FluoGuide
FluoGuide A/S is a Copenhagen-based clinical-stage biotech developing FG001, a fluorescent imaging agent that lights up cancer cells during surgery to guide tumor resection in high-grade glioma, head and neck, and other cancers.
- Company typePublic
- Founded2018
- HeadquartersCopenhagen, Denmark
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What FluoGuide does
FluoGuide A/S is a Danish clinical-stage biotechnology company developing FG001, a fluorescent intraoperative imaging agent designed to label cancer cells in real time during surgery, enabling surgeons to visually distinguish tumor tissue from healthy tissue. The company is headquartered in Copenhagen, Denmark, and has been publicly listed on Nasdaq First North Sweden under the ticker FLUO since at least November 2025. FG001 targets aggressive brain cancer (high-grade glioma) as its lead indication, with additional development in head and neck cancer, meningioma, and low-grade glioma. In February 2026 the FDA cleared the IND application for FG001 in high-grade glioma, and in March 2026 the FDA granted Fast Track Designation, positioning the asset for a U.S. Phase 2 registration trial with first patient enrollment planned for Q2 2026.
The company's technology is a small-molecule fluorescent probe that binds to cancer cells and emits a signal when illuminated intraoperatively, integrating with leading surgical microscopy platforms via non-exclusive collaborations with ZEISS Medical Technologies (signed November 2025) and Olympus. FluoGuide is pre-revenue: it reported no commercial revenue for FY2025 and a consolidated net loss of tDKK 39,459. Operations are funded primarily by equity capital, most recently a SEK 104 million directed share issue completed in November 2025 via accelerated bookbuilding to Nordic institutional investors. Headcount is small (1–10 employees as listed), with leadership consisting of CEO Morten Albrechtsen, CFO Ole Larsen, and COO Donna Haire (appointed November 2025).
Commercially, FluoGuide expects to generate revenue upon regulatory approval and launch of FG001, with go-to-market built around enterprise sales to hospitals and surgical centers, leveraging its microscopy-platform integrations. Two U.S. registration-enabling clinical trials are anticipated for the high-grade glioma program. The business model is effectively a single-asset, regulatory-driven biotech dependent on successful clinical readouts, FDA approval, and downstream commercialization or partnership economics.
FluoGuide firmographics
Firmographics- Name
- FluoGuide
- Legal name
- FluoGuide A/S
- Website
- https://fluoguide.com
- Company type
- Public
- Founded year
- 2018
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- FluoGuide A/S is a Copenhagen-based clinical-stage biotech developing FG001, a fluorescent imaging agent that lights up cancer cells during surgery to guide tumor resection in high-grade glioma, head and neck, and other cancers.
- Ownership category
- akta.pro rank
FluoGuide industry classification
Industry- Product category
- Intraoperative Surgical Oncology Imaging
- NAICS
- Surgical and Medical Instrument Manufacturing (339112), Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Pharmaceutical Preparations (2834)
- akta.pro primary industry
- Intraoperative Imaging & Guidance (C-arms, O-arm, IOUS, fluorescence) (HLAHADAH)
- akta.pro secondary industries
- Medical Imaging AI (HDAAAEAH), Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)
Keywords
Where FluoGuide is headquartered
LocationHeadquarters
- HQ city
- Copenhagen
- HQ country
- Denmark
- HQ region
- Europe
Offices1 record
Markets served
FluoGuide business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Pharmaceutical/Biotech Product Revenue: Pre-revenue company developing FG001 as an intraoperative imaging agent. The company expects to generate revenue upon regulatory approval and commercialization of its surgical imaging technology for cancer treatment.
Go-to-market motion1 record
Distribution channels2 records
Marketing channels2 records
FluoGuide product offering
Product offeringCore offering
FluoGuide develops and commercializes FG001, a proprietary surgical imaging agent designed to improve precision in cancer surgery by fluorescently labeling cancer cells so they light up intraoperatively. The product enables real-time visual identification of tumor margins during resection procedures and is being advanced for high-grade glioma, head and neck cancer, meningioma, and low-grade glioma indications through clinical trials.
Product overview
FluoGuide is a pharmaceutical/biotechnology company with a single lead product, FG001, which is a surgical imaging agent designed for intraoperative tumor visualization. The company is developing FG001 for multiple cancer indications including high-grade glioma, head and neck cancer, meningioma, and low-grade glioma. FG001 works by fluorescently labeling cancer cells to enable real-time visual identification during surgery, with strategic collaborations with ZEISS and Olympus for surgical microscopy integration.
Differentiator
Problem solved
Functional benefit
Products and services
- FG001
Quantifiable outcome
- Positive interim results from FG001 trial in meningioma and low-grade glioma
Companies that use FluoGuide
Customer profileSegments3 records
Ideal customer profiles1 record
FluoGuide technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration2 records
AI capability2 records
Feature1 record
FluoGuide partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- ZEISS Medical TechnologiescoreCollaboration agreement with ZEISS Medical Technologies to develop FG001 for tumor imaging and surgical margins assessment in head and neck cancer. The collaboration focuses on supporting the clinical phase with no initial payment. This is a non-exclusive agreement and is not expected to impact the company's financial results in 2025.
