inmode workbook pitchbook 2015 part3 lr

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IN-DEMAND AESTHETICS IN ONE PLATFORM

NON-INVASIVE BODY CONTOURING &

CELLULITE TREATMENT

FRACTIONAL RESURFACING & REJUVENATION

FACE & BODY REMODELING

LASER HAIR REMOVAL -

ULTIMATE SPEED

IPL SKIN REJUVENATION

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TABLE OF CONTENTS

Fractora

Forma

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Diolaze

BodyFX

Print & Media

Patient Materials

2

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*Exception is Fractora with nominal consumables

New Technology, Saves Time, High Patient Satisfaction.

SCIENTIF

IC R

ESEA

RCH & DEVELO

PMENT

Fast ROI No Pulse Counters

Lunch Time Procedures

Clinically Validated

2 $4000$2000Average

Package FeeRevenue

Your Monthly Payment Recouped!

X = =

For over two decades the leaders and scientists behind InMode have been revolutionizing the medical aesthetic industry with state-of-the-art light, RF and laser solutions that essentially launched and shaped an industry. The research and development team holds over 70 patents and has a proven track record of success.

No Consumables*

Dr. Victor Rueckl was able to earn $91,125 in practice revenue from the use of just ONE of the applicators in 90 days, with no marketing expendititures. Ask to read his business case study.

I HAVE NEVER BEEN MORE PLEASED WITH THE RESULTS OF ANY OTHER TECHNOLOGY IN MY OFFICE THAN WITH FRACTORA.

FRACTORA BRIDGES THE GAP BETWEEN CO2 LASERS, FACELIFTS AND FRACTIONAL LASERS WITH THE ULTIMATE IN PATIENT RESULTS AND DOWNTIME.

FRACTIONAL RESURFACING & REJUVENATION

FRACTORATMby

Fractora delivers targeted bipolar RF energy to various depths in the skin. Fractora mimics the results of more aggressive treatments without their associated downtime, prolonged redness, and pigmentation drawbacks.

VERSATILITY BENEFITS Multiple settings mimics aggressive fractional CO2, Er: YAG, IR laser and deep (dermal/sub-dermal juncture) volumetric heating

Tips with various depths and pin density configurations Before After

Dr. G. Lask - Multiple Session Low Level Fractora

Before After

Dr. S. Mulholland - 60 mJ at 6 Months

Before After

Dr. T. Loeb - Single Treatment at 60 mJ

Before After

Dr. C. Feibleman - Single Session on Acne Scar Skin Type V

DESIGNER DERMIS Fractora achieves full-scale treatment depths with customizable fractional energy to improve superficial skin tone problems (photo damage) to deep textural concerns (rhytids and tightening). Clinicians can select between variable depths, densities and energy levels previously only obtained with multiple devices.

126 HIGH DENSITY

60

24

24 COATED

Type Strong Epidermal Impact

Mid Dermal Whole Deep Dermal

Dermal & Sub Dermal

Configuration 14x9 10x6 6x4 6x4 coated

Pin Length 600 600 3000 3000

Ablation Depth 0.6 mm 0.6 - 1 mm 3 mm 3+ mm

Heating Depth Between 3-5 mm

Max Energy 62 mJ/pin

Frequency 1MHz

Rep. Rate Up to 2 pps

SPECIFICATIONS

No pulse counter limitations or expensive tip refills

1-30 Days 31-60 Days 61-90 Days Total

Tech Total $3,575 $7,875 $3,725 $15,175

MD Total $16,750 $33,900 $25,300 $75,950

Totals $20,325 $41,775 $29,025 $91,125

$20,325

$41,775

$29,025

$91,125

$-

$20,000

$40,000

$60,000

$80,000

$100,000

MD Total Tech Total Totals

This practice case examines how Dr. F. Victor Rueckl introduced Fractora Skin Treatment to his menu of

services leading to an increase in revenue of $90,000 in 90 days.

This is especially remarkable considering most practices experience a slowing of patient traffic during spring and summer months. In addition, the state of Nevada holds the highest unemployment rate in the U.S., providing a tough economy for discretionary spending to flourish. However, the results speak for themselves and even with few marketing expenses, Fractora has been able to truly affect his offices bottom line.

PRACTICE BACKGROUND: Dr. F. Victor Rueckl, M.D. is a board certified dermatologist with a practice in Las Vegas, Nevada. He opened Lakes Dermatology in 1999 and expanded his practice with The Spa at Lakes Dermatology in 2005. He has extensive experience with IPL/FotoFacial, Skin Tightening, and other lasers. Currently his office has 7 platforms and 25 applications, plus the Invasix platform with Fractora.

FRACTORA BACKGROUND: Fractora is the most advanced fractional radio-frequency treatment providing anti-aging improvements on skin tone, texture, and wrinkles for a more radiant appearance through skin resurfacing. Fractora uses a Designer Dermis approach that allows energy to target any part of the dermis and effect specific or all layers to achieve superior results through its variable tip configurations. The added benefit of RF is the enhanced contraction compared to most other energy treatments.

Dr. Rueckl acknowledges that Fractora is light years ahead of traditional CO2 laser or Fraxel and has several advantages much shorter length of redness, much faster recovery, and no pain post treatment. Additionally, Fractora has the ability to treat the neck. According to Dr. Rueckl, With Fraxel they tried to treat the neck, but the results were just not what people wanted and the CO2 laser treatment had to stop at the jawline, leaving patients with a white face and a brown neck.

3 MONTH RETURN ON INVESTMENT: Dr. Rueckl and his staff have performed 89 Fractora cases and amassed $91,125 in revenue in 90 days. Fractora is just one of the applicators available on the Invasix platform. Other applicators include laser and/or RF applicators for skin tightening, body tightening, body contouring, photofacial IPL, and laser hair removal.

They acknowledge that their ROI could have been even greater, but they havent maximized all marketing efforts or existing patients yet. Additionally, his focus has become more tuned lately to small treatment areas like the neck, crows feet, and perioral regions. Targeting these areas is great for his patients, his time, and the bottom line.

BUSINESS CASE: PRACTICE REVENUE

Fractora Increases Revenue $90K in 90 Days

I have never been more pleased with the

results of any other technology in my office

than with Fractora. - Dr. F. Rueckl -

Fractora is only one modality of this machine, and it works beautifully for me. The results are wonderful and it makes financial sense. Based only on Fractora, in just months Ive pretty much covered the costs of the entire

machine. If you take what Ive been making in only three months and extrapolate it for a year, and then add in all the other applications and their revenues, the return on investment is astonishing.

0

5

10

15

20

25

21-30 31-40 41-50 51-60 61-70 71+

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Age Range

EXCEPTIONAL PATIENT CONSULTATION AND CONVERSION: Dr. Rueckl prefers to present the treatment in two stages. Patients are advised that if they are going to treat their full face, they should also come back one month later for a neck treatment. This allows Dr. Rueckl a second chance to review the face areas for areas that require a secondary pass or touch up. Treatment in two steps optimizes patient comfort, as most patients do not want a lengthy procedure and always want to minimize downtime.

