Lumicell
Lumicell is a commercial-stage medical technology company that sells LumiSystem, the first FDA-approved fluorescence-guided drug-device combination enabling real-time intraoperative detection of residual breast cancer during lumpectomy, targeting hospital outpatient departments and academic cancer centers.
- Company typePrivate
- Founded2012
- HeadquartersWaltham, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What Lumicell does
Lumicell is a privately held clinical-stage-turned-commercial medical technology company headquartered in Waltham, Massachusetts, developing fluorescence-guided imaging systems for the intraoperative detection of residual cancer. Its commercial product, LumiSystem, is the first FDA-approved drug-device combination for breast cancer lumpectomy — combining LUMISIGHT (pegulicianine), a tumor-activated fluorescent prodrug cleaved by cathepsins and matrix metalloproteases overexpressed in malignant tissue, with the Lumicell Direct Visualization System (DVS), a handheld imaging probe that scans the lumpectomy cavity in real time. The system demonstrated 84% diagnostic accuracy in the INSITE pivotal trial (published in NEJM Evidence) and is designed to reduce the approximately 36% re-excision rate caused by positive or falsely negative margins in breast-conserving surgery.
The company sells LumiSystem to U.S. hospital outpatient departments and cancer centers via a direct enterprise sales motion led by a Chief Commercial Officer, with initial commercial use at Stanford Healthcare and expansion targeted at other academic medical centers. Reimbursement is enabled by permanent HCPCS code A9615 for the imaging agent, CPT Category III code 0945T for the procedure, and CMS transitional pass-through payments, generating a hybrid revenue model of capital equipment (DVS console), consumables (single-use probe covers), and per-injection pharmaceutical revenue. Cumulative funding exceeds $250 million across equity rounds, NIH/SBIR grants, and a recent $12M SEC-registered offering, with Intuitive Venture Partners as a notable strategic investor alongside Kodiak Venture Partners, BlueIO, Rivas Capital, Launch Capital, and Reverse-Entropy Ventures.
Beyond breast cancer, Lumicell is extending its platform across multiple solid tumor indications (gastrointestinal, peritoneal metastases, brain, sarcoma, prostate, esophageal) and is developing a novel flexible endoscopic platform for Barrett's esophagus detection under a $400K NCI SBIR grant. The company collaborates with MGH on GI programs and with Stand Up To Cancer/Cancer Research UK on a multi-country gastric cancer endoscopy trial spanning the U.S., U.K., and South Korea, signaling both vertical and geographic pipeline expansion.
Lumicell firmographics
Firmographics- Name
- Lumicell
- Legal name
- Lumicell Inc.
- Website
- https://lumicell.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Lumicell is a commercial-stage medical technology company that sells LumiSystem, the first FDA-approved fluorescence-guided drug-device combination enabling real-time intraoperative detection of residual breast cancer during lumpectomy, targeting hospital outpatient departments and academic cancer centers.
- Ownership category
- akta.pro rank
Lumicell industry classification
Industry- Product category
- Surgical Oncology Imaging
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Surgical Appliance and Supplies Manufacturing (339113), Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Pharmaceutical Preparations (2834), In Vitro & In Vivo Diagnostic Substances (2835)
- akta.pro primary industry
- Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)
- akta.pro secondary industry
- Microscopy, Imaging & Flow Cytometry Instruments (HLAGAIAE)
Keywords
Where Lumicell is headquartered
LocationHeadquarters
- HQ city
- Waltham
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Lumicell business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Supply Chain
Revenue model
- LUMISIGHT (pegulicianine) Optical Imaging Agent: Sale of pegulicianine as a pharmaceutical optical imaging agent to hospital outpatient departments for use during lumpectomy surgery. CMS granted transitional pass-through (TPT) payment (HCPCS code C9171, transitioning to permanent A9615) effective October 1, 2024, under the hospital outpatient prospective payment system (OPPS).
- Lumicell DVS Device System: The Lumicell Direct Visualization System (DVS) handheld probe and console sold to hospital surgical departments. Includes a reusable probe and single-use sterile probe covers, generating recurring consumable revenue.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | LUMISIGHT (pegulicianine) optical imaging agent - priced per mg injection under HCPCS code A9615 |
| Unit Pricing | Multi-year contract | Lumicell DVS (handheld probe + console system) - capital equipment + consumable probe covers |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels8 records
Lumicell product offering
Product offeringCore offering
Lumicell develops and commercializes LumiSystem, the first and only FDA-approved fluorescence-guided drug-device combination for real-time intraoperative detection of residual cancer during breast cancer lumpectomy surgery. LumiSystem pairs LUMISIGHT (pegulicianine), an optical imaging prodrug that fluoresces when cleaved by tumor-overexpressed cathepsins and matrix metalloproteases, with the Lumicell Direct Visualization System (DVS), a handheld imaging probe for in-cavity scanning. The technology is also being extended across additional solid tumor indications.