- OlympuscoreStrategic collaboration with Olympus for development and integration of FG001 surgical imaging technology. Olympus is a leading medical technology company focused on head and neck cancer surgery solutions.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
FluoGuide competitors and assessment
Company assessmentDirect peers
- Blaze Bioscience: Blaze Bioscience develops 'Tumor Paint' (tozuleristide/BLZ-100), a fluorescent imaging agent that labels cancer cells intraoperatively — directly comparable to FluoGuide's FG001 in mechanism, use case (real-time intraoperative tumor illumination), and target surgical indications including brain tumors.
- Lumicell: Lumicell develops the LUM System, a fluorescence-guided imaging platform combined with a tumor-targeted imaging agent (pegulicianine) for intraoperative cancer detection during breast cancer surgery — same combination-product architecture and intraoperative use case as FG001.
- Avelas Biosciences: Avelas develops fluorescent imaging agents (e.g., AVB-620 / pegloprastide) for real-time intraoperative visualization of cancer tissue, directly comparable to FluoGuide's FG001 in product category and surgical oncology application.
Broad incumbents
- Stryker: Stryker owns the Novadaq/SPY portfolio of fluorescence imaging platforms used in surgical visualization across multiple specialties — broadly overlaps with FG001's fluorescence-guided surgery application as part of a much wider surgical equipment portfolio.
- Intuitive Surgical: Intuitive's da Vinci surgical systems include Firefly fluorescence imaging for intraoperative visualization, addressing the same surgical oncology workflows FluoGuide targets with FG001, though as part of a much broader robotic surgery platform.
- Medtronic: Medtronic offers near-infrared fluorescence imaging integrated into its surgical platforms (e.g., neurosurgery visualization) — broadly competing with FG001's intraoperative tumor illumination value proposition as part of a diversified medtech portfolio.
- Karl Storz: Karl Storz provides endoscopic visualization platforms with integrated ICG-based fluorescence imaging for surgical oncology — broadly overlapping with FluoGuide's surgical microscopy / endoscopy integration use case.
- Olympus: Olympus is both a strategic collaboration partner for FG001 and a major surgical visualization competitor with its own endoscopy and microscopy platforms used in head and neck cancer surgery — a dual partner/incumbent relationship in the same surgical imaging space.
- Leica Microsystems (Danaher): Leica Microsystems, part of Danaher, supplies surgical microscopy platforms used in neurosurgery and ENT — directly relevant as a potential integration partner / competitor to FluoGuide's ZEISS and Olympus collaborations for fluorescence-guided intraoperative imaging.
Emerging players
- Perimeter Medical Imaging AI: Perimeter Medical Imaging AI develops imaging AI plus wide-field OCT for intraoperative margin assessment during breast-conserving surgery — an emerging alternative modality to fluorescence-guided imaging that overlaps with FluoGuide's surgical oncology use case.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat3 records
Key risks5 records
Key highlights6 records
Customer concentration
FluoGuide social profiles
Digital presenceFluoGuide financial estimates
Financial estimateRevenue estimate
Valuation estimate
FluoGuide leadership team
Management profileNumber of profiles
Profiles7 records
FluoGuide funding detail
Funding detailFunding overview
Funding rounds3 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
FluoGuide 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 FluoGuide
What does FluoGuide do?
FluoGuide develops and commercializes FG001, a proprietary surgical imaging agent designed to improve precision in cancer surgery by fluorescently labeling cancer cells so they light up intraoperatively. The product enables real-time visual identification of tumor margins during resection procedures and is being advanced for high-grade glioma, head and neck cancer, meningioma, and low-grade glioma indications through clinical trials.
Is FluoGuide a public or private company?
FluoGuide is a public company. It is classified as public and is currently operating.
When was FluoGuide founded?
FluoGuide was founded in 2018. It employs 1 to 10 people.
Where is FluoGuide based?
FluoGuide is headquartered in Copenhagen, Denmark, in the Europe region.
How does FluoGuide make money?
One revenue line is on record: pharmaceutical/Biotech Product Revenue.
Who are FluoGuide's main competitors?
Direct peers on record are Blaze Bioscience, Lumicell and Avelas Biosciences. Broad incumbents are Stryker, Intuitive Surgical, Medtronic, Karl Storz, Olympus and Leica Microsystems (Danaher). Perimeter Medical Imaging AI is listed as an emerging player.
Does FluoGuide have an API?
No public API is recorded for FluoGuide.
What industry is FluoGuide in?
FluoGuide's product category is Intraoperative 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 HDAAAEAH, Medical Imaging AI. Its NAICS code is 339112 and its SIC code is 3841.