A Fractora treatment will take between 45-120 minutes depending on whether Dr. Rueckl does the treatment (more time is required for anesthetic injections), as well as the size of the area being treated.

For patients worried about discomfort and healing, Dr. Rueckls practice encourages test procedures. The practice charges $100 for a Fractora disposable tip and performs a few pulses so patients can experience the pulse sensation. All of the "test" patients have now done full procedures.

Overall Dr. Rueckl has been impressed with the speed of treatment as well as the fast recovery time. All of his patients are without complications.

INDICATIONS FOR TREATMENT: Smokers lines, creases throughout marionette lines, fine lines on face, crows feet, laxity on the abdomen, and sun damage and laxity of the neck.

TREATMENT INFORMATION:

50 full face, 8 full face and neck or chest, 5 full face, neck and chest, 6 neck, 2 stomach, 14 small regions

17 had more than one Fractora treatment

DEMOGRAPHIC INFORMATION:

92% Female

Age Range: 22-84 years old

Average Age: 55 years old MARKETING PROMOTIONS: Dr. Rueckl has had limited marketing exposure. He has not been on TV, or placed ads. Fractoras presence is only through their own website, one press release, online exposure through social media (Facebook, Twitter, Pinterest, RealSelf), and marketing to the existing database. The majority of individuals who received treatment are existing patients. Many of these patients have already had FotoFacials and RF tightening and are offered Fractora in addition to what they have already purchased. Now, patients are starting to tell their friends and learn about the procedure by other means, and the practice has started to see their patient base grow.

Speak to your Fractora consultant to start growing your practice revenue today.

I am booking a Fractora treatment every day and were gaining more and more momentum as we are starting to have more individuals walk in off the street, mostly through word-of-mouth and internet searches. This is not a hard sell because I am very confident in the Fractora results. The pictures sell the procedure and the patients do

very well. Even with an increase in my fees, patients are still thrilled with their results.

Our practice has been waiting for a great treatment for the neck for years. With Fractora, patients are able to achieve a beautiful mini-neck

lift result, without going under the knife. We are

happy to finally provide a quality solution.

PHYSICIAN: Treatment performed in a two-step (face, then neck) process at 50-60 mJ, always includes anesthetic blocking.

$1000: perioral or periorbital

$1500-2000: neck or partial chest

$2500-3000: face

TECHNICIAN: Low-level Fractora at 15-20 mJ, with a maximum setting of 25 mJ. A cryo chiller and topical numbing cream are used to increase patient comfort.

$750: full face with expectation of 3 sessions;

$475: maintenance

TREATMENT PRICING

'Workhorse' tip leading to the regeneration of collagen and thicker

dermis.

Closely grouped dense columns of ablation.

Consistent re-epithelialization throughout the entire

epidermis and deep dermis.

Deep thermal stimulation and contraction, ideal for ethnic skin and deep

wrinkles.

Out from the Dark Ages

Traditionally CO2 lasers produced miraculous results, but with weeks of healing equal to that of a burn victim followed by prolonged redness, pain and possible hyper or hypo-pigmentation. Fractional lasers avoided many of these issues, but with limited outcomes and multiple sessions required.

FFractora bridges the gap. Fractora provides profound contraction, moderate and deep wrinkle results without the weeping and oozing, prolonged ushing and loss of pigment. In addition, areas like the neck that had previously been unaccounted for can now be safely and effectively treated. WWith Fractora, the fractional RF leaves the epidermal and dermal tissue intact between the columns of ablation to serve as a reservoir for re-epithelialization and dermal remodeling. Additionally, the RF energy heats the skin in a controlled manner that allows a multi-layered impact with volumetric bulk heating, while leaving the skins surface intact.

Positive / Negative RF electrode pins

Negative / Positiveelectrode bar

Ablation

Coagulation

Dermal heating

Ablation

Coagulation

Heating

Combined effects Re-epithelialization and Phagocytosis

Remodeling

Thicker organized dermis

dyschromia

Designer Dermis:

Fractora can deliver a customized dermal remodeling, or "Designer Dermis", by the selection of the tip depth and density that best addresses the vertical layer of the dermis. Supercial: Skin tone, texture, photo damage, ne lines Deep Dermal Remodeling: Wrinkles, scars, vascularities

24 Pin3000 microns

24 Pin - Coated3000 microns

1.855.411.2639www.inmodemd.com

126 Pin600 microns

60 Pin600 microns

Fractora:

DESIGNER DERMIS APPROACH TO FULL SCALE TREATMENT ALL IN ONE APPLICATOR

VERSATILE SKIN RESURFACING & REJUVENATION

Supercial:

Density:

Deep RF:

Yes Yes Yes No

Moderate High Low Low

Moderate No Yes Yes

10-15 mj/pin

20-30 mj/pin

40-62 mj/pin

50 mj/pin

Non Ablative

Ablative Less Coagulation(Fractional Erbium effects)

Ablative(Fractional CO2 effects)

Vessel Ablation

Contact us to discuss your skin resurfacing needs: [email protected] | www.inmodemd.com |1.855.411.2639

Dr. S. Mulholland

Dr. S. Mulholland

New energy based treatment allows patients to look 10-15 years younger.

2 Sessions

2 Sessions

Dr. T. Loeb

Dr. S. Mulholland

1 Session

Industry leading transformation of the neck after a single Fractora treatment.

Designer dermis for superficial and deep layers of the skin.

Dr. S. Mulholland

Dr. C. Feibleman1 Session

Providing a more youthful appearance, taking years off a patients age.

Improvement to deep acne scaring.

Contact us to discuss your skin resurfacing needs: [email protected] | www.inmodemd.com |1.855.411.2639

2 Sessions Dr. C. Feibleman

Before After 30 Days

Case Report: Skin Resurfacing & Rejuvenation

Fractora_TL_1tx4060

Background: 75 year old Caucasian FemaleArea Treated: Neck Treatment - Compromised Aged SkinNumber of Sessions: One Session with Two Passes

Treatment Parameters:

Pin Type Energy Pulse Count

Single Session 10 x 6, 60 Pins First pass over the entire area @ 40 mJ 200 Pulses

10 x 6, 60 Pins Second pass over problematic areas @ 60 mJ 78 Pulses

A single Fractora fractionated RF session was used to treat a 75 year old female concerned with compromised and sagging skin in the neck. Pre-treatment consisted of a local infusion field block. There was no oral or IV medication.

During treatment the Fractora pins were cleaned with a BD EZ-Scrub Ultradex surgical sponge approximately every 50 pulses, or as required, to remove excess debris that collected on the pins. Isopropyl alcohol was added to the EZ-Scrub for even better cleaning results.

The patient experienced 5-6 days of redness and is very happy with results.

