FIRE1
FIRE1 is a Dublin-based medical device company developing the NORM System, an implantable IVC sensor paired with a wearable belt and cloud apps, for physician-directed self-management of heart failure patients by cardiologists and specialists.
- Company typePrivate
- Founded2016
- HeadquartersDublin, Ireland
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What FIRE1 does
FIRE1 (legal entity Foundry Innovation & Research 1, Limited) is a privately held medical device company headquartered in Dublin, Ireland, developing the NORM System for physician-directed self-management of heart failure. The NORM platform comprises an implantable sensor placed in the inferior vena cava (IVC) that directly measures cross-sectional area changes as a proxy for intravascular fluid volume, a wearable NORM Belt worn briefly each day to activate the sensor and wirelessly transmit data, and cloud-connected NORM Patient and Clinician Apps that surface daily readings and intervention alerts. Unlike pressure-based cardiac monitoring approaches, NORM's direct IVC-area measurement is positioned as a first-in-class mechanism for detecting early fluid accumulation, enabling lifestyle and medication adjustments to prevent decompensation and hospitalization.
The company targets two end-user segments: heart failure patients (particularly those over 65, the population driving most heart failure hospitalizations) and the cardiologists and heart failure specialists who manage them. FIRE1 conducts clinical trials across the US (Columbia, Duke, Ohio State, Rochester General, St David's), the UK (Royal Bournemouth, Golden Jubilee, Royal Brompton, University Hospitals Leicester), Ireland (University Hospital Galway), and the Netherlands (University Medical Center Groningen, Erasmus), building evidence for future regulatory submissions. The product remains investigational and is not yet approved for clinical use in any geography, so no commercial revenue is currently generated.
FIRE1's revenue model is expected to be hardware-led once regulatory approval is secured: device sales of the NORM System (sensor plus belt) to healthcare systems and cardiac catheterization labs, with possible associated monitoring services. The go-to-market approach targets healthcare systems and clinicians who will recommend the device to eligible heart failure patients. The company is venture-backed, having raised approximately $202 million across five disclosed rounds since 2014, with investors including Andera Partners, Novo Holdings, Medtronic, NEA, Gilde Healthcare, Polaris Partners, Elevage Medical Technologies, Lightstone Ventures, Gimv, Seventure Partners, Sands Capital Ventures, Longitude Capital, and the Ireland Strategic Investment Fund.
FIRE1 firmographics
Firmographics- Name
- FIRE1
- Legal name
- Foundry Innovation & Research 1, Limited
- Website
- https://fire1foundry.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- FIRE1 is a Dublin-based medical device company developing the NORM System, an implantable IVC sensor paired with a wearable belt and cloud apps, for physician-directed self-management of heart failure patients by cardiologists and specialists.
- Ownership category
- akta.pro rank
Where FIRE1 is headquartered
LocationHeadquarters
- HQ city
- Dublin
- HQ country
- Ireland
- HQ region
- Europe
Offices1 record
Markets served
FIRE1 business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure
Revenue model
- Medical Device Sales: Once regulatory approval is obtained, the company plans to commercialize its NORM system comprising the implantable IVC sensor and wearable belt components. Revenue will come from device sales and possibly associated monitoring services to healthcare systems.
Go-to-market motion2 records
Distribution channels1 record
Marketing channels4 records
FIRE1 product offering
Product offeringCore offering
FIRE1 develops and sells the NORM System, an investigational heart failure management platform that combines an implantable sensor placed in the inferior vena cava (IVC), a wearable NORM Belt for daily activation, and cloud-connected patient and clinician applications. The system directly measures fluid volume changes in the IVC to provide early warning of worsening heart failure, supporting physician-directed patient self-management.
Product overview
FIRE1 (Foundry Innovation & Research 1 Ltd) is a Dublin, Ireland-based medical device company offering the NORM System, a breakthrough platform for physician-directed patient self-management of heart failure. The NORM System consists of an implantable sensor placed in the inferior vena cava (IVC), a wearable NORM Belt for daily activation and data collection, plus cloud-connected NORM Patient App and NORM Clinician App/Portal. The system directly measures fluid volume changes in the IVC to provide advance warning of worsening heart failure, enabling patients to make lifestyle and medication changes to prevent hospitalization. The NORM Sensor and NORM Belt work together as the core monitoring components, while the patient and clinician apps provide the interface for daily self-management and care team oversight.
Differentiator
Problem solved
Functional benefit
Brands
- NORM: NORM is the company's heart failure management system - a revolutionary medical device platform that includes an implantable sensor, a monitoring belt, and connected mobile applications for patient and clinician use.
Products and services
- NORM System
Quantifiable outcome
- NORM received Red Dot Design Awards in both Healthcare Product Design and Innovative Product categories, recognized for technological innovation and simple, futuristic design.
Companies that use FIRE1
Customer profileNamed customers12 records
Segments2 records
Ideal customer profiles1 record
FIRE1 technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
FIRE1 partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered major and core.
- Columbia University Irving Medical CentermajorUS clinical trial site for FUTURE-HF2 Early Feasibility Study of the FIRE1 System in heart failure patients, located in New York.
- Duke University Health SystemmajorUS clinical trial site for FUTURE-HF2 Early Feasibility Study of the FIRE1 System in heart failure patients, located in Durham, North Carolina.
- The Ohio State UniversitymajorUS clinical trial site for FUTURE-HF2 Early Feasibility Study of the FIRE1 System in heart failure patients, located in Columbus, Ohio.
