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 Fast Track 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.
Fast Track designation offers significant advantages to companies developing novel technologies to treat unmet clinical needs. The designation allows for more frequent meetings with the FDA to ensure appropriate data collection in support of drug approval, enables eligibility for accelerated approval and priority review, and supports rolling review, where individual sections of Biologic License Application (BLA) or New Drug Application (NDA) can be submitted once completed rather than waiting for the entire application to be reviewed.
Each year, FDA limits the Fast Track designation to only a select number of novel drugs that offer the potential to treat a serious disease. “This designation reinforces Nectero Medical’s belief that the Nectero EAST System has the potential to address a large segment of patients who suffer from a serious progressive disease with no proven treatment options. Available therapies are reserved primarily for patients who fall into the highest-risk category,” said Jack Springer, President and Chief Executive Officer of Nectero Medical. “We are proud to be advancing a treatment that has the potential to impact so many lives and are extremely pleased that FDA acknowledged this through our designation.”
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.