nvestigational dissolvable oral strips enter early stage safety and efficacy evaluation; initial research access outside the United States targeted for 2H 2027.
HUNTINGTON BEACH, Calif. — October 19, 2026 — Lionheart Health, Inc., operating as Lionheart Longevity, today unveiled KlothoStrips™, an investigational dissolvable oral strip platform being developed to explore Klotho-related peptide delivery through the mouth. The program adds to the company’s research portfolio investigating approaches intended to elevate Klotho levels or influence Klotho-related biological activity.
KlothoStrips™ is in early stage safety and efficacy testing. Its safety, absorption, biological activity and clinical effectiveness have not been established. The product is not available for sale in the United States.
The company anticipates initial availability outside the United States (OUS) in 2027 exclusively through appropriately authorized research studies, subject to completion of necessary development work, Institutional Review Board (IRB) or equivalent local ethics committee approval, applicable regulatory authorizations and properly documented, voluntary informed patient consent. This anticipated timeline concerns research access and does not represent a commercial launch commitment.
Three Proposed Research Strengths:
Lionheart plans to evaluate three nominal peptide strengths per strip:
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Proposed strength
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Equivalent amount
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100 mcg
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0.1 mg
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500 mcg
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0.5 mg
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1,000 mcg
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1 mg
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These are proposed investigational formulation strengths, not established safe or effective doses or consumer dosing recommendations. Final peptide composition, content, administration procedures, frequency and study eligibility will depend on formulation testing, supporting safety data and approved research protocols. The amount contained in a strip does not establish how much reaches the bloodstream or target tissues.
Development work will evaluate oral strip placement on the tongue or against the upper palate, with the final administration method determined through testing and protocol review.
Studying KlothoStrips™ With and Without Bioelectric Stimulation
Lionheart plans to study KlothoStrips™ both with and without bioelectric stimulation support to investigate whether stimulation changes peptide delivery, tolerability, measured Klotho levels or other prespecified biological outcomes.
This work builds on the company’s earlier announcement, “Lionheart Health, through Leonhardt Ventures LLC, Files Patent for Bioelectric Platform to Enhance Peptide Uptake and Longevity Therapies,” which described a patent filing addressing investigational combinations of bioelectric stimulation and oral, topical or injectable peptide delivery.
For KlothoStrips™, any proposed enhancement remains a hypothesis requiring direct testing. The existence of a patent application does not establish that bioelectric stimulation improves absorption or clinical outcomes.
Planned research priorities include:
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Formulation and quality: peptide identity, purity, content uniformity, dissolution, stability and packaging performance.
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Safety and tolerability: oral tissue effects, adverse events and other protocol-defined safety measures.
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Delivery and biological activity: whether intact, biologically active peptide is delivered and whether relevant biomarkers change.
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Comparative performance: differences between strip-only and strip-plus-stimulation study groups.
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Exploratory outcomes: whether any observed biological changes justify subsequent controlled studies of meaningful health outcomes.
Changes in a Klotho measurement would not, by themselves, establish improved healthspan, disease treatment or age reversal.
Expanding Lionheart’s Klotho-Related Research Lineup
KlothoStrips™ joins Lionheart Health’s broader Klotho-related research lineup, encompassing delivery concepts, bioelectric programs, testing and combination platforms:
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Research area
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Named platforms and programs
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Implant, patch and pod platforms
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KlothoImplant™; KlothoPatch™ I; KlothoPatch™ II; KlothoPod™ I; KlothoPod™ II
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Gene-related and nanostructured research
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KlothoGeno™; KlothoNanoFlowers™
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Klotho measurement
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KlothoYears™ Klotho Test
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Clinic and portable bioelectric programs
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Lionheart 240 Stimulus™ clinic stimulator with Klotho programming; Lionheart 240 Portable™ with Klotho programming
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Muscle and brain programs
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BodStim™ EMS suit with Klotho programming; Brain Band™
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Vision, skin and hair programs
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EyeCell™; SkinStim™; HairCell™
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Sexual health programs
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ErectiStim™; FemStim™
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Gut and bladder programs
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Second Brain™; BladderCell™ + B-Alive™
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Multi-organ regeneration research
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Lionheart Octopus™ Multi-Organ Regeneration System with Klotho delivery
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Exosome and peptide research
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KlothoExosomes™; KlothoPeptides™; KlothoStrips™
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Lionheart Health also has an exclusive license to the Stangl patent for Klotho expressing stem cells in combination with bioelectric enhancement.
