CLINICAL STUDIES

30 PEER REVIEWED PUBLICATIONS

*Based on 30 peer reviewed publications on HIFEM technology.

SUMMARY OF NEW EMSCULPT NEO STUDIES

*Data on file 1. Jacob C, Kent D, Ibrahim O. Efficacy and Safety of Simultaneous Application of HIFEM and Synchronized Radiofrequency for A bdo minal Fat Reduction and Muscle Toning: A Multicenter Magnetic Resonance Imaging Evaluation Study. Dermatol Surg. 2021;47(7):969 973. doi:10.1097/DSS.0000000000003086.
2. Samuels JB, Weiss RA, Katz B Radiofrequency Heating and HIFEM Delivered Simultaneously The First Sham Controlled Randomized Trial Plast Reconstr Surg In press
3. Palm M, Halaas Y, Kinney B et al MRI Multicenter Study on High Intensity Focused Electromagnetic Procedure Simultaneously Combined with Synchronized Radiofrequency for Treatment of Lateral Thighs Preliminary Data Accepted at ASDS 2021 Annual Meeting November 19 21 2021 Virtual Meeting
7. Goldberg DJ Deletion of adipocytes induced by a novel device simultaneously delivering synchronized radiofrequency and hifem Human histological study J Cosmet Dermatol 2021 20 4 1104 1109 doi 10 1111 /jocd 13970
8. Halaas Y, Duncan D, Bernardy J, Ondrackova P, Dinev I Activation of Skeletal Muscle Satellite Cells by a Device Simultaneously Applying High Intensity Focused Electromagnetic Technology and Novel RF Technology Fluorescent Microscopy Facilitated Detection of NCAM/CD 56 Aesthet Surg J 2021 41 7 NP 939 NP 947 doi 10 1093 /asj/sjab 002
10. DiBernardo B, Katz B, Goldberg D et al MulitCenter MRI Study Comparing HIFEM And HIFEM plus RF On Buttocks Musculature Presented at GAC 2021 Annual Meeting November 4 7 2021

PORCINE MUSCLE HISTOLOGY

Activation of Skeletal Muscle Satellite Cells by a Device Simultaneously Applying High Intensity Focused Electromagnetic Technology and Novel RF Technology: Fluorescent Microscopy Facilitated Detection of NCAM/CD56 Y. Halaas MD, D. Duncan MD, MVDr. J. Bernardy Ph.D., MVDr. P. Ondrackova Ph.D., I. Dinev DVM, Ph.D., DSc

• 5 white large pigs, 3x30min treatments on abdomen

• The treatment increases the satellite cells levels by 30.2% 2 weeks post treatment

• Histology showed hypertrophic changes along with signs of newly formed myofibers

• The effect is comparable with 12 16 weeks long exercise programs

30.2%

Increase in the satellite cell level

https://academic.oup.com/asj/advance article/doi/10.1093/asj/sjab002/6089068?searchresult=1

Immunofluorescence images of satellite cell levels (red) at baseline (left) and 2 weeks post treatment (right)

PORCINE FAT HISTOLOGY

Simultaneous Application of High intensity Focused Electromagnetic and Synchronized Radiofrequency for Fat Disruption: Histological and Electron Microscopy Porcine Model Study. R. A. Weiss MD, FAAD, MVDr J. Bernardy Ph.D., Prof MVDr F. Tichy CSc.

