-AV trial published in JSCAI (Jan 2025) showed 35.5% clot burden reduction, and the RECOVER-AV long-term outcomes study began enrollment in June 2025. It competes in a ~$1.9B thrombectomy device market growing ~7% CAGR, against Inari Medical's FlowTriever (acquired by Stryker for $4.9B in Dec 2025) and Penumbra's Indigo. AlphaVac is one of several growth drivers in AngioDynamics' Med Tech segment (FY2026: $150M, +18.4% YoY) but is not the company's primary near-term catalyst — that distinction belongs to the NanoKnife oncology platform.
How It Works
AlphaVac is a mechanical aspiration (vacuum-suction) device — a catheter inserted through a blood vessel that removes blood clots (thrombi/emboli) by suction. It uses a funnel-tipped cannula and ergonomic handle to clear blockages from large veins. Think of it like a tiny vacuum cleaner for blood clots in major vessels, particularly for life-threatening pulmonary embolism (blood clots in the lungs). It is NOT a drug — it is a medical device.
Trial Status
APEX-AV pivotal trial (122 patients, 25 US hospitals) completed; results published Jan 2025 in JSCAI showing 35.5% clot burden reduction. RECOVER-AV long-term outcomes trial (prospective, multi-national, single-arm) enrolled first patient June 2025. APEX-Return IDE study evaluating blood management system — FDA IDE approved Nov 2025, CMS approved Jan 2026.
The Two-Sided Case
Upcoming Catalysts
- RECOVER-AV trial enrollment updates and eventual topline readout (enrollment began June 2025, no firm completion date yet — likely 2027+)
- APEX-Return study data (AlphaReturn blood management system used with AlphaVac; IDE approved Nov 2025)
- Quarterly commercial adoption metrics in AngioDynamics earnings reports (next: Q1 FY2027, likely Oct 2026)
- Potential expansion of AlphaVac into additional venous thromboembolism (DVT) indications following the Nov 2025 expanded clearance
Source Filing
The SecBot filing or press-release report that triggered this drug report:
ANGIODYNAMICS INC 8-K ANGO ·Originating report