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Lionheart Health Announces Positive Clinical Study Results for BodStim™

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Lionheart Health Announces Positive Clinical Study Results for BodStim™

Demonstrates Measurable Gains in Strength, Mobility, Muscle Mass, and Longevity Biomarkers

Huntington Beach, CA — May 3, 2026 — Lionheart Health, Inc. today announced expanded positive clinical study results for its BodStim™ bioelectric stimulation platform, now including quantified improvements across key functional and healthspan metrics such as 6-minute walk distance, gait speed, grip strength, leg power, muscle mass, and Klotho levels.
Bodstim

Note – Investigational for all medical indications. FDA cleared for augmenting exercise benefits and building muscle in normal healthy subjects. 

Study Overview

BodStim™ protocols combine:

  • Neuromuscular Electrical Stimulation (NMES)
  • Transcutaneous Electrical Nerve Stimulation (TENS)
  • Resistance and aerobic training stimulation

Representative protocol:

  • 12-week duration
  • 24 sessions (2x per week) – some USA registry study patients have used BodStim TM now 2X a week for 12 months
  • Multi-phase sessions: warm-up, resistance, aerobic, and recovery
Patients enrolled at Federal University Brazil. Santa Casa Hospital Brazil, Lionheart Longevity & Wellness Licensed Clinics in USA

Quantified Clinical Outcomes

Functional Performance & Mobility

Participants demonstrated measurable improvements in core mobility and endurance metrics:

  • 6-Minute Walk Distance: ↑ ~8% to 18% improvement
  • Gait Speed: ↑ ~10% to 20% increase (clinically meaningful mobility gain)

These gains reflect enhanced cardiovascular endurance and neuromuscular coordination, key predictors of independence and longevity.

Strength & Power

BodStim™ significantly improved muscular performance:

  • Grip Strength: ↑ ~8% to 15%
  • Leg Power / Knee Extension Strength: ↑ ~10% to 25%

Improved muscle strength is strongly correlated with:

  • Reduced fall risk
  • Improved metabolic health
  • Increased lifespan

Muscle Mass & Composition

  • Lean Muscle Mass: ↑ ~3% to 7% (protocol-dependent)
  • Enhanced muscle activation and recruitment via NMES

These changes support BodStim™ as a non-invasive muscle-building platform, particularly valuable for aging or mobility-limited populations.

Pain Reduction & Joint Function

  • Pain Reduction (VAS): Significant decreases observed
  • WOMAC Total Score: ↓ substantial improvements across pain, stiffness, and function domains
  • Range of Motion (ROM): Improved knee flexion and joint mobility

Pain Reduction & Joint Function — OrthoStim™ / BodStim™

Measure Result
Pain Reduction (VAS) Improved by 6.2 points on 0–10 scale
Knee Flexion ROM Improved by 15.6 degrees
Gait Speed Improved by 0.2 m/s
Knee Extension Strength / Leg Power Improved by 8.1 kgf
WOMAC Pain Score Improved by 7.9 points
WOMAC Stiffness Score Improved by 2.7 points
WOMAC Physical Function Score Improved by 28.4 points
WOMAC Total Score Improved by 39.0 points
Adherence / Safety 96.7% adherence, no adverse events reported
OrthoStim™ / BodStim™ produced substantial improvements in joint pain and function, including a 6.2-point reduction in VAS pain, 15.6-degree improvement in knee flexion range of motion, 0.2 m/s improvement in gait speed, 8.1 kgf improvement in knee extension strength, and a 39-point improvement in WOMAC total score, with 96.7% adherence and no adverse events reported.

Longevity Biomarker: Klotho

BodStim™ is designed to stimulate pathways associated with:

  • Klotho protein (key regulator of aging and regeneration)

Findings and supporting data show:

  • Klotho Increase (whole-body or multi-muscle activation protocols):
    ↑ ~7% to 128%+ depending on intensity and duration (includes USA registry patients)
  • Exercise-based meta-analysis demonstrates:
    • Resistance training: up to ~88.5% increase
    • Aerobic training: up to ~56% increase
  • Localized protocols may show limited systemic change, reinforcing the importance of whole-body stimulation, which BodStim™ is designed to deliver

Safety & Compliance

  • 96.7% adherence rate
  • Zero reported adverse events

BodStim™ is a safe, scalable, and patient-friendly therapy.

Clinical Significance

These results demonstrate that BodStim™:

  • Improves strength, endurance, and mobility simultaneously
  • Enhances muscle mass and neuromuscular activation
  • Activates longevity-associated biological pathways
  • Serves as a powerful exercise mimetic platform

Strategic Integration

BodStim™ (FDA cleared via Wiemspro for augmenting health benefits of exercise including building muscle more quickly) is now being deployed across:

  • Lionheart Longevity Clinics
  • Klotho-Up™ Healthspan Protocol Study IRB Approved (XPRIZE program)
  • At-home and in-clinic bybrid regenerative programs
  • Soon to launch Cleveland Clinic Study for rehabilitation of heart and kidney failure patients

It forms a core component of Lionheart’s bioelectric protein expression platform under study. 

About Lionheart Health

Lionheart Health, Inc. is an innovation leader in bioelectric regenerative medicine, developing technologies that stimulate the body’s natural repair systems through targeted electrical signaling.

The company’s platform spans:

  • Bioelectric stimulation devices
  • Regenerative biologics and peptides
  • Longevity-focused clinical programs

Lionheart Health is a Top 40 semifinalist in the XPRIZE Healthspan competition.

Forward-Looking Statements and Disclaimer

Further randomized controlled trials are planned to expand indications and validate long-term outcomes across broader populations. Early small scale clinical study results may not hold up in larger scale studies. BodStim TM is not yet proven safe of effective in treating aging or any medical diagnosis diseases. Patents issued may be invalidated. Patents pending may not be issued.

Media Contact:
Lionheart Health, Inc.
Huntington Beach, CA