Nanowear Announces Clinical Launch of NanoSENSE, a Heart Failure Management and Alert Diagnostic Validation Study

NEW YORK — Nanowear, the leading nanotechnology-based connected-care and remote monitoring platform, today 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 Center and Hackensack Meridian Health Systems.

Utilizing 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 algorithmic score provides physicians and care management teams with alerts of worsening heart failure weeks in advance of a hospitalizing event. This allows physicians and care management teams to manage their patients remotely while reducing the number of costly heart failure-related hospitalizations. 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 Program, has worked with Nanowear since 2018 in developing the validation study and is the NanoSENSE principal investigator nationally.

"People discharged from the hospital after an episode of worsening heart failure are readmitted at a rate of 22.5%, or almost 1 in 4," says Dr. Boehmer. "This contributes to the more than 1 million heart failure-related readmissions annually costing the US Healthcare System $40 billion every year. My research involves finding ways to monitor a patient in their home to detect worsening heart failure before he or she becomes increasingly symptomatic and must go to the emergency room, and ultimately are admitted to the hospital. The goal is to make the form factor and use case as simple and as cost effective as possible, resulting in little or no effort from the patient. 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 hospitalization."

The NanoSENSE validation study is a multi-center, prospective, non-randomized, observational, non-significant risk study. The NanoSENSE study will enroll up to 500 subjects in up to 5 centers in order to collect clinical endpoints which includes at least 150 heart failure hospitalizations in participating subjects.

"We're thrilled to reach this clinical-stage milestone with our heart failure device and digital diagnostic platform," says Nanowear Co-founder & CEO, Venk Varadan. "Early patient and practitioner feedback indicates favorable 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. Further, the NanoSENSE alert diagnostic will serve as an upstream advanced screening tool for therapeutic interventions beyond medications, such as implantable devices. This will be valuable for Centers for Medicare and Medicaid Services (CMS) and commercial payers who are seeking novel, upstream heart failure management tools that are data-driven."

About Nanowear

Nanowear is the leading developer of patented, cloth-based nanosensor technology with applications in the cardiac, neurological, industrial safety / government and sports medicine / performance diagnostics monitoring markets. The company's proprietary technology enables a closed-loop platform of wireless, real-time electrical, hemodynamic, acoustic and biochemical monitoring that provides medical professionals with accurate, continuous diagnostics data and algorithmic alerts through a cost effective and non-invasive garment deployment.  Nanowear's core focus on innovation and next-gen technologies will continue to propel the company towards exploring unique and groundbreaking applications for its nanosensors.  Nanowear is headquartered in New York, NY

About Penn State Milton S. Hershey Medical Center

It is Central Pennsylvania's only heart transplant center, and offers Joint Commission-accredited programs in heart failure and in implanting ventricular assist devices for destination therapy in patients with advanced heart failure. It has more than 60 providers across cardiology, cardiac surgery, vascular surgery and interventional radiology.

About Hackensack Meridian Health Systems

Hackensack Meridian Health is a leading not-for-profit healthcare organization that is the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care.