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.

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

LUMISIGHT consists of a 4-amino acid peptide backbone flanked by a fluorescent dye that emits light in the far-red region of the light spectrum (barely visible with the naked eye) and a fluorescence quencher. In its native state, the quencher absorbs the fluorescence emission of the dye, making the molecule optically inactive. The terminal that has the dye also contains a polyethylene glycol (PEG) chain that controls the pharmacokinetics of LUMISIGHT, allowing it to be injected 2-6 hours prior to imaging. For tumors to grow and invade, cancer cells secrete enzymes that disrupt the extracellular matrix, carving a path for these cells to multiply and migrate.3 Immune cells are also recruited at the tumor microenvironment and may be reprogrammed to assist the cancer by further secreting these enzymes.4 LUMISIGHT’s design takes advantage of this tumor growth mechanism, as its peptide backbone is recognized and cleaved (cut) by these enzymes, releasing the quencher and allowing the fluorescence dye to emit a detectable signal.5

Meet Lumicell™ DVS

The Intelligence of LumiSystem

Lumicell DVS consists of a handheld probe connected to a console that contains a light source specifically designed to excite the fluorescent dye in LUMISIGHT and a computer powered by a proprietary patient-calibrated cancer detection software that calculates the baseline fluorescence for each patient. As the surgeon scans the lumpectomy cavity surface, the software displays images in real-time and highlights regions suspected to contain residual cancer on the computer monitor.

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*

*Diagnostic accuracy is based on true positive and true negative images detected in the LumiSystem pivotal trial

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

April 2020

Phase C multi-center feasibility study in breast cancer (NCT03321929)

October 2017

Single-site feasibility study. Massachusetts General Hospital (NCT02438358)

January 2016

Phase 1 safety study in breast and sarcoma. Duke University Medical Center (NCT01626066)

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)?

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.

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?

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.

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.
Please see Lumicell DVS Instructions for Use for complete product information.

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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.