Physician: Dr. Thomas Loeb, New York, USA

Area Treated: Loose, crepey skin on neck with underlying fatPatient: 64 year old femaleApplicators: Fractora 60 pinSession: Single session for 30 minutesEnergy Level: 45 mJ/pinTreatment: 5 or 6 rows done horizontally for 2 passes, not stacked. Total of 211 pulses.Pain Management: Numbing cream, then blocked with lidocaine using 2, 10cc syringes with 4 ccs of lidocaine with epinephrine injected at very shallow depth under the dermis. Physician: Dr. F. Victor Rueckl, MD


Fractora_VR_1_1tx_Neck

Before After 9 Weeks


Fractora_SM_2_1tx

Background: Caucasian Female, Skin Type IIArea Treated: Full Face - Deep Wrinkles, Fine Lines, Texture


Pin Type Energy Pain Management

Single Session 10 x 6, 60 Pins 60 - 62 mJ / pin

Subcutaneous hypodermal tumescent infiltra-tive anesthesia with a mixture of 1 bottle of 1% lidocaine mixed with 500ml of Ringers lactate

and 1ml of epinephrine 1:1000. Prior the tumes-cent hypodermal infiltrative anesthesia, nerve blocks were performed with 10cc of 1% xylo-

caine.

A single Fractora fractionated RF session was used to mimic the effects of a CO2 laser in terms of abla-tion, coagulation and residual sub necrotic thermal zones. The patient was advised to take a few days off during treatment and downtime was approximately 2 weeks with minor edema observed. Aquaphor was used after one week at home to keep the skin moist until the injury healed over. Patient as very happy with the tightening of the skin, improvement in skin texture, and overall improvement in pig-mented lesion.

Physician: Dr. S. Mulholland, Canada

Before After


Fractora_SM_1_4tx

Before After

Background: Caucasian Female, Skin Type IIArea Treated: Full Face - Deep Wrinkles, Fine Lines, TextureTime Between Sessons: 6-12 Weeks between Sessions


Pin Type Energy Pain Management

First 10 x 6, 60 Pins 25 mJ / pin Topical with Cryo CoolingSecond 10 x 6, 60 Pins 35 mJ / pin Topical with Cryo Cooling

Third 10 x 6, 60 Pins 40 mJ / pin Topical with Cryo CoolingFourth 10 x 6, 60 Pins 62 mJ / pin Lip Block

The Fractora handpiece was used in a series of treatments 6-12 weeks apart and at increasing energy levels. A more conservative parameter with increasing energy levels was used due to the patients low tolerance for pain and downtime. For lower settings pre-treatment was performed with a topical anesthesia and a cryo cooler and the highest setting was performed with a nerve block, topical anesthesia and a cryo cooler. Antibiotic ointment was applied immediately after the office based treatment. Aquaphor was used to keep the skin until the fractional injury healed over (usually at 2-5 days).

Physician: Dr. S. Mulholland, Canada


Fractora_DA_1_28

Before 3 Months After Last Treatment

Patient: 28 Year Old MaleNationality: Asian, Skin Type IVArea Treated: Full Face For Acne Scars and Skin TexturePhysician: Dr. D. Ahn, South Korea


Pin Type Energy Interval of SesssionsFirst 10 x 6, 60 Pins 30 mJ / pin First Session

Second 10 x 6, 60 Pins 35 mJ / pin 30 Days After First SessionThird 10 x 6, 60 Pins 40 mJ / pin 60 Days after First Session

Fourth 10 x 6, 60 Pins 45 mJ / pin 90 Days after First Session

It was noted that after each treatment the skin tone became lighter and more uniform, allowing for the application of higher energies at subsequent treatments. Following the Fractora treatment, edema and erythema were observed and lasted for several hours and up to a few days at higher settings. Small crusted spots appeared following treatment and were observed for 1-2 weeks after the procedure before flaking off. Treatment always was performed on fully healed epidermal skin.

Pin Type Energy Interval of Sessions

Area Treated: Full faceAreas of Concern: Bilateral cheeks, perioral areaAge of Patient: 39Applicator: FractoraPin Type: 60 pin tipEnergy Level: - 45 mJ/pin on cheeks - 50 mJ/pin on perioral areaSessions: 2 treatmentsPasses: 2 passesPain Management: Treated with topical EMLA for 30 minutes under occlusion. Nerve blocks of the supraorbital, suptratrochler, infraorbital and mental nerves were done with 1% lidocaine.Physician: Dr. A. Nelson


CaseFractora_AN_2a_2tx45mj_RS


Active Acne Treatment on 26 Year Old Female24 Pin Silicone Coated: 1 pass, double-stacked @ 20 mJ/pinPatient is very satisfied and experienced no pain during treatment. Pain was managed by numbing cream and a cryo chiller. Due to the deep 3000 micron pins and penetration of the skin, hemoglobin was present during treatment, but easily wiped away. After two months, Fractora has eliminated any existing and new cystic acne in the treatment area with no signs of hyper- pigmentation or hypopigmentation. Additional sessions are recommended to resolve pit scarring (24 pin) and overall complexion (60 pin).


Fractora_IN_Acne_1tx

Before After 2 Months Before After 2 Months

Skin Healing With Fractora 24 Pin Silicone Coated

Before During Immediately After

1 Hour 1 Day 1 Week3 Days

Age of Patient: 65 year old CaucasianGender: FemaleApplicator: FractoraSession: 1 sessionPhysician: Dr. C. Feibleman


Fractora_CF_1a_eyes


Pin Type Energy Treatment Area

Single Session Fractora

24 Pin

60 Pin

40 mJ

40 mJ

Single pass on the face with the 24 pin 3000 micron tip Two passes of the lips, chin, and lateral canthi with 60 pin and 600 micron

Before


Fractora_IN_1tx

Left Eye

Right Eye

Age: 43 years oldEthnicity: Caucasian Fitzpatrick: Skin Type IINumber of Sessions: 1Area Treated: Full Face Deep Wrinkles, Fine Lines, TexturePain Management: BLT Cream consisting of 20% Benzocaine, 8% Lidocaine, and 4% Tetracaine.


Pin Type Energy Microns to Depth Treatment Area

Single Session 10 x 6, 60 Pins

4 x 6, 24 Pins

40 mJ / pin

35 mJ / pin

600 Microns

3000 Microns

Single pass on entire face and forehead

Second pass on periorbital and cheeks

After 4 Weeks

After 4 Weeks

Area Treated: Full FaceAreas of Concern: Cheeks, chin, periocular areaAge of Patient: 59Applicator: FractoraPin Type: 60 pin tipEnergy: 30 mJ/pinSessions: 1 treatmentPasses: 2 passesPain Management: Treated with topical EMLA for 30 minutes under occlusion. Nerve blocks of the supraorbital, suptratrochler, infraorbital and mental nerves were done with 1% lidocaine.Physician: Dr. A. Nelson


CaseFractora_AN_1a_1tx30ml_F_LS_BE


Fractional Ablative Radio-Frequency Resurfacing in Asian and Caucasian Skin: A Novel Method for Deep Radiofrequency Fractional Skin Rejuvenation

