Clinical Program in Brazil Demonstrates Encouraging Improvements in Bladder Function While Company Advances Wearable, Regenerative, and Implantable Technologies
HUNTINGTON BEACH, Calif., August 5, 2026 — Lionheart Health, Inc. today announced encouraging clinical results from its BladderCell™ bioelectric neuromodulation program while unveiling an expanded multi-modality platform designed to advance the treatment of overactive bladder, urinary incontinence, and pelvic floor dysfunction.
The Company’s strategy combines precision bioelectric stimulation, wearable therapies, regenerative medicine, and next-generation implantable technologies to develop therapies intended not only to improve symptoms but ultimately to restore healthier bladder and pelvic function.
Brazil Clinical Development Program
Clinical development of BladderCell™ has been centered in Porto Alegre, Brazil, under the leadership of Dr. Cristiane Carboni, PhD, and urologist Dr. Alexandre Fornari.
The clinical program includes:
| Study | Patients | Status |
|---|---|---|
| First-in-Human Randomized Feasibility Study | 30 patients | Completed |
| BladderCell II Bioelectric + Pelvic Stimulation Study | 30 patients | Launched |
| BladderCell III Bioelectric + Regenerative Biologics Study | 10–20 patients | Planned |
Together, these studies represent a planned clinical development program involving approximately 70–80 patientsevaluating progressively more advanced approaches to restoring bladder function.
Encouraging Early Clinical Results
Results from the completed first-in-human BladderCell™ study demonstrated:
- Overall bladder symptom improvement: 30–50%
- Urgency episode reduction: 25–45%
- Urinary leakage reduction: 40–65%
The completed first-in-human clinical study is available at:
https://bladdercell.com/
Howard J. Leonhardt, Executive Chairman and Co-CEO of Lionheart Health, stated:
“These encouraging clinical findings support our belief that precise bioelectric signaling may become an important new tool for restoring healthier bladder and pelvic function. Our long-term objective is to combine bioelectric medicine with regenerative biologics to create therapies that address the underlying causes of dysfunction rather than simply managing symptoms.”
Introducing B-Alive™
Lionheart Health also announced expansion of its bladder health platform through B-Alive™, a wearable home bioelectric therapy system designed to provide convenient daily bladder and pelvic floor stimulation.
The wearable platform is intended to provide:
- Daily home treatment
- Continued therapy between clinic visits
- Pelvic floor support
- Longer-duration neuromodulation
Additional information is available at:
PelvicStim™ Clinical Study Launches
Lionheart Health also announced initiation of a new PelvicStim™ clinical program utilizing the Company’s Lionheart 240 Stimulus™ precision bioelectric stimulation platform.
PelvicStim™ combines:
- Precision neuromuscular stimulation
- Bioelectric protein expression protocols
- Pelvic floor muscle activation
- Personalized software-controlled treatment programs
- Home and clinic-based therapy
The study will evaluate improvements in:
- Overactive bladder
- Stress urinary incontinence
- Mixed urinary incontinence
- Pelvic floor dysfunction
- Sexual wellness
- Quality of life
Next-Generation Regenerative Bladder Platform
The Company also announced continued development of a regenerative bladder restoration platform integrating:
- BladderCell™ bioelectric therapy
- Klotho-expressing regenerative stem cells
- Proprietary nutrient hydrogel
- Precision bioelectric stimulation
- AI-assisted treatment optimization
- Bioelectric enhanced peptides
- Implantable micro stimulator and re-fillable infusion pump for advanced cases
The objective is to investigate whether combining regenerative biologics with bioelectric signaling can promote longer-lasting restoration of bladder tissue and function.
Implantable Regenerative Bioelectric System Under Development
Lionheart Health further announced development of a next-generation implantable regenerative therapy platform in collaboration with the University of California, Irvine (UCI) Capstone Engineering Team (“Octopus”).
The investigational system is expected to integrate:
- A miniaturized implantable bioelectric stimulator
- An implantable refillable programmable infusion pump
- Controlled delivery of Klotho-expressing regenerative stem cells suspended in a proprietary nutrient hydrogel
- Wireless programming and physician-controlled therapy
- Long-term synchronized regenerative biologic delivery with precision bioelectric stimulation
The Company’s vision is to create one of the first integrated implantable systems combining programmable neuromodulation with regenerative cell therapy for bladder restoration.
The technology remains in engineering and preclinical development and has not yet been evaluated in human clinical trials.
Building One of the Broadest Pelvic Health Platforms
Lionheart Health’s expanding bladder and pelvic health platform now includes:
- BladderCell™
- B-Alive™ wearable therapy
- PelvicStim™
- Lionheart 240 Stimulus™
- Precision bioelectric protein expression therapies
- Investigational Klotho-expressing regenerative stem cells
- Proprietary nutrient hydrogel technologies
- AI-assisted treatment planning
- Investigational implantable bioelectric stimulators
- Investigational refillable programmable biologic infusion pumps
“Our vision is to redefine bladder and pelvic medicine by combining bioelectric signaling, regenerative medicine, intelligent software, wearable therapies, and implantable technologies into a comprehensive treatment platform,” Leonhardt added. “We believe this integrated approach has the potential to expand treatment options for physicians and improve the lives of millions of patients affected by bladder and pelvic floor disorders.”
About Lionheart Health
Lionheart Health, Inc. is a regenerative bioelectric medicine company developing precision bioelectric therapies, wearable technologies, regenerative biologics, and protein expression platforms designed to restore tissue function and improve healthspan. The Company’s intellectual property portfolio includes more than 800 patent claims spanning bioelectric protein expression, regenerative medicine, neuromodulation, and precision stimulation technologies.
INVESTIGATIONAL RESEARCH USE ONLY
Forward-Looking Statements
This press release contains forward-looking statements regarding future product development, clinical studies, regulatory activities, commercialization plans, and anticipated therapeutic benefits. BladderCell TM, B-Alive™, PelvicStim™, investigational Klotho-expressing stem cell therapies, proprietary nutrient hydrogel technologies, implantable stimulation systems, and implantable refillable infusion pump technologies, bioelectric enhanced biologics and peptides, are under development and have NOT been approved by the U.S. Food and Drug Administration. No head-to-head clinical trials have compared Lionheart technologies with other commercially available neuromodulation systems, and future clinical outcomes may differ from preliminary findings.
Howard J. Leonhardt
Executive Chairman & CEO
Lionheart Health, Inc.
Leonhardt Ventures LLC
4440 Von Karman, Ste 100
Newport Beach, CA 92660
http://www.leonhardtventures.
http://www.
http://www.lionheartlongevity.