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FemCelz is an **autologous stem cell-based regenerative procedure** developed for the treatment of female sexual dysfunction, specifically addressing issues such as genital sensitivity loss, dryness, difficulty with arousal, and pain associated with sexual stimulation or vaginal contact. The therapy uses the patient's own stem cells—including hematopoietic and mesenchymal stem cells, as well as endothelial progenitor cells—administered without chemical or genetic modification, expansion, or extensive processing. These cells are injected into the clitoral area during a single surgical session, aiming to restore and regenerate smooth muscle cells, blood vessels, and nerves necessary for clitoral and vaginal function. There is no chemical or genetic manipulation involved; the cells are minimally manipulated and reintroduced into the same patient within the same procedure. The therapy is designed to induce recovery of damaged tissue and restore sexual function by reconstituting the vascular and smooth muscle integrity of the genital region[1][6][7]. FemCelz is similar in mechanism and approach to Creative Medical Technology Holdings' CaverStem, which targets male erectile dysfunction, but is specifically optimized for female anatomy and indications. This treatment is *not currently classified as a pharmaceutical drug* or device requiring FDA premarket review, per Section 361/Same Surgical Procedure Exception, because it involves autologous, minimally manipulated cells used in the same patient during the same procedure[6][1]. Currently, marketing efforts for FemCelz have been paused pending strategic re-evaluation, and no revenue has been generated to date[6].
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