Novo, Medtronic add $25M in fuel to FIRE1 and its heart failure monitoring device

A group of high-profile healthcare investors have found an apt outlet for the money seemingly burning holes in their pockets.

Foundry Innovation & Research 1—known by its much catchier acronym, FIRE1—announced Wednesday the close of a $25 million financing round. It was led by a pair of new investors in the company: Andera Partners and Novo Holdings, the holding and investment company that serves as the controlling shareholder for Novo Nordisk and Novozymes.

Representatives from each of the round’s leaders were tapped to join FIRE1’s board of directors.

Also adding kindling to the multimillion-dollar blaze were several of the Dublin-based devicemaker’s existing investors, including Medtronic, Lightstone Ventures, the federally funded Ireland Strategic Investment Fund and more.

Medtronic is a longtime backer of FIRE1: The company launched in early 2014 with support from Covidien, among others, and when Medtronic completed its acquisition of Covidien the following year, it also assumed the role of stoking up FIRE1.

The financing was an extension round, according to Andera Partners. It follows a series C raise that brought in €40 million (then the equivalent of about $50 million) in 2018 and a subsequent €7.5 million awarded by the Ireland Strategic Investment Fund in 2020.

The new funding will help FIRE1 continue to develop its first product, an implanted sensor for remote monitoring of heart failure patients. A clinical trial of the device is already in the works, with a primary completion date set for August of this year, according to the national clinical trials database. It’s recruiting 50 patients in the U.K., Georgia and the Czech Republic who have been diagnosed with heart failure and have seen the condition worsen in recent months.

Though FIRE1 has long kept the inner workings of the system under wraps, the hospital where the trial’s first U.K. implant of the device was performed earlier this year provided some of the details to the BBC last month.

According to a spokesperson for University Hospital Southampton, the pen cap-sized sensor is placed inside the inferior vena cava in a short, minimally invasive procedure. It continuously measures the size of the vein to determine how well the heart is pumping blood through the body; if fluid begins to build up in the lungs, it can put a strain on the body and cause a heart failure patient’s condition to deteriorate. The sensor is programmed to send out an external alert if that occurs.

“Heart failure affects over 60 million patients worldwide and is the leading cause of hospitalization in patients over 65. Hemodynamic monitoring in heart failure has tremendous potential to improve care for patients and reduce the need for hospitalizations,” Eric Snyder, Novo Holdings’ newly named representative on the FIRE1 board, said in Wednesday’s announcement.

FIRE1 isn’t the only devicemaker hoping to shine some light in this area since heart failure can be difficult to accurately diagnose and track. The paper clip-sized CardioMEMS implant now owned by Abbott was cleared by the FDA in 2014—and scored an expanded indication last year—to monitor changes in the pulmonary artery’s blood pressure that could indicate worsening heart failure.

Biofourmis, meanwhile, has developed a software solution dubbed BiovitalsHF that analyzes a user’s medical history, lab test results and real-time heart rate and blood pressure to make sure they’re taking prescribed heart failure medications at the right time and in the right quantities. The system was given the FDA’s breakthrough device designation in 2021 and is already being used by Novartis and by Yale University and the Mayo Clinic in separate research projects.

Taking an even less conventional approach to heart failure monitoring is Casana Care, a spinout of the Rochester Institute of Technology. Casana is developing the Heart Seat, a “smart” toilet seat that’s embedded with sensors to track heart rate, blood pressure, oxygenation levels and other vital signs, which are then analyzed to spot signs of congestive heart failure and other cardiac conditions.