• 7 White Large pigs, 3x30 min treatments on abdomen

• Post treatment the adipocytes were damaged (apoptosis) and/or shrunk (lipolysis)

• 31.1% decrease of adipocytes’ area at 2 weeks post treatment

• The fat temperature was maintained just below 45°C for more than 20 minutes

• Histology and SEM showed efficacy of the procedure for disruption of adipocytes

BASELINE

4 DAYS AFTER

2 WEEKS AFTER

https://journals.lww.com/dermatologicsurgery/Abstract/2021/08000
/Simultaneous_Application_of_High_Intensity_Focused.4.aspx

HUMAN FAT HISTOLOGY

Deletion of Adipocytes Induced by a Novel Device Simultaneously Delivering Synchronized Radiofrequency and HIFEM: Human Histological Study . D. J. Goldberg, MD, JD

• Elimination of adipocytes and significant reduction in size of fat cells resulted in overall reduction of fat tissue

• Adipocytes were shrunk with noticeable ruptures of cytoplasmic membrane

• Control samples demonstrated no treatment related changes in fat tissue

• Fat temperature was maintained between 43°C - 45°C for the entire treatment

BASELINE

Healthy fat cells with well defined shape

1 MONTH AFTER

Disrupted (C) and shrunk fat cells

https://onlinelibrary.wiley.com/doi/10.1111/jocd.13970

THE ABDOMINAL MRI STUDY

Efficacy and Safety of Simultaneous Application of HIFEM and Synchronized Radiofrequency for Abdominal Fat Reduction and Muscle Toning: A Multicenter Magnetic Resonance Imaging Evaluation StudyC. Jacob MD, D. Kent MD. N = 41 patients

RESULTS AT 3 MONTHS POST TREATMENT

30.8%

Average fat reduction

26.1%

Average increase in muscle

18.8%

Average reduction in abdominal separation

5.9 cm

Average circumferential reduction

Before

3 months after

https://journals.lww.com/dermatologicsurgery/Abstract/2021/07000
/Efficacy_and_Safety_of_Simultaneous_Application_of.19.aspx

THE ABDOMINAL ULTRASOUND STUDY

Novel Radiofrequency Device Used in Combination with HIFEM Procedure for Abdominal Body Shaping: Sham controlled Randomized Trial. B.E. Katz MD, R. Weiss MD, J. Samuels MD. N = 72 patients.

RESULTS AT 3 MONTHS

28.3%

Average fat reduction

24.2%

Average increase in muscle

93.9%

Patient satisfaction

Before

1 month after

2 Samuels JB, Weiss RA, Katz B Radiofrequency Heating and HIFEM Delivered Simultaneously The First Sham Controlled Randomized Trial Plast Reconstr Surg In press

DOCUMENTED RESULTS OVER TIME*

Data based on results of 3 clinical studies^(1-3) and 145+ patients:

Best results were documented 3 months post treatment.

*The results are based on the average results observed in the study patients. These results may vary in standard clinical set tin gs.
1. Jacob C, Kent D, Ibrahim O Efficacy and Safety of Simultaneous Application of HIFEM and Synchronized Radiofrequency for Abdominal Fat Reduction and Muscle Toning A Multicenter Magnetic Resonance Imaging Evaluation Study Dermatol Surg 2021 47 7 969 973 doi 10 1097 /DSS 0000000000003086
2. Samuels JB, Weiss RA, Katz B Radiofrequency Heating and HIFEM Delivered Simultaneously The First Sham Controlled Randomized Trial Plast Reconstr Surg In press
3. Palm M, Halaas Y, Kinney B et al MRI Multicenter Study on High Intensity Focused Electromagnetic Procedure Simultaneously Combined with Synchronized Radiofrequency for Treatment of Lateral Thighs Preliminary Data Accepted at ASDS 2021 Annual Meeting November 19 21 2021 Virtual Meeting

THE OUTER THIGH STUDY

MRI Multicenter Study on High Intensity Focused Electromagnetic Procedure Simultaneously Combined with Synchronized Radiofrequency for Treatment of Lateral Thighs: Preliminary 3 Month Follow up Data. M. Palm MD, MBA, B.M. Kinney MD, FACS, MSME, Y. Halaas MD, FACS, Richard Goldfarb MD, FACS³

• 93 subjects were recruited (21-70 years old, 19 34.5 kg/m²

• Four bilateral treatments combining HIFEM+RF on lateral thighs (“Saddlebags”)

