Dive Brief:
- Fire1 said Tuesday it raised $120 million to complete a pivotal trial of its Norm heart failure management system.
- Norm monitors changes in a large vein to show patients and clinicians how the heart is working. The implant assesses fluid volume, differentiating it from devices such as Abbott’s Cardiomems that use pulmonary artery pressure as an indicator of heart failure.
- Fire1 emerged from The Foundry, a medical device incubator in California that spawned companies such as Ardian, Concentric Medical, Evalve and Twelve. Abbott, Medtronic and Stryker collectively paid more than $1.6 billion to acquire those startups and add technologies to their portfolios. Medtronic was among the investors in Fire1’s latest funding round.
Dive Insight:
Investors including Covidien, now part of Medtronic, helped Fire1 get set up in 2014 and continued to fund the startup across a series of subsequent financing rounds. The support has enabled Fire1 to move its technology into an early feasibility study and start planning to run a pivotal trial.
The clinical development program is testing a system with three components. One component, the Norm sensor, is implanted in a large vein, the inferior vena cava, by a cardiac catheterization lab in a same-day procedure. The sensor expands and contracts with the inferior vena cava, allowing it to monitor changes in the fluid volume in the vein.
Patients wear a belt for a few minutes a day to activate the sensor and send data from the implant to the cloud. Algorithms process the data to create results for patient and clinician apps, allowing the care team to see if they need to intervene.
Norm has received breakthrough device designation from the Food and Drug Administration, giving Fire1 additional access to the agency as it works to bring the product to market. The early feasibility study is scheduled to reach primary completion this year, according to ClinicalTrials.gov, and Fire1 will use its new funding to run a pivotal trial.
If approved, Norm will offer an alternative to Abbott’s Cardiomems and Edwards Lifesciences’ Cordella. Cardiomems and Cordella, which Edwards acquired in its Endotronix buyout last year, monitor heart failure by assessing changes in pulmonary artery pressure.
The new funding round was led by Polaris Partners and Elevage Medical Technologies. New investors Sands Capital and Longitude Capital joined existing investors Andera Partners, Gilde Healthcare, Gimv, the Ireland Strategic Investment Fund, Lightstone Ventures, Medtronic, New Enterprise Associates, Novo Holdings, and Seventure Partners.
