BREAKING NEWS: We are pleased to announce FDA approval of LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. To the hundreds of women and dedicated investigators who participated in this important clinical work that brought us to where we are today, THANK YOU! We wouldn’t be here without your support. 

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See what matters most. Illuminate breast cancer in real-time.

Revolutionary Approach to Imaging Tumor Cells Achieved 100% Detection of Residual Cancer and Well Tolerated in First Patient Samples

Poster Presentation of Trial Findings at The American Society of Breast Surgeons Annual Meeting

Wellesley, Mass., April 13, 2016 – Lumicell, a leader in the field of image-guided cancer surgery, today announced it successfully completed its Phase 2a feasibility study on the Company’s groundbreaking LUM Imaging System, consisting of an optical contrast agent, LUM015, and the LUM Imaging DeviceCollaborators from the Breast Program at Massachusetts General Hospital will present a poster based on the clinical study titled “Feasibility of the LUM imaging system for real-time, intraoperative detection of residual breast cancer in lumpectomy cavity margins.” This poster will be presented at The American Society of Breast Surgeons 17th Annual Meeting in Dallas, Texas on Friday, April 15th, 2016 from 6:00 pm-7:30 pm CDT.  

Lumicell is addressing the number one challenge in breast cancer surgery – the need to remove all cancer cells within the lumpectomy cavity during the first surgery. In the field of cancer surgery, the goal is clean margins. Obtaining tumor-free margins is crucial for local control in breast conserving surgery. Every year more than 60,000 women undergoing lumpectomy must endure re-excision due to positive margins discovered on final histopathology examination. Second surgeries increase discomfort, add emotional and cosmetic expenses to the patient, and may cost the healthcare system close to $1B annually. The LUM Imaging System could be used for intraoperative, in vivo detection of microscopic residual cancer in the lumpectomy cavity to achieve tumor-free margins at the time of surgery, thus reducing rates of re-excision. The Company’s feasibility study is the first to use the LUM Imaging System in vivo in human cancers.  

“Obtaining tumor-free margins is critical in breast conserving surgeries,” said Barbara L. Smith, MD, PhD, Director of the Breast Program at Massachusetts General Hospital, who led the study. “We are encouraged by our initial findings demonstrating the potential of the LUM Imaging System for real-time identification of residual cancer cells in the lumpectomy cavity of patients with breast cancer.”

Research from a prior study, recently published in Science Translational Medicinehighlights the use of LUM015 to detect cancer in vivo in a mouse model of soft tissue sarcoma (STS) and ex vivo in a first-in-human Phase 1 clinical trial (NCT01626066). This Phase 2a feasibility study (NCT02438358) in breast cancer patients demonstrates the first-ever use of the LUM Imaging System for in vivo imaging in breast conserving surgeries. The study results show that the LUM Imaging System differentiates between tumor and normal tissue in vivo and ex vivo with administration of LUM015 just a few hours before the surgery with no impact to pre-operative and surgical workflow. Most importantly, it displayed 100% detection of residual cancer. Based on these results, the feasibility study is being expanded into a larger cohort of breast cancer patients in which the LUM Imaging System will be used in vivo to guide the resection of tumor and evaluate the reduction in positive margins and re-excisions.

“We aim to help surgeons increase the chances of success in the first surgery by giving real-time visual feedback of residual cancer in the tumor cavity,” said W. David Lee, CEO of Lumicell. “A diagnosis of breast cancer can be devastating, and increasing the chances of success with the first surgery can be tremendously reassuring to patients and their families. We are proud to partner with Massachusetts General Hospital and the National Cancer Institute and are encouraged by our first-in-human study results.”

Pre-clinical toxicology studies and clinical production of LUM015 was financed with federal funds from the National Cancer Institute, National Institutes of Health, under NCI’s Experimental Therapeutics Program (next.cancer.gov). Part of this clinical trial is conducted with federal funds from the National Cancer Institute, National Institutes of Health, Grant R21 CA173762.

About Lumicell, Inc.

Lumicell is a leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative margin assessment system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable optical contrast agent and a novel hand-held imaging device with exquisite single-cell detection. The unprecedented ability to see and remove all cancer cells during the initial surgery has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is initially investigating its margin assessment system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications may include surgeries for lung, prostate, ovarian, colorectal and brain cancers. For more information, please visit www.lumicell.com.

What is LumiSystem™?

LumiSystem is the combination of the following FDA approved products – LUMISIGHT™, an optical imaging agent, and Lumicell™ DVS, a fluorescence imaging device. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.

Indications for Use (Test)

LUMISIGHT, an optical imaging agent, and Lumicell DVS, a fluorescence imaging device, are indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

IMPORTANT SAFETY INFORMATION FOR LUMICELL™ DVS and LUMISIGHT™

LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG).

Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and if one is suspected, immediately discontinue the injection and initiate appropriate therapy.

LUMISIGHT™ (pegulicianine) Important Safety Information

What is LUMISIGHT (pegulicianine)?

LUMISIGHT (pegulicianine) is an optical fluorescence imaging agent used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.

Important Safety Information

  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid using dyes before imaging with LUMISIGHT.

What are the most common side effects of LUMISIGHT?

The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Boxed Warning.

Lumicell™ Direct Visualization System (DVS) Important Safety Information

What is the Lumicell™ DVS?

The Lumicell™ Direct Visualization System (DVS) is for use in patients with breast cancer to help detect cancerous tissue within the lumpectomy cavity after the removal of the primary specimen during surgery. The Lumicell DVS is used with LUMISIGHT™ (pegulicianine), an imaging agent to visualize the lumpectomy cavity.

Important Safety Information

  • Adjunctive use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care procedures and pathology. Your healthcare provider must be trained on proper use of the Lumicell DVS, and breast conserving surgery prior to performing any procedures.
  • Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity who have received LUMISIGHT.
  • Tissue perforation or damage: During the procedure, your healthcare provider should avoid excessive pressure or torque with the handheld probe while inside the cavity as it can cause tissue perforation or damage.
  • Infection risk: To avoid infection risk, the reusable handheld probe and cables should be properly and completely disinfected and reprocessed after each use by your healthcare provider. Your healthcare provider should also ensure proper use of the sterile, single-use probe cover.
  • Eye discomfort: Your healthcare provider should avoid direct eye exposure to handheld light probe as it may cause pain.

Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.  For complete product information visit www.LumiSystem.com