AT HOME REMOVAL AND REDUCTION WITH ELŌS TECHNOLOGY USING SYNERON MĒ, MY ELŌS DEVICE David J. Friedman, MD Director, David J. Friedman Skin & Laser Center, Jerusalem, Israel

THE SYNERON INVENTION – THE ULTRA HIGH SAFETY AND PERFORMANCE AND ULTRA The advantages in this TRIO combination are TARGETING OF PERMANENT HAIR REDUCTION multi-fold: Syneron Medical Ltd. has pioneered a novel device A. Safety. Because both RF and IPL are (based on optical, electrical and mechanical employed in forming the ELectro-Optical epilation), intended for home use, which can Synergy (elōs) effect, the level of IPL remove hair with outstanding safety and efficacy, energy required is reduced, making the due to targeted focusing of energy into the follicle. system safer, especially for darker skin. The mē, my elōs device (Figure 1) is based on the safe elōs energy, with appropriate energy levels for B. All skin type’s applicability: Due to usage home use. It combines with its operation of both RF and IPL (forming the elōs), mechanical – a tweezers-shaped allowing usage of lower level of IPL rotating type . The synergistic effect of the energy, the mē, my elōs is the only device RF and light energy is amplified when combined in the market that is uniquely designed to with mechanical epilation, resulting in a TRIO be suitable for all skin types (colors). synergistic effect between the: C. Targeted action: By mechanically I. Radio Frequency energy-RF (electrical the hair out of the follicle energy) immediately prior to the elōs pulse, application of elōs results in focused II. Intense Pulse Light-IPL (optical energy) energy to the follicle. Thus, lower amounts III. Mechanical epilation inducing vaso- of energy are required (making it safer and dilatation less painful). D. Fair hair removal. Even if the hair shaft is fair (clear), a target that standard technology does not address, elōs energy will be targeted to the follicle thus retarding hair re-growth. This occurs due to

Elōs Cartridge the replacement of the invisible target (fair hair) by a visible target (blood). Therefore, mē, my elōs is applicable to retard the growth of fair hair as well. Epilator Cartridge E. Speed. Due to the fact that one has the

mechanical hair removal in parallel with

Interchangeable Shaver Cartridge the elōs treatment, the overall hair removal treatment is quicker. F. Modularity. For practical reasons and convenience, the device may also be Figure 1: mē, my elōs Device supplied with an attachment (which can replace the epilator attachment), for those who prefer conventional

to epilation- based procedures.

"At Home Hair Removal with elōs Technology Using the Syneron mē, my elōs Device" 2 March 2011

STUDY GROUP RESULTS 4. Results Several studies were performed by several groups The mean dark reduction after just of women. Participants in studies were women aged three treatments on the forearms and legs, for study 25-50, skin type 1-5. Figure 2 displays the results Groups Ia and Ib, is shown in Fig 2. The group II obtained. trial is ongoing. Protocol (HR is the Hair Removal ratio (in percentage), defined as the number of present at the given 1. Study Group Ia: 24 women participated in day compared to the number of hairs at baseline). the study. They underwent 4 treatments, spaced two weeks apart with follow up 12 weeks after the last treatment. In the Discussion treatment phase, the elōs was employed in parallel with shaving. In the follow-up The mē, my elōs device has been shown to phase, only shaving was employed, dramatically decrease hair growth. supplemented by monthly periodic The proposed regimen of four treatments, two treatment. elōs power Setting: High weeks apart, resulted in 89% hair reduction, one 2. Study Group Ib: 23 women participated in month after the 4th treatment. We were able to the study. They underwent 4 treatments, maintain this hair reduction by monthly spaced two weeks apart with follow up 12 maintenance treatments. Such a regimen will weeks after the last treatment. In the greatly ease the hair removal care at the treatment phase, the elōs was employed in convenience of the home. parallel with shaving. In the follow-up From patient experience on skin type 6 (darkest phase, only shaving was employed, skin type) subjects, the results are promising, with supplemented by monthly periodic no side effects, specifically no post inflammatory treatment. elōs power Setting: Medium hyper-pigmentation and no bruising. 3. Study Group II: 16 women participated in the study. They underwent 4 treatments, spaced three weeks apart with follow up of 24 weeks after the last treatment. In the treatment phase, the elōs was employed in parallel with mechanical epilation (plucking). In the monitoring phase, only mechanical epilation (plucking) was employed, supplemented by monthly periodic treatment. elōs power Setting: High

% Hair Reduction Vs Weeks (elōs setting ‐ Medium & High), Monthly maintenance 100 H 91% 89% th 85% a 4 treatment 1 month after i 80 4th treatment 3 months after r 74% th 3rd treatment 4 treatment R e 60 d u c 38% 40 t 2nd treatment i Treatment o Maintenance n 20

( % ) 1st treatment 0 0246810 14 18 Weeks since begining of Treatment

Figure 2: Average % HR Vs weeks (Legs and forearms, using shaver)

"At Home Hair Removal with elōs Technology Using the Syneron mē, my elōs Device" 2 March 2011

FACIAL TREATMENT SAFETY - STUDY GROUP RESULTS EXTENSION 3. Results There is an increasing need to remove . Although protocol conditions in the two Facial As the face is a part which is of high esthetic studies are significantly more stressful than that sensitivity, several studies were performed in order expected, representing an extreme use of the to confirm the safety of the mē device in various device, no adverse events occurred in both groups- extreme configurations. The studies were performed including those with very dark skin types (skin type without an epilator/shaver. VI). Several studies were performed by several groups The below comparison table summarizes the usage of women. Participants in studies were women aged parameters as employed in the studies. 25-63, skin type I-VI.

The protocols of these studies were intended to verify the safety of the mē device on the face, in Group IIIa IIIb various operational conditions, and therefore Parameter represented significantly harsher conditions as well as significantly more frequent use than expected. Skin Types I-III I-VI Protocol Operation Continuous 3 repeats regime (“gliding”) (“stamping”) 1. Study Group IIIa-Completed: 7 females participated in the study. Face areas All On and below (excluding eyes) cheek line only • Ages 38-63. Repetitions on 2 (average) 3 • Skin types I-III. same spot, in • Treatment method: continuous gliding each treatment across all facial areas, with 1-2 elōs pulses Frequency of Daily for 12 Every 2 days emitted each second, depending on the use weeks (over for 1 week energy setting selected. Protective eyewear 80 treatments (dark glasses) were used cumulatively on all • Treatment protocol: 2 minutes of self, subjects) daily treatment, 5 days a week, for twelve weeks. • Elōs energy level: Low-High (Most though used Low-Medium). 2. Study Group IIIb (ongoing): 10 females Discussion participating in the study. As facial hair removal involves different safety • Ages 20-30 Skin type’s I-VI: considerations than body treatment, special i. 5 subjects skin type I-V attention should be paid in design and in labeling and user instructions. ii. 5 subjects skin type VI The mē was designed in line with the most • Treatment method: discrete pulses method stringent safety standards of eye safety and on cheek (parotid), chin (mental) and usability safety. mustache zones. Protective eyewear (dark glasses) are used. The mē was tested under extreme regimens of use, to verify that there are no safety related events. • Treatment protocol: Self, bi-daily, treatment (3 treatment visits in total). In each treatment, each No adverse events were reported. area is treated 3 times. • Elōs energy level: High. This study establishes the safety of the mē device for use on the face.

"At Home Hair Removal with elōs Technology Using the Syneron mē, my elōs Device" 2 March 2011