Dr. Charles Runels, founder of the Cellular Medicine Association and creator of the O-Shot® procedure, suggests that the surge of interest in personalized sexual health treatments highlights a fundamental split in clinical philosophy. While some practitioners prioritize treatments solely based on FDA approval and insurance reimbursement, others are increasingly focused on biological plausibility, patient-reported outcomes, and evolving scientific evidence. This second group seeks to address menopause, sexual function, and quality of life with the same medical rigor traditionally reserved for systemic diseases like diabetes or heart failure.

Runels clarifies that the confusion often stems from a misunderstanding of regulatory oversight. The FDA regulates specific drugs and medical devices, yet it does not grant approval for medical procedures. Interventions such as hysterectomies or platelet-rich plasma protocols are evaluated through professional standards, informed consent, and peer-reviewed research. According to Runels, insurance coverage is a financial decision rather than a scientific validation, leading to situations where valuable treatments remain uncovered while others are standard despite varying patient needs.

As the popularity of procedures like the O-Shot® and the Clitoxin® protocol grows, so does the risk of non-standardized imitators. Runels urges patients to vet their practitioners by verifying their specific training, the scientific basis of the protocols used, and their commitment to standardized methodology. Ultimately, the goal is to ensure that advanced sexual healthcare remains accessible to all women, rather than being treated as a luxury commodity.