IMPORTANT REGULATORY NOTICE INVESTIGATIONAL USE ONLY
No exosome product is currently FDA-approved to diagnose, treat, cure, mitigate or prevent any disease or medical condition. Products labeled for topical use may be used only as expressly stated on their labeling and for lawful topical cosmetic purposes or specifically authorized uses.
Any injectable, systemic, ophthalmic, implantable or other therapeutic use is investigational and may occur only under all required regulatory authorizations, including an FDA-authorized IND when applicable, IRB approval, written informed consent, qualified-investigator training and appropriate safety oversight. IRB approval alone is not sufficient.
Investigational exosome therapies are not available for clinical treatment or sale in the United States.
What Is Exosome Therapy?
Exosome therapy is an advanced regenerative treatment designed to support the body’s natural repair and communication systems at the cellular level. Exosomes are microscopic extracellular vesicles released by cells that carry biologically active signaling molecules such as proteins, growth factors, RNA, and lipids.
These nano-sized vesicles function as biological messengers. They transfer genetic and molecular instructions between cells, helping regulate processes such as cellular repair, immune signaling, tissue regeneration, and inflammatory responses.
In regenerative medicine, purified exosome preparations derived from biologic tissue sources are used to deliver concentrated signaling molecules that may help support healing and restoration in targeted areas of the body.
Unlike therapies that rely on living cells, exosome therapy focuses on the cellular communication signals responsible for coordinating many of the body’s regenerative processes.
How Exosomes Work
Exosomes act as communication vehicles between cells. When introduced into the body, they interact with surrounding tissues and may help activate regenerative signaling pathways.
Key mechanisms associated with exosome therapy include:
Cell-to-Cell Communication
Exosomes deliver molecular instructions from one cell to another, helping coordinate repair responses in damaged or stressed tissue.
Genetic and Protein Signaling
They carry messenger RNA (mRNA), microRNA (miRNA), proteins, enzymes, and lipids that influence how recipient cells behave and respond to injury or stress.
Immune System Modulation
Exosomes may help regulate immune signaling pathways that contribute to inflammation and tissue recovery.
Cellular Recruitment
These signaling molecules may assist in recruiting local cells involved in tissue maintenance and regeneration.
Neurological Signaling Potential
Due to their nanoscale size, exosomes can interact with biological barriers and cellular environments that are difficult for larger molecules to reach.
Through these mechanisms, exosomes may support the body’s natural ability to restore balance, repair damaged tissues, and regulate inflammatory processes.
Biologic Composition
Exosome-based biologic preparations contain a concentrated collection of regenerative signaling factors produced by mesenchymal stem cells and other regenerative tissues.
These biologic components may include:
- Messenger RNA (mRNA)
- MicroRNA (miRNA)
- Growth factors
- Cytokines
- Proteins and enzymes
- Lipids involved in cellular signaling
Together, these components represent part of the cellular secretome — the complete set of signaling molecules released by regenerative cells that coordinate healing processes throughout the body.
Potential Clinical Applications
Exosome therapy is currently being explored in a variety of regenerative medicine settings. Physicians may incorporate exosome-based therapies into treatment protocols addressing areas such as:
- Orthopedic and musculoskeletal conditions
- Joint and soft tissue support
- Neurological health and recovery programs
- Aesthetic and skin rejuvenation treatments
- Performance and recovery protocols
- Wellness and longevity programs
The specific treatment approach depends on each patient’s condition, health history, and treatment goals.
What to Expect During Treatment
Exosome therapy is generally performed as a minimally invasive procedure in a clinical setting.
Consultation
Your provider will begin with a detailed consultation to review your medical history, symptoms, and goals. Based on this evaluation, a personalized treatment plan will be developed.
Procedure
The procedure typically involves delivering the exosome preparation to the targeted area using precise medical techniques. Depending on the treatment protocol, this may involve localized injections or other administration methods.
Most procedures are completed during a single clinical visit.
Recovery
Exosome therapy is generally well tolerated. Most patients can return to normal activities shortly after treatment, though specific recovery instructions may vary depending on the application.
When Results May Be Noticed
Every patient responds differently to regenerative therapies. Some individuals report noticing changes within several weeks, while others experience gradual improvements over time as cellular signaling and repair processes develop.
Your provider will discuss realistic expectations and potential timelines based on your individual treatment plan.
Safety and Ethical Sourcing
Safety and product integrity are critical considerations in regenerative biologic therapies.
Biologic materials used in exosome preparations are sourced from ethically donated perinatal tissue following healthy full-term births with donor consent. Rigorous donor screening protocols help ensure high safety and quality standards.
Safety practices may include:
- Extensive donor health screening and medical history review
- Infectious disease testing and laboratory verification
- Controlled laboratory processing environments
- Strict chain-of-custody and traceability protocols
- Quality control testing before clinical use
These measures help ensure that biologic materials meet strict safety and quality standards prior to use in regenerative medicine protocols.
