First Device Therapy for AF-HFpEF: Unlocking a $6B U.S. Market

MaxWell Biomedical is developing Rhythm360™, the first Cardiac Resynchronization Therapy for the Atrium (CRT-A).

Unlike ablation or drugs, Rhythm360 restores atrial function non-destructively, continuously, and intelligently—transforming outcomes for AF-HFpEF, one of the largest and fastest-growing gaps in cardiovascular care.

The Unmet Need

  • HFpEF patients now equal HFrEF patients—yet no device therapy exists for AF-HFpEF, despite its $6B U.S. addressable market.

  • Atrial dysfunction is the hidden driver of HFpEF decline: fueling AF, hospitalizations, and mortality.

  • Current therapies fail: drugs don’t restore atrial mechanics, and ablation leaves atria scarred and dysfunctional.

Why the Atrium? Why Now?

  • HFpEF is a dual-chamber disease. Ventricular devices (CRT, ICD, LVAD) ignore the atrium.

  • Loss of atrial contraction worsens filling pressures, exercise tolerance, and survival.

  • Treating atrial function early prevents irreversible remodeling, preserving both rhythm and pump efficiency.

Clinical evidence is clear:

  • Atrial dysfunction doubles hospitalization and death risk in HFpEF.

  • LA strain abnormalities persist post-ablation → AF recurrence is inevitable.

  • No approved therapy exists to restore atrial synchrony.

Rhythm360™: Intelligent, Multi-Mode CRT-A

The first implantable system designed to restore atrial function through non-destructive, closed-loop therapy.

Four programmable modes, addressing the full spectrum of atrial rhythm disorders:

  1. Prevention – Detects and suppresses AF triggers before initiation.

  2. Sinus Rhythm Restoration – Imperceptibly terminates AF episodes without ablation or shocks.

  3. BBp (Bachmann’s Bundle pacing) – Restores biatrial synchrony and optimizes AV timing.

Together, these modes deliver continuous, adaptive CRT-A—sustaining sinus rhythm, preserving atrial transport, and modifying the course of HFpEF.

Rhythm360 is positioned to become the first device therapy for AF-HFpEF, capturing a massive, untapped market while creating a durable moat in atrial resynchronization.

  • Exciting News from MaxWell Biomedical!

    Maxwell Biomedical is expanding its ongoing clinical study to further validate the groundbreaking Spatial Resynchronization Therapy (SRT) for patients with atrial fibrillation (AF) and heart failure with preserved ejection fraction (HFpEF).
    SRT is designed to imperceptibly terminate AF and restore atrial function and atrial synchrony —a non-destructive, next-generation approach that sets it apart from conventional ablation therapies. With this expansion, we aim to accelerate clinical insights, broaden patient access, and drive a paradigm shift in AF treatment for the AF-HFpEF population.

    Why It Matters:
    ·        Better Outcomes – SRT enhances atrial heart function while preventing AF, addressing a critical unmet need.
    ·        Expanded Study Scope – More patients, more data, stronger clinical validation.
    ·        Innovative Non-Destructive Approach – Unlike ablation, SRT does not destroy cardiac tissue but restores atrial conduction.

    As we take this next step, we’re grateful for our investors, clinical partners, and dedicated team members working to bring a new era of AF treatment to patients worldwide.

    Stay tuned for more updates!
    March 13, 2025

Active Atrial Fibrillation Management

Transforming AF Care: A Device Approach That Overcomes Past Limitations

Maximum Wellness

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Decades of AF Treatment Have Focused Soley on Tissue Destruction

Medicine Evolves: 🟥 Cox-Maze Surgery (1980s) →🟧 Catheter Ablation (1990s–Present) →🟩 Non-destructive (Future)