Product overview
Lumicell offers the LumiSystem, a drug-device combination product comprising two FDA-approved components: LUMISIGHT (pegulicianine), an optical imaging agent/prodrug, and the Lumicell Direct Visualization System (DVS), a handheld fluorescence imaging device. Together, they enable real-time intraoperative detection of residual breast cancer during lumpectomy surgery with 84% diagnostic accuracy. The system is the first and only FDA-approved fluorescence-guided imaging technology for breast cancer detection and is also being explored for additional solid tumor indications including gastrointestinal cancers, peritoneal metastases, brain cancer, sarcoma, and prostate cancer.
Differentiator
Problem solved
Functional benefit
Brands
- LumiSystem: The combination of LUMISIGHT (pegulicianine) optical imaging agent and Lumicell Direct Visualization System (DVS) for fluorescence-guided breast cancer surgery
- LUMISIGHT
- Lumicell DVS
Products and services
- LumiSystem LumiSystem is the first and only FDA-approved fluorescence-guided drug-device combination for breast cancer surgery. It combines the LUMISIGHT optical imaging agent with the Lumicell DVS device to enable real-time detection of residual cancer within the breast cavity during lumpectomy surgery, achieving 84% diagnostic accuracy. It is intended for breast surgeons and surgical oncologists at hospital outpatient departments and cancer centers.
- LUMISIGHT (pegulicianine) LUMISIGHT is an FDA-approved optical imaging agent (prodrug) that fluoresces at sites of suspected cancerous tissue. It is optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs), enzymes that are elevated in and around tumor tissue. It is administered to patients undergoing breast cancer lumpectomy surgery.
- Lumicell Direct Visualization System (DVS) The Lumicell Direct Visualization System (DVS) is an FDA-approved fluorescence imaging device that provides real-time visualization of cancer inside the breast cavity. The handheld probe scans the lumpectomy cavity following removal of the primary specimen to detect residual cancer via fluorescent signals from LUMISIGHT. It is intended for breast surgeons and surgical oncologists in hospital operating rooms.
Quantifiable outcome
- 84% diagnostic accuracy in detecting residual breast cancer during lumpectomy (INSITE pivotal trial, NEJM Evidence 2023)
- +3 more outcomes
Companies that use Lumicell
Customer profileNamed customers5 records
Segments2 records
Ideal customer profiles1 record
Lumicell technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability1 record
Feature4 records
Lumicell partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered core and minor.
- Stand Up To Cancer (SU2C) and Cancer Research UKcoreSU2C and Cancer Research UK announced extended funding of $3 million for the SU2C Gastric Cancer Interception Dream Team to launch a clinical trial testing a novel fluorescence-guided endoscopy approach. Lumicell is supporting this initiative with an investigational device and new drug, collaborating with institutions in the US, UK, and South Korea to validate a blood biomarker (ORF1p) and expand early detection of gastric cancer.
- Learn Look LocateminorLumicell announced a collaboration with Learn Look Locate to develop educational content about breast cancer surgery, including lumpectomy procedures and associated technology. The partnership produces patient-friendly educational materials and digital campaigns to improve awareness and understanding of advanced surgical technologies like LumiSystem, aiming to enhance patient education and awareness of breast cancer treatment innovations.
- Dr. Andrew T. Chan, MD, MPH and Dr. David A. Drew, Ph.D. (Massachusetts General Hospital)coreDr. Chan (Vice-chair of Research, Division of Gastroenterology, MGH) and Dr. Drew (Assistant Professor, MGH Clinical and Translational Epidemiology Unit) collaborated with Lumicell on a Phase I NIH SBIR to develop a novel flexible endoscopic platform for fluorescence imaging of LUMISIGHT to detect early esophageal lesions in Barrett's esophagus. Dr. Chan and Dr. Drew also led the first clinical trial of pegulicianine in gastrointestinal cancer patients, presenting compelling findings at AACR Annual Meeting 2025.
- National Cancer Institute (NCI) / National Institutes of Health (NIH)coreLumicell awarded a Phase I NIH SBIR contract from the NCI to develop a novel flexible endoscopic platform combining far-red fluorescence and reflected light imaging to detect precancerous and early-stage esophageal adenocarcinoma under standard clinical endoscopy. Funding of approximately $400,000 with a one-year award period beginning September 2024.
Scale indicators6 records
Recent moves7 records
Expansion highlights6 records
Lumicell competitors and assessment
Company assessmentBroad incumbents
- Stryker: Stryker acquired Novadaq and now markets the SPY-PHI fluorescence imaging platform for intraoperative perfusion and tissue assessment, making it the most direct large incumbent in fluorescence-guided surgery. Comparable to Lumicell in targeting intraoperative visualization during surgical procedures.
