TEMPE, Ariz.–(BUSINESS WIRE)–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System to treat patients with infrarenal AAAs, maximum diameter 3.5 – 5.0cm. Nectero Medical is initiating a randomized, controlled Phase II/III clinical trial (stAAAble) to evaluate the product’s safety and effectiveness with first subject enrollment targeted in Q4 2023.
Breakthrough Therapy designation is an FDA program intended to facilitate design and conduct of an efficient product development program. It is a challenging status to obtain. 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). Nectero Medical’s Breakthrough Therapy designation is supported by results from the first-in-human (FIH) study (NCT05133492) of the Nectero EAST System. Early clinical results of the FIH study were recently published in the Journal of Vascular Surgery and showed that a single, localized PGG administration 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 will be presented at the VEITH Symposium in New York later this year.
In addition to the benefits of Fast Track (received in August 2023), which allows for more frequent FDA interactions and eligibility for priority and rolling review, Breakthrough Designation adds FDA’s organizational commitment to involve senior managers. Nectero Medical will meet with the Agency near term to review the development program and establish a plan for ongoing communications.
AAA is a serious condition associated with the potential for rupture and sudden death. The Nectero EAST System is intended to treat early, in small to mid-size aneurysms, and potentially avoid the need for a future, more invasive procedure that carries greater risks of morbidity and mortality.
“This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to have a significant impact for patients with AAA disease,” said Jack Springer, President and Chief Executive Officer of Nectero Medical. “We look forward to working closely with the FDA to advance this product to patients as quickly and efficiently as possible.”
About the Nectero EAST® System
The Nectero EAST System is a single-use, endovascular system for the treatment of infrarenal abdominal aortic aneurysms (AAA). It is estimated that >1M Americans are living with AAA and ~60,000 undergo treatment each year; complications of AAA account for approximately 10,000 deaths in the U.S. annually. Available treatments are primarily reserved for AAAs larger than 5.0/5.5cm (female/male) in diameter, symptomatic patients, or rapidly expanding aneurysms. Smaller AAAs are traditionally monitored with serial ultrasound or CT surveillance. Patients with small- and mid-sized aneurysms carry a .5-5% annual risk of rupture. The Nectero EAST 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 to potentially reduce the risk of further degradation. The procedure does not require any specialized tools, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. If successful, the Nectero EAST System may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance. For more information, please visit necteromedical.com.
CAUTION: There is no assurance as to the results of the study described in this press release or the efficacy of the Nectero EAST System.