- Rochester General HospitalmajorUS clinical trial site for FUTURE-HF2 Early Feasibility Study of the FIRE1 System in heart failure patients.
- Royal Bournemouth HospitalmajorUK clinical trial site for the FIRE1 System in heart failure patients, located in Bournemouth, England.
- Golden Jubilee National HospitalmajorUK clinical trial site for the FIRE1 System in heart failure patients, located in Glasgow, Scotland.
- Royal Brompton and Harefield HospitalsmajorUK clinical trial site for the FIRE1 System in heart failure patients, located in London.
- University Medical Center GroningenmajorEuropean clinical trial site for the FIRE1 System in heart failure patients, located in Groningen, The Netherlands.
- Erasmus University Medical CentermajorEuropean clinical trial site for the FIRE1 System in heart failure patients, located in Rotterdam, The Netherlands.
- University Hospital GalwaymajorEuropean clinical trial site for the FIRE1 System in heart failure patients, located in Galway, Ireland.
- The FoundrycoreThe Foundry in Menlo Park, California is the medical device incubator where FIRE1 originated. It is a leading medical device incubator that provided the foundation for FIRE1's founding and early development.
Scale indicators6 records
Recent moves6 records
Expansion highlights6 records
FIRE1 competitors and assessment
Company assessmentDirect peers
- Abbott: Abbott markets the CardioMEMS HF System, an FDA-approved implantable pulmonary artery pressure sensor for remote heart failure monitoring. CardioMEMS is FIRE1's most direct competitor and the current standard-of-care that FIRE1 must displace in the implantable HF monitoring category.
- Vectorious Medical Technologies: Israeli medtech developing the V-LAP left atrial pressure sensor, an implantable wireless monitor for heart failure patients. Closest competitor to FIRE1 in the implantable HF hemodynamic monitoring space, with a different anatomical measurement site but overlapping patient population and use case.
Broad incumbents
- Medtronic: Medtronic has the HeartLogic diagnostic algorithm embedded in ICDs/CIEDs for heart failure decompensation detection. Although also an investor in FIRE1, Medtronic is both a strategic partner and a competitor with broader cardiac device portfolio and established hospital salesforce.
- Edwards Lifesciences: Edwards acquired Vectorious's development-stage assets and is a major structural heart player with growing interest in remote HF management. Comparable as a broader cardiac care incumbent with overlapping HF hemodynamic monitoring ambitions.
- Boston Scientific: Boston Scientific operates across interventional cardiology and cardiac rhythm management and owns the Preventice ECG remote monitoring business. Comparable as a broad cardiac incumbent with overlapping HF patient touchpoints, though no direct implantable HF pressure monitor.
Emerging players
- iRhythm Technologies: iRhythm's Zio long-term continuous cardiac monitoring patch serves arrhythmia and emerging HF patient populations. Comparable as a connected cardiac monitoring company with a wearable-to-cloud data model, though its mechanism (ECG) is different from FIRE1's IVC volume approach.
- Eko Health: Eko combines AI-enabled digital stethoscopes with cardiac monitoring algorithms, including emerging HF detection capabilities. Comparable as an emerging connected cardiac monitoring player pursuing earlier HF detection via non-invasive approaches.
- Corvia Medical: Corvia is developing the Corvia Atrial Shunt, an interventional implant for HFpEF patients. Comparable as an emerging implantable HF therapeutic targeting a similar patient population and hospital cardiology channel as FIRE1.
- Sensible Medical Innovations: Israeli company developing the ReDS lung fluid measurement system, a non-invasive radar-based thoracic fluid monitor for HF patients. Comparable as an emerging HF monitoring competitor with a contrasting non-invasive mechanism targeting the same clinical use case.
- Qura Inc. Qura is developing an implantable wireless pulmonary artery pressure sensor for heart failure monitoring. Closest emerging direct peer to CardioMEMS and FIRE1, pursuing an adjacent anatomical measurement site with overlapping clinical and commercial use case.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
FIRE1 social profiles
Digital presenceFIRE1 financial estimates
Financial estimateRevenue estimate
Valuation estimate
FIRE1 leadership team
Management profileNumber of profiles
Profiles5 records
FIRE1 funding detail
Funding detailFunding overview
Funding rounds5 records
Investors15 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
FIRE1 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 FIRE1
What does FIRE1 do?
FIRE1 develops and sells the NORM System, an investigational heart failure management platform that combines an implantable sensor placed in the inferior vena cava (IVC), a wearable NORM Belt for daily activation, and cloud-connected patient and clinician applications. The system directly measures fluid volume changes in the IVC to provide early warning of worsening heart failure, supporting physician-directed patient self-management.
Is FIRE1 a public or private company?
FIRE1 is a private company. It is classified as venture growth investor backed and is currently operating.
When was FIRE1 founded?
FIRE1 was founded in 2016. It employs 51 to 100 people.
Where is FIRE1 based?
FIRE1 is headquartered in Dublin, Ireland, in the Europe region.
How does FIRE1 make money?
One revenue line is on record: medical Device Sales.
Who are FIRE1's main competitors?
Direct peers on record are Abbott and Vectorious Medical Technologies. Broad incumbents are Medtronic, Edwards Lifesciences and Boston Scientific. Emerging players are iRhythm Technologies, Eko Health, Corvia Medical, Sensible Medical Innovations and Qura Inc..
Does FIRE1 have an API?
No public API is recorded for FIRE1.