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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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 and technologies.  The foundation of Lumicell’s product development plan is the integration of three proprietary components:  the immuno- and cancer-targeted optical contrast agent LUM015, the Lumicell handheld imaging device, and the company’s customized software for real-time display. 

Lumicell’s new developments with product advancements and patents include:

“We are on a strong trajectory to bring our Lumicell System to meet the needs of cancer patients, based on the solid foundation of product innovation and intellectual property work that are key to our platform’s long-term success,” said Kelly Londy, Chief Executive Officer of Lumicell.  “We continue to grow and strengthen our capabilities to develop a revolutionary product that can provide real-time visual identification of residual cancer during surgeries, offering patients and surgeons a new approach with the potential to improve surgical outcomes and avoid the need for repeat cancer surgeries.”

Under the leadership of W. David Lee, Lumicell’s founder and CEO from inception to mid-2017, the product development for the Lumicell System has achieved significant accomplishments.  The product’s clinical milestones include successful completion of a Phase 2 feasibility study in patients during breast cancer surgeries demonstrating 100% detection of residual cancer, and an earlier first-in-human Phase 1 clinical trial published in Science Translational Medicine.  Mr. Lee will continue to drive the company’s focus on innovation, new product development and the next generation of Lumicell technology as President and Chief Scientific Officer.  He also continues to hold a position at MIT’s Koch Institute for Integrated Cancer Research. Prior to joining Lumicell, Mr. Lee was a founder and CEO of T2 Biosystems.  Earlier in his career, he held leadership roles and was SVP of Arthur D Little Technology and Product Development Business Unit.

“The opportunities for Lumicell are more exciting than ever as we enter the next stage of growth and accelerate the development of our platform and product pipeline to realize our founding vision to deliver our Lumicell System to revolutionize how cancer is detected in the operating room,” said W. David Lee, President and Chief Scientific Officer.  “I am energized by our expanded leadership team that is enabling our company to grow in all the dimensions of our business to maximize the value we bring to building our business and improving outcomes for patients.”

Andrey Zarur, Chairman of the Board for Lumicell, said “David’s unique skill for applying concurrent engineering – the convergence of engineering and biological research – as a means to accelerate new innovation has allowed him to continually leverage today’s capabilities, anticipate tomorrows needs and apply his expertise to new ideas to solve critical problems. Lumicell is the result of David’s passion in action and we want to thank him and recognize all his work as founder and CEO that has enabled Lumicell to reach this inflection point of product development approaching pivotal studies and commercialization.”

About Lumicell, Inc.

Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative margin assessment system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable optical contrast agent and a novel hand-held imaging device with exquisite single-cell detection. The unprecedented ability to see and remove all cancer cells during the initial surgery has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating its cavity assessment system in patients undergoing surgery for breast cancer, sarcomas, and gastrointestinal cancer. Additional future indications are planned to include surgeries for lung, prostate, ovarian, and brain cancers. For more information, please visit

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.


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