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

Lionheart Health, Inc., in collaboration with Leonhardt Ventures LLC, has received a Letter of Allowance from the United States Patent and Trademark Office 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 patent includes bioelectric signaling at 2 mA to 4 mA direct current positive polarity, with optimized stimulation at approximately 3 mA positive polarity, measured at the target tissue level. It also encompasses 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. The company has completed pre-clinical animal studies and a pilot clinical study in Brazil utilizing its Brain Band™ platform incorporating GDF10 and BDNF signaling protocols. The pre-clinical study, conducted with AccuLab Life Sciences and research grant support, successfully validated safety and feasibility in animal models, demonstrated measurable modulation of regenerative signaling pathways, and confirmed activation of neuroplasticity-related proteins including Klotho, BDNF, GDF10, and SDF-1. Follow-on optimization was supported through a University of California Irvine Capstone Research Grant.

In the pilot clinical study in Brazil, participants receiving non-invasive bioelectric brain stimulation demonstrated improvements in cognition, memory, and mood, along with reduction in depression symptoms. The study provided early human validation of non-invasive bioelectric modulation targeting regenerative protein pathways. 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. Potential investigational applications disclosed in the patent include neurological and brain health applications such as stroke rehabilitation, traumatic brain injury recovery, and investigational approaches for Alzheimer's disease and Parkinson's disease. Other areas include muscle and mobility health for post-stroke motor recovery and functional strength improvement, immune and regenerative resilience for tissue repair coordination, and vascular and circulatory health for vascular remodeling research.

The patent also includes liver tissue targeting for investigational applications in liver and metabolic health, with mechanistic rationale involving TGF-β superfamily involvement in hepatic regeneration and fibrosis modulation research. Additional tissue targets include retina, cochlea, bone, adipose tissue, lung, prostate, uterus, spleen, and other organs. Howard J. Leonhardt, Executive Chairman of Lionheart Health, stated that this allowance represents a significant milestone in the mission to harness bioelectric signaling to activate the body's own regenerative repair systems. 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. For more information, visit https://www.LionheartLongevity.com or https://www.LionheartHealthStim.com.