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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Wellesley, Mass., May 29, 2013 – Lumicell announced it was awarded a $1 million accelerator loan from the Massachusetts Life Sciences Center (MLSC), a quasi-public agency charged with implementing the state’s 10-year, $1-billion Life Sciences Initiative. The MLSC’s Accelerator Loan Program provides loans of up to $1 million to early-stage companies engaged in life sciences research and development, commercialization and manufacturing.

“This accelerator loan is of critical importance to the next stage of our company’s growth,” said W. David Lee, CEO of Lumicell. “As our company moves toward completion of a Phase 1 clinical trial in collaboration with Duke University Medical Center, this early funding will allow us to expand our staff and further deepen our roots in Massachusetts.”

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. 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 cancer-targeted injectable imaging agent and a novel hand-held imaging device with exquisite single-cell detection. With this system, surgeons have the unprecedented ability to remove all cancer cells during an initial surgery eliminating the need for repeat surgeries. This image-guided technology system is designed to fit within the existing surgical workflow and takes less than 5 seconds to image the entire tumor bed.

The MLSC’s Accelerator Loan Program supports early-stage companies by providing loans that will match other sources of capital. By leveraging other sources of capital, the Accelerator Loan Program provides support to companies at the most critical stages of their development cycle, enabling them to conduct vital research and proof-of-concept studies and to attract subsequent investment while improving the odds of bringing cutting-edge innovation to the marketplace.

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 cancer-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.

About the Massachusetts Life Sciences Center

The Massachusetts Life Sciences Center (MLSC) is a quasi-public agency of the Commonwealth of Massachusetts tasked with implementing the Massachusetts Life Sciences Act, a 10-year, $1-billion initiative that was signed into law in June of 2008. The MLSC’s mission is to create jobs in the life sciences and support vital scientific research that will improve the human condition. This work includes making financial investments in public and private institutions that are advancing life sciences research, development and commercialization as well as building ties among sectors of the Massachusetts life sciences community. For more information, visit www.masslifesciences.com.

About the Life Sciences Accelerator ProgramIn order to expand life-sciences-related employment opportunities, promote health-related innovations and stimulate research and development, manufacturing and commercialization in the life sciences, the Life Sciences Accelerator program provides loans to companies engaged in life sciences research and development, commercialization, and manufacturing in Massachusetts. Target entities are generally early-stage life sciences companies with a high-potential for technology commercialization, rapid growth and downstream private equity financing. The program is designed to help sustain these companies through a critical stage of development and to leverage additional sources of capital to bring cutting-edge innovation to the marketplace.

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