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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Lumicell Announces FDA Acceptance and Priority Review of New Drug Application for LUMISIGHT™ Optical Imaging Agent for Breast Cancer

NEWTON, Mass., May 22, 2023—Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, today announced the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the New Drug Application (NDA) for the LUMISIGHT™ Optical Imaging Agent and accepted the Premarket Approval (PMA) application for the Lumicell™ Direct Visualization System (DVS).

The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with the investigational optical imaging agent LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity.

“The FDA acceptances of both the NDA and PMA submissions for our LUMISIGHT Optical Imaging Agent and Lumicell Direct Visualization System bring us one step closer to advancing care for women with breast cancer,” said Kevin Hershberger, president and chief executive officer of Lumicell. “Priority Review designation is further recognition of the potential of our system to significantly improve the effectiveness of breast cancer treatment. We look forward to the FDA’s review of our applications, and the potential to offer surgeons the first visualization system to enable a more complete cancer resection during the initial lumpectomy.”

These submissions are supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial were published in NEJM Evidence and the Phase C study in JAMA Surgery. The FDA previously granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy. 

The standard of care for lumpectomy surgery involves breast surgeons and pathologists examining the margins of excised tissue to infer whether any residual cancer remains behind in the breast cavity. As a result, 20-40% of lumpectomies have positive margins only identified days after surgery, necessitating a second surgery to obtain clear margins.[i],[ii] Moreover, as reported in published literature, approximately 14% of patients determined by pathology to have negative margins, implying that no cancer remained inside the cavity, had residual cancer left behind.[iii]  With future approval of our system, surgeons will be able to look inside the lumpectomy cavity to find, and remove residual cancer during the initial lumpectomy, and achieve a more complete cancer resection.  

About the Lumicell Direct Visualization System and LUMISIGHT Optical Imaging Agent

The Lumicell™ DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual malignant tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete cancer resection. Lumicell’s proprietary, pan-oncologic optical imaging agent LUMISIGHT is also being explored across a wide variety of solid tumor indications.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.

About Lumicell, Inc.

Lumicell is a privately held company focused on improving surgical outcomes and reducing healthcare costs by utilizing its innovative fluorescence-guided surgical technologies to enable a more complete resection of cancer that may have otherwise been left behind. The company’s first product in development is the Lumicell Direct Visualization System, designed to illuminate residual breast cancer tissue within the breast cavity following removal of the primary specimen during the initial lumpectomy procedure. For more information, please visit www.lumicell.com and follow the company on Facebook, Twitter and LinkedIn.

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[i] Wilke, et al, 2014, JAMA Surg; 149:1296-1305

[ii] McCahill, et al, 2012, JAMA; 307:467-475

[iii] Dupont, et al, 2021, Ann Surg; 273; 876-881

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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.