Nectero Medical, a clinical-stage biotechnology company pioneering novel therapies to treat aneurysmal disease, 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.”
SOURCE: BusinessWire