Cardiosense Begins SEISMIC-HF I Heart Failure Trial

Cardiosense began enrolling patients in its SEISMIC-HF I trial, a nationwide clinical study to refine and validate algorithms to assess intracardiac filling pressure, an early physiological marker for acute heart failure decompensation.
 
The algorithms use data captured by Cardiosense’s non-invasive CardioTag patch, which measures key cardiac function parameters. Cardiosense was awarded breakthrough status from the U.S. Food and Drug Administration (FDA) in 2022.
 
“Elevated intracardiac filling pressures are a clinically proven indicator for decompensated heart failure and hospitalization, but so far has largely been possible only through invasive methods, limiting its utility to a broader population,” Anjan Tibrewala, MD of Northwestern Medicine’s Bluhm Cardiovascular Institute told the press. “Cardiosense’s technology has the potential to be a game-changing solution in remotely monitoring patients with heart failure. I’m excited to participate in the SEISMIC-HF I study and that Northwestern Medicine was the first site to enroll patients.”
 
The company also welcomed Judy Lenane to its board as an independent director. This appointment follows last year’s $15.1 million Series A raise and the additions of Daniel Gottlieb of Broadview Ventures and Jeff Terrell of Hatteras Venture Partners to the board.
 
Lenane was an early member of the iRhythm team, and served in the roles of executive VP of products, chief clinical officer, and executive VP of operations. Before iRhythm, she was VP of cardiovascular business development for Centura Health.
 
“On behalf of the entire Cardiosense team, we are thrilled to welcome Judy Lenane to our Board of Directors,” said Cardiosense co-founder and CEO Amit Gupta. “Judy brings a wealth of operating and company-building experience that will play a pivotal role in scaling and shaping the future of our company and product offerings. Her extensive background in healthcare management, cardiac wearables, remote patient monitoring, and clinical AI combined with her passion for advancing patient-centric solutions make her a welcome addition to the team.”