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." The allowed claims cover a low-voltage, pulsed bioelectric stimulation system programmed to upregulate the expression and/or release of Growth Differentiation Factor 10 and Brain Derived Neurotrophic Factor in target tissues. This patent, with Publication No. 20230133737 and Application No. 18/051,425, was filed on October 31, 2022, and published on May 4, 2023.
The system uses 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 includes programmable stimulation to enhance expression of complementary regenerative proteins such as Klotho, stromal cell-derived factor 1, and insulin-like growth factor 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 animal studies and a pilot clinical study in Brazil have been completed using the company's Brain Band™ platform, which incorporates GDF10 and BDNF signaling protocols. The pre-clinical study, conducted with AccuLab Life Sciences and research grant support, 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 involving five PhD-level engineers over seven months.
In the pilot clinical study in Brazil, participants receiving non-invasive bioelectric brain stimulation showed improvements in cognition, memory, and mood, along with a reduction in depression symptoms. This study provided early human validation of non-invasive bioelectric modulation targeting regenerative protein pathways, with functional improvements 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, which is currently competing in the Semi-Finals of the $101 million XPRIZE Healthspan competition.
Potential investigational applications disclosed in the patent span neurological and brain health, such as stroke rehabilitation, traumatic brain injury recovery, and investigational uses 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 covers liver and metabolic health investigational applications, noting liver tissue targeting due to 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. By precisely modulating GDF10 and synergistic proteins such as Klotho and BDNF, the company aims to 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 its 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.
