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.

Our Mission

My wife died of breast cancer in 2003. Since then, I have made it my mission to help prevent others from experiencing the same pain from cancer left behind after surgery.

At Lumicell, our mission is to improve the way cancer surgery is performed, starting with breast cancer.  Our innovative, fluorescence-guided imaging technology is designed to illuminate cancerous tissue inside the breast cavity following initial lumpectomy to help surgeons achieve a more complete surgical resection.

In the United States,

The Problem

The standard of care for lumpectomies has well-known limitations as cancer is left behind 20-40% of the time.

Today’s Standard of Care

The focus is on analyzing cancerous tissue that has already been removed after the initial lumpectomy instead of looking inside the patient where the cancer may still remain.

Our Aim

Enhance the standard of care by assisting surgeons with intracavity detection of residual cancer in real-time.

Incomplete tumor resection (i.e., positive margins) has been shown to more than double the risk of recurrence.

Lumicell recognizes the challenge surgeons face in finding and removing all cancerous tissue while conserving as much healthy breast tissue as possible. That’s why we are committed to pioneering new technologies to help surgeons make more informed decisions in real-time.

Leadership Team

Howard Hechler

Howard joined Lumicell in 2020 as Senior Vice President of Strategy and Corporate Development, and now serves as Chief Business and Strategy Officer. He brings almost 20 years of focused life-sciences experience in market access, strategy, and operations. Prior to Lumicell, Howard worked at Locust Walk, PolarityTE, Smith & Nephew, Medtronic, and Mallinckrodt Pharmaceuticals. Howard graduated cum laude with a B.A. from Harvard University, and received his M.B.A. and Juris Doctorate degrees from the University of Virginia.

Jorge Ferrer, PhD

Jorge joined Lumicell in 2010. He leads the company’s clinical research and strategy for cancer applications, and manages the company’s regulatory strategy, preparation of communications and reporting to the FDA. Jorge co-developed Lumicell’s optical imaging agent, LUMISIGHT™, as Senior Director of R&D at Lumicell. He also co-developed the prototype of the Lumicell Direct Visualization System™ (DVS) during his post-doctoral tenure with Dr. Moungi Bawendi at MIT. Prior to his post-graduate studies, Jorge worked as a Mechanical Design Engineer at Texas Instruments. He holds a doctorate in biological engineering and a M.S. in mechanical engineering from Massachusetts Institute of Technology, and a B.S. in mechanical engineering from University of Puerto Rico Mayagüez.

Brent Palmisano

Brent joined Lumicell in May 2022 and is responsible for building the company’s commercial strategy and organization. Brent brings more than 20 years’ experience and a demonstrated track record in building and leading medical device commercial organizations. Previously, Brent was Senior Vice President of Global Commercial Operations at DYSIS Medical, where he oversaw building the business to new heights. He also spent 15 years at Boston Scientific, where he held multiple commercial positions with increasing responsibilities, including Area Vice President of Boston Scientific’s National Accounts team and Director of Marketing and Commercial Integration, where he oversaw the development of dozens of devices. Earlier in his career, Brent spent seven years at Black and Decker in various sales and marketing positions. He holds a B.S. in marketing from the University of South Florida.

Daniel K. Harris, PhD

Daniel joined Lumicell in 2017 as a Principal Scientist. In his current role as Vice President of Pharmaceutical Development and Chemistry, Manufacturing and Controls, Daniel is responsible for the co-development of Lumicell’s optical imaging agent, LUMISIGHT™, as well as regulatory strategy and preparation of drug-related regulatory filings, including the New Drug Application. Prior to joining Lumicell, Daniel led the chemistry R&D group at QD Vision, a nanomaterials company developing fluorescent materials for the consumer display market and supported the company through its acquisition by Samsung. He earned his PhD from MIT, studying in the laboratory of Dr. Moungi Bawendi, and received a B.S. in chemical engineering from the University of Southern California.

Brian Schlossberg, PhD

Brian joined Lumicell in 2018 as Director of Medical Affairs and is currently responsible for leading development of new indications for Lumicell’s fluorescence imaging technologies.  He brings over 15 years of product development experience from medical device start-ups.  Prior to joining Lumicell, Brian served as Director of Research and Development at Osteonovus; a medical device company developing biomaterials for spine and orthopedic indications. Brian earned his PhD in Biomedical Engineering from The University of New South Wales, where he studied in the Surgical & Orthopaedic Research Laboratories under Professor Bill Walsh.

