Trial to randomize 400 subjects at multiple sites, primarily in the U.S., to evaluate safety and efficacy of the investigational Nectero EAST System for treatment of infrarenal AAA, maximum diameter 3.5-5.0cm
TEMPE, Ariz.–(BUSINESS WIRE)–Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease and improve patients’ lives, today announced initiation of a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm.
The Nectero EAST System is a single-use, endovascular system 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 can bind to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation.
“If proven safe and efficacious, the Nectero EAST System has the potential to positively impact thousands of patients living with aneurysmal disease,” said Dr. Grace Wang, Associate Professor of Surgery in the Division of Vascular and Endovascular Surgery at the Hospital of the University of Pennsylvania and stAAAble Study Co-Principal Investigator. “We are honored and excited to be one of the participating sites in this groundbreaking trial.”
The stAAAble trial is a prospective, multi-center, clinical trial of 400 subjects with small- to medium-sized infrareneal AAA randomized (1:1) to the Nectero EAST System vs. active surveillance, the current standard of care. Subjects will be enrolled across multiple sites, predominantly in the U.S. The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, EVAR, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm). The secondary endpoint is growth in aneurysm diameter over time based on CT scan core laboratory readings at 24 months. The study will have continued follow-up annually at 3, 4, and 5 years.
“The Nectero EAST System aims to be the first proven early intervention therapy for small- to mid-sized AAA,” commented Jack Springer, President and Chief Executive Officer of Nectero Medical. “Initiation of our randomized clinical trial is a significant milestone in our journey to bring this potentially transformative therapy to AAA patients.”
About the Nectero EAST® System
The Nectero EAST System is a single-use, endovascular system for the treatment of infrarenal abdominal aortic aneurysm (AAA). It is estimated that >1M diagnosed 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 and carry a 0.5-5% 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 can bind to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation. The procedure does not require any specialized tools for vascular surgeons trained in endovascular techniques, takes less than an hour to complete, leaves no permanent implant behind and does not preclude any future interventions. Early clinical results of the FIH study were recently published in the Journal of Vascular Surgery. The safety and efficacy of the Nectero EAST System in treating patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5 – 5.0cm, is being investigated in the Nectero EAST System for Small- to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy (stAAAble) clinical trial. If successful, the Nectero EAST System may offer patients with smaller AAAs a first approved therapeutic option beyond surveillance.
For more information, please visit https://necteromedical.com.
Disclaimer
There is no assurance as to the results of the study described in this press release or the efficacy of the Nectero EAST System.
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