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. 

Close this search box.

See what matters most. Illuminate breast cancer in real-time.

Lauren Cohen Recently Joined as Vice President of Marketing and Communications

Newton, Mass., June 13, 2022  —Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced it is building a commercial team to prepare for market launch of the Lumicell Direct Visualization System (DVS), which includes its novel optical imaging agent LUMISIGHT, upon FDA approval. The company appointed industry veterans Brent Palmisano as chief commercial officer and Lauren Cohen as vice president of marketing and communications.

“Brent and Lauren’s experience in launching women’s health and medical device technologies will be instrumental as we focus on bringing our innovative Lumicell DVS to market,” said Kevin Hershberger, president and chief executive officer of Lumicell. “Lumicell is at an incredible inflection point. Robust data from clinical trials enrolling more than 700 breast cancer patients have shown our Lumicell DVS has the potential to improve care, and we’re excited to build a world class commercial organization to bring this technology to surgeons and patients.”

Palmisano brings more than 20 years of experience to Lumicell and has a demonstrated track record in building and leading medical device commercial organizations. Most recently he served as senior vice president of global commercial operations for Dysis Medical, a company focused on the cervical cancer market. Previously, he spent 15 years at Boston Scientific in a variety of sales and marketing leadership roles and oversaw the commercial development of more than 25 devices.

Cohen has more than 25 years of experience managing global integrated marketing and communications across new product launches, expanded indications and commercialization at industry-leading and start-up medical device organizations. Prior to joining Lumicell, she spent over 17 years at Boston Scientific in roles of increasing responsibility, most recently serving as director of global digital marketing, which will be invaluable to the future launch of the Lumicell DVS given the increase in digital today. Earlier in her career, she held marketing positions at Endius, Odin Medical Technologies and ESC/Sharplan Lasers.

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is a novel solution designed to enable real-time assessment of the breast cavity, illuminating cancerous tissue that may have otherwise been left behind during the initial lumpectomy procedure. The Lumicell DVS features the proprietary LUMISIGHT investigational optical imaging agent, hand-held imaging probe and patient calibrated software.

The safety and efficacy of the Lumicell DVS in detecting residual cancer missed by standard of care surgical procedures has been evaluated in two studies: Results of a feasibility study of 234 patients at 16 sites were published recently in JAMA Surgery, and findings from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial of 406 patients at 14 sites are pending peer-review. Data from the INSITE study will be used to support the company’s Premarket Approval and New Drug Application submissions to the U.S. Food & Drug Administration, which granted Breakthrough Device and Fast Track designations to the Lumicell DVS in recognition of the potential to fill an unmet need in the marketplace.

The Lumicell DVS is a new combination product, and its components, including the new drug LUMISIGHT, are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.

About Lumicell, Inc.

Lumicell is a privately held company focused on innovative fluorescence-guided technologies for cancer surgery with the potential to improve patient outcomes and reduce healthcare costs. The company’s first product in development is the Lumicell Direct Visualization System, designed to illuminate cancerous tissue within the breast cavity during the initial lumpectomy procedure, potentially reducing repeat surgeries. Lumicell’s proprietary, pan-oncologic optical imaging agent is also being explored across a wide variety of solid tumor indications. The company aims to enhance the standard of care treatment by guiding the resection of additional cancer that may have otherwise been left behind. For more information, please visit and follow the company on FacebookTwitter and LinkedIn.

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