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.

What is LumiSystem?

In combination, LUMISIGHT™ (pegulicianine) and Lumicell™ Direct Visualization System (DVS), is the only fluorescence imaging system that enables surgeons to scan inside breast cavity post-lumpectomy, in real-time and intraoperatively, to detect and resect residual cancer, potentially sparing some patients from second surgeries1

Inject

LUMISIGHT is delivered by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging.

Detect

The hand-held imaging probe enables the surgeon to scan inside the breast cavity to illuminate and find activated LUMISIGHT in residual cancer.

Resect

Real-time images from the cavity, based on a patient-calibrated cancer detection software, guide the surgeon in the removal of residual cancerous tissue.

What if you had the power to see invasive cancer and DCIS, in real-time, during surgery?

See invasive breast cancer and ductal carcinoma in situ (DCIS) where and when it matters most

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Clinical Evidence: Study Overview

The pivotal INSITE study was a multi-center, prospectively
randomized trial in women undergoing lumpectomy surgery for breast cancer1

Study Design & Patient Selection

The study was conducted across 14 U.S. medical centers. In this prospective study, the investigators assessed the ability of LumiSystem to identify residual cancer in the cavity after SoC lumpectomy surgery was completed.

Patients were injected with LUMISIGHT 2 – 6 hours prior to imaging in the preoperative area under medical supervision. The surgeon then proceeded to complete their standard of care (SoC) procedure.

After the surgeon declared that they had completed their SoC procedure, randomization was revealed. Patients were randomized 10:1 to either LumiSystem-guided surgery or SoC without LumiSystem guidance.

Study Procedures

In the LumiSystem guidance arm, after SoC, the lumpectomy cavity was scanned using the handheld probe.  If the LumiSystem signal was displayed onscreen as positive, then the surgeon resected a “LumiSystem-guided shave” from that region.  All tissues were oriented and underwent histopathology assessment for margin evaluation. 

Study endpoints

The pivotal trial had three co-primary endpoints: Residual Cancer Detection, Sensitivity, and Specificity, with performance goals of > 3%, >40%, and >60%, respectively

Residual Cancer Detection

Sensitivity

Specificity

Exploratory Endpoint†

Patient-reported outcomes evaluating the impact of LumiSystem-guided shaves to patients' perceived cosmesis

† Participation in this exploratory endpoint decreased at the longer data collection timepoints. Results show that at every timepoint, the patient-reported breast cosmesis satisfaction score did not differ between patients with or without LumiSystem-guided shaves.

Secondary Endpoint

LumiSystem-guided conversion of positive margins to final negative margins

* Two additional patients were converted from pathology negative margins to pathology positive margins from LumiSystem-guided shaves and underwent a second surgery.

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.​

Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence.

View pivotal INSITE study

 1. Smith, et al.  NEJM Evidence 2023;2(7).  DOI: 10.1056/EVIDoa2200333 ​

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The LumiSystem Journey

Years of work went into LumiSystem, from understanding the unmet need to developing to developing the concept of fluorescent guided surgery. We are proud to bring this solution to market for patients and surgeons.

LumiSystem is designed to provide significant value to the healthcare system in the form of:

  • Identifying residual cancer, undetected by the current standard of care
  • Potentially avoiding the need for a second surgery
  • Seamlessly integrating into the surgical workflow, with approximately <10 minutes of added time to the procedure

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?

LUMISIGHT (pegulicianine) is an optical imaging agent 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.

What is the most important information I should know about LUMISIGHT?

  • Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis, during or following administration. Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Before LUMISIGHT administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). LUMISIGHT is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine. Always have emergency resuscitation drugs, equipment, and trained personnel available. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy.
  • Risk of Misdiagnosis: Absence of signal in the surgical field does not rule out the presence of cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
  • Interference from Dyes Used for Sentinel Lymph Node Mapping: Avoid administration of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
  • Adverse Reactions: The most common adverse reactions (≥1%) were hypersensitivity and chromaturia.

Please see full Prescribing Information, including Boxed Warning.

Lumicell™ Direct Visualization System (DVS) Important Safety Information

What is the Lumicell™ DVS?

Lumicell™ Direct Visualization System (DVS) is 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. Lumicell DVS is used with LUMISIGHT™ (pegulicianine) for fluorescence imaging of the lumpectomy cavity.

What is the most important information I should know about Lumicell DVS?

  • Adjunctive use: Lumicell DVS is for adjunctive use and is not a replacement for the standard of care procedures and pathology. Training and proficiency in the use of Lumicell DVS are essential prior to employing the system in a lumpectomy procedure. Lumicell DVS detection of breast cancer may not be generalizable to all subpopulations at increased risk for positive margins. Physicians using the system must be trained in breast conserving surgery.
  • 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: Avoid administration of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
  • Tissue perforation or damage: 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 when using reusable equipment, properly and completely disinfect and reprocess the handheld probe and cables after each use. To avoid infection risk when using sterile single-use equipment, ensure you use the sterile probe cover properly.
  • Eye discomfort: Avoid direct eye exposure to handheld light probe as it may cause discomfort.

Please see Lumicell DVS Instructions for Use.  For complete product information, visit www.LumiSystem.com. 

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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.