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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Fast Track Designation augments previously granted Breakthrough Device Designation 

Newton, Mass., Nov. 17, 2020 Lumicell, Inc., an innovation leader in image guided cancer surgery, today announced it has received Fast Track designation with rolling review from the FDA Center for Drug Evaluation and Research (CDER) to expedite the development and review of the LUM Imaging System in the treatment of Breast Cancer. Fast Track designation represents another major milestone in Lumicell’s path to FDA approval.

“The FDA’s decision to grant Fast Track Designation is an important step in bringing the Lumicell Imaging System closer to FDA approval and providing surgeons with this innovative technology to detect and remove cancerous tissue more confidently and efficiently than ever before,” said Kevin Hershberger, President and CEO at Lumicell. “We are very excited with the progress as we continue enrollment in our Breast Cancer Pivotal Trial which we expect will further build on the strong clinical data Lumicell demonstrated in our multi-center feasibility clinical study.”

Fast Track is a program designed to facilitate the development and expedite the review of new drugs that treat serious conditions and fill an unmet medical need.  Filling an unmet need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapies.  As a Fast Track designee, Lumicell will have access to early and frequent communications with the FDA to discuss Lumicell’s development plans and ensure collection of appropriate data to support the approval process. Additionally, with rolling review Lumicell plans to submit modules for the New Drug Application (NDA) for FDA review as they are ready, rather than submitting the full NDA package upon the completion of clinical trials.

This latest milestone complements our previously received FDA Breakthrough Device designation for breast cancer and all solid tumors from the FDA Center for Devices and Radiological Health (CDRH).  Similar to Fast Track, Breakthrough Device Designation is awarded to medical devices or combination products that provide more effective treatment of life-threatening diseases or conditions with the goal of providing physicians and patients access to these technologies.

“Lumicell’s technology is a paradigm shift – we’re now looking at the surface of the cavity instead of lumpectomy margins,” said Irene Wapnir, MD, Surgical Oncologist at Stanford Health Care. “It’s a fresh approach to in-vivo cancer surgeries. Instead of focusing on what was in the lumpectomy specimen, we prioritize what’s left behind in the cavity.”

Existing surgical tools often fail to identify and remove all of the cancerous tissue in the initial surgical intervention, resulting in 20 – 40% of breast cancer patients requiring a second surgery to remove additional cancerous tissue. The LUM Imaging System was developed to allow surgeons to see and remove residual cancer in real-time—significantly reducing the risk of leaving cancer behind, second surgeries and cancer recurrence.

For more information about the LUM Imaging System and Lumicell’s clinical trials, visit

About Lumicell, Inc.

Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM Imaging System has unprecedented ability to see and guide removal of cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM Imaging System in patients undergoing surgery for breast cancer, ovarian cancer, prostate cancer, brain cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include perfusion, wound care and infection, and surgeries for lung, and liver 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