Kate Smith

Kate joined Lumicell in 2017 to build and execute Lumicell’s clinical trial program and has since managed multiple large multi-center and feasibility studies testing Lumicell’s technology.  She has over 15 years of leading clinical affairs teams in the cancer field, most prominently in breast and lung cancers. Previously, Kate has led programs at Veracyte, Inc and Allegro Diagnostics, contributing to the success of novel cancer diagnostic technologies becoming available to clinicians and patients.  Kate holds a MPH degree from Boston University with a focus in Cancer Epidemiology.  Prior to working in Industry, Kate held roles at the Boston Public Health Commission focusing on program development, grant writing, and data collection methods to generate advocacy packages for pediatric and elder health initiatives. Additionally, Kate has held the position of Clinical Instructor at Boston University’s School of Graduate Medical Sciences in the Healthcare Emergency Management Program teaching both Epidemiology and Intro to Public Health courses for over 10 years. Kate enjoys leveraging her academic interests and industry experience by supporting young companies, like Lumicell, to bridge the gap between the bench and the bedside. Lastly, Kate is a Certified Clinical Research Professional (CCRP) by the Society of Clinical Research Associates.

Elisabeth Carroll

Elisabeth Carroll is strategic global human resources professional with 20 years experience aligning employee performance with business strategy.  She has an ability to quickly build strong partnerships with diverse leadership styles in a broad range of industries with demonstrated capability to work strategically and operationally in parallel. Previously, Elisabeth served as VP of Human Resources at Sensei Biotherapeutics to build the HR function and scale the organization after going public.  At Quanterix she oversaw Human Resources as the organization scaled quickly, went public and acquired and integrated two organizations.  She has deep experience supporting R&D as well as Commercialized global organizations within biotech start ups through large pharma.  Elisabeth holds a Bachelors degree in Art History from Simmons University.

Board of Directors

Andrey Zarur, PhD

Executive Chairman, Lumicell CEO, Green Light Biosciences

Elon Boms

Launch Capital, LLC

Cosimo Fiorenza

Vice President & General Counsel, Quantum Valley Investments.

David Furneaux

CEO, BlueIO & Managing Partner, Kodiak Venture Partners

Kevin Hershberger (Board Observer)

Former President & CEO, Lumicell

Kevin Krenitsky, MD

Former COO, CCO, Foundation Medicine

W. David Lee

Founder, Lumicell

Mike Ruettgers

Retired Chairman, Lahey Clinic, and Former CEO, EMC Corporation

Investors

References

1. National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer. Accessed April 19, 2023. https://seer.cancer.gov/statfacts/html/breast.html 2. Fefferman M, Nicholson K, Kuchta K, Pesce C, Kopkash K, Yao K. Rates of Bilateral Mastectomy in Patients With Early-Stage Breast Cancer [published correction appears in JAMA Netw Open. 2023 Mar 1;6(3):e236719]. JAMA Netw Open. 2023;6(1):e2251348. Published 2023 Jan 3. 3. Brigham and Women’s Hospital. Mastectomy and Double Mastectomy. Accessed April 24, 2023. https://www.brighamandwomens.org/surgery/surgical-oncology/resources/mastectomy 4. Breastcancer.org. Breast Cancer Facts and Statistics. Updated January 18, 2023. Accessed April 7, 2023. https://www.breastcancer.org/facts-statistics 5. McCahill LE, Single RM, Aiello Bowles EJ, et al. Variability in Reexcision Following Breast Conservation Surgery. JAMA. 2012;307(5):467-475. 6. Havel L, Naik H, Ramirez L, Morrow M, Landercasper J. Impact of the SSO-ASTRO Margin Guideline on Rates of Re-excision After Lumpectomy for Breast Cancer: A Meta-analysis. Ann Surg Oncol. 2019;26(5):1238-1244. 7. Chagpar AB, Killelea BK, Tsangaris TN, et al. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015;373(6):503-510. 8. Tang R, Coopey SB, Specht MC, et al. Lumpectomy Specimen Margins Are Not Reliable in Predicting Residual Disease in Breast Conserving Surgery. Am J Surg. 2015;210(1):93–8.

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