Program builds on decades of bioelectric and regenerative-medicine research and is advancing an investigational multi-modality protocol combining precision bioelectric signaling, regenerative biologics, photobiomodulation, PEMF and at-home bioelectric bandages
HUNTINGTON BEACH / NEWPORT BEACH, Calif. — August 18, 2026 — Lionheart Health, Inc. today shared historical research and clinical experience supporting the development of VascuStim™, its investigational multi-modality platform for difficult-to-heal lower-limb wounds, and announced the launch of new clinical studies evaluating a combination of precision bioelectric signaling, regenerative biologics and complementary energy-based therapies.
The VascuStim™ development program traces its origins to 1987, when the Leonhardt Ventures team began exploring technologies designed to improve tissue repair, circulation and regeneration. Early clinical work included a pilot study in England, followed by research examining the potential of controlled electrical stimulation to activate biological pathways associated with angiogenesis and tissue repair.
In 1999, research involving Dr. Shinichi Kanno and collaborators was published in Circulation demonstrating that electrical stimulation could promote angiogenesis through increased VEGF expression. The work provided important scientific support for the concept that precisely delivered electrical signals may influence endogenous regenerative pathways rather than serving solely as conventional muscle or nerve stimulation.
Czech Republic Limb-Salvage Experience
In subsequent work during the 2000s, a 16-patient clinical study in the Czech Republic evaluated adipose-tissue-derived stromal fraction in patients with severe lower-extremity disease who had been placed on a short-term amputation pathway.
According to the program’s historical clinical records, 12 of the 16 patients avoided the anticipated amputation following a single treatment session involving cell injections. Lionheart Health considers this experience an important foundation for its continuing investigation of regenerative biologics for limb preservation and difficult-to-heal wounds.
Mexico Bioelectric Wound-Healing Study
In 2012, the development team worked with the Regenerative Medicine Institute in Mexico on an eight-patient clinical experience evaluating bioelectric stimulation for lower-limb wound healing.
According to the investigators’ clinical observations, 8 of 8 treated patients demonstrated accelerated wound-healing progression following treatment. This early experience helped guide subsequent development of more precise bioelectric signaling protocols intended to regulate regenerative protein expression and improve the local environment for tissue repair.
These historical results are being reported as investigational research findings and should not be interpreted as establishing the safety or effectiveness of VascuStim™ for any disease or medical condition.
New VascuStim™ Multi-Modality Study
Lionheart Health is now advancing a new generation of the VascuStim™ program through an IRB-approved investigational clinical study at selected U.S. and international sites.
The study is designed to evaluate a comprehensive wound-healing protocol rather than a single therapeutic modality.
The investigational protocol is expected to include:
- Two precision bioelectric treatment sessions per week in the clinic using the Lionheart 240 Stimulus™ platform and selected signaling sequences being studied for regenerative applications, including pathways associated with stem-cell homing, circulation/angiogenesis, Klotho and additional tissue-repair factors.
- Adipose-derived stromal fraction preparations, where permitted, produced at the point of care using the SynovaWave™ bedside adipose-tissue processing system, subject to applicable regulatory requirements and the specific investigational protocol.
- Super PRF / platelet-derived regenerative preparations, as specified by the individual study protocol.
- Bioelectric-enhanced exosome-containing investigational formulations, where legally and regulatorily permitted.
- A proprietary investigational Sonic Hedgehog (SHH) pathway-targeting gel formulation combined with additional wound-support ingredients.
- Red-light photobiomodulation (PBM) intended to complement the regenerative treatment environment.
- Pulsed electromagnetic field (PEMF) therapy as an additional noninvasive investigational modality.
- At-home bioelectric bandage treatments designed to continue controlled stimulation between clinic visits, according to the study protocol and physician instructions.
Targeting Multiple Regenerative Pathways
A central premise of VascuStim™ is that difficult wounds may benefit from addressing several biological limitations simultaneously.
Rather than relying exclusively on a dressing, biologic injection or energy modality, the new studies are designed to investigate whether precision bioelectric signaling can help create a regenerative environment while complementary biologics provide cellular and extracellular signaling support.
The bioelectric component is being developed to investigate signaling patterns associated with stem-cell recruitment/homing, angiogenesis and improved microcirculation, extracellular-matrix remodeling, tissue regeneration, Klotho expression and other regenerative protein pathways.
The program is also designed to determine whether continued at-home bioelectric stimulation can help maintain regenerative signaling between physician-supervised clinic treatments.
From Limb Salvage to Regenerative Wound Care
“Our team has been pursuing bioelectric regeneration for decades, beginning long before regenerative medicine became a major field,” said Howard J. Leonhardt, Executive Chairman & Co-CEO of Lionheart Health and founder of Leonhardt Ventures. “Our objective with VascuStim is to bring together what we have learned from bioelectric signaling, angiogenesis, regenerative cells and biologics into one carefully studied multi-modality protocol. Difficult lower-limb wounds remain an enormous unmet clinical challenge, and we believe the appropriate next step is rigorous clinical evaluation of these technologies under physician supervision.”
The new studies are expected to collect objective measures including wound area and volume, percentage wound closure, time to closure, perfusion and circulation measurements, pain and functional assessments, infection-related outcomes, limb-salvage outcomes, adverse events and longer-term wound recurrence, as applicable to each protocol.
Enrollment Underway
The new VascuStim™ investigational studies are enrolling now at selected locations in the United States and outside the United States.
Participation is limited to patients meeting the applicable inclusion and exclusion criteria. Each participant must undergo appropriate physician evaluation and complete IRB-approved informed consent before participating. Protocol components may vary by jurisdiction because regulatory requirements governing devices, cellular preparations, exosomes and other investigational biologics differ substantially between countries.
About VascuStim™
VascuStim™ by Lionheart Health is an investigational regenerative wound-care development program combining precision bioelectric signaling with complementary regenerative technologies. The platform is being studied for difficult-to-heal wounds and lower-extremity tissue regeneration through physician-supervised clinical research.
The development strategy combines Lionheart’s programmable bioelectric protein-expression technology with regenerative biologics, photobiomodulation, PEMF and continued at-home bioelectric stimulation.
About Lionheart Health
Lionheart Health, Inc. is a health-optimization and regenerative-technology company developing bioelectric signaling platforms and multi-modality protocols intended to support tissue repair, healthy longevity and regenerative medicine research. The company’s research programs investigate precisely programmed electrical signals designed to influence endogenous protein-expression pathways in combination with complementary regenerative technologies.
Important Investigational-Use Notice
VascuStim™ and the multi-modality protocols described in this release are investigational. They have not been established as safe or effective for the treatment, cure or prevention of diabetic ulcers, peripheral vascular disease, limb ischemia or other medical conditions. Certain devices, biologics, cellular preparations, exosome products and investigational formulations described above may not be FDA-approved or cleared for the uses discussed. Availability and permitted use vary by jurisdiction. Participation in clinical research is subject to protocol eligibility, physician oversight, applicable regulatory requirements, IRB approval and informed consent. Historical or preliminary study observations do not guarantee outcomes in future patients or clinical trials.