HyperCharge Health & Aesthetics
- Vitamin IV Therapy
- PRP Therapy
- Ozone Therapy
- IV Therapy
- Transcranial Magnetic Stimulation (TMS)
Edina, MN
Edina supports a regenerative medicine market shaped by both private clinics and regional academic medicine. Local referral networks run through Fairview Southdale Hospital and nearby Mayo Clinic Square, and stem cell practice in the area spans Southdale, 50th & France, and the Interlachen corridor. Patient demand splits across three buckets: orthopedic injections for active adults and aging athletes, neurological and autoimmune protocols marketed to longevity-focused patients, and IV-based allogeneic products offered by private wellness clinics. The FDA classifies most stem cell injections for orthopedic, neurological, or longevity use as investigational biologics under 21 CFR Part 1271, meaning they require either a Biologics License or an active Investigational New Drug authorization. Autologous bone marrow and adipose products may qualify as Section 361 when minimally manipulated and used for homologous function. Minnesota regulates physician practice through the Minnesota Board of Medical Practice. There is no state-specific stem cell statute, so federal 21 CFR Part 1271 rules apply. The Mayo Clinic's Rochester campus anchors significant academic trial activity. The 3 Edina clinics listed below have been reviewed against our vetting criteria, including federal NPI lookup, OIG exclusion screening, and Minnesota Board of Medical Practice licensure checks.
Regulatory context
Minnesota cellular therapy is governed by 21 CFR Part 1271. Section 361 covers minimally manipulated HCT/Ps used for homologous use without premarket approval. Section 351 covers products that are more than minimally manipulated, used non-homologously, or combined with another article, and these require an IND for clinical use or a BLA for marketing. Most stem cell, stromal vascular fraction, and exosome therapies marketed in Minnesota for orthopedic, neurologic, and longevity indications are Section 351 biologics that lack FDA approval. The state is also home to Mayo Clinic, which conducts substantial IND-based regenerative research.
The FDA has corresponded with Minnesota providers offering cellular therapies, and warning letters have been issued to regional clinics with operations in or near Minnesota. The Minnesota Board of Medical Practice has disciplined physicians for unprofessional conduct including misleading regenerative medicine advertising. The Minnesota Attorney General has used the Prevention of Consumer Fraud Act to pursue deceptive health marketing. Mayo Clinic's regenerative medicine programs operate under FDA-cleared INDs, providing a high-compliance benchmark in the state.