Bioelectric stimulation approach designed to promote controlled endogenous tissue regeneration showed encouraging safety and tissue-growth findings in early animal studies; subsequent limited human studies reported no adverse events
The investigational technology utilizes precisely programmed electrical signaling intended to stimulate the body’s own regenerative processes, including signaling pathways associated with stem-cell homing, tissue formation and vascular support.
The early preclinical program evaluated the approach in large animals, including sheep and bovine models. Safety observations gathered during the program included histopathology examinations and ultrasound/echo imaging.
According to the research team, the animal studies demonstrated encouraging preliminary findings, including:
- No observed fibrosis or treatment-associated inflammation;
- No observed teratomas or other identified tissue or vascular malformations;
- Improvement in connective-tissue quality;
- Increased glandular units;
- Approximately 20% to 30% increases in breast fullness/volume reported in the early animal work;
- Histological evidence interpreted by the investigators as consistent with new tissue formation;
- Tissue-volume increases observed as persisting approximately two months following treatment; and
- Good tolerance of the stimulation sessions by the treated animals.
The investigational treatment regimen in the early animal work involved approximately one hour of stimulation every other day for four weeks. The research program evaluated bioelectric signaling sequences associated with regenerative protein-expression pathways, including SDF1 and angiogenic/tissue-support signaling.
“These early studies were particularly encouraging because we observed tissue growth without the fibrosis, inflammation or abnormal tissue formation that would have raised significant safety concerns,” said Dr. Jorge Genovese, M.D., Ph.D., Vice President of Bioelectric Regeneration Research at Lionheart Health. “The animals also tolerated the stimulation remarkably well. Histopathology and imaging follow-up showed healthy-appearing tissue in the treated animals without adverse effects identified by our research team.”
Dr. Genovese previously served as Director of the Cardiac Regeneration Laboratory at the University of Utah and conducted regenerative medicine research at the McGowan Institute for Regenerative Medicine in Pittsburgh. His research background includes numerous peer-reviewed publications and work related to bioelectric regeneration intellectual property.
Subsequent Human Feasibility Research
Following the initial animal work, the research program advanced into limited human feasibility and safety studies.
An initial low-dose safety program included nine patients in Brazil, according to the research team, with no adverse events reported. The investigators subsequently evaluated a higher-duration stimulation protocol.
A later 2021–2022 study conducted at Clinica O’Nay in Spain evaluated 15 patients receiving approximately one hour of electrical stimulation every other day for four weeks.
In that limited study:
- Approximately one-third of participants were reported to have increased breast volume by approximately one cup size;
- Approximately one-third experienced an average breast-volume increase of about 10%;
- Approximately one-third showed no measurable increase in breast volume; and
- No safety or adverse events were reported in the 15-patient series.
Investigators noted that participants with greater baseline body fat appeared to demonstrate greater increases, while the leanest participants were disproportionately represented among non-responders.
The investigators concluded that the limited study produced encouraging evidence of feasibility and tolerability but emphasized that additional controlled studies are required before firm conclusions can be reached regarding either efficacy or long-term safety.
A Non-Surgical Regenerative Approach
Lionheart Health believes bioelectric regenerative medicine may eventually provide an alternative or complement to existing breast augmentation approaches, including implants and fat-transfer procedures.
Rather than introducing a permanent implant, the investigational technology is designed to use precisely controlled electrical signals to influence endogenous regenerative signaling and potentially recruit and direct the patient’s own regenerative cells.
The Company’s broader bioelectric regeneration platform is focused on controlling the expression of regenerative proteins through programmable electrical stimulation.
Planned U.S. Clinical Development
Lionheart Health is now preparing for the next stage of research development, including pursuing an appropriately designed U.S. clinical study under Institutional Review Board and Independent Data Safety Monitoring Board oversight.
Any U.S. study would be conducted under applicable regulatory and ethical requirements and would be designed to further evaluate safety, tolerability, dosing, durability of response and objective measures of tissue-volume change.
About Lionheart Health
Forward-Looking Statements
This press release contains forward-looking statements, including statements concerning planned clinical studies, potential regulatory development, future commercialization and the potential therapeutic or aesthetic applications of Lionheart Health technologies. Forward-looking statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied.
The research described in this release includes early-stage preclinical and limited clinical feasibility studies. Results from animal studies and small, uncontrolled human studies may not be replicated in larger, randomized or controlled clinical trials and should not be interpreted as establishing safety or efficacy for the general population. Additional research and, where applicable, regulatory authorization or clearance may be required before commercialization for specific medical or aesthetic indications.
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