Profound 2017

Profound 2017

• Market Overview

• Product Overview

• Clinical Overview

• Before/After Pictures

MARKET OVERVIEW

The Problem: Skin Begins to Sag As People Age

The Problem

Collagen levels

decrease as we

age.

Our bodies stop

producing elastin

when we are in

our 20’s.

So our skin

begins to sag.

Profound Face – Areas of Treatment

Most Common Facial Concerns for Women

1 Syneron on-line consumer survey, 2015 Syneron Proprietary and Confidential

28%

25%

21%

14%

7% 6%

Double chin Sagging skin injawline/jowls

Turkey neck Wrinkles in thecheek area

Loss of volumein cheeks

Other

Profound Market Summary

• Profound Face– Jawline

– Jowls

– Submentum

– Neck

• Profound Body– Cellulite

– Abdomen

– Arms

– Knees

PRODUCT OVERVIEW

First FDA Indication for Use

Profound is indicated for use in dermatologic

and general surgical procedures for

electrocoagulation and hemostasis, and the

percutaneous treatment of facial wrinkles.

Second FDA Indication for Use

Profound is indicated for use when using the

SubQ Handpiece and Cartridge to improve the

appearance of cellulite in patients with

Fitzpatrick Skin Types I-III, as supported by long-

term data (6 Months)

Patent Protection

SYNERON ANNOUNCES STRENGTHENING OF PATENT PROTECTION

FOR THE PROFOUND™ SYSTEM

New Patent Allowances from USPTO Enhance Intellectual Property Covering

the Profound Micro-Needle Technology

Yokneam, Israel, November 8, 2016 — Syneron Medical Ltd. (NASDAQ:

ELOS), a leading global aesthetic device company, announced today that the

United States Patent and Trademark Office (USPTO) has allowed new claims

to a key patent covering the micro-needle technology used in the Company’s

Profound™ system. The new allowances expand the patent claims to cover

any device that uses a module to control and deliver radiofrequency (RF)

energy through an array of needles to deliver energy into the dermal layer of

skin to induce fractional damage for the purpose of collagen generation. The

patent is owned by Massachusetts General Hospital (MGH) and Syneron

holds an exclusive worldwide license to the patent for use in aesthetic

applications. In addition to this patent, Syneron holds several additional U.S.

and international patents covering the Profound system.

Profound Best in Class

• 1st and Only Patented Device (MGH) with Temperature-

Controlled RF clinically proven to create Elastin, Collagen, and

Hyaluronic Acid.

• Customized Treatments:

– Dermal Handpiece – 1.5mm in Dermis for optimal volume addition of new

elastin, hyaluronic acid, collagen. skin tightening

– SubQ Handpiece – 2.9mm to 5.8mm in Adipose Tissue for volume

reduction and tissue remodeling.

• 100% response rate: 1 treatment. 1 hour.

• Unique Real Time Feedback: Optimal Partial De-Naturing of

Collagen at 67 Degrees for 3 Seconds measured 10 times a

second. (Alexiades Arch Derm 2010 - Beckman Laser Institute)

Applicator - Proprietary Design for Optimal Treatment

• 5 pairs of electrically-isolated 32 gauge needles

• 6 mm length; insulated; specially beveled to maintain sharpness

• Fractionated zones of thermal injury created in and limited to the deep dermis (1-2 mm deep into the skin)

Profound Best in Class

Profound Best in Class

Profound System

• Bi-polar RF energy delivery system

• Micro-needle RF energy delivery

▪ Real Time Temperature Controlled RF

▪ Specific Temperature Endpoints

▪ Real Time impedance feedback from

tissue

• Console

▪ Color touch screen

▪ Intuitive GUI

• Ergonomic handpiece

▪ Single button

• Single use cartridge per patient

Applicator & Cartridge

applicator

cartridge

electrodes

cold plate

Treatment Screen

1 sec 3sec 5 sec

1 sec 3 sec 5 sec

Precise Control Over Thermal Endpoints of Treatment

• 96% of the energy is absorbed in the dermal layer

• Thermal profile confined along and between needles

• Temperature controlled lesion created

• Precise fractionated zone of

thermal injury

• Temperature readings every 1/10

of a second

• Adjusts temperature based on

Real Time feedback to maintain

optimal treatment

Precise Temperature Control – 10 Times/Second

• A specific target temperature is reached regardless of skin condition

• Energy is adjusted to reach and maintain target temperature

Impedance

Power Temperature

Optimal Parameters For Treatment (Alexiades/Aksan/MGH/Nelson/Beckman Laser Institute)

Figure 1 - Thermal dose for collagen. The blue curve indicates the dose necessary to start collagen denaturation, while the red curve indicates when the denaturation process is fully completed.

Partially denatured collagen is more effective at triggering

a strong wound healing response

67°C, 4 sec

Tissue Volume – Clinical Efficacy

Invasiveness

No

n-

Inva

sive

Min

Inva

sive

Inva

sive

Profound

Face-lifting Surgery

Efficacy

ilooda

Sublative, Pixel RF,Endymed,

Viora,Venus Viva, Invasix

Fractora, etc.

