The FDA on May 4 granted biotechnology company Alume Biosciences permission to investigate the use of a nerve imaging drug during spine surgery, Biospace reports.
Alume's ALM-488 peptide-dye conjugate is designed for the fluorescent highlighting of nerves during head and neck procedures.
ALM-488 binds to the extracellular matrix of nerves, allowing real-time nerve illumination intraoperatively.
The phase 1/2 trial will explore the safety and efficacy of ALM-488 in up to 36 patients undergoing surgery.
Beginning in the second quarter, the trial will take place at the University California San Diego, Stanford Medical Center in Palo Alto, Calif., and Harvard-Massachusetts Eye & Ear in Boston.