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 release of Growth Differentiation Factor 10 and Brain Derived Neurotrophic Factor in target tissues. This development represents a significant step in non-invasive approaches to activating the body's endogenous repair mechanisms without systemic drug exposure.
The patented system utilizes 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. The technology also includes programmable stimulation to enhance expression of complementary regenerative proteins including 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, making this technology particularly relevant for neurological applications.
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. The pre-clinical study, conducted with AccuLab Life Sciences and research grant support, demonstrated measurable modulation of regenerative signaling pathways and confirmed activation of neuroplasticity-related proteins. The pilot clinical study in Brazil showed that participants receiving non-invasive bioelectric brain stimulation demonstrated improvements in cognition, memory, and mood, along with reduction in depression symptoms. These studies provided early human validation of non-invasive bioelectric modulation targeting regenerative protein pathways.
Potential investigational applications disclosed in the patent span multiple health domains. Neurological and brain health applications include stroke rehabilitation, traumatic brain injury recovery, and investigational approaches to Alzheimer's disease and Parkinson's disease. Muscle and mobility health applications target post-stroke motor recovery, functional strength improvement, and gait speed enhancement. The technology also has potential applications in immune and regenerative resilience, vascular and circulatory health, and investigational approaches to liver and metabolic health. Additional tissue targets include retina, cochlea, bone, adipose tissue, lung, prostate, uterus, spleen, and other organs.
The Brain Band™ programming, which includes DepressiStim™, MemoryStim™, CerebraCell™, and AddictiStim™ protocols, forms part of Lionheart Health's KLOTHO-UP Study currently competing in the Semi-Finals of the $101 million XPRIZE Healthspan competition. 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. More information about the company's research can be found at https://www.LionheartLongevity.com and https://www.LionheartHealthStim.com.
