Intraoperative Detection Articles & Analysis
3 news found
Avelas is developing pegloprastide (AVB-620), a novel fluorescent imaging agent used in combination with a fluorescence camera system, which has FDA Breakthrough Therapy Designation, for the intraoperative detection and visualization of positive margins during breast cancer surgery. The goal of intraoperative image-guided surgery with ...
SAN DIEGO, CA – Avelas Biosciences, Inc., pioneering the field of intraoperative fluorescent cancer imaging, today announced that the company has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for pegloprastide (AVB-620) for the intraoperative detection and visualization of positive margins during ...
The secondary endpoint of intraoperative patient-level cancer detection performance in margin-relevant tissue, using prespecified thresholds, indicated that up to 75% of patients that would have had a positive margin could benefit from this investigation product at a statistically significant level. ...