Five Clinical Studies Demonstrate Improvements in Male Sexual Wellness and Erectile Function as Lionheart Expands into Multi-Modality Regenerative Male Health Protocols and New Clinical Sites
HUNTINGTON BEACH, Calif. — August 13, 2026 — Lionheart Health, Inc., a bioelectric regenerative medicine and longevity company developing precision bioelectric signaling, wearable technologies and regenerative health platforms, today announced positive clinical results supporting its ErectiStim™ Male Sexual Wellness Platform and the expansion of its clinical research program to additional U.S. and international sites.
Across a series of prospective clinical investigations involving more than 100 men, electrical stimulation-based male sexual health protocols have demonstrated improvements across multiple measures of erectile function and sexual wellness. The clinical development program includes men with erectile dysfunction as well as difficult-to-treat populations, including men experiencing erectile dysfunction following prostate cancer treatment.
See more detail on clinical studies data here > https://erectistim.
The company is now expanding this work into a broader Male Sexual Health Protocol at participating Lionheart Health licensed clinics, combining bioelectric stimulation with additional complementary technologies intended to address vascular, muscular, neurological, metabolic and regenerative contributors to male sexual health.
Foundation in Peer-Reviewed Clinical Research
An important foundation for this clinical development program was the peer-reviewed publication led by Dr. Cristiane Carboni and colleagues, titled:
“An Initial Study on the Effect of Functional Electrical Stimulation in Erectile Dysfunction: A Randomized Controlled Trial.”
The study was published in the International Journal of Impotence Research in 2018.
Carboni and colleagues evaluated functional electrical stimulation in men with erectile dysfunction in a randomized controlled clinical study. The investigators reported that functional electrical stimulation could represent a beneficial treatment approach, particularly where erectile dysfunction is associated with degeneration or dysfunction of cavernous smooth muscle.
The publication was authored by Cristiane Carboni, Alexandre Fornari, Karoline C. Bragante, Marcio A. Averbeck, Patrícia Vianna da Rosa and Rodrigo Della Mea Plentz, affiliated with the Department of Health Science and Rehabilitation at the Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.
Reference: Carboni C, Fornari A, Bragante KC, et al. An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial. International Journal of Impotence Research. 2018;30:97–101. DOI: 10.1038/s41443-018-0024-8.
This peer-reviewed randomized study helped establish the scientific foundation for the subsequent series of investigations and continued development of electrical and bioelectric approaches to male sexual health.
Positive Clinical Findings Across the Development Program
Clinical investigations in the ErectiStim™ development program have evaluated patients using internationally recognized measures of male sexual function, including:
- International Index of Erectile Function (IIEF)
- Erection Hardness Score (EHS)
- Sexual Encounter Profile (SEP)
- Penile Doppler blood-flow ultrasound
- Patient-reported quality-of-life and satisfaction measures
Across the clinical development program, investigators have reported improvements in areas including:
- Erectile function
- Erection hardness
- Successful sexual intercourse
- Penile blood circulation
- Patient satisfaction and confidence
- Durability of response during follow-up
- Overall treatment tolerability
The clinical studies provide the foundation for Lionheart Health’s next phase of development: evaluating whether a comprehensive multi-modality approach can produce larger and more durable improvements than electrical stimulation alone.
Expanding Clinical Sites and Investigators
Lionheart Health is expanding its male sexual wellness clinical research and treatment network through participating licensed clinics and collaborating physicians.
Current and planned participating locations include:
Original Health Institute — Phoenix, Arizona
Principal clinician: Dr. Boris Schwartz, N.M.D.
Original Health Institute, 14040 N. Cave Creek Road, Suite 107, Phoenix, Arizona 85022. Dr. Schwartz’s practice focuses on regenerative medicine and currently offers erectile dysfunction services. The site is enrolling appropriate patients for Lionheart Health’s developing male sexual health program.
Life Booster Wellness Center — Costa Rica
Principal clinician: Dr. William Rojas Flores
Dr. Rojas Flores is a physician specializing in regenerative medicine and cellular therapies and is participating in the expansion of Lionheart Health’s outside-the-United-States clinical research program. The Costa Rica site is enrolling appropriate patients for investigational male sexual health protocols, including evaluation of advanced regenerative approaches where legally and medically permitted.
Lionheart Longevity Research Clinic — Newport Beach, California
4440 Von Karman Avenue, Suite 100, Newport Beach, CA 92660
Lionheart Health’s Orange County research location is enrolling appropriate participants in collaboration with local Orange County physicians and clinical partners.
Additional clinical investigators and licensed Lionheart Health locations are expected to join the program as the company expands its male sexual wellness clinical network.
New Lionheart Health Male Sexual Health Protocol
The next-generation Lionheart Health Male Sexual Health Protocol moves beyond a single treatment modality.