Lionheart RRG Extracellular Matrix, Exosomes and Secretomes Price List
EXM (Extracellular Matrix) Products
Available in DMSO or Glycerol
| # | SKU | Description | Dosage | Price |
|---|---|---|---|---|
| 1 | EXM-1 | RRG Extracellular Matrix | 1ML / Vial | $900 |
| 2 | EXM-2 | RRG Extracellular Matrix | 2ML / Vial | $1,700 |
EXO (Exosome) Vesicle Products w/ Growth Factors
For topical use only
| # | SKU | Description | Dosage | Price |
|---|---|---|---|---|
| 3 | EXO-ELITE | MSC Derived Exosome Matrix with Growth Factors | 110 Billion EXOS / 1ML Vial | $600 |
| 4 | EXO-SKIN | Epidermal Specialized Exosome Matrix with Growth Factors | 110 Billion EXOS / 1ML Vial | $700 |
| 5 | EXO-PV-MAX | Neural, Muscle and General Specialized Exosome Matrix with Growth Factors | 330 Billion EXOS (110B Elite + 110B Neural + 110B Muscle) / 3ML Vial | $750 |
| 6 | EXO-MOVE | Condrosite Specialized Exosome Matrix with Growth Factors | 110 Billion EXOS / 1ML Vial | $1,000 |
| 7 | EXO-HAIR | Dermal Papilla Specialized Exosome Matrix with Growth Factors | 600 Billion EXOS / 3ML Vial | $1,500 |
| 8 | EXO-NEURAL | Neuro Specialized Exosome Matrix with Growth Factors | 110 Billion EXOS / 1ML Vial | $1,100 |
EXS (Secretomes) Products w/ Growth Factors
For topical use only
| # | SKU | Description | Dosage | Price |
|---|---|---|---|---|
| 9 | EXS | MSC Derived Secretome Matrix with Growth Factors | 40–50 Billion Exos / 300+ Growth Factors / 1ML Vial | $400 |
Lionheart RRG Extracellular Matrix, Exosomes and Secretomes Price List Ver 1.0 March 2026
Disclaimer
EXOSOME PRODUCT USE, REGULATORY STATUS AND COMPLIANCE ACKNOWLEDGMENT
IMPORTANT FDA AND INVESTIGATIONAL-USE NOTICE
Exosome products have not been approved by the U.S. Food and Drug Administration (“FDA”) to diagnose, treat, cure, mitigate, or prevent any disease or medical condition.
1. Permitted Topical Use
Any product supplied or made available for topical use may be used only as expressly stated on its labeling and only for lawful topical cosmetic purposes or other specifically authorized indications and uses.
The product may not be injected, infused, implanted, inhaled, applied to the eyes, introduced into the body, or used for any unapproved therapeutic purpose.
No representation is made that a topical cosmetic product is FDA-approved unless the specific product and indication have received applicable FDA approval.
2. Investigational or Other Uses
Any administration or use outside the product’s lawful labeled topical use—including injection, infusion, implantation, systemic administration, ophthalmic administration, or use intended to diagnose, treat, cure, mitigate, or prevent disease—is investigational.
Such investigational use may occur only through a properly authorized clinical investigation that includes, as applicable:
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An FDA-authorized Investigational New Drug application (“IND”) or other required FDA authorization;
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Review and approval by a duly constituted Institutional Review Board (“IRB”);
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A written research protocol;
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Proper written informed consent from every participant;
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Qualified-investigator and personnel training;
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Appropriate product manufacturing, handling, storage and accountability controls;
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Medical monitoring, safety reporting and independent oversight; and
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Compliance with all applicable federal, state and local laws and regulations.
IRB approval alone does not authorize the administration of an unapproved exosome product. FDA authorization and all other applicable regulatory requirements must be satisfied before an investigational product may be administered in the United States.
INVESTIGATIONAL USE ONLY
NOT AVAILABLE IN THE UNITED STATES
Investigational exosome therapies described on Lionheart Longevity’s website are presented solely for scientific, educational and clinical-research planning purposes. They are not offered for sale, routine clinical treatment or administration in the United States.
Information on the website does not constitute medical advice, an offer to provide an unapproved treatment, or a representation that any investigational exosome product is safe or effective for any medical condition.
ACKNOWLEDGMENT AND VERIFICATION
By signing below, I acknowledge and verify that:
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I have read and understand this notice.
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I understand that no exosome product is FDA-approved to diagnose, treat, cure, mitigate or prevent disease.
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I will limit any topical product to the lawful use expressly stated on its labeling.
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I will not inject, infuse, implant, systemically administer, or otherwise use the product for an unapproved or investigational purpose outside a legally authorized clinical investigation.
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I understand that informed consent or IRB approval by itself does not replace required FDA authorization.
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I will comply with all applicable FDA requirements, professional licensing rules, state laws, training requirements and clinical-trial obligations.
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I understand that Lionheart Longevity does not authorize or direct any person to use an exosome product in violation of applicable law.
Topical exosome products are available only to qualified, appropriately licensed clinicians. Orders are drop-shipped directly from the production laboratory in Utah, USA, to the verified purchasing clinic. Products will not be shipped directly to patients or consumers and must be stored, handled and used strictly according to their labeling and all applicable federal and state requirements. Certified training is a mandatory prerequisite for any clinic to being a topical exosomes program.