Proposed system combines programmable bioelectric protein-expression signaling with regenerative biologics intended to support restoration of natural pigment in gray and white hair
HUNTINGTON BEACH, Calif. – August 22, 2026 – Leonhardt Ventures LLC and Lionheart Health, Inc. today announced the filing of a U.S. provisional patent application covering systems and methods designed to promote repigmentation of gray or white hair through targeted bioelectric signaling, alone or in combination with regenerative biologics and supportive scalp treatments.
The proposed platform is designed to deliver programmed electrical signals intended to modulate endogenous protein expression and cellular pathways associated with melanocyte survival, melanocyte-stem-cell activation, melanin synthesis, oxidative-stress control, follicular vascular support and hair-follicle regeneration. The application also describes optional combinations with bioelectric-enhanced peptides, platelet-rich fibrin (PRF), autologous stromal vascular fraction, extracellular vesicles/exosomes, Klotho nanoflowers, and Klotho-expressing stem cells delivered in a nutrient hydrogel.
The companies emphasize that the technology is investigational. Filing a provisional patent application does not establish safety, effectiveness, regulatory clearance or patent issuance. The proposed gray-hair repigmentation indication has not been cleared or approved by the U.S. Food and Drug Administration, and clinical studies are required to determine whether the approach can reliably restore natural hair pigment.
A Multi-Pathway Strategy for the Hair-Follicle Pigmentary Unit
Hair color depends on coordinated signaling among melanocyte stem cells, mature melanocytes, keratinocytes, dermal papilla cells, the follicular niche, blood vessels, immune cells and local redox metabolism. The patent strategy is therefore designed as a configurable platform rather than a single-target treatment. Candidate programs may be selected according to scalp region, hair-cycle state, baseline pigmentation, follicular viability and patient-specific biology.
- Reactivate or preserve melanocyte stem cells and encourage their migration and differentiation within the follicle.
- Increase melanogenic signaling and the enzymatic machinery needed to produce and transfer eumelanin or pheomelanin.
- Reduce hydrogen-peroxide burden, mitochondrial dysfunction, chronic inflammation and other stresses associated with pigment-cell depletion.
- Improve microvascular perfusion, extracellular-matrix support and anagen-phase follicular activity.
- Pair bioelectric signaling with autologous or cell-derived regenerative options intended to strengthen or replenish the pigmentary niche.
Proposed Bioelectric Protein-Expression and Signaling Targets
The following target families are included as candidate expressions or pathways for screening and protocol development. They are not represented as having all been clinically validated by Leonhardt Ventures or Lionheart Health for gray-hair reversal.
| Candidate target(s) | Primary role | Proposed mechanism | Evidence posture |
| SCF (KITLG) / c-KIT | Melanocyte survival and migration | Supports melanocyte-lineage maintenance and follicular pigmentation. | Strong biological rationale; human efficacy unproven. |
| WNT3A, WNT10B / beta-catenin | Stem-cell activation and melanocyte differentiation | May activate melanocyte stem cells and coordinate anagen-associated pigment regeneration. | Established pathway biology; delivery approach investigational. |
| MITF | Master melanocyte transcription factor | Coordinates melanocyte identity and expression of tyrosinase-family enzymes. | Mechanistic target; direct clinical modulation unproven. |
| Tyrosinase (TYR), TYRP1 and DCT/TYRP2 | Melanin synthesis | Catalyzes key steps in eumelanin/pheomelanin production. | Core melanogenesis machinery; therapeutic expression investigational. |
| alpha-MSH / POMC and MC1R | Melanocortin signaling | Stimulates cAMP-MITF signaling and favors eumelanin production where MC1R is functional. | Genotype-dependent; clinical protocol unproven. |
| Endothelin-1 (EDN1) / EDNRB | Melanocyte proliferation and dendricity | Keratinocyte-to-melanocyte signaling may support melanocyte activity and melanin transfer. | Plausible target; dose and safety require study. |
| FGF2 and FGF7/KGF | Follicular niche and growth support | May support dermal papilla, keratinocytes and melanocyte-niche signaling. | Indirect repigmentation rationale. |
| VEGF-A | Microvascular support | May improve perifollicular perfusion and anagen support. | Indirect; excessive angiogenic signaling requires control. |
