Investigational platform combines patented bioelectric signaling intended to promote BDNF and Klotho expression, stem-cell homing and auditory-system repair
IRVINE, Calif. — Sep 8, 2026 — Lionheart Health, Inc. announced that its investigational EarCell™ Plus technology is entering planned studies designed to evaluate its potential to improve hearing and auditory processing.
EarCell™ Plus is being developed as a non-surgical regenerative-hearing platform led by patented bioelectric signaling intended to promote the controlled expression of brain-derived neurotrophic factor (BDNF) and Klotho, while supporting endogenous stem-cell homing and tissue-repair pathways.
BDNF plays an important role in neuronal survival, nerve growth and synaptic function. Preclinical research from independent laboratories suggests that neurotrophic factors may help restore connections between surviving inner-ear hair cells and auditory-nerve fibers. Klotho is associated with cellular resilience, healthy aging, inflammation regulation and protection against oxidative stress—processes that may be relevant to age-related and noise-associated hearing decline.
The planned EarCell™ Plus studies are intended to determine whether the combined approach can:
- Improve hearing thresholds and speech recognition.
- Improve the ability to understand speech in noisy environments.
- Support auditory-nerve synapse formation and functional connectivity.
- Promote BDNF and Klotho expression.
- Encourage stem-cell homing and endogenous repair activity.
- Reduce inflammation and oxidative stress within tissues associated with hearing.
- Produce measurable, durable improvements in auditory function and quality of life.
“Loss of sensory hair cells and their connections to the auditory nerve represents one of the greatest unmet challenges in hearing care,” said Howard J. Leonhardt, founder and Executive Chairman and Co-CEO of Lionheart Health. “EarCell™ Plus is designed to activate several complementary repair pathways rather than relying on a single biological mechanism. These studies will rigorously evaluate whether our technology can produce meaningful improvements in hearing and complex sound processing.”
The research program is expected to use objective and patient-centered measurements, potentially including pure-tone audiometry, speech-in-noise testing, word-recognition scores, otoacoustic emissions, auditory brainstem responses and validated quality-of-life assessments. Biomarker evaluations may also be used to investigate changes in BDNF, Klotho, inflammation and regenerative signaling.
EarCell™ Plus builds upon Leonhardt’s broader portfolio of bioelectric technologies designed to activate precise regenerative protein-expression sequences. The platform is intended to combine targeted bioelectric stimulation with complementary modalities that may include photobiomodulation, pulsed electromagnetic fields and regenerative biologics, depending upon the final study protocol and applicable regulatory authorization.
The studies are specifically intended to establish safety, feasibility, biological activity and preliminary effectiveness. EarCell™ Plus has not yet been proven to regenerate human cochlear hair cells, restore auditory-nerve connections or improve hearing. It remains investigational and is not cleared or approved by the U.S. Food and Drug Administration for treating hearing loss.
About Lionheart Health, Inc.
Lionheart Health develops bioelectric and biologic technologies intended to support organ regeneration, healthy longevity and improved quality of life. Its development portfolio focuses on precisely controlled signaling designed to activate the body’s natural repair mechanisms, including regenerative protein expression, improved circulation, neuromodulation and stem-cell homing.
For additional information, visit www.LionheartHealth.com or www.LionheartLongevity.com.
Media Contact:
Lionheart Health, Inc.
www.LionheartLongevity.com
email howard@lionheartlongevity.com
Forward-Looking Statements
This press release contains forward-looking statements concerning investigational technologies, planned research, anticipated biological mechanisms and potential clinical benefits. These statements involve risks and uncertainties, and actual study designs, regulatory requirements and results may differ materially from current expectations. EarCell™ Plus is investigational, and no representation is made that it will successfully improve hearing or obtain regulatory clearance or approval.