Proceeds of the financing will enable the company to prepare for commercialization of its groundbreaking non-invasive cardiac assessment platform, Cardiac Performance System (CPS™). Sensydia continues to push the boundaries of its heart-sound AI technology, which promises to transform the diagnosis and management of heart disease, the leading cause of death worldwide.
“We are thrilled to have the support of investors who share our vision for transforming heart failure management,” said Anthony Arnold, President and CEO of Sensydia. “This funding will enable us to accelerate our march to commercialization by expanding development and operations for our CPS platform.”
The funding was led by Florida-based Orlando Health Ventures, with participation from Colle Capital, Frontier Venture Capital, and others. Concurrent with this financing, Erick Hawkins, Chief Administrative Officer for Orlando Health, will join the Sensydia board of directors.
“Sensydia’s CPS technology is a game-changing AI application that makes crucial cardiac data both accessible and affordable,” said Victoria Grace, Founder of Colle Capital and Sensydia Board Member. “This technology transcends geographical and financial barriers to care, unlocking new markets while enhancing early diagnosis and treatment protocols.”
Sensydia’s CPS platform uses ultra-sensitive biosensors and AI algorithms to provide clinicians with rapid, non-invasive measurement of ejection fraction, cardiac output, pulmonary artery pressure, and pulmonary capillary wedge pressure in a handheld device without the need for in-hospital catheterization.
"Non-invasive and real-time cardiac function measures will lead to early diagnosis and personalized care for heart disease," said Farhan Khawaja, MD, President of the Orlando Health Heart & Vascular Institute. "This technology has the potential to vastly improve patient lives by enabling faster and more affordable disease management, moving healthcare from the hospital setting into the patient’s home."
This funding will enable the company to finalize the development of the CPS platform and submit to the United States Food and Drug Administration (FDA) in 2024 for prioritized review as part of the FDA Breakthrough Devices Program.
Sensydia intends to revolutionize heart failure therapy by expanding access to cardiac performance assessment outside the hospital’s catheterization lab with its non-invasive Cardiac Performance System (CPS). Today the U.S. spends more than $30 billion annually on the diagnosis and management of heart failure, which requires costly and risky in-hospital catheterization procedures to obtain an accurate cardiac performance assessment. Sensydia’s CPS platform delivers accurate, non-invasive assessment of cardiac performance (cardiac output, ejection fraction, and pulmonary pressures) almost anywhere in under 5 minutes. CPS utilizes proprietary waveform machine learning methods that have been trained against gold-standard measurements from in-hospital catheterization lab data.
In 2018, Sensydia received FDA 510(k) clearance for non-invasive measurement of ejection fraction by CPS, and in 2022, Sensydia CPS was granted Breakthrough Device Designation by the FDA. Sensydia is on a mission to improve the quality of human life by democratizing health assessment and is committed to serving the needs of patients and healthcare providers by delivering non-invasive and easy-to-use products. Learn more at sensydia.com.