Lionheart Health, Inc., in collaboration with Leonhardt Ventures LLC, announced it has received a Letter of Allowance from the U.S. Patent and Trademark Office for its patent application titled “Modulation of Growth Differentiation Factor 10 (GDF10) and BDNF” (Publication No. 20230133737). The allowed claims cover a low-voltage, pulsed bioelectric stimulation system programmed to upregulate the expression and/or release of GDF10 and BDNF in target tissues. The inventors are Howard J. Leonhardt and neuroscientist Kelsie Leonhardt.
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 covers programmable stimulation to enhance expression of complementary regenerative proteins including Klotho, SDF1, and 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 platform is designed to stimulate endogenous repair pathways without systemic drug exposure.
Lionheart Health has completed preclinical animal studies and a pilot clinical study in Brazil utilizing its Brain Band™ platform incorporating GDF10 and BDNF signaling protocols. The preclinical study, conducted at AccuLab Life Sciences with research grant support, 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 demonstrated improvements in cognition, memory, and mood, as well as reduction in depression symptoms. The pilot 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 stroke rehabilitation, traumatic brain injury recovery, Alzheimer’s disease, Parkinson’s disease, essential tremors, anxiety disorders, and brain cancer adjunct therapy. In muscle and mobility health, applications include post-stroke motor recovery, functional strength improvement, gait speed enhancement, and sarcopenia mitigation. The patent also covers immune and regenerative resilience, vascular and circulatory health, and liver and metabolic health, including hepatic regeneration and fibrosis modulation.
“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 intellectual property portfolio in bioelectric regenerative medicine.
For more information, visit LionheartLongevity.com, LionheartHealthStim.com, or LeonhardtVentures.com.
