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

Wellesley, Mass., July 12, 2017 – The Board of Directors of Lumicell, Inc., a leader in the field of image-guided cancer surgery, announced today the appointment of Kelly Londy as Chief Executive Officer and member of the Board of Directors. W. David Lee, Founder of Lumicell, has moved into the role of President and Chief Scientific Officer.

Dr. Andrey Zarur, Chairman of the Board of Lumicell, said “We are extremely excited to welcome Kelly to Lumicell. Kelly was chosen as CEO for her passion for innovation, ability to optimize business strategy, and her overarching desire to make the Lumicell technology available to patients around the globe. With over 25 years of experience in the medical device field, the Board is confident in her ability to lead Lumicell on their mission to change the landscape of cancer surgery.”

Lumicell also announced an additional closing of its Series C financing, securing an aggregate total of $13.5 million. Londy’s appointment, together with this additional funding, will support Lumicell’s pivotal trial in breast cancer this year and development of additional cancer applications.

“Our team at Lumicell is developing a truly revolutionary intraoperative margin assessment system that gives surgeons real-time visual feedback of residual cancer in the tumor bed,” said Kelly Londy, CEO of Lumicell. “I am honored to lead this team as we strive to greatly improve surgical outcomes and possibly remove the need for repeat cancer surgeries.”

Every year approximately 300,000 cancer lumpectomies take place in the United States. More than 60,000 of the patients who undergo a lumpectomy must endure a second surgery, or re-excision, due to positive margins discovered on final histopathology examination. Second surgeries may increase discomfort, add emotional and cosmetic expenses to the patient, and may cost the healthcare system close to $1 billion annually. Londy said “I am passionate about the battle against cancer, and especially breast cancer, where removing the whole tumor the first time can have dramatic impact to the patient, surgeons and health care system. I believe Lumicell will provide a new platform to surgeons around the world that will allow patients to have the highest level of care possible.”

Londy was most recently the Chief Operating Officer at Accuray Incorporated, where she provided end-to-end leadership across all customer facing activities, from product development through customer adoption, education, and service. Previously, she held leadership roles at GE Healthcare and Philips Healthcare.

About Lumicell, Inc.

Lumicell is a 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 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 may include surgeries for lung, prostate, ovarian, and brain cancers. For more information, please visit www.lumicell.com.

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