R. Stephen Mulholland1*, D. H. Ahn2, Michael Kreindel3, Malcolm Paul4

1Private Plastic Surgery Practice, Toronto, Canada; 2Daeyoung Plastic Surgery Practice, Seoul, South Korea; 3Invasix Ltd., Toronto, Canada; 4Department of Surgery, Aesthetic and Plastic Institute, University of California, Irvine, California. Email: *[email protected] Received May 9th, 2012; revised June 13th, 2012; accepted June 28th, 2012

ABSTRACT This paper reports the clinical experience of a multi-center, multiple physician trial with a novel fractional radiofre-quency ablative skin resurfacing and rejuvenation device (Fractora, Invasix, Israel) deployed on both Caucasian skin types I - III and Asian skin type IV. Histological study demonstrated deep ablation and collagen restructuring in the papillary and reticular dermis. The Fractora device combines the more cone shaped ablation seen with CO2 and Er-bium lasers with a deep non-ablative heating pattern, seen with other bipolar RF fractional needle resurfacing devices. Ablation, coagulation zones and healing dynamics are analyzed for different energy settings. Two different treatment protocols are suggested: one for light skin and then one for darker skin with a higher risk of post-inflammatory hypper-pigmentation. Treatment results show improvement in skin texture, pores, wrinkles and skin dyschromia. Keywords: Skin Resurfacing; Skin Rejuvenation; Fractional Treatment

1. Introduction Since its inception in the 1990s, carbon dioxide (CO2) laser resurfacing has enjoyed the distinction of being the gold standard in the treatment of rhytides, texture con-cerns, acne scars and photo-damage skin. Numerous peer reviewed articles documenting its excellent long-term skin resurfacing results have been reported [1-8]. One of the unique characteristics of the CO2 laser is that it cre-ates almost equal degrees of ablation, coagulation and residual sub-necrotic thermal zones in the skin with vol- umes of 50 - 100 microns [3]. Although full surface CO2 laser ablation provides some highly regarded results in the treatment of wrinkles, acne scars and photo-damage, it also presents some disadvantages. These problems include a long recovery period, prolonged erythema, un-certain wound healing characteristics derived from the re-epithelialization process, post-inflammatory hyperpigmentation in darker skin types, and long-term hypopigmentation in the majority of patients [9-12].

In response to the disadvantages of ablative CO2 and Erbium YAG lasers, the era of non-ablative near-infrared wavelength lasers and radiofrequency devices arose for sub-necrotic tissue heating inducing collagen remodeling [13,14]. All of these non-ablative technologies worked

through targeting the relatively thick dermal layer of skin, sometimes in combination with external cooling, to pre-serve the epidermal skin surface from damage and create significant heating in the sub-dermal space. With the correct parameters and wavelengths, the temperature in the dermis can be very close to necrotic levels, inducing col-lagen remodeling and delivering modest results for skin tightening and wrinkle reduction. With the non-abla-tive approach to skin enhancement, multiple treatments were usually required and results were generally less dramatic than ablative therapies. Clinical data suggests that RF based devices provide stronger tightening effect [15-18], through the ability to penetrate more deeply into the sub-dermal space, while laser penetration depth is limited by the dermis.

Fractional skin resurfacing with non-ablative near infrared laser wavelengths were introduced in 2004, in an effort to deliver high non-ablative columns of energy into the dermis, creating micro-coagulation zones and collagen remodeling, but leaving a significant portion of the adjacent skin untreated to act as a healing reservoir of cells for the non-ablative micro-coagulation zones [19]. The first of the fractional devices were in the near-to mid- infrared wavelengths range including 1550 nm Erbium lasers, 1320 nm and 1440 nm wavelengths Nd: YAG la- *Corresponding author.

rjohnsonTypewritten Text

sers [19-21]. In order to produce more significant results than could

be achieved with fractional non-ablative coagulative de-vices, the ablative technologies, like CO2, used a frac-tionated approach to create ablation columns with depth up to 2 mm. These fractional ablative lasers provided the outcome advantages of ablative technique, but with improved recovery and minor risk of side effects. Fractional CO2 and other fractionally ablative wavelengths have shown excellent improvements in wrinkles, photo-aging and acne scars [22-27]. With the advent of ablative frac-tional CO2, Thulium and Erbium ablative lasers, dramatic improvement in skin discoloration, texture, wrinkles and acne scars with short downtime and low rate of side ef-fects can be achieved in a single treatment with only several days of recovery time or no downtime and multiple lower fluence treatments.

More recently, alternative ablative technology was in-troduced that fractionates radiofrequency (RF) energy for skin resurfacing. It creates a low density fractional epidermal and superficial dermal coagulation under the conductive pins and delivers RF travelling through the reticular dermis combining a low density ablative effect in the epidermis with sub-necrotic heating in deeper layers of the skin [28]. This fractional RF approach, with rela-tively low impact epidermal-junctional effect and deep dermal effect, has been coined fractional sublative resurfacing. This relatively comfortable treatment demon-strates improvement in lines, acne scars and pigmenta-tion after multiple treatment sessions. The technology compromises with treatment efficiency in comparison to deep ablative fractional lasers, but due to deeper collagen remodeling delivers consistent results after a number of non-aggressive treatment sessions and is particularly good for tissue tightening and some results in acne scar treatment.

This paper reviews the results of using a new frac-tional RF ablative technology, Fractora (Invasix Ltd.), on Caucasian skin types I - III and Asian skin type IV. Frac-tora introduces RF energy to the reticular dermis through ablative craters that reproduce the ablative effects of a fractional CO2 laser and an expanded zone of sub-necrotic dermal heating seen with the non-ablative lasers and RF devices. The Fractora combines in one treatment the histological and clinical benefits of epidermal-dermal dominant ablative cone type laser resurfacing with the pyramidal shape sublative dermal effect seen with other fractional RF systems. The combined effect of the new technology does not appear to be limited only to skin tightening, wrinkles and acne scar improvement, but ini-tial work appears to provide a synchronous fractional RF improvement in melanin pigmentation, facial telangiectasia, and active acne. The fractional RF device described

in this article may also serve to deliver ablative and reju-venative outcomes in more difficult dyschromia prone skin type IV patients.

2. Materials and Methods The Fractora hand piece used in this study is powered by the BodyTite platform (Invasix, Israel). The Fractora hand pieces come in an array of sharp RF conductive needles. Each needle is 600 long and 100 wide. There is a 60 pin tip array that provides 10% surface coverage and a 20 pin tip for the lower lid, upper lid, lip lines and vascular lesions. RF energy per pin and repetition rate is set on the interface prior to treatment. Energy per pin was varied depending on the skin type and thickness. For light skin types I - III and thick skin 50 - 62 mJ/pin was applied, while for darker skin type IV patients and thinner skin 10 - 40 mJ/pin was used.

With the Fractora electrode geometry (Figure 1), in addition to the typical cone shaped ablative injury seen with CO2, Fractora pins also acts as an array of multiple bipolar electrodes and each sends RF energy through the whole thickness of the papillary and reticular dermis, from the tip of the ablative pin effects to the side flat rail electrodes. This non-ablative, non-specific dermal matrix heating adds a very significant potential of additional skin tightening, that one does not receive with traditional laser fractional ablative treatment. The resulting double injury of this device is combination of a cone shaped superficial epdiermal-dermal ablation seen with CO2, combined with a dense woven matrix of deep dermal heating in a pyramidal distribution (Figure 1).