• Interim 3 month MRI data showed an average reduction of fat thickness by 30.9% (1.9 cm)in each thigh on average

• Patients reported a high satisfaction rate with the treatments

30.9%

Increase in the satellite cell level

Baseline

1 month after

3. Palm M, Halaas Y, Kinney B et al MRI Multicenter Study on High Intensity Focused Electromagnetic Procedure Simultaneously Combined with Synchronized Radiofrequency for Treatment of Lateral Thighs Preliminary Data Accepted at ASDS 2021 Annual Meeting November 19 21 2021 Virtual Meeting

THE INNER THIGH STUDY

Efficacy and Safety of Simultaneous Application of HIFEM and Synchronized Radiofrequency for Non invasive Lipolysis in Inner Thighs. D. Duncan MD, FACS ¹⁵

• 16 subjects (24-69 y/o, 21.3-35.0 kg/m²

• Four bilateral treatments with small applicators placed over the inner thigh region

• Results showed reduced fat thickness by 0.84 cm at 1 month and 1.01 cm at 3 months post treatment in each thigh

• Thickness of medial thigh adductor muscles was increased by 23.2% at 3 months

• Thigh circumference decreased by 1.0 cm and 1.8 cm at 1 month and 3 months respectively

27.4%

Fat thickness reduction at 3 months

94%

Patient satisfaction

15. Duncan D Inner Thigh Muscle Toning and Fat Reduction as a Result of Simultaneous Treatment with High Intensity Focused Electromagnetic Field ( procedure and Synchronized Radiofrequency Submitted to Miami Cosmetic Surgery Aesthetic Dermatology 2022 Miami Beach, FL

THE BUTTOCK STUDY

Gluteal Contouring by HIFEM and Synchronized Radiofrequency: Interim 1 month Results of the Multicenter Magnetic Resonance Imaging Study. Suneel Chilukuri MD, FAAD, FACSM, David J. Goldberg MD, JD, Bruce E. Katz MD, JD McCoy NMD, Barry DiBernardo MD¹⁰

• 67 recruited subjects divided into HIFEM+RF and HIFEM groups

• Thickness of all three gluteal muscles (maximus, medius and minimus) and adjacent fat layer was measured in MRI axial slices

• 1 month results showed that the HIFEM+RF therapy has 40% higher efficacy when compared to HIFEM only procedure

10. DiBernardo B, Katz B, Goldberg D et al MulitCenter MRI Study Comparing HIFEM And HIFEM plus RF On Buttocks Musculature Presented at GAC 2021 Annual Meeting November 4 7 2021

EMSCULPT™ NEO

EMFACE™

EMSELLA™

TÄYTEAINEET (HYALURONIHAPPO)

BOTULIINITOKSIINI

PROFHILO

HIFU 5D V MAX LOW PAIN, HIFU 3D

KRYOLIPOLYYSI

RF MIKRONEULAUS

CLINICAL STUDIES

30 PEER REVIEWED PUBLICATIONS

SUMMARY OF NEW EMSCULPT NEO STUDIES

PORCINE MUSCLE HISTOLOGY

Increase in the satellite cell level

PORCINE FAT HISTOLOGY

HUMAN FAT HISTOLOGY

THE ABDOMINAL MRI STUDY

RESULTS AT 3 MONTHS POST TREATMENT

THE ABDOMINAL ULTRASOUND STUDY

RESULTS AT 3 MONTHS

DOCUMENTED RESULTS OVER TIME*

Data based on results of 3 clinical studies(1-3) and 145+ patients:

Best results were documented 3 months post treatment.

THE OUTER THIGH STUDY

Increase in the satellite cell level

THE INNER THIGH STUDY

Fat thickness reduction at 3 months

Patient satisfaction

THE BUTTOCK STUDY

MESQ on BTL Emsculpt virallinen edustaja Suomessa

MESQ® Rekisteri- ja tietosuojaseloste

Data based on results of 3 clinical studies^(1-3) and 145+ patients: