Independent randomized clinical study demonstrates significant blood pressure reductions with sensory electrical stimulation applied over the kidney region
HUNTINGTON BEACH, Calif. — July 30, 2026 — Lionheart Health, Inc. today announced encouraging results from an independently conducted pilot randomized clinical trial evaluating low-frequency sensory transcutaneous electrical nerve stimulation (TENS) in adults with essential hypertension. The findings support further investigation of the company’s PressureStim™ investigational wellness technology.
The randomized, single-blind clinical trial enrolled 40 participants and compared four study groups:
- Cervicothoracic Stimulation Group (CTG)
- Renal (Kidney Region) Stimulation Group (RG)
- Combined Stimulation Group (ComG)
- Control Group (CG)
The study was approved by the Institutional Review Board Research Ethics Committee (CAAE 40091020.0.0000.5335), registered as ClinicalTrials.gov NCT06025643, and sponsored by Leonhardt’s Launchpads Brazil a unit of Leonhardt Ventures LLC
Reporting Pressure Stim.pdf
Key Findings
The Renal (Kidney Region) Stimulation Group demonstrated the greatest improvement following ten treatment sessions over four weeks:
- Mean systolic blood pressure reduction: 11 mmHg
- Mean diastolic blood pressure reduction: 4 mmHg
- Both reductions reached statistical significance compared with baseline measurements.
- No serious adverse events were reported.
- The intervention was well tolerated across all treatment groups.
Reporting Pressure Stim.pdf
Additional findings included:
- Cervicothoracic stimulation reduced systolic pressure by approximately 5 mmHg
- Combined stimulation reduced systolic pressure by approximately 5 mmHg
- Control participants demonstrated approximately 3 mmHg change over the observation period
- The kidney-region stimulation group demonstrated the largest overall reduction in blood pressure among the groups studied.
Reporting Pressure Stim.pdf
Study Design
Participants received:
- Low-frequency sensory stimulation (5 Hz)
- 200 μs pulse width
- Sensory-level intensity below motor threshold
- 30-minute treatment sessions
- Ten total sessions over four weeks
The primary endpoint was 24-hour ambulatory blood pressure monitoring (ABPM). Secondary outcomes included autonomic nervous system assessment through heart-rate variability analysis.
Reporting Pressure Stim.pdf
Safety
Investigators reported:
- No significant safety concerns
- No treatment-related adverse events
- Excellent participant tolerance
- Stable vital signs throughout treatment, with only a modest reduction in heart rate observed in the renal stimulation group immediately following treatment.
Reporting Pressure Stim.pdf
Investigators
The study was led by:
- Principal Investigator: Dr. Rodrigo Della Méa Plentz
- Dr Leslie Miller provided study oversight
The research was conducted through:
- Irmandade Santa Casa de Misericórdia de Porto Alegre (ISCMPA)
- São Francisco Hospital Cardiology Center
- Integrated Cardiopulmonary and Metabolic Rehabilitation Service
- La Salle University
The multidisciplinary study team included physicians, physical therapists, research coordinators, and clinical investigators specializing in cardiovascular rehabilitation and hypertension research.
Reporting Pressure Stim.pdf
Statement from Lionheart Health
“These pilot findings provide encouraging evidence supporting additional investigation of sensory bioelectric stimulation as a potential non-pharmacologic wellness approach. While these results are promising, larger multicenter clinical studies will be needed to confirm the findings and better understand which patients may benefit most.”
Next Steps
Lionheart Health plans to:
- Expand PressureStim™ clinical investigations with larger patient populations.
- Further evaluate optimal stimulation parameters and treatment duration.
- Investigate mechanisms involving autonomic regulation, vascular function, and renal neural pathways.
- Explore integration of PressureStim™ within Lionheart Health’s broader investigational Klotho-Up™ wellness research program.
Important Regulatory Statement
PressureStim™ is an investigational wellness technology. It has not been cleared or approved by the U.S. Food and Drug Administration for the diagnosis, treatment, cure, mitigation, or prevention of hypertension or any other disease. The findings reported here are from a pilot clinical study and should be considered preliminary. The study authors concluded that a larger sample size is needed before definitive conclusions can be drawn.
Link to full study report
About Lionheart Health
Lionheart Health develops investigational bioelectric wellness technologies intended for research into healthy aging, regenerative medicine, performance optimization, and non-invasive neuromodulation. The company is advancing multiple clinical research programs evaluating how targeted electrical stimulation may influence biological pathways associated with healthspan and wellness www.LionheartLongevity.com