| IGF-1 and HGF | Cell survival, migration and anagen support | May improve follicular cell survival and trophic signaling. | Supportive/preclinical rationale. |
| PDGF-AA/BB and EGF | Repair and tissue remodeling | Potentially supports regenerative signaling after PRF or micro-injury. | Supportive, not proven to repigment hair. |
| BDNF, NGF and GDNF | Neurotrophic/follicular signaling | May support neuro-cutaneous signaling and cellular resilience in the follicle. | Exploratory. |
| CXCL12/SDF-1 | Progenitor recruitment | May recruit reparative cells and support niche organization. | Exploratory; systemic effects require control. |
| Klotho (KL) | Anti-aging, redox and growth-factor modulation | Proposed to improve cellular resilience, mitochondrial/redox balance and regenerative signaling. | Exploratory for human hair repigmentation. |
| NRF2 (NFE2L2), catalase, SOD1/SOD2, GPX1 | Antioxidant defense | May lower oxidative injury and hydrogen-peroxide burden affecting melanocytes and melanogenesis. | Strong redox rationale; clinical repigmentation unproven. |
| BCL-2 and survivin/BIRC5 | Cell-survival signaling | May protect melanocytes or niche cells from apoptosis when locally and transiently controlled. | High safety sensitivity; investigational only. |
| FOXO3, SIRT1 and PGC-1alpha | Stress resistance and mitochondrial quality | May improve metabolic resilience and melanocyte-stem-cell maintenance. | Exploratory. |
| TGF-beta modulation / BMP antagonism | Stem-cell quiescence versus activation | Temporal modulation may help shift melanocyte stem cells from quiescence toward regeneration. | Complex and context-dependent. |
| Noggin and Sonic hedgehog (SHH) | Follicular morphogenesis and anagen signaling | May support follicular cycling and niche reconstruction. | Developmental pathways require strict local control. |
| Follistatin | Regenerative balance and follicular support | May counter activin/myostatin-family signaling and support tissue regeneration. | Indirect and exploratory for pigment. |
| IL-10; reduction of TNF-alpha, IL-6 and IL-17 signaling | Inflammation control | May reduce inflammatory suppression or injury of melanocytes and the follicular niche. | Rationale supported by drug-associated case reports; causal efficacy unproven. |
Optional Combination Components Described in the Application
| Component | Intended contribution | Development considerations |
| Bioelectric-enhanced peptides | Peptide cocktails selected to support melanogenesis, redox control, follicle cycling or matrix health, paired with signal programs intended to improve local uptake, release or endogenous expression. | Topical, intradermal or hydrogel-based; formulation-specific testing required. |
| Platelet-rich fibrin (PRF) | Autologous fibrin scaffold containing platelet-derived signaling factors such as PDGF, VEGF, TGF-beta, EGF and IGF-related activity. | Intended to provide sustained local trophic support; no established PRF indication for gray-hair reversal. |
| Autologous stromal vascular fraction | Heterogeneous regenerative cell fraction that may provide paracrine, vascular and immunomodulatory support. | Regulatory status depends on processing and use; only under appropriate medical, ethical and regulatory oversight. |
| Extracellular vesicles / exosomes | Cell-derived vesicles carrying proteins, lipids and RNAs that may influence follicular cells, inflammation and melanogenesis. | Product identity, source, purity, potency, biodistribution and FDA status must be established. |
| Klotho nanoflowers | Localized Klotho-containing or Klotho-associated nanostructures proposed for sustained presentation and redox/regenerative support. | Exploratory delivery concept; requires physicochemical, toxicology and efficacy validation. |
| Klotho-expressing stem cells in nutrient hydrogel | Cells engineered or selected to express Klotho, embedded in a supportive hydrogel intended to improve retention, viability and local trophic signaling. | Advanced investigational option; gene/cell-therapy requirements may apply. |
| Photobiomodulation, PEMF and scalp conditioning | Supportive energy-based modalities intended to improve mitochondrial function, perfusion, inflammation control and tissue readiness. | Adjunctive; parameters and interactions require controlled evaluation. |
Development and Measurement Plan
Proposed studies would use standardized macrophotography and microscopy, hair-shaft pigment-intensity mapping, melanin quantification, digital gray-hair counts, hair density/diameter measures, scalp safety assessments and, where feasible, biomarker analysis. Early feasibility work would prioritize reproducibility, localized exposure, treatment-emergent adverse events and durability of pigment return over cosmetic impressions alone.
