Lionheart Health Announces Top 25 Clinical Study Priorities for 2027

HUNTINGTON BEACH, Calif., October 22, 2026 — Lionheart Health, Inc. today announced its top 25 clinical study priorities for 2027, led by a planned BioLeonhardt first-in-human heart regeneration study outside the United States and the Lionheart Klotho-Up healthspan and longevity study.The research agenda places Klotho at the center of the company’s healthspan strategy while advancing studies across regenerative medicine, functional health and aesthetics. The priorities include expanded studies of existing programs and planned clinical evaluation of investigational platforms.

Top 25 Clinical Study Priorities for 2027

1. BioLeonhardt Heart Regeneration — Planned first-in-human study outside the United States (OUS) to investigate heart regeneration.
2. Lionheart Klotho-Up — Healthspan and longevity study centered on the Klotho-Up protocol.
3. HairCell™ Plus — Expanded study investigating hair regeneration.
4. SkinStim™ Plus — Expanded study investigating skin rejuvenation.
5. EyeCell™ Plus — Expanded study investigating vision improvement.
6. OrthoStim™ Plus — Expanded study investigating joint health and function.
7. ErectiStim™ or FemStim™ — Expanded study investigating sexual vitality.
8. EarCell™ Plus — Study investigating hearing improvement.
9. TestiStim™ — Study investigating testosterone management.
10. PressureStim™ — Study investigating blood pressure modulation.
11. BodStim™ HF — Study investigating potential applications in heart failure.
12. BladderCell™ with B-Alive™ Plus and PelvicStim™ — Expanded study investigating bladder health.
13. Stem Cell Bra™ and BreastStim™ — Expanded study investigating breast augmentation.
14. VascuStim™ Plus — Study investigating accelerated wound healing.
15. Brain Band™ Plus — Expanded studies investigating brain health.
16. AddictiStim™ — Study investigating addiction treatment.
17. BoneStim™ Plus — Study investigating bone density improvement.
18. KlothoStrips™ — Study investigating Klotho peptide oral dissolvable strips.
19. KlothoPatch I and KlothoPod I — Combination study investigating these two platforms together.
20. KlothoPod II — Study investigating the KlothoPod II platform.
21. Valvublator — Planned first-in-human study investigating heart valve regeneration.
22. Second Brain™ — Study investigating gut health.
23. KlothoExosomes — Study investigating a Klotho-focused exosome approach.
24. KlothoGeno™ — Study investigating Klotho gene therapy.
25. CancerCell™ — Study investigating cancer treatment.

About Lionheart Health

Forward Looking Statements

IMPORTANT RESEARCH, REGULATORY AND INVESTMENT DISCLOSURES

Investigational status and research objectives. This announcement describes Lionheart Health, Inc.’s planned clinical research priorities for 2027. Product names and references to regeneration, rejuvenation, improvement or treatment identify intended research objectives and should not be interpreted as established clinical benefits. Inclusion of a program does not establish its safety, effectiveness, regulatory authorization or availability for commercial use. Regulatory status varies by product, indication and jurisdiction.

FDA and other regulatory requirements. Any existing clearance or approval of an underlying device applies only to its authorized indications and labeling and does not automatically extend to new protocols, combinations or uses involving peptides, exosomes, cells or gene therapies. Institutional Review Board (IRB) or ethics committee approval permits research within its approved scope; it does not constitute FDA marketing authorization or establish clinical effectiveness. Research conducted outside the United States remains subject to applicable local requirements and does not, by itself, authorize U.S. marketing.

Clinical risks and limitations of evidence. Investigational interventions may provide no benefit and may cause serious, unforeseen or long-term adverse effects. Laboratory, animal, pilot, observational or uncontrolled findings may not predict results in larger controlled human trials. Individual outcomes may vary. Changes in biomarkers, including Klotho levels, do not alone establish improved healthspan, lifespan or clinical outcomes. No cure, reversal of aging, organ regeneration or other therapeutic outcome is guaranteed.

Study readiness and participation. Listing a study as a priority does not mean that it has received all required authorizations, begun enrollment or secured sufficient funding. Initiation and continuation depend on protocol development, appropriate supporting evidence, manufacturing and quality requirements, investigator and site readiness, enrollment, funding, and applicable regulatory and ethics approvals. Studies may be modified, delayed, suspended or discontinued. Participation requires study-specific eligibility review and informed consent. This announcement is not medical advice or a substitute for consultation with a qualified healthcare professional.

Expanded Disclaimer on Forward-looking statements and business risks. Statements concerning 2027 priorities, anticipated studies, development milestones and potential applications are forward-looking and reflect current plans rather than assured outcomes. Actual results may differ materially because of clinical failures, adverse events, regulatory decisions, manufacturing challenges, funding constraints, competition, intellectual property disputes or other business risks. No assurance is given that any program will achieve its endpoints, receive marketing authorization, become commercially viable or generate revenue or profits. These statements speak as of the announcement date. Except as required by law, Lionheart Health undertakes no obligation to update them.

Investment risks and securities disclosure. Investment in Lionheart Health involves substantial risk, including dilution, limited liquidity and possible loss of the entire investment. Clinical development progress does not guarantee increased company value, investment returns, a public listing or an active trading market. This announcement is not an offer to sell or a solicitation to purchase securities and does not replace applicable offering documents, financial statements or risk disclosures. Prospective investors should review those materials and consult their own legal, tax and financial advisers. No regulatory filing or acceptance should be interpreted as government endorsement of the company, its programs or an investment.