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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Grant will support development of novel image-guided laser ablation system in collaboration with Massachusetts General Hospital, Brigham and Women’s Hospital and Duke University Medical Center

Wellesley, Mass., May 14, 2014 – Lumicell, a leader in the field of image-guided cancer surgery, has received a Phase IIB Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF). The grant will support the company’s expansion into brain and ovarian cancer indications and the further development of its intraoperative hand-held imaging device in collaboration with Massachusetts General Hospital, Brigham and Women’s Hospital and Duke University Medical Center.

“We are very pleased to receive our third NSF award,” said W. David Lee, CEO of Lumicell. “This NSF grant will allow us, in collaboration with MGH, Brigham and Women’s Hospital and Duke University Medical Center, to support pre-clinical testing in ovarian and brain cancers and to continue the development of a novel image-guided laser ablation system to quickly and precisely remove microscopic residual cancer. By enabling surgeons to remove sub-millimeter residual cancer, we expect to improve patient survival rates.”

Lumicell is addressing the number one challenge in cancer surgery – the need to remove all cancer cells within the tumor bed during the first surgery. In the field of cancer surgery, the goal is clean margins. Lumicell’s intraoperative detection system provides surgeons with the needed tools to perform a thorough removal of any residual cancer cells in real-time within the tumor bed thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Lumicell’s surgical system combines a lightweight hand-held single-cell detection imaging device and a cancer-specific molecular imaging agent. This image-guided technology is designed to fit within the existing surgical workflow. The company’s devices and imaging agents are optimized for the specific cancer-type and surgical procedure.

About Lumicell, Inc.

Lumicell is a leader in the field of image-guided cancer surgery. The company is developing a revolutionary intraoperative imaging system that gives surgeons real-time visual feedback of residual cancer in the tumor bed. Lumicell’s surgical system includes a margin-targeted injectable imaging 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 initially investigating its imaging system in patients undergoing surgery for breast cancer and sarcomas. Additional future indications will include surgeries for lung, prostate, ovarian, colorectal 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