Nanowear unveils NanoSENSE heart failure management study

July 25, 2019 - United States Of America

Nanowear has announced the clinical launch of NanoSENSE, a heart failure management and alert diagnostic validation study. The study will initially be conducted at Penn State Milton S. Hershey Medical Centre and Hackensack Meridian Health Systems. Nanowear is a developer of patented nanosensor technology with applications in cardiac and other industries.

Utilising proprietary and first-and-only FDA 510(k)-cleared cloth-based nanosensors, Nanowear has developed SimpleSENSE, a monitoring undergarment and closed-loop machine learning platform, which captures and algorithmically scores phonocardiography, impedance cardiography measuring stroke volume and cardiac output, multi-channel ECG assessing heart rate and heart rate variability, respiratory rate, thoracic impedance, activity, and posture, the company said in a media statement.

The algorithmic score provides physicians and care management teams with alerts of worsening heart failure weeks in advance of a hospitalising event. This allows physicians and care management teams to manage their patients remotely while reducing the number of costly heart failure-related hospitalisations. A similar multi-parameter, multi-vector algorithmic scoring thesis has been proven and validated for FDA clearance in implantable devices, but has yet to have been achieved through a non-invasive and cost effective delivery mechanism. The NanoSENSE clinical study aims to validate and provide a pathway to clear its own diagnostic algorithm generated from its non-invasive, size adjustable, and gender neutral SimpleSENSE garment.

John Boehmer, MD, a national thought-leader and director of Penn State Hershey’s Heart Failure Programme, has worked with Nanowear since 2018 in developing the validation study and is the NanoSENSE principal investigator nationally.

“Nanowear’s core technology of cloth-based, dry-contact electrodes provides both excellent electrical signals to monitor the heart as well as impedance cardiography and thoracic impedance measurements to monitor both heart and lung function. Combined with heart sounds, activity, and posture, a high fidelity multi-sensor recorder can be generated to monitor the heart failure condition. The majority of patients with heart failure do not require a permanent implant for the management of their heart failure. The greatest need for remote monitoring is addressed by Nanowear’s non-invasive short-term connected-care system, particularly for high risk patients such as those being discharged from the hospital following an episode of worsening heart failure. Nanowear’s platform allows recordings of higher fidelity information for longer periods of time than can be accomplished with implantable systems that are compromised by memory and power limits. We are excited to collect multiple terabytes of patient data in validating Nanowear’s alert algorithm for the early detection of worsening heart failure following a heart failure hospitalisation.”

The NanoSENSE validation study is a multi-centre, prospective, non-randomised, observational, non-significant risk study. The NanoSENSE study will enrol up to 500 subjects in up to five centres in order to collect clinical endpoints which includes at least 150 heart failure hospitalisations in participating subjects. (GK)