“Our goal is to investigate whether precisely timed bioelectric signals can help the aging hair follicle recover multiple elements of its own pigment-producing environment,” said Howard J. Leonhardt, Executive Chairman and Co-CEO of Lionheart Health and founder of Leonhardt Ventures. “The provisional application is designed to protect a broad platform: protein-expression signaling, regenerative biologics and localized delivery working together. We intend to advance it through disciplined laboratory and clinical validation.”
Scientific Precedent: Reports of Gray or White Hair Regaining Pigment
Published reports show that human gray-hair repigmentation can occur, but it remains uncommon and the overall evidence is limited. These observations do not validate the companies’ platform; they support the biological premise that pigment loss is not invariably irreversible.
| Reported context | What was observed | Key limitation | Ref. |
| Natural within-shaft reversal | Rosenberg et al. documented individual human gray/white hairs that regained pigmentation and found associations with changes in psychological stress. | Human observational/proteomic study; not a treatment trial. | [1] |
| Medication-associated repigmentation | A systematic review identified more than 130 reported cases across anti-inflammatory agents, melanogenesis-related drugs and supplements; evidence was mostly case reports. | Low overall evidence; causation and generalizability uncertain. | [2] |
| PUVA in premature graying | A prospective study summarized in the review reported complete repigmentation in 46% of 37 young participants after 13 months, with partial responses in others. | Older, small uncontrolled/limited evidence; PUVA carries known risks. | [2] |
| Imatinib-associated change | A retrospective study summarized in the review reported repigmentation in 7% of 133 patients. | Drug-associated observation in oncology population. | [2] |
| Acitretin | A published case report described gray-hair repigmentation during systemic acitretin therapy. | Single case; systemic retinoid risks; not a cosmetic recommendation. | [3] |
| Cyclosporine A | A case report described hair repigmentation during cyclosporine treatment. | Single case; immunosuppressive drug risks. | [4] |
| Anti-IL-17 therapy | A case report described repigmentation and new growth with secukinumab in a patient treated for psoriasis. | Single case; cannot establish mechanism or efficacy. | [5] |
| Topical peptide/cosmetic approaches | Case reports have described improvement with topical products marketed to stimulate melanogenesis, including alpha-MSH–mimetic peptide approaches. | Case-level evidence; randomized trials lacking. | [6],[7] |
| Plant stem-cell-derived extracellular vesicle product | A small observational study reported repigmentation outcomes in ten treated patients. | Very small, uncontrolled evidence; requires independent replication. | [8] |
Patent and Regulatory Notice
This release summarizes subject matter described as part of a U.S. provisional patent application. A provisional application is not an issued patent and is not examined on its merits unless followed by a non-provisional application. Patent scope, inventorship, ownership, priority, and application particulars should be confirmed against counsel-approved filing records before distribution.
