Lionheart Health Announces Patent for Bioelectric Modulation of GDF10 & BDNF for Brain and Healthspan Applications

Lionheart Health, Inc., with Leonhardt Ventures LLC, today announced it has received a Letter of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled “Modulation of Growth Differentiation Factor 10 (GDF10) and BDNF” (Publication No. 20230133737; Application No. 18/051,425).

The allowed claims cover a low-voltage, pulsed bioelectric stimulation system programmed to upregulate the expression and/or release of Growth Differentiation Factor 10 (GDF10) and Brain Derived Neurotrophic Factor (BDNF) in target tissues. The application was filed October 31, 2022, and published May 4, 2023. The inventors are Howard J. Leonhardt and neuroscientist Kelsie Leonhardt.

The allowed claims include bioelectric signaling at 2 mA to 4 mA direct current positive polarity, including optimized stimulation at approximately 3 mA positive polarity, measured at the target tissue level. The patent also includes programmable stimulation to enhance expression of complementary regenerative proteins including Klotho, stromal cell-derived factor 1 (SDF1), and insulin-like growth factor 1 (IGF-1).

GDF10 has been identified in preclinical research as a signaling protein associated with axonal sprouting and neural network repair following ischemic stroke. Lionheart Health’s patented bioelectric platform is designed to stimulate endogenous repair pathways without systemic drug exposure.

Pre-Clinical & Pilot Clinical Validation

Lionheart Health has completed pre-clinical animal studies and a pilot clinical study in Brazil utilizing its Brain Band™ platform incorporating GDF10 and BDNF signaling protocols.

Pre-Clinical Study – San Diego (AccuLab Life Sciences, with Research Grant Support)
• Successful completion of safety and feasibility validation in animal models
• Demonstrated measurable modulation of regenerative signaling pathways
• Confirmed activation of neuroplasticity-related proteins including Klotho, BDNF, GDF10, and SDF-1
• Established translational foundation for human pilot evaluation
• Follow-on optimization supported through a University of California Irvine Capstone Research Grant involving five PhD-level engineers over seven months

Pilot Clinical Study – Brazil (Brain Band™ Program)
Participants receiving non-invasive bioelectric brain stimulation demonstrated:
• Improvements in cognition
• Improvements in memory
• Improvements in mood
• Reduction in depression symptoms

The pilot study provided early human validation of non-invasive bioelectric modulation targeting regenerative protein pathways. Functional improvements were observed alongside mechanistic protein-target signaling strategies.

Brain Band™ programming included DepressiStim™, MemoryStim™, CerebraCell™, and AddictiStim™ protocols and forms part of Lionheart Health’s KLOTHO-UP Study currently competing in the Semi-Finals of the $101 million XPRIZE Healthspan competition.

Investigational Applications

Potential investigational applications disclosed in the patent include:

Neurological & Brain Health
• Stroke rehabilitation
• Traumatic brain injury recovery
• Alzheimer’s disease (investigational)
• Parkinson’s disease (investigational)
• Essential tremors
• Anxiety disorders
• Brain cancer adjunct therapy

Muscle & Mobility Health
• Post-stroke motor recovery
• Functional strength improvement
• Gait speed enhancement
• 6-minute walk performance improvement
• Sarcopenia mitigation (investigational)

Immune & Regenerative Resilience
• Tissue repair coordination
• Inflammatory resolution support
• Cellular recovery signaling
• Organ resilience after injury

Vascular & Circulatory Health
• Vascular remodeling research
• Endothelial repair signaling
• Post-ischemic tissue recovery

Liver & Metabolic Health (Investigational)
The patent includes liver tissue targeting. Mechanistic rationale includes:
• TGF-β superfamily involvement in hepatic regeneration
• Hepatic tissue remodeling pathways
• Fibrosis modulation research
• Metabolic resilience enhancement

Liver health plays a central role in systemic inflammation control, insulin sensitivity, detoxification, and metabolic stability — core determinants of healthspan longevity.

Additional tissue targets include retina, cochlea, bone, adipose tissue, lung, prostate, uterus, spleen, and other organs.

“This allowance represents a significant milestone in our mission to harness bioelectric signaling to activate the body’s own regenerative repair systems,” said Howard J. Leonhardt, Executive Chairman of Lionheart Health. “By precisely modulating GDF10 and synergistic proteins such as Klotho and BDNF, we believe we can accelerate recovery in stroke and other neurological conditions while supporting broader healthspan optimization.”

The issuance of this patent strengthens Lionheart Health’s expanding intellectual property portfolio in bioelectric regenerative medicine and supports the company’s multi-protein regenerative platform strategy focused on brain health, muscle function, vascular recovery, liver resilience, and systemic longevity.

About Lionheart Health, Inc.

Lionheart Health, Inc., operating in collaboration with Leonhardt Ventures LLC, is a bioelectric regenerative medicine company developing patented technologies designed to modulate endogenous protein expression to support tissue repair, neuroplasticity, vascular recovery, metabolic resilience, and healthspan optimization. This includes research protocols for bioelectric enhanced biologics and micro implantable stimulators and re-fillable infusion pumps. The flagship devleopment of the company is a whole body regeneration system currently in pre-clinical studies. The company’s platform technologies include Brain Band™, BodStim™, OrthoStim™, SkinStim™, HairCell™, EyeCell™, ErectiStim TM, FemStim TM, TestiStim TM, PressureStim TM, Stem Cell Bra TM (many still in investigational research stage) and additional programmable bioelectric systems targeting multi-organ regenerative signaling pathways. Lionheart Health integrates bioelectric stimulation with biomarker-guided protocols and is advancing clinical research programs aligned with functional healthspan endpoints, including mobility, cognition, muscle strength, and systemic resilience. The company is currently a Semi-Finalist competitor in the $101 million XPRIZE Healthspan competition through its KLOTHO-UP™ study initiative.

Forward-Looking Statements

This press release contains forward-looking statements regarding investigational technologies and potential health applications. These technologies are investigational and are not approved by the U.S. Food and Drug Administration for the treatment of specific diseases unless otherwise indicated. Actual results may differ materially from those expressed or implied.

Contact: email [email protected] Web Sites: www.LionheartLongevity.com + www.LionheartHealthStim.com + www.LeonhardtVentures.com