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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Category: Clinical Studies

Lumicell™ DVS Pivotal Trial Results Published in NEJM Evidence and to Be Presented at ASBrS Assess Safety and Effectiveness of System for Identifying Residual Breast Cancer During Lumpectomy

NEWTON, Mass., April 27, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced that results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial have been published online in NEJM Evidence and will be presented at the American Society of Breast Surgeons (ASBrS) annual meeting. The […]

Clinical Data on Lumicell’s Direct Visualization System to Be Presented at International Conference on Surgical Cancer Care

Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced that clinical data from a 234-patient, multi-center feasibility study of the Lumicell Direct Visualization System (DVS) will be presented at the Society of Surgical Oncology’s International Conference on Surgical Cancer Care (SSO2022).

Lumicell Announces Initiation of NIH/NCI Academic-Industry Study of its LUM Imaging System

R01 Award to fund multi-phase randomized study to expand clinical safety and efficacy data of the system in the detection of residual tumor in breast cancer patients receiving neoadjuvant therapies Newton, Mass., Sept. 29, 2020 – Lumicell, Inc. today announced that Dr. Barbara Smith, Director of the Breast Program at Massachusetts General Hospital, has begun a multi-phase, […]

Lumicell Initiates Pivotal Trial for Breast Cancer Surgical Guidance Solution

Success with In Vivo Examination of Cancerous Tissue via the Lumicell Imaging System During the Pivotal Trial will Propel the Technology Toward FDA Submission Newton, Mass., November 5, 2019 – Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has begun its pivotal trial of the Lumicell Imaging System for breast cancer — a major […]

Feasibility Study Underway to Assess Lumicell Technology for Removing Ovarian and Peritoneal Cancer Tumors During the First Surgery

Positive Clinical Results in Breast Cancer Trial Shows Promise for Ovarian and Other Cancers Newton, Mass., April 10, 2019 — Lumicell, Inc. today announced that a feasibility study is underway at Massachusetts General Hospital in Boston to determine the initial safety and efficacy of its Lumicell System for in vivo imaging of metastases to the peritoneum from primary […]

Lumicell Presents Phase 2 Clinical Data Showing LUM System Provided

Complete and Immediate Detection of Residual Cancer in Tumor Cavity During Lumpectomy Surgery Data Presented by Investigators from Massachusetts General Hospital’s Breast Program at 2017 San Antonio Breast Cancer Symposium Integrated LUM System Correctly Identified Residual Cancer Cells Across Breast Cancer Subtypes Wellesley, Mass., Dec. 7, 2017— Lumicell, Inc. today announced the presentation of clinical data from its ongoing Phase 2 […]

Lumicell Initiates New Clinical Studies in Breast Cancer and Prostate Cancer with LUM System for Real-time Detection of Tumor Tissue in Patients During Surgery

Company receives FDA Approval to initiate multiple IDE studies, Including Path to Pivotal Trial in Breast Cancer Integrated LUM System with Drug, Device and Software Currently Under Investigation in Five Solid Tumor Cancers Wellesley, Mass., Sept. 6, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, today announced the initiation of clinical […]

Lumicell Announces Product Development Progress with LUM015 in Lumicell System for Image-guided Cancer Surgery

Product innovation continues to advance under scientific leadership of company’s founder, W. David Lee Wellesley, Mass., Aug. 10, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, today announced the company’s progress with its product development of the Lumicell System, as well as the expansion of patent protection for the company’s product […]

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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.