At participating Lionheart Health licensed clinics, physician-supervised programs may incorporate multiple complementary modalities selected according to the patient’s health status, objectives and applicable regulatory requirements.
The developing protocol may include:
ErectiStim™ precision bioelectric stimulation designed to support circulation, neuromuscular function and male sexual wellness.
Bioelectric protein-expression research protocols investigating precisely programmed bioelectric signaling intended to influence selected endogenous regenerative protein pathways.
Pelvic floor stimulation and muscle conditioning designed to strengthen muscles involved in erectile and sexual function.
BodStim™ EMS exercise and conditioning to support muscle performance, circulation, metabolic health and broader healthy-aging objectives.
PEMF — Pulsed Electromagnetic Field Therapy as an adjunctive modality supporting tissue and circulatory health.
Red-light photobiomodulation (PBM) as an adjunctive approach to supporting cellular energy, circulation and tissue health.
Acoustic pulse therapy, administered through appropriate in-clinic protocols and, where suitable, adjunctive home-treatment programs.
Vibrational therapy as an additional non-invasive modality intended to support circulation and neuromuscular stimulation.
Bioelectric-enhanced peptide research evaluating combinations of targeted signaling protocols with physician-selected peptides where medically and legally appropriate.
Platelet-rich fibrin (PRF) protocols administered by appropriately licensed clinicians where indicated and permitted.
KlothoPod II multi-modality med bed sessions are optional with 8 integrated therapy modes.
Clinic + Home Treatment Model
Lionheart Health is also developing a combined in-clinic plus adjunctive at-home treatment model.
Patients may receive comprehensive evaluations and higher-intensity or physician-administered therapies at participating clinics while continuing selected non-invasive supportive modalities at home under an individualized protocol.
The company believes that appropriately designed home programs could improve treatment consistency and enable patients to maintain therapeutic routines between clinic visits.
Home-use components will be limited to technologies and protocols appropriate for home administration and subject to applicable labeling, physician oversight and regulatory requirements.
Investigational Bioelectric Protein Expression
A key area differentiating Lionheart Health’s research program is its work in bioelectric protein expression.
Rather than viewing electrical stimulation exclusively as muscle stimulation, Lionheart Health is developing patented and patent-pending signaling sequences intended to influence endogenous biological pathways associated with circulation, tissue repair, inflammation, angiogenesis, muscle health and healthy aging.
The company is investigating bioelectric signaling programs targeting regenerative proteins and pathways that may have applications in male sexual wellness.
These protein-expression applications remain investigational and have not been approved by the U.S. Food and Drug Administration for the treatment of erectile dysfunction.
Advanced OUS Regenerative Research
For severe or treatment-resistant cases, selected outside-the-United-
Potential investigational protocols include:
- Klotho-expressing cell preparations delivered in a nutrient-supporting hydrogel
- Umbilical cord-derived cellular preparations where legally permitted
- Bioelectric-enhanced regenerative biologic approaches
- Physician-selected peptide protocols
- PRF and related autologous regenerative approaches
- Combination protocols integrating biologics with bioelectric protein-expression signaling
Lionheart Health is particularly interested in investigating whether combining regenerative cells with supportive biomaterials and precisely timed bioelectric signaling may improve cellular retention, signaling and tissue response.
These advanced cellular and biologic approaches are investigational. They are not FDA-approved treatments for erectile dysfunction in the United States, and references to their use describe planned or ongoing research outside the United States where permitted by applicable law and under qualified medical supervision.
Addressing Multiple Contributors to Declining Male Sexual Health
Erectile dysfunction can involve multiple overlapping biological factors, including vascular disease, declining endothelial function, metabolic dysfunction, smooth-muscle deterioration, neurological impairment, pelvic floor weakness, hormonal changes, inflammation and age-related declines in regenerative capacity.
Lionheart Health’s research strategy therefore seeks to address several of these pathways simultaneously through an integrated protocol involving:
Circulation + Muscle + Nerves + Metabolic Health + Regenerative Signaling + Healthy Aging
The company believes this systems-oriented strategy warrants rigorous prospective clinical investigation to determine whether it can improve outcomes compared with individual modalities alone.
Treating More Than Temporary Symptoms
Many established erectile dysfunction medications are designed to provide temporary pharmacologic assistance around the time of sexual activity.
Lionheart Health’s longer-term research objective is different: to investigate technologies intended to improve the biological systems contributing to healthy sexual function.
ErectiStim™ and the broader Male Sexual Health Protocol are being developed to support areas including:
- Healthy vascular and endothelial function
- Penile circulation
- Pelvic floor strength
- Neuromuscular activation
- Tissue oxygenation
- Healthy inflammatory balance
- Smooth-muscle function
- Regenerative signaling
- Overall cardiovascular and metabolic health
Lionheart Health believes restoration-oriented approaches could eventually complement established pharmaceutical and medical treatments, subject to validation in appropriately designed clinical studies.
