LumiSystem™ was developed to address some key limitations of lumpectomy
The goal of lumpectomy surgery is to remove as much of the tumor as possible and a margin of healthy tissue to achieve what surgeons call "negative margins"
Until now, no current surgical tools directly assess the presence of residual cancer within the surgical cavity. Pathology margin assessment has well-known limitations including: tissue deformation, false readings, and the inability to fully examine the surface area of the specimen. These limitations result in 19% of negative margins having residual cancer remaining.1 Up to 36% of patients who undergo a lumpectomy surgery are subjected to a second surgery to remove residual cancer that was missed in the initial operation.2
A New Approach to Lumpectomy: Inject, Detect, and Resect
Discover a new approach to real-time excision that potentially removes more residual cancer during the initial surgery
What if the surgeon had the power to see residual breast cancer during surgery and remove it in real-time? LumiSystem is the first and only solution designed for use in patients with breast cancer to assist surgeons in the detection of cancerous tissue within the lumpectomy cavity following removal of the primary specimen during lumpectomy surgery. LUMISIGHT (pegulicianine) and Lumicell™ Direct Visualization System (DVS) enable surgeons to detect and resect residual cancer, in real-time.
Meet LUMISIGHT™
The Strength of LumiSystem
Meet Lumicell™ DVS
The Intelligence of LumiSystem
When the strength and the intelligence combine, residual cancer may be detected with LumiSystem
LumiSystem has been clinically proven to help surgeons find cancer that would have otherwise been missed with 84% diagnostic accuracy*
Safety
- LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine. LUMISIGHT is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.
- The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
- Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT.
1. Tang et. Al 2015.
2. Dupont et al. 2021.
3. Tsegaye, et al., Breast Cancer; 2021.
5. Oelshlaegel, et al., Cancers; 2020.
6. Whitley, et al., Sci Transl Med; 2016.
Completed Clinical Trials
February 2024
Feasibility study (NCT04440982), to evaluate for the first-time use of the Lumicell DVS in breast cancer patients undergoing neoadjuvant therapy
May 2022
Lumicell’s pivotal INSITE (Investigation of Novel Surgical Imaging for Tumor Excision) Breast Cancer clinical study (NCT03686215). Results of the INSITE trial are published in NEJM Evidence and have been included in Lumicell’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration
- Publication: NEJM Evidence
April 2020
Phase C multi-center feasibility study in breast cancer (NCT03321929)
- Publication: JAMA Surgery
October 2017
Single-site feasibility study. Massachusetts General Hospital (NCT02438358)
- Initial Cohort Publication: Breast Cancer Research and Treatment
- Second Cohort Publication: Annals of Surgical Oncology
- Overall Performance Publication: Breast Cancer Research and Treatment
January 2016
Phase 1 safety study in breast and sarcoma. Duke University Medical Center (NCT01626066)
- Publication: Science Translational Medicine
Important Safety Information
What is LumiSystem™?
LumiSystem is the combination of the following FDA approved products – LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.
IMPORTANT SAFETY INFORMATION for LUMISIGHT™ and LUMICELL™ DVS
LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies.
LUMISIGHT™ (pegulicianine) Important Safety Information
What is LUMISIGHT (pegulicianine)?
What is the most important information I should know about LUMISIGHT?
- Hypersensitivity Reactions: 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.
- 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?
What is the most important information I should know about Lumicell DVS?
- 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.