Alume Biosciences Announces U.S. FDA Breakthrough Therapy Designation Granted for Bevonescein, a First-in-Class adjunct in the real-time intraoperative visualization of nerves during head and neck surgical procedures in adults
Alume Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for bevonescein for use as an adjunct in the real-time intraoperative visualization of nerves during head and neck surgical procedures in adults. Bevonescein is an investigational, intravenously administered fluorescent peptide-dye conjugate that binds to nerve tissue. Because the fluorescent signal is in the visible spectrum, surgeons can see highlighted nerves directly with their eyes in real time during surgery, without the need for a camera, imaging interface, or display monitor. The designation follows Fast Track designation for bevonescein, which FDA granted in 2022.
