Initially, the trial will be carried out at Penn State Milton S. Hershey Medical Centre and Hackensack Meridian Health Systems.
Nanowear has developed a patented and cloth-based nanosensor technology, which can be in various applications such as the cardiac, neurological, industrial safety/government and sports medicine/performance diagnostics monitoring markets.
Using FDA 510(k)-cleared cloth-based nanosensors, the company has designed SimpleSENSE monitoring undergarment and closed-loop machine learning platform.
SimpleSENSE platform 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 algorithmic score provides alerts to physicians and care management teams to know worsening heart failure weeks in advance of a hospitalising event.
It will help physicians and care management teams to supervise their patients remotely and reduce costly heart failure-related hospitalisations.
Penn State Hershey’s Heart Failure Programme director John Boehmer has worked with Nanowear since 2018 for the development of validation study. He is the principal investigator for NanoSENSE trial.
Boehmer said: “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.”
NanoSENSE clinical study has been designed to validate and offer a pathway to clear its own diagnostic algorithm generated from its non-invasive, size adjustable and gender-neutral SimpleSENSE garment.
A NanoSENSE validation study is a multi-centre, prospective, non-randomised, observational, non-significant risk study that will recruit around 500 subjects in up to five centres for the collection of clinical endpoints that includes about 150 heart failure hospitalisations in participating subjects.
Nanowear co-founder and CEO Venk Varadan said: “Early patient and practitioner feedback indicates favourable experience with our garment as well as engagement with our patient-facing mobile application and provider-facing web portal.
“We firmly believe that our platform can reduce the burden of costly heart failure-related hospitalizations for millions of patients, many of whom are Medicaid or uninsured.”