20 Caucasian (skin types I - II) and 30 Asian patients (skin types III - IV) with an age range of 21 - 70 years old, received a single full face, ablative fractional radiof-requency treatment using the Fractora hand piece. All patients were observed 3 and 6 months following treat-ment. For pain control some Caucasian patients treated with high parameters (40 - 60 mJ/pin) underwent subcu-

Side Electrode Electrode Pins Side Electrode

Figure 1. Schematic distribution between pins and side elec-trodes. The Fractora pins create a CO2 like injury with a zone of vaporization (ablation), zone of irreversible coagu-lation (red) and zone of non-specific thermal stimulation (purple).

taneous hypodermal tumescent infiltrative anesthesia with a mixture of 1 bottle of 1% lidocaine mixed in 500 ml of Ringers lactate and 1 ml of epinephrine 1:1000. Ap-proximately 150 cc of infiltrate was used in the hypo-dermal space of the brow, cheek and lower face and an-other 100 cc if the neck was treated. Prior the tumescent hypodermal infiltrative anesthesia, supra-orbital, infraorbital, zygomatical facial, temporal, and mental nerve blocks were performed with 10cc of 1% xylocaine. At medium settings (30 - 40 mJ/pin) nerve blocks, topical anesthesia and a Zimmer cold air cooler were used, while at low energy settings (10 - 30 mJ/pin) pretreatment was performed with a topical analgesia and a Zimmer air cooler, or no anesthesia at all.

A single pass, ablative fractional RF treatment was applied using the 60 pin Fractora hand piece. For those regions with deeper rhytides, such as the upper lips, lower lids or acne scars, a second pass was delivered for patients with lighter skin. Smaller areas such as the lower lid, upper lid and the area around the nose, was treated with the 20 pin tip.

RF energy settings used for Asian and Caucasian pa-tients differed significantly. For Caucasian patients, the energy per pin was varied depending on skin type and thickness. For light and thick skin types I - III patients, 50 - 62 mJ/pin was applied, while for darker skin type IV and thinner skin patients, 30 - 40 mJ/pin was used. In most cases a single treatment was effective enough at high energy settings to achieve the treatment objectives.

For Asian patients the energy per pin was varied in the range of 10 - 20 mJ/pin at the first treatment and was gradually increased up to 30 - 40 mJ/pin over the next 3 treatments, performed once a month intervals. It was discov- ered that after several treatments the skin tone of Skin type IV patients became lighter and more uniform, al-lowing for the application of higher energies at subse-quent treatments. For lighter skin tones and younger pa-tients, higher energy was used, while more conservative parameters were selected for darker and older patients.

Antibiotic ointment was applied immediately after the office based treatment. At home, Aquaphor was used to keep the skin moist and until the fractional injury had healed over (usually at 2 - 5 days) at which camouflage make-up could be applied. Standard Herpes Simplex pro- phylaxis consisting of 500 mg of Valtrex orally twice dai- ly for 7 days was used. Standard photographs were taken prior to the treatment and at the 6 month follow up ap- pointments. Patients were advised to take a few days off following the treatment.

Following the treatment and depending upon the pa-rameters, intense edema and erythema were observed and lasted for several hours and up to 1 week, with a minor degree of edema being observed for up to 2 weeks. Small

crusted dots, representing the ablated epidermaldermal tissue at the opening of the ablative crater, appeared the next day following the treatment and were observed up to 1 - 2 weeks after the procedure before flaking off.

Histological samples were taken immediately after treatment and at 1 week, 2 and 6 weeks post treatment to ana-lyze character of fractional lesions and the wound heal-ing process. Samples stained with hematoxylin and eosin show classic signs of fractional carbon dioxide ablative coagulated tissue (a), phagocytosis and healing (b) and collagen remodeling (c). Because different groups of patients are required for different treatment parameters, the histological study consists of 3 energy settings: 10 mJ/pin, 30 mJ/pin and 60 mJ/pin.

Histology images shown in Figure 2 presents treatment results and healing process after the Fractora fractional ablative RF treatment with energy settings of 60 mJ/pin. Histology of this treatment demonstrated a typical, strong, cone shaped epidermal-dermal dominant ablation ef-fect as shown in Figure 2(a). The ablation crater depth is about 500 - 600 in depth, going through the epidermis, the papillary dermis to the mid- and deep reticular dermis. The architecture and shape of the zone of ablation is a typical cone shaped lesion (smaller at the base), also seen with CO2 ablative lasers. The zone of coagulation measures 60 - 100 surrounding ablation crater (Figure 2(a)).

Figure 2(b) shows phagocytosis in the healing crater (zone of ablation) at 1 week follow-up. Figure 2(c) shows the treated zone structure at 6 weeks post treat-ment. The phagocytosis is mostly completed and initia-tion of new collagen formed in the healed crater and around.

At medium energy settings the ablation crater is more shallow, reaching 300 - 400 in depth (Figure 3(a)). When using lower energy the ablation crater ablative depth is approximately 200 - 250 (Figure 4(a)). Simi-larly, phagocytosis is less active when using lower en-ergy settings (Figure 3(b)) and is completed after one week when using minimal (Figure 4(b)), indicating much faster healing. Collagen remodeling is observed even at minimal energy (Figure 4(c)), but it is more su-perficial.

Highest energy histologies taken 1 week following treatment is presented in Figure 5. The histology shows the skin with multiple fractional zones and collagen contraction and remodeling in the deep dermal space between the craters, supporting the effect of RF sub-necrotic heating through the entire dermal matrix, from the RF current that flows from the ablative pins to the side rail electrodes. This pyramidal zone of sub-necrotic collagen tightening and remodeling is reflective of the sublative effects seen with other frac ional RF pin technologies t


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Figure 2. Zone treated with 60 mJ/pin immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks fol-lowing the procedure (c).

Figure 3. Histological images of a zone treated with 30 mJ/pin showing results immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks following the procedure (c).

Figure 4. Images capture of a zone treated with 10 mJ/pin immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks following the procedure (c).

[28]. Fractora is unique in that it combines the strong epidermal cone shaped ablation of carbon dioxide with the deep non-ablative tightening, or sublative effects seen with fractional RF devices that have a relatively low epidermal impact.

Treatment results and before and after photographs of each patients individual improvement were analyzed and scored using software driven photographic analogue scoring devices for the following clinical concerns: Tightening of lax skin; Improvement in wrinkles and lines; Skin texture improvement; Reduction in pore size; Improvement in pigmented lesions and skin tone; Reduction in facial telangiectasia;

Figure 5. Histology of skin treated with 60 mJ/pin at 1 week after the treatment showing collagen restructuring in the space between the two healing craters.

Acne scar improvement. From 50 patients satisfaction survey we had 1 patient

non-satisfied with treatment results, 10 patients mildly satisfied, 14 patients satisfied, 18 patients happy with results and 7 patients extremely happy.