Neck TiteCannula based

technology

Micro-needling with no thermal feedback

Surgical procedures

Different RF technologies

US Technology

Mono-polarRF technology

Competitive Products

Profound Specifications

Bi-polar Radio Frequency 460 +/- 5kHz

Maximum Output Voltage 84 VRMS. 5 W per channel

Channels 5 independent bi-polar channels

Mode PID temperature control

Target Temperature Range 65-75 degrees C (149 – 167 degrees F) +/- 1 degree C

Treatment Duration 3.5 seconds. 0.2 second increments

User Interface GUI – color touch screen

System Dimensions 125 x 46.5 x 44.5 centimeters29.5 x 18.5 x 17.5 inches

System Weight 23 kg. / 55 lbs.

Electrical Requirements 100-240 VAC, 2.5 A, 50-60 Hz, single phase

Focal edema following heating.

Minimally invasive 32g needles

Profound Treatment

CLINICAL OVERVIEW

PEER REVIEWED ARTICLES

Summaries of 8 Peer Reviewed Articles

“The healing process of Profound was shown to produce a profoundincrease in collagen and elastin content.”

(DERM SURG 2010)

Prospective Multicenter Clinical Trial of a Minimally Invasive

Temperature-Controlled Bipolar Fractional Radiofrequency

System for Rhytid and Laxity Treatment

Alexiades M, et al. Dermatology Surg. 2013;39(2):263-73.

STUDY DETAILS

• 100 subjects at 7 centers

• Single pass fractional RF (FRF) treatment (temp. 62 to

78°C, 3-5 sec energy, impedance restriction 200 -

3,000 Ohms)

• 5 physicians - blinded assessment of photos

• Wrinkles and skin laxity assessment. 4 treatment zones(all subjects treated in gray area)

RESULTS AT 6 MONTHS AFTER TREATMENT

• 100% response rate with average of 26% improvement in wrinkles

(Fitzpatrick Wrinkle Scale)

• 95% of patients showed improvement in skin laxity (Alexiades scale)

• >90% of patients were satisfied or very satisfied

• Precise intradermal real-time temperature control - minimal side

effects only.

Blinded, Randomized, Quantitative Grading Comparison of

Minimally Invasive, Fractional Radiofrequency and Surgical

Face-lift to Treat Skin Laxity

Alexiades M, et al. Arch Dermatology. 2010 Apr;146(4):396-405.

STUDY DETAILS

• 15 subjects with facial skin laxity

• Single pass fractional RF (FRF) treatment

(temp. 62 to 78°C, 3-5 sec energy, impedance

300 - 2,000 Ohms)

• 5 evaluators - blinded assessment of photos

compared with 6 sets of surgical face-lifts.

Preselected target temperatures (eg, 70ºC)

are maintained for a desired duration (eg, 5

seconds); parameters are selected for optimal

collagen denaturation.

RESULTS

• Average laxity improvement was 37% of surgical face-lift

• Patient satisfaction was high

• Transient side effects with return to normal activities within 24 hours

• Surgical face-lift group experienced scarring and other side effects with

7-10 days downtime.

Elastometry and Clinical Results After Bipolar Radiofrequency

Treatment of Skin

Willey A, Kilmer S, Newman J, et al. Dermatology Surg. 2010 Jun;36(6):877-

84.

STUDY DETAILS

• 44 patients (41 females, 3 males)

• 1 Fractional RF (FRF) treatment session to thermal

zones on lower part of face

• Elasticity measurements

• Blinded physician assessment of photos.

RESULTS AT 6 MONTHS AFTER TREATMENT

• 100% of patients showed improvement in wrinkles

(Fitzpatrick Wrinkle Scale)

• 98% of patients showed improvement in skin laxity (Alexiades scale)

• 96% of patients reported ‘moderate to dramatic’ benefit

• Significant improvement in elasticity (3 months).

Treated area (in gray)

5 measurement sites (circles)

Bipolar fractional radiofrequency treatment induces

neoelastogenesis and neocollagenesis

Hantash BM, et al. Lasers Surge Med. 2009;41(1):1-9.

STUDY DETAILS

• 22 subjects treated by FRF

• Treated immediately, 2 days, 14 days, 28 days,

or 10 weeks prior to pre-scheduled abdominoplasty

• Dermal tissue temperature maintained at

72°C for 4 sec

• Wound healing response was studied.Long-term dermal remodeling and

neocollagenesis post-FRF treatment. RESULTS

• Histology showed zones of denatured collagen within the reticular

dermis with zones of spared dermis up to 28 days post-treatment

• New dermal tissue by 10 weeks

• Dermal volume, hyaluronic acid, and elastin content increased

• Vigorous wound healing + active dermal remodeling process.

2 Review Papers:

Noninvasive radio frequency for skin tightening and body contouring.

Weiss RA. Semin Cutan Med Surg. 2013 Mar;32(1):9-17.

