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Category: Press Release

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 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 […]

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 Direct Phase II Small Business Innovation Research (SBIR) Grant from the National Cancer Institute to Conduct Multi-Center Pivotal Study

Funding will Support Trial of the Lumicell Margin Assessment System (MAS) in Breast Cancer Surgery Wellesley, Mass., August 9, 2016 – Lumicell, a leader in the field of image-guided surgery, today announced that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) grant to fund a prospective multi-center pivotal […]

Lumicell Successfully Completes Phase 2a Feasibility Study

Revolutionary Approach to Imaging Tumor Cells Achieved 100% Detection of Residual Cancer and Well Tolerated in First Patient Samples Poster Presentation of Trial Findings at The American Society of Breast Surgeons Annual Meeting Wellesley, Mass., April 13, 2016 – Lumicell, a leader in the field of image-guided cancer surgery, today announced it successfully completed its Phase 2a […]

Lumicell Publishes Data Supporting LUM015, Fluorescent Probe for Imaging Cancer, in Science Translational Medicine

Revolutionary Approach to Imaging Tumor Cells Demonstrated to be Well Tolerated in First Patient Samples Wellesley, Mass., January 6, 2016 – Lumicell, a leader in the field of image-guided cancer surgery, today announced the publication of research supporting the Company’s groundbreaking protease-activated fluorescent imaging probe, LUM015, in Science Translational Medicine. The research highlights the use of LUM015 […]

Lumicell Announces FDA Approval to Launch Feasibility Study in Gastrointestinal Cancers

Trial is funded by National Cancer Institute’s SPORE program Wellesley, Mass., September 10, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, has received approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study in gastrointestinal cancers. The study will focus on imaging tissue in patients with esophageal, […]

Lumicell Announces FDA Approval to Launch Feasibility Study

Trial is funded by National Cancer Institute grant Wellesley, Mass., May 20, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to launch a feasibility (pilot) study for intraoperative imaging of breast cancer during surgery. The study will […]

Lumicell Phase 1 Results Presented at SSO 2015 Annual Cancer Symposium

Phase 1 Results Also Presented at AACR 2015 Annual Meeting Wellesley, Mass., May 8, 2015 – Lumicell, a leader in the field of image-guided cancer surgery, announced that Phase 1 trial results were recently presented at the SSO 2015 Annual Cancer Symposium in March and the AACR 2015 Annual Meeting in April. Both sessions were presented […]

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.