Thursday, the FDA granted 510(k) clearance to AngioDynamics Inc’s AlphaVac F1885 System for pulmonary embolism (PE).

The expanded FDA indication allows for the utilization of the AlphaVac F1885 System for PE, which broadens the applicability of the AlphaVac F1885 System in the non-surgical removal of thrombi or emboli from the venous vasculature. 

The indication expands treatment options for patients with PE, reducing thrombus burden and improving right ventricular function.

Also Read: AngioDynamics Resolves Decade-Long Patent Litigation With Becton, Dickinson In Settlement Agreement.

In December 2023, AngioDynamics ( ANGO ) completed patient enrollment in its Acute Pulmonary Embolism Extraction Trial with the AlphaVac System (APEX-AV) study that enrolled 122 patients.

The APEX-AV Study showed a mean decrease in the RV/LV ratio from baseline to 48 hours post-procedure of 0.45 (significantly greater than the pre-defined performance goal of 0.12 and an MAEs rate of 4.1% (significantly lower than the pre-defined performance goal of 25%. 

The study also showed a 35.5% mean reduction in clot burden from baseline to 48 hours post-procedure.

Concurrently, AngioDynamics ( ANGO ) reported third-quarter 2024 sales of $75.18 million, slightly below the consensus of $75.73 million.

On a pro forma basis, excluding the Dialysis and BioSentry businesses, sales increased 8% to $66.0 million, an increase of 8.0% compared to the prior-year quarter. 

Pro forma Med Tech net sales of $25.7 million increased 12.6% Y/Y, and med device net sales reached $40.3 million, up 5.5%.

The company reported an adjusted EPS loss of $(0.16), missing the consensus of $(0.13).

Guidance: Angiodynamic expects the fiscal year 2024 sales of $270 million-$275 million, reflecting the PICC and midline businesses divestiture and discontinuance of radiofrequency ablation and syntrax businesses, which accounted for ~$50 million of prior guidance of $320 million -$325 million vs. the consensus of $312.14 million.

The company expects FY2024 gross margin to be approximately 52%-54% and adjusted EPS of $(0.54)-$(0.58) versus consensus of $(0.43).

Price Action: ANGO shares are up 11.9% at $6.81 on the last check Thursday.