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CLINICAL STUDIES

CLINICAL STUDY ABSTRACT

Improved methods for evaluating pre-clinical and histological effects of subcutaneous fat reduction using high-intensity focused ultrasound in a porcine model

Skin Research and Technology 2016; 0: 1–8
B.J. Kim et al.

Research Objective
Pre-clinically and histologically evaluate the efficacy,
safety and mechanism of action of the SCIZER™(Classys Inc.)
for subcutaneous fat reduction.
Methods of Analysis
Effective subcutaneous fat thickness reduction
before & 90day after SCIZER treatment
Ultrasonography
Ultrasound pulses showing subcutaneous fat tissue of porcine abdomens in 90 days post treatment signified a clear reduction in fat thickness on the treatment site as opposed to non-treatment sites.

13.02 + 0.2128mm is the depth detected

Distance Measurements
The focal distance of the target area of coagulation, measured post treatment with the 13.0mm Cartridge of the SCIZER™(Classys Inc.), indicated that layers from the skin surface down to the dermis were pulled upwards as a result of collagen tightening and contractions triggered by the SCIZER™(Classys Inc.) treatment.

Monitoring Histological Changes

Examination of skin tissue under select dye solutions through 90 days following procedure showed a rapid reduction and tightening of collagen within the focal area without damage to surrounding tissues or nerves. Through the early stages of recovery, post treatment examinations as indicated by the oil red O staining solution also yielded heightened macrophage activity of cleaning up dead fat cells disrupted by HIFU from the SCIZER™(Classys Inc.) treatment.

PPAR delta

o day

Immediately after

7 day

30 day

30 days following treatment with the SCIZER™(Classys Inc.) on subcutaneous fat tissue, researchers found that adipocytes in the target region had undergone increased oxidation of fatty acids and energy dissipation, resulting in a faster metabolic buildup of fat cells during the early stages of recovery.

Temperature Changes During Treatment

As the SCIZER™(Classys Inc.) delivers both stable and uniform High Intensity Focused Ultrasound into the subcutaneous fat tissue during treatment, transmissions at 55-70°C of thermal energy into the focal area causes coagulative necrosis for fat reduction and tightening of collagen.

Serum Lipid Levels via Blood Tests
Blood Test Categories
Triglyceride(TG)
Free fatty acid
HDL-cholesterol
Normal Range
28-199
176-586
40-60
Unit of Measurement
mg/dl
uEq/L
mg/dl

Serum lipid levels to assess high-density lipoproteins (HDL), triglycerides, and free fatty acids following treatment with the SCIZER™(Classys Inc.) fluctuated temporarily until the 24-hour mark but returned to normal levels within 48 hours.

Conclusion
In this study, we examined the efficacy and safety of the SCIZER™(Classys Inc.) for subcutaneous fat reduction.
Our findings, through the utilization of diverse and improved methods for close assessment, showed a significant reduction of adipocytes in target subcutaneous fat layers without affecting surrounding tissues or nerves as indicated post treatment.
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