Sensydia has secured an oversubscribed initial closing of more than $6 million in new financing to advance its Cardiac Performance System through its ongoing ACOUSTIC-1 study and prepare the technology for potential commercial launch. The financing was led by Colle Capital Partners with substantial participation from Orlando Health Ventures.
Sensydia plans to use the funding to advance CPS through clinical development toward FDA authorization while supporting commercialization preparations.
CPS is an investigational, non-invasive cardiac assessment platform that acquires acoustic and electrical signals and analyzes them using artificial intelligence algorithms. Sensydia is developing the system to provide pulmonary pressure assessments in office, hospital, and clinic settings without requiring invasive catheterization.
The company sees potential applications in managing heart failure and pulmonary hypertension, where clinicians often need objective hemodynamic information to assess congestion and guide treatment.
A new Category III CPT code, 1036T, became effective in July 2026 for non-invasive hemodynamic assessment based on passively acquired acoustic and electrical signals, algorithmic analysis, and physician review and interpretation. Sensydia said those elements align with CPS’s approach.
Sensydia has built the system using catheterization data as a clinical reference and previously received FDA Breakthrough Device designation for CPS. The company also received FDA 510(k) clearance in 2018 for an algorithm that noninvasively measures ejection fraction.
CPS remains investigational and has not yet received FDA authorization.
With the latest financing, Sensydia expects to complete the ACOUSTIC-1 study, continue regulatory work, and prepare for deployment if authorized.
KEY QUOTES:
“The most important medical technology companies create categories rather than compete in them. Sensydia has the makings of one: a new way to bring pressure information to the point of care, and the foundation to scale it.”
Bill Hawkins, Retired Chairman And CEO Of Medtronic And Advisor To Sensydia
“Cardiologists treating heart failure need the right metric, in the right place, at the right time. We built CPS to give clinicians objective pressure information in the office, where therapy decisions are made.”
Anthony Arnold, CEO Of Sensydia
“Sensydia built CPS on catheterization data, the clinical gold standard, at a scale few companies attempt.”
Victoria Grace, Founding Partner Of Colle Capital Partners
