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June 30, 2026

FIH AAA Study of Nectero EAST System Evaluates 2-Year Proximal Neck Dynamics

KEY TAKEAWAYS

  • 2-year results from the first-in-human study of the investigational Nectero EAST system met the study's safety endpoints and showed lower-than-expected AAA growth rates.
  • The study demonstrated stable proximal neck anatomy through 2 years after treatment with pentagalloylglucose.
  • Enrollment is ongoing in a 400-patient randomized pivotal trial comparing the Nectero EAST system with standard-of-care surveillance.

June 30, 2026—Nectero Therapeutics announced the 2-year findings from a first-in-human (FIH) multicenter study evaluating treatment of small- to medium-sized abdominal aortic aneurysms (AAA) with pentagalloylglucose (PGG) using the company’s investigational Nectero endovascular aneurysm stabilization treatment (EAST) system.

Nectero stated that the study met safety endpoints, and AAA growth rates were significantly lower than expected through 2 years posttreatment.

According to Nectero, the FIH study enrolled 46 patients with AAAs of a median maximum diameter of 4.3 cm. Patients were treated with a PGG drug solution delivered directly to the aneurysm wall through a dual-balloon catheter. Patient follow-up was completed with 44 patients through year 1 and 41 patients through year 2.

The endpoints of the FIH study focused on patient safety, procedural success, and AAA growth dynamics. However, the investigators also examined the morphology of the adjacent proximal neck tissue, including changes in diameter, length, angulation, and thrombus burden.

The company noted that the findings on the impact of PGG treatment on proximal neck dynamics were recently presented at the 2026 Vascular Annual Meeting (VAM) by Matthew Eagleton, MD.

“The data show stable proximal neck diameters in the first 15 mm below the lowest main renal artery with angulation remaining stable and a slight reduction in proximal neck thrombus through 2 years,” commented Dr. Eagleton in Nectero’s press release. “Maintaining proximal neck anatomy and future seal zone eligibility would allow these patients to retain access to less invasive endovascular repair should they eventually reach treatment thresholds. Patients will continue to be followed through 3 years.”

In addition to ongoing follow-up in the FIH study, Nectero advised that it is currently conducting enrollment in a pivotal 400-patient randomized controlled clinical trial evaluating the effect of PGG treatment versus standard-of-care surveillance of small- to medium-sized AAA.

Previously, the company announced that Andrew Holden, MD, presented the initial 2-year findings from the Nectero EAST FIH AAA trial data in April at the CX 2026, the 48th Charing Cross Symposium.

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