Fluorescence-Guided Breast Cancer Surgery: International Pivotal Phase III RCT receives FDA IND Clearance
https://dacostalab.ca/wp-content/uploads/2021/04/US-food-and-drug-display-pic-1030x579.png 1030 579 DaCosta Lab DaCosta Lab https://dacostalab.ca/wp-content/uploads/2021/04/US-food-and-drug-display-pic-1030x579.pngToday, SBI ALApharma Canada Inc., a subsidiary of photonamic GmbH & Co. KG ( Pinneberg, Germany), a subsidiary of SBI Holdings, Inc. (Minato-ku, Tokyo); received FDA Investigational New Drug (IND) clearance for its Pivotal Phase III randomized controlled trial (RCT) evaluating the safety and efficacy of PD G 506 A (5-ALA HCl) in intraoperative margin assessment during breast conserving surgery. This multicenter trial involves over 400 patients across 20 centers across the US and Canada and will use SBI Canada’s patented intraoperative handheld Eagle Fluorescence Imaging SystemTM to visualize 5-ALA-induced protoporphyrin IX (PpIX) fluorescence in real-time in breast cancer tissues during surgery.…
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