Figure 6 shows a female patient before and 4 months after a full-face Fractora treatment. The Fractora treat-ment was delivered at 60 mJ/pin and the before and after photographs demonstrate skin tightening, peri-oral wrin-kle reduction and an overall improvement of skin quality. Figure 7 shows a Caucasian patient before and 6 months after a full-face Fractora treatment. The energy delivery was 60 mJ/pin and the treatment demonstrated a signifi-cant reduction of pigmented lesions (comparable with an IPL treatment), reduction of peri-oral lines and signifi-cant improvement of skin quality. Figure 8 shows a male patient before and immediately after Fractora treatment on vascular lesions. Figure 9 illustrates an Asian 50 years old male with skin type IV before the treatment and 3 months following the last treatment. The patient received 2 treatments with a gradual energy increase from 10 mJ/ pin at the first treatment up to 25 mJ/pin at the second treatment. Improvement of peri-orbital lines, skin texture and skin tightening was indicated 3 months following the last treatment. Figure 10 shows a 28 years old skin type IV Asian patient with acne scars before the treatment and 3 months following the last treatment. The patient re-ceived 4 treatments where energy was gradually in-creased from 30 mJ/pin up to 45 mJ/pin.

The Visia system (Canfield Inc.) and Korean analog Aramo TS skin diagnostic device (Aram Huvis Co. Ltd.) were used for quantitative analysis of treatment results.

Figure 6. Caucasian female patient before and 4 months after a single full face Fractora treatment.

Figure 7. Female patient before and 6 months after a single full face Fractora treatment.

Figure 8. Caucasian patient with vascular lesions (left) and immediate improvements after treatment (right).

Figure 9. Asian male patient with aged skin before (left) and 3 months after the treatment (right).

Figure 10. A 28-year-old Asian male before (left) and 3 months after the last treatment (right).

The results are presented in Table 1.

3. Conclusions This study confirms the efficacy and safety of a novel RF fractional ablative device. The histological results con-firm the compatibility of Fractora treatment outcomes and many of the clinical skin enhancement that are seen with fractional CO2 resurfacing. The Fractora has the additional benefits of a strong, bipolar RF non-ablative, non- coagulative dermal matrix stimulation not seen with ablative lasers. Fractora also reduces superficial and mid- dermal melanin pigmentation. We also documented a reduction of facial telangiectasia in Caucasian patients, however future studies are recommended on a higher number of patients to fully assess the vascular reduction and pa-ameters required. The review of patients 3 - 6 months r


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Table 1. Visia and Aramo TS Skin Diagnostic measured improvements in light and dark skin type patients.

Indication Average Improvement Asian Skin (skin types III - IV) Average Improvement Caucasian Skin (skin types I - II)

Texture 70% 67%

Pores 40% 22%

Wrinkles and lines 45% 63%

Acne scars 40% 40%

Pigmentation 30% 60%

following treatment confirms that the Fractora delivers significant improvements in wrinkles, laxity, brown pigmentation, skin tightening and acne scars.

The safety profile was excellent with no significant adverse events. Patients with skin type IV appear as suitable candidates for treatment using the graduated low fluence parameters set out in this paper without an exces- sive risk of post inflammatory hyper-pigmentation (PIH) or hypo-pigmentation when receiving gradual energy increase over the series of treatment sessions or accompa- nied with melanocyte suppression management regimen prior and post treatment.

Fractional ablative RF treatment with a deep needle based delivery system is a novel and unique fractional, ablative technology that provides a total skin rejuvena-tion solution:

1) Stimulates and produces the wrinkle reduction and skin tightening seen with ablative fractional CO2 resur-facing;

2) Provides additional non-ablative, bipolar dermal matrix thermal stimulation which provides additional skin tightening similar to non-ablative RF devices;

3) Improves pigmented lesions and dyschromia similar to intense pulsed light;

4) Potentially improves superficial vascular lesions (additional study with higher statistics is required to deter- mine consistency);

All patients re-epithelialized within 4 - 7 days. There were no cases or instances of delayed healing, no significant adverse reactions and specifically, no hypo-pig-mentation, PIH and no hypertrophic/hypotrophic scars.

The fractional RF multi-needle technology appears to be a suitable for facial treatment of both Caucasian and Asian patients.

REFERENCES [1] R. E. Fitzpatrick, W. D. Tope, M. P. Goldman and N. M.

Satur, Pulsed Carbon Dioxide Laser, Trichloroacetic Acid, Baker-Gordon Phenol, and Dermabrasion: A Com- parative Clinical and Histologic Study of Cutaneous Re- surfacing in a Porcine Model, Archives of Dermatology, Vol. 132, No. 4, 1996, pp. 469-471.

doi:10.1001/archderm.1996.03890280135023 [2] D. B. Apfelberg, The Ultrapulse Carbon Dioxide Laser

with Computer Generator Automatic Scanner for Facial Cosmetic Surgery and Resurfacing, Annals of Plastic Sur- gery, Vol. 36, No. 5, 1996, pp. 522-529. doi:10.1097/00000637-199605000-00015

[3] T. S. Alster, A. N. Kauvar and R. G. Geronemus, Histo- logy of High-Energy Pulsed CO2 Laser Resurfacing, Se- minars in Cutaneous Medicine and Surgery, Vol. 15, No. 3, 1996, pp. 189-193. doi:10.1016/S1085-5629(96)80010-1

[4] D. B. Apfelberg, Ultrapulse Carbon Dioxide Laser with CPG Scanner for Full-Face Resurfacing for Rhytides, Photoaging, and Acne Scars, Plastic & Reconstructive Surgery, Vol. 99, No. 7, 1997, pp. 1817-1825. doi:10.1097/00006534-199706000-00003

[5] T. X. Alster and T. B. West, Resurfacing of Atophic Fa- cial Acnes Scars with a High-Energy, Pulsed Carbon Di- oxide Laser, Dermatologic Surgery, Vol. 22, No. 2, 1996, pp. 151-154. doi:10.1016/1076-0512(95)00460-2

[6] D. B. Apfelberg, A Critical Appraosal of High-Energy Pulsed Carbon Disoxide Laser Resurfacing for Acne Scars, Annals of Plastic Surgery, Vol. 38, No. 2, 1997, pp. 95- 100. doi:10.1097/00000637-199702000-00001

[7] T. X. Alster and S. Garg, Treatment of Facial Rhytides with a High-Energy Pulsed Carbon Dioxide Laser, Plas- tic & Reconstructive Surgery, Vol. 98, No. 5, 1996, pp. 791-794doi:10.1097/00006534-199610000-00005

[8] E. V. Ross, J. R. McKinlay and R. R. Anderson, Why Does Carbon Dioxide Resurfacing Work? A Review, Ar- chives of Dermatology, Vol. 135, No. 4, 1999, pp. 444-454. doi:10.1001/archderm.135.4.444

[9] L. J. Bernstein, A. N. Kauvar, M. C. Grossman, R. F. Ge- ronemus, The Short- and Long-Term Side Effects of Car- bon Dioxide Laser Resurfacing, Dermatologic Surgery, Vol. 23, No. 7, 1997, pp. 519-525.