- Olympus Corporation: Olympus provides endoscopic imaging platforms with integrated fluorescence modes (NBI, IR) used in surgical and GI applications. Comparable to Lumicell through overlap in intraoperative visualization and adjacent GI/endoscopy markets where LUMISIGHT is being expanded.
- GE HealthCare: GE HealthCare is a broad medical imaging and diagnostics incumbent that develops contrast agents, imaging equipment, and surgical visualization tools. Comparable to Lumicell as a hospital imaging partner with overlapping surgical and diagnostic imaging customers.
- Guerbet: Guerbet is a global specialist in contrast media and imaging solutions for medical imaging (CT, MRI, interventional radiology). Comparable to Lumicell as a diagnostic imaging agent company with hospital-channel sales, regulatory expertise, and established payor relationships.
- Medtronic: Medtronic is a broad medical-device incumbent with surgical, imaging, and oncology-adjacent portfolios (e.g., Surgical Innovations, AIS). Comparable to Lumicell as a large hospital-channel partner with overlapping surgical oncology customer relationships and capital to acquire emerging intraoperative imaging technologies.
Direct peers
- Karl Storz: Karl Storz offers fluorescence endoscopy systems (e.g., ICG-based platforms) for minimally invasive and open surgery, directly competing with Lumicell's DVS in surgical imaging workflow and targeting similar OR customers.
- Bracco Imaging: Bracco markets imaging agents such as Lumason (sulfur hexafluoride microbubbles) used in echocardiography and ultrasound imaging. Comparable to Lumicell as a contrast/imaging-agent company selling into hospitals and ambulatory surgery centers with established reimbursement infrastructure.
Others
- Intuitive Surgical: Intuitive Surgical is the leading robotic-assisted surgery platform (da Vinci) and a strategic investor in Lumicell through Intuitive Venture Partners with board representation. Comparable as a strategic ecosystem partner whose installed base could distribute intraoperative imaging capabilities.
- Revvity (formerly PerkinElmer Life Sciences): Revvity supplies imaging reagents, molecular probes, and life-science tools used in research and clinical diagnostics. Comparable to Lumicell in developing and commercializing fluorescence-based molecular imaging technologies, though with a broader life-science research focus.
Emerging players
- OnLume: OnLume is an emerging fluorescence-guided surgery imaging company developing real-time surgical visualization systems. Comparable to Lumicell as a similarly sized fluorescence-guided surgery technology developer with overlapping target surgical use cases.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Lumicell social profiles
Digital presenceLumicell compliance and trust
Trust signalCompliance1 record
Lumicell financial estimates
Financial estimateRevenue estimate
Valuation estimate
Lumicell leadership team
Management profileNumber of profiles
Profiles10 records
Lumicell funding detail
Funding detailFunding overview
Funding rounds11 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Lumicell M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Lumicell
What does Lumicell do?
Lumicell develops and commercializes LumiSystem, the first and only FDA-approved fluorescence-guided drug-device combination for real-time intraoperative detection of residual cancer during breast cancer lumpectomy surgery. LumiSystem pairs LUMISIGHT (pegulicianine), an optical imaging prodrug that fluoresces when cleaved by tumor-overexpressed cathepsins and matrix metalloproteases, with the Lumicell Direct Visualization System (DVS), a handheld imaging probe for in-cavity scanning. The technology is also being extended across additional solid tumor indications.
Is Lumicell a public or private company?
Lumicell is a private company. It is classified as venture growth investor backed and is currently operating.
When was Lumicell founded?
Lumicell was founded in 2012. It employs 51 to 100 people.
Where is Lumicell based?
Lumicell is headquartered in Waltham, United States, in the North America region.
How does Lumicell make money?
Two revenue lines are on record. LUMISIGHT (pegulicianine) Optical Imaging Agent is the primary driver. The others are lumicell DVS Device System.
Who are Lumicell's main competitors?
Broad incumbents on record are Stryker, Olympus Corporation, GE HealthCare, Guerbet and Medtronic. Direct peers are Karl Storz and Bracco Imaging. Others are Intuitive Surgical and Revvity (formerly PerkinElmer Life Sciences). OnLume is listed as an emerging player.
Does Lumicell have an API?
No public API is recorded for Lumicell.
What industry is Lumicell in?
Lumicell's product category is Surgical Oncology Imaging. Its primary akta.pro industry code is HLAHADAH, Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence), with a secondary code of HLAGAIAE, Microscopy, Imaging & Flow Cytometry Instruments. Its NAICS code is 334510 and its SIC code is 3841.