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Devices Cardiology FDA

 News Release - February 15, 2022

Cardiosense Receives FDA Breakthrough Device Designation for Algorithm to Identify Patients at Risk of Decompensated Heart Failure

CHICAGO, Feb. 15, 2022 -- (Healthcare Sales & Marketing Network) -- Cardiosense, Inc., a Chicago-based digital health company building a physiological waveform AI platform to manage cardiac disease, announced today that the U.S. Food and Drug Administration (FDA) has granted the company Breakthrough Device status for its novel algorithm to identify patients at risk of decompensated heart failure. The algorithm analyzes data collected from the multi-sensor CardioTag device to noninvasively assess pulmonary capillary wedge pressure (PCWP), a measure that currently can only be captured through an invasive catheterization procedure. The FDA Breakthrough Device designation will enable expedited regulatory review of the algorithm and is only awarded to breakthrough technologies that have the potential to provide more effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions.

"The Breakthrough Device designation recognizes our platform's potential to address one of the biggest unmet clinical needs in managing heart failure," said Amit Gupta, CEO and a co-founder of Cardiosense. "The fact is there are clear physiological changes that occur well before an acute heart failure event, and we look forward to working with the FDA to deliver a noninvasive solution to identify them."

Cardiosense's platform is built on over a decade of research led by Omer Inan, Ph.D., Linda J. and Mark C. Smith Chair in Bioscience and Bioengineering at Georgia Institute of Technology, and Mozziyar Etemadi, M.D., Ph.D., Medical Director, Advanced Technologies at Northwestern Medicine. "We've combined noninvasive sensors and industry-leading AI to develop digital biomarkers for early disease detection and to guide therapy," said Dr. Inan, who is also a co-founder of Cardiosense. "CardioTag, the company's proprietary wearable device captures high-fidelity, multi-modal physiological signals that are analyzed to assess cardiac function parameters that typically require invasive devices only available in intensive care settings."

Cardiosense's technology can have a particularly strong impact in heart failure. More than 6 million patients in the US live with heart failure, leading to over 1 million hospitalizations annually. Despite current best practice guidelines, including regular physical exams in clinic and daily weight monitoring, nearly 50% of patients are re-hospitalized within 6 months of a heart failure hospitalization. An increase in cardiac filling pressures, assessed using PCWP, often precedes clinical symptoms by several weeks but currently requires an invasive catheterization procedure to measure. The CardioTag device, coupled with Cardiosense's novel algorithm, is addressing this gap with the capability to assess PCWP in any setting, enabling care providers to identify early signs of acute heart failure, implement therapeutic interventions, and avoid hospitalizations.

The Breakthrough Device designation was supported in part by National Institutes of Health funded research led by Dr. Liviu Klein, M.D., M.S., Section Chief, Advanced Heart Failure, Mechanical Circulatory Support, Pulmonary Hypertension & Heart Transplantation at UCSF and Lead Clinical Advisor at Cardiosense, in collaboration with Dr. Inan and Dr. Etemadi. "Cardiosense's technology has the potential to be a revolutionary advance in the noninvasive assessment of the hemodynamic state of patients with heart failure," said Dr. Klein. "One of the greatest challenges in the management of patients with chronic heart failure is forecasting and preventing the development of acute worsening leading to hospitalizations. This technology could be used to identify time periods at risk and opportunities for intervention for patients with heart failure."

About Cardiosense

Cardiosense is building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes. For more information, visit:

About the FDA Breakthrough Device Program

The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

Source: Cardiosense

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