“My wife died of breast cancer in 2003. Since then, I’ve made it my mission to help prevent others from experiencing the same pain from cancer left behind after surgery.”
-W. David Lee, Co-Founder
A Personal Mission Leads to Innovation
Following our founding in 2008 by David Lee in response to his own loss, Lumicell has spent more than a decade reimagining the practice of cancer surgery. Our initial focus is on breast cancer.
More than 280,000 women are diagnosed with invasive breast cancer or ductal carcinoma in situ (DCIS) each year in the U.S., leading to approximately 175,000 lumpectomies, 105,000 mastectomies, and 43,000 deaths annually.1 2
The purpose of breast-conserving surgeries, also known as lumpectomies, is to remove all traces of tumor. However, until now, the only way to infer whether residual cancer might remain inside the cavity is by looking at the margins of removed tissue outside the cavity.
Striving to Remove the Uncertainty from Cancer Surgery
Lumicell engineers from MIT, in close collaboration with leading breast surgeons, are developing the Lumicell™ Direct Visualization System* (DVS) to detect and guide the removal of residual cancerous tissue within the breast cavity, in real time, during breast conserving surgery.
Our combination product consists of an investigational proprietary, pan-oncological solid tumor optical imaging agent, LUMISIGHT*™, and our investigational intra-cavity hand-held imaging probe and patient calibrated tumor detection software designed to empower surgeons to take guided shaves during the initial surgery.
The investigational Lumicell DVS has the potential to guide the removal of residual cancer in real time, thereby identifying cancer during the initial surgery that may otherwise remain undetected and recur or require a second surgery to address.
In recognition of the potential to fill an unmet need in the marketplace, the U.S. Food & Drug Administration has granted two designations related to the system. In 2018, Lumicell received Breakthrough Device Designation for the Lumicell DVS for breast, GI and all solid tumors. In 2020, Lumicell received Fast Track Designation for LUMISIGHT, our optical imaging agent.
The INSITE Breast Cancer pivotal trial is complete, and Lumicell is in the process of submitting marketing applications to the FDA.
The Lumicell Direct Visualization System (DVS) has potential utility in multiple solid tumor indications. Seven different cancer types have been clinically evaluated in more than 800 patients at 18 leading medical centers across the U.S.
*CAUTION: LUMISIGHT and Lumicell Direct Visualization System (DVS) are investigational products that are limited by Federal (or United States) law to investigational use. LUMISIGHT and Lumicell DVS are not authorized for marketing for any indication in any jurisdiction.