All products, protocols and combinations discussed for gray/white hair repigmentation are investigational unless expressly identified otherwise. References to biological pathways describe hypotheses or candidate mechanisms and do not constitute claims of demonstrated clinical benefit. Cell, gene, exosome, stromal-fraction and drug-device combination products may be subject to substantial regulatory requirements. Nothing in this release is medical advice or an offer to sell an unapproved medical product.
About Leonhardt Ventures LLC
Leonhardt Ventures LLC is a life-science innovation and venture-development organization focused on bioelectric, biologic and regenerative technologies. Its portfolio strategy emphasizes combinations of programmable bioelectric signaling, biologics, devices and data-guided protocols across cardiovascular, organ-recovery, longevity and aesthetic applications.
About Lionheart Health, Inc.
Lionheart Health, Inc. develops and commercializes health-optimization and regenerative-wellness technologies centered on bioelectric signaling and multi-modal protocols. The company’s research programs include hair and skin health, musculoskeletal performance, cognitive and healthy-aging applications. Product availability and regulatory status vary by jurisdiction and intended use.
Media and Investor Contact
Lionheart Health, Inc.
Attn: Corporate Communications
Email: howard@leonhardtventures.com
Website: https://lionheartlongevity.com/
Forward-Looking Statements
This press release contains forward-looking statements, including statements concerning patent protection, research plans, mechanisms of action, product development, regulatory pathways, clinical studies, commercialization and potential therapeutic or cosmetic outcomes. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. These risks include scientific and technical failure, inability to reproduce preliminary observations, safety findings, manufacturing and quality challenges, intellectual-property disputes, financing needs, regulatory requirements and market acceptance. Leonhardt Ventures LLC and Lionheart Health, Inc. undertake no obligation to update forward-looking statements except as required by law. No statement in this release should be understood as a guarantee that any patent will issue or that any investigational technology will be safe, effective, approved or commercially available.
References
1. Rosenberg AM, et al. Quantitative mapping of human hair greying and reversal in relation to life stress. eLife. 2021;10:e67437. doi:10.7554/eLife.67437. PMID: 34155974.
2. Yale K, Juhasz M, Atanaskova Mesinkovska N. Medication-Induced Repigmentation of Gray Hair: A Systematic Review. Skin Appendage Disord. 2020;6(1):1-10. PMCID: PMC6995950.
3. Acitretin-Induced Repigmentation of Gray Hair: A Case Report. Case Reports in Dermatology. 2024. PMCID: PMC11094511.
4. Cyclosporine A-induced Hair Repigmentation in a Patient With Psoriasis. Indian Dermatology Online Journal. 2023. PMCID: PMC10148980.
5. Rivera N, et al. Repigmentation and new growth of hairs after anti-interleukin-17 therapy with secukinumab. JAAD Case Reports. 2018;4(5):486-488. PMCID: PMC6031562.
6. Chakrabarty S, et al. Case report on premature hair graying treated with Melitane 5% and oral hair supplements. International Journal of Trichology. 2019. PMCID: PMC6892010.
7. Reversal of Premature Hair Graying Treated with a Topical Formulation Containing Palmitoyl Tetrapeptide-20. International Journal of Trichology. 2023. PMCID: PMC10075347.
8. Hair Repigmentation Outcomes in Patients With Graying Hair Treated With Rose Stem Cell-Derived Extracellular Vesicle Formulation: A Cross-Sectional Observational Study. Journal of Cosmetic Dermatology. 2025. PMCID: PMC12593320.
9. Koch SL, et al. The biology of human hair: A multidisciplinary review. American Journal of Human Biology. 2020;32(2):e23316. doi:10.1002/ajhb.23316. PMID: 31479564.
10. Drug-induced hair colour changes. European Journal of Dermatology. 2016. PMID: 27545142.
Howard J. Leonhardt
Executive Chairman & CEO
Lionheart Health, Inc.
Leonhardt Ventures LLC
4440 Von Karman, Ste 1000
Newport Beach, CA 92660
https://www.leonhardtventures.
https://www.
https://www.lionheartlongevity.