MaxWell Biomedical

Managing Atrial Fibrillation and Heart Failure together requires a comprehensive strategy;
Restoring left atrial transport function with a healthy sinus rhythm is essential for improving patient outcomes.

These two conditions often coexist and influence each other’s progression. When present together, they are associated with worse outcomes, including an increased risk of stroke, dementia, HF hospitalization, and all-cause mortality.

Maxwell Biomedical is innovating a new device, the first non-ablative AF therapy and heart failure monitoring system explicitly designed for heart failure patients with AF.

  • MaxWell Biomedical, a leader in cardiac care innovation, is excited to announce a significant milestone: the receipt of a $1.86 million grant from the National Institutes of Health (NIH), complemented by investments from private investors.

    This funding will accelerate the development of the MaxWell Biomedical Spatial Resynchronization Therapy (SRT) System, an innovative non-ablative technology designed to restore and maintain Functional Sinus Rhythm in patients with atrial fibrillation (AF).

    AF, a condition linked to severe complications such as stroke and heart failure, results in over 450,000 hospitalizations and approximately 160,000 deaths annually in the U.S. The MaxWell SRT System employs cutting-edge ultra-low energy stimulation to non-ablatively terminate AF, restoring left atrial function, without the discomfort associated with traditional high-energy cardioversion.
    Early trials have demonstrated the system's efficacy, with an impressive 83.3% success rate within 15 seconds and 100% success within 5-10 minutes.
    The SRT System is set to revolutionize cardiovascular care.

    Successfully executing the NIH SBIR Phase II award will position the SRT System for Investigational Device Exemption (IDE) approval, paving the way for the clinical studies needed to secure Pre-Market Approval (PMA) for this transformative technology aimed at treating the growing population of patients with AF and heart failure.

Functional Sinus Rhythm Does Matter

Improve HFHA Classification

Surgical Ablation of Atrial Fibrillation in Patients
With Tachycardia-Induced Cardiomyopathy

Taylan Adademir, MD,* Ali J. Khiabani, MD,* Matthew R. Schill, MD, Laurie A. Sinn, RN, BSN, Richard B. Schuessler, PhD, Marc R. Moon, MD, Spencer J. Melby, MD, and Ralph J. Damiano, Jr, MD

The graph above emphasizes the crucial need to restore not just sinus rhythm but also atrial function.

Effective left atrial contraction and the related fiber-stretch feedback are key factors in improving cardiac output in heart failure patients with atrial fibrillation.

The MaxWell Solution

MaxWell Biomedical is at the forefront of innovation with its pioneering non-destructive therapy device for atrial fibrillation (AF), designed specifically for patients also suffering from heart failure.

Our cutting-edge SRT technology integrates the latest scientific and technological advancements, revolutionizing the restoration of sinus rhythm (SR) without damaging heart tissue. Restoring SR and Left Atrial Function (LAF) is critical for patients also affected by heart failure (HF)—conditions known for their severity.

MaxWell’s unique SRT technology facilitates Active Atrial Fibrillation Management by offering a continuous, non-invasive solution to prevent AF episodes and restore Sinus Rhythm (SR) when AF occurs, helping to maintain the heart in normal rhythm. This externally applied device not only maintains a steady heartbeat but also supports positive structural changes in heart failure patients with AF.

Our system seamlessly integrates preemptive and postemptive strategies for AF management while also providing comprehensive patient monitoring for the tele-health management of heart failure. The left atrial lead is placed on the epicardial posterior wall of the left atrium, near AF sources, without the need to enter or puncture the heart or damage heart tissue.

Spatial Resynchronization™ Therapy System (SRT)

Maximum Wellness

[ mak-suh-muhm ] [ wel-nis ]

Preemptive SRT

Monitoring detects early warning signs of atrial fibrillation (AF) by continuously tracking premature atrial contractions (PACs), ectopic foci, pulmonary vein triggers, atrial flutter, atrial tachycardia, and changes in left atrial pressure. The device collects real-time data and feeds it into an algorithm that identifies potential AF episodes before they occur.

The algorithm then determines optimal pacing locations to maintain sinus rhythm, preventing AF episodes.

Resynchronization Therapy (SRT)
2 Modes of Operation

Postemptive SRT

If AF is detected, the SRT algorithm conducts a pre-treatment analysis and then implements a targeted pacing strategy based on the recorded AF pattern. The SRT system captures the tissue beneath each electrode by pacing within the excitable gap, creating zones of arrhythmia-free tissue.

These zones are gradually expanded and merged until they encompass the entire atrium, allowing normal sinus rhythm to be restored

Tele-health

MaxWell’s Device monitors, tracks, and records patient information for continuous patient care and management

Monitoring

+ AF Episodes

+ ECGs

+ Heart Rate

+ Left-atrial Pressure

+ Bioimpedance

Tele-Health and Remote Monitoring