Nectero Medical Launches Phase II/III Trial for Small to Medium AAA Treatment

Nectero Medical, a biotech firm at the forefront of innovative aneurysmal disease treatments, has embarked on a pivotal clinical trial to assess a groundbreaking treatment for small to medium-sized abdominal aortic aneurysms (AAA). The Phase II/III study, named stAAAble, aims to evaluate the safety and effectiveness of the Nectero Endovascular Aneurysm Stabilization Treatment (EAST) System in patients with infrarenal AAAs measuring between 3.5 to 5.0 centimeters in diameter.
The Nectero EAST System introduces a novel, single-use endovascular device that includes a dual-balloon catheter and a proprietary compound containing pentagalloyl glucose (PGG). This compound is designed to be delivered directly to the aneurysmal wall, where it can adhere to elastin and collagen fibers, potentially reinforcing the aortic wall and mitigating the risk of aneurysm deterioration.
Dr. Grace Wang, a vascular surgery expert and co-principal investigator of the stAAAble study, expressed optimism about the potential impact of the Nectero EAST System on the lives of thousands of patients afflicted with aneurysmal disease. The trial is set to enroll 400 participants across numerous U.S. sites, with a 1:1 randomization to either the Nectero EAST System or active surveillance, which is the current standard of care.
The primary outcome measure of the trial will be a composite of AAA-related fatalities, ruptures, and repairs, while the secondary endpoint will focus on aneurysm growth as determined by CT scan assessments at the 24-month mark. The study will also include annual follow-ups at the 3, 4, and 5-year intervals.
Jack Springer, CEO of Nectero Medical, highlighted the significance of the trial's initiation, noting that the Nectero EAST System could become the first early intervention therapy approved for small to mid-sized AAAs. The system's procedure is straightforward for vascular surgeons well-versed in endovascular techniques, taking under an hour to perform, and it does not necessitate any specialized tools or leave a permanent implant. Furthermore, it does not impede any subsequent interventions that may be required.
The Nectero EAST System is poised to offer an alternative treatment option for the over 1 million diagnosed Americans living with AAA, with approximately 60,000 undergoing treatment annually. Current treatments are typically reserved for larger aneurysms or those that are symptomatic or rapidly expanding. Smaller aneurysms are usually monitored through serial imaging, which carries a 0.5-5% annual risk of rupture.
The company's commitment to advancing patient care is evident in their ongoing research and development efforts. Early clinical results from the first-in-human study were recently published in a reputable medical journal, providing a foundation for the current trial's objectives. If the Nectero EAST System proves successful in the stAAAble trial, it could revolutionize the treatment landscape for patients with smaller AAAs, offering them a therapeutic alternative to surveillance alone.