These names identify programs at varying stages of development. Their inclusion does not mean that all are clinically validated, authorized for Klotho-related uses, available commercially or supported by equivalent evidence. The KlothoYears™ Klotho Test is a measurement offering, rather than an intervention intended to elevate Klotho.
Lionheart’s research strategy is to compare different approaches to Klotho delivery and modulation while determining which, if any, can demonstrate acceptable safety and reproducible biological or clinical effects.
Research Status, Safety and Availability Disclosures
Early stage and unproven. KlothoStrips™ is experimental. It has not been proven to elevate circulating or tissue Klotho levels, improve healthspan, reverse aging, regenerate organs, or prevent, diagnose, treat or cure any disease.
No established human dosing. The proposed 100 mcg, 500 mcg and 1,000 mcg strengths do not establish a safe starting dose, effective dose, dosing schedule or suitability for any individual. Higher peptide content should not be interpreted as greater benefit.
Uncertain absorption and activity. Dissolution in the mouth does not demonstrate effective absorption. Peptide degradation, oral tissue permeability, formulation differences and individual variability may affect delivery. Klotho-related peptides should not be assumed to reproduce the functions of full-length Klotho protein.
Unknown risks. Potential risks may include oral irritation, hypersensitivity, immune responses, unintended biological effects and interactions with medications or other interventions. Additional risks may emerge during development. Combination use with bioelectric stimulation requires separate safety evaluation.
Research oversight and consent. Planned human studies will require appropriate scientific and ethics review, applicable regulatory permissions, qualified investigator oversight, safety monitoring and informed consent explaining foreseeable risks, uncertainties, alternatives and the voluntary nature of participation. IRB approval and informed consent do not establish safety or effectiveness and do not replace other required authorizations.
United States status. KlothoStrips™ is not FDA approved and is not available for sale in the United States. This announcement is informational and does not offer the investigational product for U.S. purchase or general clinical use.
OUS access is conditional. Any research access outside the United States will depend on the laws and approvals applicable to each participating jurisdiction. Overseas study participation does not establish approval in the United States or elsewhere.
Device authorizations are use specific. Any clearance or authorization held by a device for another purpose should not be interpreted as authorization for Klotho elevation, peptide enhancement or the combinations described in this announcement.
No guaranteed benefit. Research participants may receive no benefit. Findings from other products, laboratory experiments, animal studies or earlier company programs cannot establish the safety or effectiveness of KlothoStrips™.
Intellectual property. Patent filings describe claimed inventions and research concepts. They do not establish clinical efficacy, regulatory approval, patent issuance or freedom to operate.
Packaging concepts. Any illustrated AI created packaging graphics, quantities or supply descriptions are preliminary concepts and do not establish an approved administration schedule or commercial availability.
KlothoStrips TM will be produced in Utah USA in a cGMP manufacturing facility.
Forward-Looking Statements
This release contains forward-looking statements concerning proposed formulations, research strengths, study designs, bioelectric combinations, anticipated OUS research access in 2027 and future development. These statements reflect current plans and expectations and are subject to scientific, manufacturing, financing, operational, ethics review and regulatory uncertainties. Studies may be modified, delayed or discontinued; proposed strengths may change; and research may fail to demonstrate acceptable safety, absorption, biological activity or clinical benefit. No assurance is given that KlothoStrips™ or any related program will obtain authorization or become commercially available.
About Lionheart Health
Lionheart Health, Inc., operating as Lionheart Longevity, develops and studies bioelectric technologies, peptide and biologic delivery concepts, and regenerative health platforms. Its Klotho-related research portfolio explores measurement, delivery and biological modulation through multiple investigational approaches.
Company information: www.