Lumicell said it completed enrollment in a Phase C feasibility clinical trial for its intraoperative breast cancer imaging system.
The Newton, Mass.-based company expects results later this year and plans to start a pivotal trial by the end of 2019 before it applies for FDA approval.
Lumicell’s imaging system is designed to enable surgeons to observe and remove residual cancer cells during the initial surgery in order to reduce the risk of second surgeries and cancer recurrence while minimizing the removal of healthy tissue and improving operation efficiency.
The Phase C feasibility study includes 234 patients across 16 sites, led by director of the breast program at Massachusetts General Hospital, Dr. Barbara Smith. In 2017, Lumicell received $28.7 million in Series C funding and used it to fund its clinical program for the breast cancer surgery tech.
Lumicell’s system is also in early feasibility trials for treating prostate, brain, colorectal, esophageal and pancreatic cancer, along with peritoneal metastases from primary ovarian and colon cancers.
“The Lumicell System gives me increased confidence during my lumpectomy procedures; for numerous patients enrolled in the Phase C trial, my team was able to avoid a second surgery by identifying and removing tissue highlighted by the Lumicell System,” said Dr. David Carr, general surgeon at Novant Health Salem Surgical Associates and principal investigator for the trial at Novant Health. “I’m encouraged by our experiences with the system thus far, and I’m eager to have this as an option available for all of our breast cancer patients.”
“With the Lumicell Phase C trial now fully enrolled, we are quickly moving forward with the data review, and finalizing the design and plans for the pivotal study to begin later this year,” added Lumicell executive chairman Andrey Zarur in prepared remarks. “We’re confident that we have developed a pivotal trial design that is compelling to patients and surgeons. And we’re optimistic that the pivotal trial will deliver results clearly demonstrating the clinical value of the Lumicell System in the treatment of breast cancer and benefits to the patients.”