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Our Regenerative Medicine Treatments are FDA Regulated under section 361
Surgenex Surforce™ and Surfactor™ Products
All of our regenerative treatments are purchased from Surgenex which is a FDA regulated lab that follows and exceeds FDA guidance.
All regenerative medicine procedures performed at StemX by Spark are performed using an Amniotic Tissue injection which is Regulated by the United States Food and Drug Administration as Human Cells, Tissues, Cellular and Tissue-Based Products (HCT/P's) under Section 361.decision.
This healthcare practitioner performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care physician prior to undergoing a regenerative therapy.