[10] C. A. Nanni and T. S. Alster, Complications of Carbon Dioxide Laser Resurfacing: An Evaluation of 500 Pa- tients, Dermatologic Surgery, Vol. 24, No. 3, 1998, pp. 315-320. doi:10.1016/S1076-0512(97)00510-4

[11] W. Manuskiatti, R. E. Fitzpatrick and M. P. Goldman, Long-Term Effectiveness and Side Effects of Carbon Dio- xide Laser Resurfacing for Photoaged Facial Skin, Jour- nal of the American Academy of Dermatology, Vol. 40, No. 3, 1999, pp. 401-411.

http://dx.doi.org/10.1001/archderm.1996.03890280135023http://dx.doi.org/10.1097/00000637-199605000-00015http://dx.doi.org/10.1016/S1085-5629(96)80010-1http://dx.doi.org/10.1097/00006534-199706000-00003http://dx.doi.org/10.1016/1076-0512(95)00460-2http://dx.doi.org/10.1097/00000637-199702000-00001http://dx.doi.org/10.1097/00006534-199610000-00005http://dx.doi.org/10.1001/archderm.135.4.444http://dx.doi.org/10.1016/S1076-0512(97)00510-4

IntroductIonFacial aging is a combination of in-

trinsic, hereditary and extrinsic forces. Extrinsic factors, including UV light exposure, smoking and diet, com-bined with the heretics and intrinsic aging factors results in facial defla-tion (loss of fat), descent (laxity) and deterioration (aging skin). Skin aging and deterioration is characterized by reduced and abnormal collagen, elas-tin and ground substances, together with discoloration, both in increased melanin based lesions and vascular proliferation. Anti-aging physicians have generally had to combine vari-ous lasers, intense pulsed light (IPL), infrared (IR) and radio-frequency (RF) energy systems to treat the combina-tion of these aging dermal and epider-mal elements. (Table 1). Fractional and non-fractional radio-frequency energy systems have become popular options in the treatment of skin laxity and wrinkles, but have not been gener-ally effective in treating vascular and melanin based dyschromia of the aging skin. This paper reports on the com-prehensive anti-aging effects of a novel new fractional radio-frequency device, the Fractora (Invasix, Yokneam, Israel).An analysis of the technologies

listed in Table 1 reveals the following therapeutic interventions are required for the wide array of aging effects we

see in the skin: Pigmented malformation treatment requires superficial ablation or co-agulation

Vascular lesion treatment requires coagulation of blood vessels in papil-lary and reticular dermis

Wrinkle treatment requires ablative and/or sub-necrotic heating of the reticular dermis

Skin laxity improvement requires deeper heating of the reticular der-mis and dermal-fat junction The ideal situation for the aesthetic

professional would be to have one technology with the tunable ability to address all the clinical manifestations of aging skin. The principal difference between the ablative and non-ablative RF in the novel device used in the current study, when compared with light based deep fractional ablation is that the action of RF is not limited by the ablation crater and adjacent tissue based upon a chromophore, but rather, RF current flows through the ablative lesion and the entire reticular dermis, creating the potential for additional anti-aging effects [10]. This current study describes the

results of the clinical evaluation of a novel fractional radio-frequency abla-tive and semi-ablative treatment used to treat the multiple aging pathologies of the skin.

By: Spero Theodorou, MD, PPS, New York, NY, USAR. Stephen Mulholland, MD, FRCS(C), Toronto, CanadaMichael Kreindel, PhD., Invasix Corp, Toronto, Canada

SynchronousFractionalRadio-FrequencyAblative

andNon-AblativeTreatmentforComprehensiveRejuvenation

ofAgingSkin

Materials and MethodsThe Fractora radio-frequency reju-

venation hand piece has a matrix of 600 micron sharp pins and flat side electrodes. The RF current, operating at 1Khz, flows down each positively charged pin, causing epidermal-dermal ablation in a classic CO2 cone-shaped lesion. Following the ablative effect, the RF current then flows from the tip of each pin to the negatively charged side electrodes, closing the RF cur-rent loop. Consequently, this flow of energy exposes the entire non-ablated papillary and reticular dermis to a strong non-ablative RF thermal effect. (Figure 1) This unique combination of synchronous ablative RF resurfac-ing with non-ablative RF remodeling facilitates superficial wrinkle, texture and discoloration improvements with skin tightening in the same pulse. As demonstrated in Figure 1, the

RF current (purple) is concentrated at the tip of the pins, creating the high RF power density for tissue ablation. Following divergence of RF current

toward side electrodes, there is a sub-necrotic thermal stimulation (red) in the reticular dermis and dermal-fat junc-tion, leading to a non-ablative, thermal neo-collagenasis and neo-elastosis. The ablative effects of the Fractional RF injury will provide thermal disruption of superifical brown spots, sun damage and melanin based dyschromia, while, if the tips of the Fractora applicator are purposely applied over superifical spider telangiectasia, there will be a coagula-tion of the vessels.The maximal applied RF energy per

pin was 60mJ. 30 patients, with an age range of 29 to 70, Fitzpatrick skin type I to V, and demonstrating multiple cutaneous aging signs, were treated once and observed for a period up to 6 months. Patients with skin type IV and V received a hydroquinone treatment for a period of two months prior the treatment and two months following the treatment to reduce the risk of post-inflammatory hyper-pigmentation (PIH). For pain control some Caucasian patients treated

with high parameters (40-60mJ/pin) underwent subcutaneous tumescent anesthesia with a mixture of 1 bottle of 1% lidocaine mixed in 1 liter of Ringers lactate and 2ml of epineph-rine 1:1000. Approximately 150 cc of infiltrate was used on the brow, cheek and lower face and another 100 cc if the neck was treated. Prior the tumes-cent anesthesia, supra-orbital, infra-orbital, zygomatical facial, temporal, and mental nerve blocks were per-formed with 10cc of 1% xylocaine. At medium settings (30-40mJ/pin) nerve blocks were used, while at low energy settings (10-30mJ/pin) pretreatment was performed with a topical analgesia or no anesthesia at all. Antibiotic oint-ment was applied after the treatments and the skin was kept moist with Aquaphor for 3-4 days, at which point camouflage make-up could be applied.The clinical outcomes were collected

using 3 evaluation methods: Histological evaluation of treated

skin and ablation craters. Histologi-cal samples were taken immediately

Table 1. Summary of Technologies by Application

Aging Pathology Technology Treatment Effect

Pigmented Lesions

IPL [1]Coagulation of the portion of the epidermis with higher

melanin concentration

Q-switch Lasers [5] Selective destruction of melanin

Dermabrasion Removes pigmented stratum corneum

Fractional Laser and RF [6,9,10]Fractional ablation of the epidermal and junctional

