Press Release
April 18, 2024

Lumicell’s Novel Optical Imaging Agent Platform LUMISIGHT™ & Direct Visualization System for Detection of Residual Breast Cancer Receives FDA Approval

The Life Sciences Regulatory & Compliance and Life Sciences teams 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.

Lumicell is 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 by Julie Tibbets, Steve Tjoe, Matt Wetzel and Elizabeth Mulkey (Regulatory), and Michael Bison (Life Sciences), Paul Rosie and Blake Tyler (Technology).

For additional details on the approval, please see the Lumicell’s press release.