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 Expands Development Strategy and Pipeline Across Five Solid Tumor Cancers Supported by $28.7 Million Series C Financing

Proceeds to Fund Pivotal Trial in Breast Cancer Leverages Broad Potential of LUM System with Drug, Device and Software for Real-time Detection of Tumor Tissue in Patients During Surgery

Wellesley, Mass., Dec. 7, 2017— Lumicell, Inc., a technology leader in the field of image-guided cancer surgery, today provided an update on the company’s development strategy for its LUM system pipeline including plans to initiate its pivotal trial in breast cancer as well as expansion of its clinical studies in four other solid tumor cancers.

Advancement of the LUM System clinical pipeline will be funded through a $28.7 million Series C financing, which the company recently closed. Existing and new investors, including Launch Capital and BlueIO participated in the financing.

Lumicell is investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancer, among others. The LUM System was designed by leading engineers and scientists in partnership with surgeons from academic and medical centers as an integrated system with three unified components: drug, device and decision software to guide cancer surgeons in the detection and removal of cancer cells in real-time during surgery.

Kelly Londy, Chief Executive Officer of Lumicell, stated, “We are grateful for the funding and support from our investors which will be used to drive completion of our breast cancer studies as well as expand the LUM System pipeline into additional cancer indications, with a focus on driving innovation to improve patient outcomes. “We look forward to several key development milestones, over the next year, as our platform moves into the next stages and our company grows.”

“We are pleased to support Lumicell in its drive toward providing cancer surgeons with a single integrated system to detect and remove cancer cells in real-time during surgery and potentially reducing the need for repeat surgeries”, said Elon Boms, Founder and Chairman, Launch Capital.

“The clinical applications for the LUM System are far-reaching and we look forward to working with the Lumicell team to expand this potential game-changing advance in cancer surgery and beyond with their innovative platform.  We are very proud to be involved in supporting Lumicell’s immediate go to market growth phase as they work to advance clinical care for all cancer patients.” said Dave Furneaux, CEO of BlueIO and Managing General Partner, Kodiak Venture Partners

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 LUM System includes three integrated components: a fluorescent optical contrast agent that is cancer- and immuno-activated, a novel hand-held imaging device that instantly scans the cavity walls to view the fluorescent cells with single-cell detection, and proprietary decision software that displays the image instantly on a monitor to guide surgical removal of cancerous tissue. The unprecedented ability to see and remove cancer cells remaining in the cavity – beyond the margin of the specimen – 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 the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers. For more information, please visit www.lumicell.com.

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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.