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CLINICAL STUDIES

CLINICAL STUDY ABSTRACT

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Efficacy and safety of non-invasive body
tightening with high-intensity focused ultrasound
(HIFU)

Skin Research and Technology 2017; 1-5

Research Objective
Determine the efficacy of the ULTRAFORMER III™ (Classys Inc.) as a practical alternative to invasive procedures
and surgery for increasing skin elasticity in the face and tightening areas of the body through HIFU.

Cutometer (R7) Test

  • Before
  • After 4 weeks
  • After 12 weeks

Significant differences; p<0.001 versus before by paired-samples t-test

Measuring changes to the cheeks, abdomen, and lower leg regions after receiving treatment with 5 Depth Cartridges of
the ULTRAFORMER III, subjects were assessed as clinically improved according to the cutometer (R7) test measuring for
skin elasticity between 1 and 4 weeks post treatment.

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SGAIS Improvement Rate
At 4 weeks post treatment, all subjects rated SGAIS scores as greater than 1 on the cheeks and thighs.
The improvement rate assessed for the abdomen as greater than SGAIS was 93.8%, which, up to the 12-week mark, increased to 96.8%.
96.9%
Cheek & Thigh
96.8%
Abdomen
Conclusion
In these studies, we evaluated the safety and efficacy of the ULTRAFORMER III™ (Classys Inc.) for dermal and subdermal
tightening performed on more than 30 eligible participants. Our findings, obtained through certified tools for objective
clinical assessments, show significant improvements to skin elasticity and tightening of multiple target areas of the face
and body over a stretch between 1 week and 90 days after receiving the ULTRAFORMER III.

BROW LIFTING EFFICACY

Clinical Study Abstract
Over the course of 12 weeks, 30 patients participated in a clinical study to assess the efficacy of brow lift procedures using the
Ultraformer III. Clinical photos were recorded at the start of each session to document improvement in results.

Baseline

Post Procedure

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Baseline

Post Procedure

Measurement of AEH Improvement

1.56mm
Patients evaluated in the course of 90
days achieved an average lifting effect of
1.56mm.
90%
90% of 30 subjects receiving brow lifts
under clinical evaluation reported significant
lifting and tightening just above
the eyebrows 90 days post procedure.
30days
The highest rate of clinical improvement was
commonly recorded in the first 30 days
following the first session of treatment.
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1.56mm
Patients evaluated in the course of 90
days achieved an average lifting effect of
1.56mm.
90%
90% of 30 subjects receiving brow lifts
under clinical evaluation reported significant
lifting and tightening just above
the eyebrows 90 days post procedure.
30days
The highest rate of clinical improvement was
commonly recorded in the first 30 days
following the first session of treatment.
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