Fast Track Designation augments previously granted Breakthrough Device Designation
Newton, Mass., Nov. 17, 2020 –Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer. Fast Track designation represents another major milestone in Lumicell’s path to FDA approval.
“The FDA’s decision to grant Fast Track Designation is an important step in bringing the Lumicell Imaging System closer to FDA approval and providing surgeons with this innovative technology to detect and remove cancerous tissue more confidently and efficiently than ever before,” said Kevin Hershberger, President and CEO at Lumicell. “We are very excited with the progress as we continue enrollment in our Breast Cancer Pivotal Trial which we expect will further build on the strong clinical data Lumicell demonstrated in our multi-center feasibility clinical study.”
Fast Track is a program designed to facilitate the development and expedite the review of new drugs that treat serious conditions and fill an unmet medical need. Filling an unmet need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapies. As a Fast Track designee, Lumicell will have access to early and frequent communications with the FDA to discuss Lumicell’s development plans and ensure collection of appropriate data to support the approval process. Additionally, with rolling review Lumicell plans to submit modules for the New Drug Application (NDA) for FDA review as they are ready, rather than submitting the full NDA package upon the completion of clinical trials.
This latest milestone complements our previously received FDA Breakthrough Device designation for breast cancer and all solid tumors from the FDA Center for Devices and Radiological Health (CDRH). Similar to Fast Track, Breakthrough Device Designation is awarded to medical devices or combination products that provide more effective treatment of life-threatening diseases or conditions with the goal of providing physicians and patients access to these technologies.
“Lumicell’s technology is a paradigm shift – we’re now looking at the surface of the cavity instead of lumpectomy margins,” said Irene Wapnir, MD, Surgical Oncologist at Stanford Health Care. “It’s a fresh approach to in-vivo cancer surgeries. Instead of focusing on what was in the lumpectomy specimen, we prioritize what’s left behind in the cavity.”
Existing surgical tools often fail to identify and remove all of the cancerous tissue in the initial surgical intervention, resulting in 20 – 40% of breast cancer patients requiring a second surgery to remove additional cancerous tissue. The LUM Imaging System was developed to allow surgeons to see and remove residual cancer in real-time—significantly reducing the risk of leaving cancer behind, second surgeries and cancer recurrence.
For more information about the LUM Imaging System and Lumicell’s clinical trials, visit https://lumicell.com/clinical-trials/clinical-trials.php.
About Lumicell, Inc.
Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM Imaging System has unprecedented ability to see and guide removal of cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM Imaging System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver cancers. For more information, please visit www.lumicell.com.
