Nectero Medical, a leading clinical-stage biotechnology firm dedicated to advancing therapies for aneurysmal diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for its Nectero Endovascular Aneurysm Stabilization Treatment (Nectero EAST®) System. This designation specifically applies to the treatment of patients with infrarenal AAAs (maximum diameter 3.5 – 5.0cm).
In a strategic move, Nectero Medical is set to commence a Phase II/III clinical trial (stAAAble) in Q4 2023 to rigorously evaluate the safety and efficacy of the Nectero EAST® System. The Breakthrough Therapy status, a recognition of the system's potential to markedly improve existing therapies, is backed by compelling results from its first-in-human study (NCT05133492).
The Breakthrough Therapy designation aligns with the advantages of the Fast Track program and underscores the FDA's commitment to actively engage in the development process. Nectero Medical, emphasizing the gravity of AAA as a serious condition, is optimistic about the Nectero EAST® System's ability to make a substantial impact by addressing early-stage aneurysms. This proactive approach may potentially mitigate the need for more invasive procedures in the future.
The Nectero EAST® System targets a significant demographic, estimated to be over one million Americans living with AAA. Complications from AAA contribute to approximately 10,000 deaths annually in the U.S. Current treatments are typically reserved for larger or symptomatic AAAs, making the Nectero EAST® System a promising advancement in the field of aneurysm care.
