FIRE1
- Industry
- Medical Devices
- Founded Year
- 2014
- Headquarters
- Dublin, Ireland
- Employee Count
- 60
Key People
- Conor Hanley - CEO and President
- Ellie McGuire - Board Member, Partner at Polaris Partners
- Michael Wasserman - Board Member, COO at Elevage Medical Technologies
- Aneta Sottil - Board Member, Director at Andera Life Sciences
- Eric Snyder - Board Member, Partner at Novo Holdings
Assessment
- Team
-
Aspect: 1 successful MedTech entrepreneur
Summary: Led by CEO Conor Hanley, an experienced MedTech entrepreneur.
Conor Hanley, CEO and President of FIRE1, has a strong background in medical devices, including co-founding BiancaMed Ltd, which was acquired by ResMed. His experience positions the company well for navigating the complexities of MedTech development and commercialization.
- Clinical Need
-
Aspect: Very Strong
Summary: Addresses a significant unmet need in heart failure management.
Heart failure affects approximately 64 million people worldwide, with increasing prevalence. FIRE1's Norm system provides a direct measurement of fluid volume, potentially reducing hospitalizations and improving patient outcomes, addressing a critical gap in current heart failure management.
- Competition
-
Aspect: Somewhat crowded
Summary: Competes in a market with existing solutions but offers differentiation.
While the heart failure monitoring market has existing devices such as Abbott's CardioMEMS, FIRE1's Norm system differentiates itself by directly measuring fluid volume in the inferior vena cava, potentially offering more accurate and actionable data for patient management.
- Technical Challenge
-
Aspect: Moderate
Summary: Developing an implantable sensor with daily external data collection.
The Norm system involves implanting a sensor in the inferior vena cava and requires patients to wear an external belt daily for data collection. Challenges include ensuring the sensor's long-term functionality, patient adherence to daily monitoring, and seamless data transmission to healthcare providers.
- Patent
-
Aspect: Strong
Summary: Holds patents for its heart failure monitoring technology.
FIRE1 has secured patents for its Norm system, covering the implantable sensor and associated monitoring technology. This intellectual property protection is vital for maintaining a competitive position and attracting further investment in the MedTech sector.
- Financing
-
Aspect: Well-funded
Summary: Secured significant funding from reputable investors.
In January 2025, FIRE1 completed a $120 million financing round led by Polaris Partners and Elevage Medical Technologies, with participation from new and existing investors. This substantial funding enables the company to advance its Norm system through pivotal clinical trials, a critical step toward regulatory approval and commercialization.
- Regulatory
-
Aspect: Pivotal Trial
Summary: Preparing for pivotal clinical trials to support FDA approval.
FIRE1's Norm system has received FDA Breakthrough Device Designation and is part of the Total Product Lifecycle Advisory Program (TAP). The company is planning a pivotal clinical trial involving approximately 800 patients to demonstrate the device's safety and efficacy, a necessary step for obtaining FDA approval and subsequent market launch.
Opportunity Rollup
- Odds of Success
- 3.35
- Peak Market Share
- 4.3
- Segment CAGR
- 5.8%
- Market Segment
- Cardiac Assist Devices
- Market Sub Segment
- Implantable Heart Failure Monitoring Devices
| Year Post Launch | Market Penetration (%) |
|---|---|
| 1 | 0.22 |
| 2 | 0.64 |
| 3 | 1.50 |
| 4 | 3.01 |
| 5 | 4.30 |
Key Takeaway
FIRE1's Norm system addresses a significant need in heart failure management with strong leadership and substantial funding, but faces challenges in a competitive market and regulatory approval process.