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: Company News

Lumicell Announces Initial Data Demonstrating LUMISIGHT™’s Ability to Detect Tumors Metastasized to Multiple Organs in the Peritoneum

Promising feasibility study results for imaging technology that identified malignant peritoneal tumor metastasis during surgery NEWTON, Mass.–(BUSINESS WIRE)–Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced promising initial data from its ongoing feasibility study for lead candidate LUMISIGHT™ to detect peritoneal malignancies during surgical debulking. The ongoing study is […]

Lumicell Co-Founder Moungi Bawendi Awarded Nobel Prize in Chemistry

Bawendi’s expertise in optics, fluorescent molecules and tissue imaging were instrumental in development of Lumicell Direct Visualization System, which is currently under FDA review NEWTON, Mass., October 5, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced company co-founder Moungi G. Bawendi, PhD, is one of three […]

Howard Hechler Joins Lumicell as Senior Vice President of Strategy & Business Development

Hechler brings more than 15 years of focused life-sciences experience in M&A, strategy, andoperations Newton, Mass., Sept. 16, 2020 – Lumicell, Inc., a leader in image-guided cancer surgery, today announced the addition of Howard Hechler as Senior Vice President of Strategy & Business Development. In this new role, Mr. Hechler will leverage his depth of transactional and […]

Lumicell Headquarters Expands Into New Boston-Area Office Space

New location offers more space for expansion and designed to inspire innovation of Lumicell technology through further employee collaboration Newton, Mass., Feb. 22, 2019— Lumicell, Inc., an innovation leader in molecular imaging within healthcare focused in cancer, perfusion, wound care and infection, has expanded into a new headquarters location in Newton, Mass., just outside of […]

Lumicell Expands Development Strategy and Pipeline Across Five Solid Tumor Cancers Supported by $28.7 Million Series C Financing

Proceeds to Fund Pivotal Trial in Breast Cancer Leverages Broad Potential of LUM System with Drug, Device and Software for Real-time Detection of Tumor Tissue in Patients During Surgery Wellesley, Mass., Dec. 7, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, today provided an update on the company’s development strategy for its […]

Lumicell to Participate in Upcoming Conferences

Wellesley, Mass., September 5, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, announced today that management will participate in two upcoming September meetings, including:  “We are delighted to represent Lumicell at these important industry meetings and look forward to providing further updates on our progress with the LUM System in […]

Lumicell Appoints Felix Geissler, M.D., Ph.D. as Chief Medical Officer

Wellesley, Mass., June 28, 2017 – Lumicell, a leader in the field of image-guided cancer surgery, today announced the appointment of Felix Geissler, M.D., Ph.D. as Chief Medical Officer. As a central member of Lumicell’s senior executive team, he will drive the clinical direction of the company and will work closely with the R&D and marketing teams […]

Lumicell Awarded SBIR Phase IIB Grant from National Science Foundation

Grant will support development of novel image-guided laser ablation system in collaboration with Massachusetts General Hospital, Brigham and Women’s Hospital and Duke University Medical Center Wellesley, Mass., May 14, 2014 – Lumicell, a leader in the field of image-guided cancer surgery, has received a Phase IIB Small Business Innovation Research (SBIR) grant from the National Science […]

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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.