This page presents the full methodology, quantitative results and limitations of the clinical study and preclinical studies behind the efficacy and safety data communicated elsewhere on this site. We publish this summary so any practitioner can independently assess the evidence level before integrating the device into their practice.
19 patients, aged 35-55 (mean 45 ± 10), BMI 23.7-35.8, treated on the abdomen. One group received a single session (day-28 follow-up), a second group received two sessions two weeks apart (day-42 follow-up). Identical "medium" setting for all patients (50% of the device's parameters: ultrasound power, working time, electrostimulation, suction speed), not individualised — 5 cycles per session across 6 applications, ~400 cm² treated, 25 minutes of active treatment time. 900 suction+ultrasound cycles were performed across the study in total.
Safety monitored via blood tests at 5 time points (triglycerides, glycerol, total cholesterol, LDL, HDL, β-HCG, lipase, creatinine, urea — 180 analyses in total) and a dermatological exam before/after each session. Efficacy measured via constant-tension tape waist measurements, standardised photographs, and a self-assessment questionnaire.
One erythema resolved the same evening, the other within a week. No other adverse event reported.
Waist-circumference reduction varied between patients: some had little or no measurable reduction, others up to 4-5 cm after one to two sessions. A second treatment improved results by around 20% on average vs. a single session. No significant weight variation over the follow-up period.
100% of patients wanted further sessions (excluding the extra blood draw).
Five protocols were run on full-thickness human skin explants (epidermis, dermis, subcutaneous fat) from abdominoplasty procedures, to determine optimal ultrasound parameters. Histology: targeted alterations of adipocytes and septa, preserved epidermal/dermal structures. Key quantitative study (13E2738, 38-year-old donor): selected condition → +27% triglycerides, +46% free fatty acids, +18% glycerol released vs. control at day 2 — three concordant markers of adipolytic activity. Independent confirmation (11E2300): +16% triglyceride release.
Individual results may vary depending on the patient, treated area, and tissue characteristics. This information is intended for healthcare professionals and does not constitute medical advice.