FDA Evaluated and Deemed Safe
Investigational Research Exosomes
Provide Exosome Therapy
Under FDA Recognized
Research Trials
- Purchase exosome products the FDA has evalutated and deemed safe for human research.
- Lawfully participate in IND phase III clinical trial research with patients, for a various conditions.
- Gain protecton by agreeing to follow our compliant IND protocol with reporting requirements.
- Training and certification provided.
- *Exosome IND ideas? Let’s talk.
Our Research Facility
FDA-registered, CDPH-certified lab with ISO 8, ISO 7, ISO 6 and ISO 5 clean rooms. The 60,000 sq. ft. facility is also cGMP-certified. All products produced in USA.
About Our Exosomes
Per FDA Requirements the Lab/Manufacturer is Prohibited from Soliciting or Selling Direct.
- 9 Years in Exosome Research and Development, (longer than any other exosome product).
- Developed proprietary mechanism for high concentration, potency, sterility and pharmaceutical grade consistency required for drug products.
- Has followed FDA guidance with intention to produce the first line of Therapeutic Exosome Drugs.
- The ONLY Exosome product available with an FDA Drug Master File, Evaluated and Deemed Safe for Human Research.
Apply to provide FDA compliant Exosome Therapy!
Contribute to Breakthrough Medical Research
Work With Us
Currently seeking Physicians, Hospitals, Sales Representatives, Referral Partners and Trainers.
- Purchase exosome products the FDA has evaluated and deemed safe for human research.
- Gain protection by agreeing to follow our compliant investigational research protocol.
- All documentation provided.
- *Have your own IND? Let’s talk.
Regulatory Compliance
The FDA has recently notified the industry that all regenerative medicine products intended for clinical use must go through their regulatory process. Our (lab/mfg.) has worked tirelessly to abide by all FDA regulations and has recently registered a Biologic Drug Masterfile with the FDA for its MSC Exosomes. This landmark achievement makes it the only product legally permitted to be sold for clinical use through research.
Exosome Research
ASC-Derived Exosomes in Combination with Hyaluronic Acid Accelerate Wound Healing Through
Exosomes: A New Effective Non-Surgical Therapy for Androgenetic Alopecia?
The Role of Extracellular Vesicles in Cutaneous Remodeling and Hair Follicle Dynamics