Nectero EAST System Granted FDA Breakthrough Therapy Designation

November 7, 2023—Nectero Medical recently announced that the FDA has granted Breakthrough Therapy designation for the Nectero endovascular aneurysm stabilization treatment (EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5 to 5 cm.

The single-use endovascular system is comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall where it binds to elastin and collagen to strengthen the aortic vessel wall and potentially reduce the risk of further degradation.

The company stated that Breakthrough Therapy designation for Nectero EAST is supported by results from the first-in-human (FIH) study of the device. Early clinical results of the FIH study were recently published by Stephen W.K. Cheng, MS, et al in Journal of Vascular Surgery (2023;78:929-935).

The study showed that a single, localized administration of PGG to patients with small- to medium-sized infrarenal AAAs was safe and demonstrated the potential to slow the growth of AAAs. Additional follow-up data from the FIH study will be presented at the 50th annual VEITHsymposium held November 14-18 in New York, New York, advised Nectero.

According to the company, the FDA Breakthrough Therapy designation requires that the novel drug treats a serious condition, and preliminary clinical evidence indicates that the drug may provide a substantial improvement over available therapy on a clinically significant endpoint(s).

In August 2023, Nectero announced it received FDA Fast Track designation, which allows for more frequent FDA interactions and eligibility for priority and rolling review.

The newly granted Breakthrough designation expands FDA’s organizational commitment to involve senior managers. Nectero Medical will meet with FDA in the near term to review the development program and establish a plan for ongoing communications.

Additionally, the company advised that patient enrollment for the phase 2/3 STAAABLE randomized controlled clinical trial is targeted to begin in Q4. STAABLE, which was first announced in July, will evaluate the safety and effectiveness of the Nectero EAST.