August 27, 2026 – PRESSADVANTAGE –

Denver Regenerative Medicine has published patient-education materials defining what the clinic means by “rejuvenation therapy” and setting out the regulatory status, evidence base and known risks of the procedures the term covers.

The materials address a labeling problem rather than announcing a new service. Across the wellness industry, “rejuvenation therapy” is applied to everything from topical skin treatments to injectable protocols. At Denver Regenerative Medicine, the term refers to the clinic’s REjuvenate protocol, which pairs prescribed bio-identical hormone replacement therapy with autologous cell-based injections prepared from a patient’s own adipose tissue and bone marrow.

The documents separate those two components by regulatory pathway. Hormone therapy is prescribed by Andrew Hong, MD, the clinic’s medical director, using FDA-approved hormone products and only after laboratory testing; each product carries its own labeled risks and contraindications. The cell-based component is different. The FDA has not approved any stem cell product for orthopedic or age-related indications. Certain procedures using a patient’s own minimally manipulated tissue, removed and reimplanted in the same procedure, fall under Section 361 of the Public Health Service Act and 21 CFR 1271.10(a), which exempts them from premarket review. The materials state plainly that an exemption from premarket review is not an FDA approval.

On evidence, the materials say published research on cell-based orthopedic procedures remains early-stage, that the American Academy of Orthopaedic Surgeons has described the supporting evidence as lacking, and that individual response varies and cannot be predicted. Listed material risks include infection, bleeding, injection-site pain, nerve irritation and the possibility of no clinical benefit. The FDA has reported adverse events, including serious infections, blindness and tumor formation, in patients treated with unapproved regenerative medicine products. The clinic also notes these procedures are generally not covered by insurance, and that patients pay out of pocket.

Two environmental figures cited in the materials are limited to published measurements. Denver’s elevation of roughly 5,280 feet lowers barometric pressure and therefore the partial pressure of inspired oxygen relative to sea level, and the World Health Organization estimates ultraviolet levels rise about 10 percent per 1,000 meters of elevation. The clinic does not assert that Colorado’s elevation causes accelerated cellular aging, and the materials do not present altitude as an indication for treatment.

“Patients deserve to know which parts of a protocol are FDA-approved drugs and which are procedures operating under an exemption, because those are not the same thing,” said Andrew Hong, MD, medical director of Denver Regenerative Medicine. “We would rather publish the limits of the evidence than let a marketing term stand in for a clinical explanation.”

The materials describe an evaluation process that begins with blood panels measuring hormone baselines, inflammatory markers and metabolic function, followed by repeat laboratory testing at 90 days and reviews every six to 12 months. The clinic says patients it evaluates for the protocol are typically adults between 35 and 65, and that most return to normal activity the same day.

The patient-education materials are posted at https://denverregenerativemedicine.com/rejuvenate-therapy/. Denver Regenerative Medicine operates clinics in Denver, Fort Collins and Colorado Springs, and consultations are available by appointment at each location.

This information is provided for educational purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Always consult a qualified healthcare provider for personal health decisions.

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For more information about Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic, contact the company here:

Denver Regenerative Medicine | Stem Cell Therapy, HRT, Testosterone Clinic
Dr. Joel Cherdack
+17205831648
info@denverregenerativemedicine.com
455 Sherman St #450, Denver, CO 80203, United States

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