Leadership Commentary
“Our objective is to build on the clinical evidence for electrical stimulation and move male sexual health toward a much more comprehensive regenerative model,” said Howard J. Leonhardt, Founder, Executive Chairman and Co-Chief Executive Officer of Lionheart Health, Inc.
“The early peer-reviewed work by Dr. Cristiane Carboni and her colleagues helped demonstrate that functional electrical stimulation deserved serious investigation in erectile dysfunction. We have continued building upon that foundation through a series of clinical studies and are now advancing toward a much broader protocol.”
Leonhardt continued:
“We believe male sexual health should be approached by addressing circulation, smooth muscle, pelvic floor strength, neurological signaling, metabolic health, inflammation and regenerative capacity together. Our next-generation program is designed to study bioelectric protein expression alongside PEMF, photobiomodulation, acoustic pulse and vibrational therapies, exercise conditioning, peptides and PRF, with selected advanced regenerative biologic approaches investigated outside the United States where legally permitted.”
“Our goal is not simply a temporary response. Our research goal is to determine whether we can help restore healthier underlying tissue function and produce durable improvements in male sexual wellness.”
Growing Global Need
Erectile dysfunction is one of the most prevalent male sexual health conditions worldwide, and prevalence rises substantially with age and cardiovascular, metabolic and neurological disease.
Despite the availability of oral medications and other established treatments, a substantial population of men continues to seek additional non-pharmaceutical, non-invasive and regenerative approaches.
Lionheart Health believes this creates an opportunity for rigorously studied bioelectric and multi-modality technologies that complement—not replace—appropriate physician evaluation and established standards of care.
About ErectiStim™
ErectiStim™ is Lionheart Health’s proprietary male sexual wellness platform utilizing programmed bioelectric stimulation delivered through external electrodes.
The platform is being developed to support healthy circulation, pelvic and smooth-muscle conditioning, neuromuscular activation and regenerative bioelectric signaling.
ErectiStim™ forms part of Lionheart Health’s broader portfolio of bioelectric technologies under development across cardiovascular health, neurological wellness, musculoskeletal regeneration, bladder health, sexual wellness, hair and skin health, vision, healthy aging and longevity.
About Lionheart Health
Lionheart Health, Inc. is a bioelectric regenerative medicine and longevity company developing technologies designed to harness and enhance the body’s natural repair mechanisms through precision bioelectric signaling, bioelectric protein expression, wearable technologies, regenerative biologics and personalized health-optimization programs.
The company’s technology portfolio spans cardiovascular health, neurological wellness, musculoskeletal regeneration, bladder and pelvic health, male and female sexual wellness, hair and skin regeneration, vision health, inflammation, muscle performance and healthy aging.
Lionheart Health’s long-term mission is to develop technologies capable of extending human healthspan by restoring healthier tissue function and activating endogenous regenerative pathways.
For more information, visit:
LionheartHealthStim.com
ErectiStim.com
LionheartLongevity.com
Media Contact
Howard J. Leonhardt
Founder, Executive Chairman & Co-Chief Executive Officer
Lionheart Health, Inc.
4440 Von Karman Avenue, Suite 100
Newport Beach, CA 92660
CS@lionhearthealthstim.com
Scientific Reference
Carboni C, Fornari A, Bragante KC, Averbeck MA, Vianna da Rosa P, Della Mea Plentz R. An initial study on the effect of functional electrical stimulation in erectile dysfunction: a randomized controlled trial. International Journal of Impotence Research. 2018;30(3):97–101. DOI: 10.1038/s41443-018-0024-8.
Forward-Looking Statements and Investigational-Use Notice
This press release contains forward-looking statements concerning planned and ongoing clinical studies, investigational technologies, potential mechanisms of action, anticipated product development, clinical-network expansion and future regulatory pathways. Such statements involve risks and uncertainties, and actual results may differ materially.
Certain ErectiStim™ applications, bioelectric protein-expression protocols and combination therapies described in this release are investigational and have not been reviewed or approved by the U.S. Food and Drug Administration for the treatment of erectile dysfunction.
References to Klotho-expressing cells, umbilical cord-derived cellular preparations, nutrient hydrogels, peptides, regenerative biologics and related advanced interventions describe investigational research approaches. Certain such research may be conducted only at qualified outside-the-United-States sites where permitted by applicable laws and regulations and under appropriately licensed medical supervision.
Results observed in earlier clinical studies do not guarantee results in subsequent studies or individual patients. Additional controlled clinical investigation will be required to establish the safety, effectiveness, durability and appropriate clinical use of the combination protocols described herein.
Howard J. Leonhardt
Executive Chairman & CEO
Lionheart Health, Inc.
Leonhardt Ventures LLC
4740 Von Karman, Ste 150
Newport Beach, CA 92660
http://www.leonhardtventures.
http://www.
http://www.lionheartlongevity.