TheLife Sciences Regulatory & ComplianceandLife Sciencesteams are pleased to have supported Lumicell in connection with its U.S. Food & Drug Administration approval of the company's New Drug Application for its LUMISIGHT" (pegulicianine) optical imaging agent and its Premarket Approval application for Lumicell" Direct Visualization System, together referred to as LumiSystem". This new agent and technology are important to the public health as 1 in 8 women in the U.S. has a risk of developing breast cancer in her lifetime. LumiSystem is for use as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.
Lumicellis a privately held company focused on enabling a more complete resection of cancer by advancing the development and commercialization of its innovative fluorescence guided surgery technology.
The Goodwin team is led byJulie Tibbets,Steve Tjoe,Matt WetzelandElizabeth Mulkey(Regulatory), andMichael Bison(Life Sciences),Paul RosieandBlake Tyler(Technology).
For additional details on the approval, please see the Lumicell'spress release.