There is a demand for noninvasive methods for skin tightening,

wrinkle reduction & body contouring.

• Fractional bipolar RF is a newer non-ablative approach

• An array of micro-needles delivers bipolar RF energy to specific

depths in tissue

• Fractionated zones of thermal damage to deep dermal collagen

• Induce wound healing, dermal remodeling and new collagen,

elastin, and hyaluronic acid formation

• Achieve desired cosmetic results for wrinkle reduction, tissue tightening, and

body contouring.

Lolis MS, Goldberg DJ. Dermatology Surg. 2012 Nov;38(11):1765-76.

Radiofrequency in cosmetic dermatology.

Pilot clinical study of a novel minimally invasive bipolar

microneedle radiofrequency device

Hantash BM, et al. Lasers Surg Med. 2009;41(2):87-95.

STUDY DETAILS

• 15 subjects

• Treated with 5 pairs of 35 W bipolar electrode tips

• Maximum power delivered at beginning and

then reduced to maintain target temperature

• Range of pulse durations (1 - 25 sec)

• Lesion temperatures between 60-80°C.Lesion size is dependent on treatment time.

Undamaged zones after 1 sec of treatment at 70°C.RESULTS

• Histology showed zones of denatured collagen within the reticular

dermis with sparing of adnexal structures and adipose tissue

• Controlled creation of zones of thermal damage in the dermis

• Varying pulse length allowed for fractional sparing of dermal tissue.

A predictive model of minimally invasive bipolar fractional

radiofrequency skin treatment

Berube D, Renton B, Hantash BM. Lasers Surg Med. 2009;41(7):473-8.

STUDY DETAILS

• Develop a model for optimal treatment parameters

• The model incorporated temperature feedback,

selectable target dermal temperatures & an

epidermal cooling plate

• Areas of thermal injury were validated with In vivo

histology. Model geometry

RESULTS

• Lesion size predicted by the model matched histology samples

• Heating confined to both ends of the electrodes

• 96% of the power was deposited in the dermis without spreading to

nearby skin layers.

Profound Histology

Fractional Lesions in Deep Dermis

NOTE: Dermal sparing between lesions

Zone of Sparing

New Dermal Tissue Created

Profound amount of new elastin and collagen observed at

10 weeks post Profound treatment

Elastin Deposition

New Collagen

Old Collagen

Full Dermal StructureOld Collagen

Mixed

New Collagen

New Hyaluronic Acid

1. New dermal volume

2. Collagen, hyaluronic acid, and

elastin content profoundly

increased

3. Unique wound healing response

BEFORE / AFTER PICTURES

PROFOUND FACE

3 months post 1 treatment

Courtesy

Suzanne Kilmer M.D., Andrea Willey, M.D.

Before

Profound Face

Before

6 months

2 years later

Before

Results still visible 2 years after

Profound treatment

Profound Face – Long Term Results

Profound Face

Before 3 months post 1 treatment

Courtesy Suzanne Kilmer M.D.

/ Andrea Willey, M.D.

Significant tightening in neck area

Better defined jaw line

Improved wrinkles

Profound Face

Before 3 months post 1 treatment

Courtesy James Newman, MDSignificant tightening in neck area

Fuller and tighter appearance

Profound Face

Profound Face

6 months post 1 treatment

Courtesy Macrene Alexiades M.D.

Before

1.67 mm

Baseline

3 Month Follow up

Calculated degree of elevation

Contour change greatest at site noted clinically

4 mm

3.5 mm

3.0 mm

2.5 mm

2.0 mm

1.5 mm

1.0 mm

0.5 mm

0 mm

-0.5 mm

-1.0 mm

Profound Volume - Treatment Results

Before Post 2 months

Profound Face

Courtesy Stephen Eubanks, MD

4 Months Post 1 Treatment

Profound Face

Before

Profound Face

Courtesy Ben Talei, MD

Before 3 Months After

Profound Face

Courtesy Ben Talei, MD

Before 6 Months After

Profound Face

Courtesy Julene Samuels, MD

Before 6 Weeks After 6 Months After

Profound Face

Courtesy Julene Samuels, MD

Before 1 Month After

Profound Neck

Courtesy Stephen Bloch, MD

Before 3 Months After

Profound Neck

Courtesy Andrew Kornstein, MD

Before 6 Months After

Profound Neck

Profound Neck

Profound Neck

Profound Neck

Profound Body

Profound Body

Profound Body

Courtesy Christine Gould, MD

Before 6 Weeks After

Dermal & Sub Q HP

Profound Body

Courtesy Andrew Kornstein, MD

Before 4 Months After Dermal HP

Physician Testimonials

Physician Testimonials

Real Patient Testimonials about Profound Treatments

Profound Diary

Day 1 Day 2

Profound Diary

Day 3 Day 4

Profound Diary

Day 5 Day 6

Profound Diary

Before/90 Days AfterCourtesy Ben Talei, MD

Profound Diary

Before/90 Days AfterCourtesy of Ben Talei, MD