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NEWA® was created by EndyMed, a medical aesthetic company that offers energy-based aesthetic treatment systems for both the professional and consumer markets. EndyMed’s innovative, FDA cleared 3DEEP® RF technology is a clinically proven, effective solution for wrinkle reduction. 3DEEP® delivers focused energy deep into the dermis, providing safe treatments. 3DEEP® RF technology has been used in thousands of treatments by dermatologists, plastic surgeons and skin rejuvenation clinics worldwide.

 

EndyMed’s clinically proven 3DEEP® technology delivers focused RF energy 3 layers deep into the skin to reduce the appearance of wrinkles. EndyMed has taken the same 3DEEP® technology which powers its medical/professional treatment systems and has adapted it for NEWA®, so consumers can enjoy 3DEEP® treatments in the comfort and convenience of their home.

 

EndyMed consistently invests in clinical studies to ensure that the 3DEEP® RF technology that powers both the professional and consumer lines is the most effective and safest available today. With over 30 published peer-reviewed studies by international-renowned dermatologists and plastic surgeons, EndyMed is very proud to offer our clients the next level in the evolution of RF technology.

 

NEWA Study 1

 

Study Design

Participants:

69 participants (average age 54.3 years; 37-72 years old). Treatments were performed 5 times a week for three weeks, with a follow up evaluation after 3 months (without further treatment). 41 participants, with an average age of 57 (range of 39-77 years).

Results:

Objective Assessments:NEWA Study 1 Graphic

Objective assessments were performed according to the Fitzpatrick’s Wrinkle and Elastosis Grading Scale by three impartial Dermatologists.

  • 36.6% average wrinkle reduction at the three month follow up evaluation.
  • 90% of subjects showed improvement at the completion of one month of treatments.
  • 79% of subjects showed further improvement 3 months after the completion of the treatment.

Subjective Assessments:

  • 89.1% of study participants noticed an improvement in wrinkle appearance.
  • 72.7% rated the level of improvement as greater than 50%.
  • 91.8% of study participants reported that the NEWA® was easy to use during treatments.
  • No side effects were reported by any of the study participants.

NEWA Test 1 Before & Afters

NEWA Study 2

 

Study Design:

Participants:

47 participants (ages 37-65).
3 treatments per week for the first 4 weeks, then twice a week for 8 more weeks.

Results:

Objective Assessment:NEWA Study 2 Graph

Methods used: expert assessment, image analysis, Cutometer, Siascope.
Statistically significant results at the 12 week follow-up:

  • 93% of participants showed improvement in wrinkle severity
  • 100% of participants showed improvement in overall wrinkle appearance
  • 72% of participants showed improvement in deep lines
  • Other statistically signi cant improvements reported at the 12 week follow-up:
    • reduced marionette lines (67% of users)
    • increased elasticity (60% of users)
    • lift effect (facial) (62% of users)
    • lift effect (jaw line) (78% of users)
    • increased radiance/glow (84% of users)
    • improved skin texture/smoothness (69% of users)
    • improved skin tone (67% of users)
  • 84% of participants showed an improvement in firmness by an average of 22.4%
  • 55% of participants showed an improvement in elasticity by an average of 48.6%
  • 75.6 % of participants showed a statistically significant increase in skin collagen content (an average increase of 3.82%)

Subjective assessment:NEWA Study 2 B&A

Comments from study participants at the 4 week follow up:

  • 89% stated “the test product immediately made my skin look and feel tighter.”
  • 78% stated “the test product immediately made my skin feel lifted.”
  • 82% stated “I would recommend to my friends.”
  • 87% stated “I look forward to using the device again.”

NEWA Study 2 Conclusions

 

Sadick N, Harth Y: A 12-Week Clinical and Instrumental Study Evaluating the Efficacy of a multisource radiofrequency home use device for wrinkle reduction and improvement is skin tone, skin elasticity and dermal collagen content. Submitted.
 NEWA Study 5

 

Study Design:

17 users participated in this study (two groups of 8 and 9 participants respectively, average age of 58.52 (51-64))

Results:

Objective image analysis (Clarity 2D, 12 weeks):NEWA Study 5a

Reduction of wrinkle severity:

  • Top Brand Cream 1: an average of 3.25 % (improvement in 55.6% of users)
  • Top Brand Cream 2: an average 8.9 % (improvement in 87.5% of users)
  • NEWA® device: an average 13.3 % (improvement in 93% of users)

 

Objective expert visual grading:NEWA Study 5b

Jaw line lift at 12 weeks:

  • Top Brand Cream 1: no improvement
  • Top Brand Cream 2: no improvement
  • NEWA® device: 9.28% improvement in 77.8% of users

Objective Siascope measurement:

  • Increase in collagen measured by Siascope (at 12 weeks)
  • Top Brand Cream 1: no improvement (actual measured decreased)
  • Top Brand Cream 2: no improvement (actual measured decreased)
  • NEWA® device: 3.82% improvement in 75.6 % of users

 

NEWA Study 6

 

Products Tested:

  • NEWA® Lift Activator gel
  • NEWA® Lift Activator gel for Delicate Skin
  • Branded ultrasound gel

Study Design:

IRB approved, 60 participants were tested for a duration of 6 weeks. The original patch sites exhibited no reactions during the induction phase and the rest period. No other reactions were noted.

NEWA Conclusions

 

NEWA Graph

 

NEWA Study 4Week Tx

 

NEWA Approved By

*Studies provided by EndyMed. Results may vary.
NEWA® is an FDA Class II registered device. See intended use, contraindications and warnings.
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