Nectero Medical, a clinical-stage biotechnology company developing therapies for aneurysmal disease, announced today that the American Medical Association’s CPT Editorial Panel has approved two Category III CPT codes applicable to the Nectero Medical EAST® System procedure via a percutaneous or open approach. This designation represents a key milestone toward future reimbursement and broader clinical adoption.
Jack Springer, President and Chief Executive Officer of Nectero Medical said:
“This approval is a meaningful step forward in validating our technology and preparing for reimbursement. It reflects extensive collaboration with multiple medical societies to build consensus and define the procedure accurately.”
Category III CPT codes are designated for emerging technologies, services, and procedures. The two newly approved codes will facilitate physician and hospital billing and reimbursement for treatment with the Nectero EAST System in clinical practice.
The Nectero Medical EAST System is currently being evaluated in the IND Phase II/III stAAAble Study, a multi-center, randomized clinical trial assessing safety and efficacy in patients with small- to medium-sized abdominal aortic aneurysms (AAAs). The IND submission was supported by a prospective, first-in-human study of 46 patients treated outside the U.S., which demonstrated that a single, localized administration of pentagalloylglucose (PGG) was safe and showed the potential to slow aneurysm growth. One-year follow-up results on the full cohort of patients from this study were recently presented at the Charing Cross Conference in London, U.K. The data showed a significant reduction in aneurysm diameter growth compared to historical control data, with 91% of patients growing at less than the expected growth rate.
Background on AAA and Treatment Challenges
Small- to medium-sized AAAs (3.5–5.0 cm in women, 3.5–5.5 cm in men) are typically managed with imaging surveillance, as no proven therapeutic interventions currently exist for this patient group. Once an AAA reaches a critical size, open surgery or endovascular repair becomes warranted—but both carry significant procedural risks. The ability to slow aneurysm growth and delay or avoid invasive procedures would represent a major advancement in patient care.