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Technology Name: Intraoperative cancer imaging system

Company Background

The Lumicell Imaging System combines a hand-held, single-cell detection imaging device and a cancer-specific molecular imaging agent (LUM015) for real-time identification of residual cancer in the patient’s tumor bed. The system provides surgeons with visual information to perform a thorough removal of residual cancer cells, thus eliminating the need for repeat surgeries due to positive margins or local recurrence.

Technology Overview

The Lumicell Imaging System is a clinical-stage intraoperative technology for detecting and guiding the removal of all residual cancer during the initial surgery. After the initial breast cancer surgery over 35% of patients undergo a second surgery due to residual cancer.  LUM015, which is injected several hours prior to surgery, emits a fluorescence signal having been activated by cancer enzymes in and around the tumor cells. Lumicell’s imaging head is a hand-held device designed for maneuverability in the tumor bed providing seamless operation within the existing surgical workflow. The system uses Lumicell’s proprietary detection algorithm to highlight regions containing residual cancer in a computer display.

Market Potential

Lumicell addresses the unmet need for locating microscopic residual cancer and guiding its removal during the initial surgery. Lumicell is in human clinical trials for breast cancer and sarcoma and have IRB approval to begin trials in esophageal and colon cancers. The U.S. market for Lumicell is a combined $1.43 billion for breast, lung, prostate, colon, esophageal, ovarian, and brain cancers and sarcoma. Most large cancer practices are at risk for the cost of the second surgery and view Lumicell’s product as an immediate financial benefit. The cost savings to the hospitals together with expected additional reimbursement for the guided surgery procedure ensures attractive revenues to Lumicell.

Competitive Advantage

A number of devices attempting to detect cancer without an imaging agent have shown poor sensitivity (below 60%) and specificity (below 40%) and struggled to be adopted. Other competitors are developing comparable technology using an imaging agent and device, but Lumicell is far along in the development process having successfully completed a Phase I clinical trial that demonstrates safety and preliminary efficacy (91% sensitivity and 86% specificity). In contrast with competitors’ imaging agents, LUM015 is also specific to cells at the tumor margin, which reduces the dose requirement and increases the signal to background ratio. Unlike the same-day injection of LUM015, some competitors attempting to use antibody-based agents, which take days for clearance, require an extra visit to the clinic by the patient in advance of the surgery. The handheld device, which is insensitive to surgeon’s and patient’s motion, has unprecedented detection of sub-millimeter residual cancer in a large field of view.

Financial Overview

Lumicell is very capital efficient and has raised $6.7 million in Series A and B venture capital funding. Through NSF and NCI SBIR programs, Lumicell has been awarded $2.4 million. The company has also received a $1 million Massachusetts Life Sciences Accelerator Loan, and our academic and clinical collaborators have received about $1.6 million in funding to support pre-clinical and clinical studies with the Lumicell system.

Intellectual Property

Lumicell has obtained an exclusive license from MIT for the use and commercialization of the imaging device. The company also has an expansive IP portfolio (U.S. and international) including specific architectures of imaging agents, methods for labeling the tumor margin, and a novel laser ablation technology for instantaneous and precise removal of residual cancer.

Commercialization Strategy

Lumicell has secured funds to finance operations through the pivotal trial (2015) and expects to raise $10 million upon FDA product marketing approval (PMA) in late 2015 for product launch.

Regulatory strategy and Pipeline Products

Lumicell’s LUM015, combined with our first device, has completed a Phase 1 safety study at Duke University Medical Center. Lumicell’s combination product has been assigned to the device group (CDRH) of the FDA. Lumicell has completed a pre-IDE meeting with the FDA to discuss upcoming trials in breast cancer.  Lumicell aims for FDA approval under a PMA in breast cancer by late 2015. In parallel, Lumicell has developed a laser ablation module to perform precision surgeries required in brain and ovarian cancers. Lumicell has a pipeline of imaging agents offering further benefits including higher signal-to-background ratios, higher specificity for certain types of cancers and at lower doses.

Management Team

• David Lee, CEO and co-Founder, has 25 years of demonstrated success in product development at Arthur D. Little and has experience running R&D groups and early commercialization of products. He is a co-Founder and the founding CEO of T2 Biosystems, Inc. (NASDAQ:  TTOO) which is about to enter the market.
• Jorge Ferrer, Ph.D., Director of R&D, developed the original imaging system and LUM015. He has 8 years of experience in research, development, and project management.
• David Strasfeld, Ph.D., Senior Scientist, trained in physical chemistry, instrument design, and experimentation, leads the device development efforts.