Key Takeaways
- • Sensydia, a clinical-stage medical technology company developing non-invasive cardiac assessment tools, announced an oversubscribed initial closing of more than $6 million in its latest financing round.
- • The round was led by Colle Capital Partners, with substantial participation from Orlando Health Ventures.
- • Proceeds will fund the ACOUSTIC'1 study for Sensydia's Cardiac Performance System (CPS) through to FDA authorization, while supporting commercial launch preparation.
- • The CPS platform has received FDA Breakthrough Device designation, and the company previously obtained FDA 510(k) clearance in 2018 for an ejection fraction measurement algorithm.
Summary
The capital will advance Sensydia's Cardiac Performance System (CPS) through its ACOUSTIC'1 study toward FDA authorization, while also supporting preparations for commercial launch. The CPS is a non-invasive platform designed to allow clinicians to rapidly, safely, and accurately assess hemodynamic function in the office or clinic. The company positions the system as a tool to help clinicians better diagnose and manage heart failure and pulmonary hypertension, with the stated goal of improving patient outcomes.
The CPS has received FDA Breakthrough Device designation, a status intended to expedite development and review of certain devices. Sensydia's regulatory history also includes FDA 510(k) clearance granted in 2018 for an algorithm enabling non-invasive measurement of ejection fraction.
The announcement was made by the company and the financing is described as an initial closing, indicating that additional tranches or further closings may follow, though the source does not specify a final round size or timing.
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