pigmented lesions

Vascular Lesions

IPL [1,2] Coagulation of superficial blood vessels

Pulsed Dye Laser [2]Coagulation of superficial blood vessels, including small

capillary vessels

Nd:YAG Laser [4] Facial telangiectasia

Wrinkles

IR Light [3] Sub-necrotic heating of the reticular dermis

IR Lasers Sub-necrotic heating of the reticular dermis

Mono-polar and Bi-polar RF [7,8]Sub-necrotic heating of the reticular dermis and the

dermal-fat junction

Fractional Laser and RF [6,9,10] Fractional ablation of the papillary dermis

Skin Laxity and Tightening

Mono-polar and Bi-polar RF [7,8]Sub-necrotic heating of the reticular dermis and the

dermal-fat junction

IR Light [3] Sub-necrotic heating of the reticular dermis

30 ANTI-AGING MEDICAL NEWS WINTER 2011

after treatment, 1 and 2 weeks post treatment to analyze the character of fractional lesions and the wound healing process. Samples were stained with hematoxylin and eosin show classic signs of fractional abla-tive coagulated tissue which include (a) phagocytosis, (b) healing and (c) collagen remodeling. Because differ-ent groups of patients are required for different treatment parameters, the histological study consisted of 3 energy settings: 10mJ/pin, 30mJ/pin and 60mJ/pin.

Evaluation of treatment results using Visio system (Canfield Inc.) before the treatment and at the fol-low up visits at 3 and 6 months.

Thermal profile monitoring on ex-vivo tissue using thermal camera FlirA320 (Trek Equipment Corp.). Heat distribution in the cross section of tissues were analyzed to correlate the thermal effect with clinical results.

Results and DiscussionThe histological analysis demon-

strated that ablation craters are varied from a depth of 250 micron for the lower fluence settings, up to 1000 microns for the highest energies. The coagulation zone around the crater measured 60-100 microns and, over time, consistent collagen remodel-ing was observed in both the ablative

craters and non-ablated thermally stimulated tissue. Figure 2a is the histology taken immediately follow-ing the treatment and shows a typical ablation crater. The ablated crater has a triangle or cone shape and the zone of irreversible coagulation is clearly observed around the crater. Figure 2b represents histology taken 1 week af-ter the treatment. Re-epithelialization was completed by 48 hours and now an inflammatory infiltrate and phago-cytosis is observed in crater region. The ablated collagen and epidermis is being replaced by a new collagen, elas-tin and ground substances. Two weeks after the treatment the acute heal-ing process is completed and a new epidermis is fully restructured and the reconstituted dermis is undergoing remodeling. (Figure 2c)Figure 3 shows collagen remodeling

occurring in the zones of non-ablative RF stimulation, between the pins and the ablative craters. This is the region of RF sub-necrotic heating in entire dermis induced by the flow of RF current from the ablative pin tips to the side electrodes. One can see that already at 1 week after the treatment visible changes in collagen, specifi-cally shortening and thickening are observed. We expected that collagen remodeling is not limited by 1 week and continues for a few months.

Cross sectional imagery of the Fractora pulse structure where heat is represented by red and radio-frequency is represented by purple. The white cone shaped regions are the zones of RF ablation.

Figure 1

Ablation crater histology taken 1 week after treat-ment showing collagen restructuring between 2 healing craters.

Figure 3

Thermal evaluation of ex-vivo tissue shows temperature increase in papillary and reticular dermis. This thermal stim-ulation is caused by the non-ablative flow of RF current from the pins to the side electrodes. The temperature in-crease is approximately 10-15 degrees Centigrade, or 46-51 degrees Centi-grade, depending on energy setting and is well within the therapeutic range required for non-ablative collagen and dermal stimulation and consequent remodeling. Figure 4 demonstrates the temperature distribution in the tissue following the RF ablative pulse. It is important to note that ablation

craters are not visible in the image. Due to the very short pulse duration, the spatial camera resolution does not al-low for the visual depiction of the abla-tion zones with a size of 100 microns. Sub-necrotic heating in the dermis

is very uniform with only a minor reduction of temperature in the center and a depth of the heating zone depth reaching of 2.7 mm. This uniform deep heating matrix of the dermal tissue allows energy to penetrates through the entire papillary and reticular dermis to the dermal-fat junction, and remodel-ing results in wrinkle reduction and skin tightening.Clinical evaluation of patients dem-

onstrated improvement in skin texture, wrinkles and fine lines, pigmented le-sions and some vascular lesions.Figures 5-7 illustrate some before

and after photos from the study.

WINTER 2011 ANTI-AGING MEDICAL NEWS 31

Ablation crater histology taken immediately (a), 1 week after (b) and 2 weeks after the treatment (c).

Figure 2

3 months, indicating a long process of collagen remodeling. There was no dif-ference in pigmentation between two follow-up visits. Only two patients in the study were presented with vascu-lar lesions and both responded with vascular reduction, however, more clinical research is required to assess the versatility treating a variety of vascular lesions. It is not uncommon for an aesthetic physician to invest in 3-4 aesthetic devices to treat myriad

The Visia system (Canfield Inc.) was used for quantitative analysis of treatment results. The results were tabulated in Table 2.

ConclusionA single full-face Fractora treatment

is able to demonstrate more than 50% improvement in an array of indications for the aging face. Wrinkle and tight-ening improvement was slightly better at the 6 month follow-up than after

Thermal image of tissue treated with Fractora: before the treatment (a), at the end of the pulse (b) and 1 sec after the pulse (c). The orange and yellow zone is the result of the non-ablative RF heating.

Figure 4

Table 2 Visia measured Improvements of the Signs of the Aging Face 6 Months after Treatment

Indication Average Improvement

Texture 65%

Wrinkles and lines 65%

Pigmentation 60%

Vascular 45%

32 ANTI-AGING MEDICAL NEWS WINTER 2011

of diverse aging skin pathologies. Frac-tora Fractional RF is a tunable device that allows for the selection of ablative and non-ablative approaches, and may provide a single, cost effective, versa-tile option to owning multiple tech-

nologies. In general, deep RF fractional treatment with Fractora was effective for most aging face signs and can be a versatile solution for medical-aesthetic practices dealing with the many com-plexities of the aging skin. u

Female patient with skin type V demonstrating multiple signs of aging skin pre-treatment (pigmentation, poor skin texture, wrinkles and lines) and 6 months after a single full face Fractora treatment.

Figure 5

Female patient before and 6 months after a single full face Fractora treatment. The patient shows dramatic improvements in peri-oral wrinkles and improvements in skin tightening.

Figure 6

Improvement in nasal telangiectasia 6 months after treatment. Vasoconstriction resulting from RF heating allows results to be seen immediately after the Fractora treatment.

Figure 7

RefeRenceS

1. Li YH, Wu Y, Chen JZ, Gao XH, Liu M, Shu CM, Dong GH, Chen HD. Application of a new intense pulsed light device in the treatment of photoa-ging skin in Asian patients. Dermatol Surg. 2008 Nov;34(11):1459-64.

2. Galeckas KJ, Collins M, Ross EV, Uebelhoer NS. Split-face treatment of facial dyschromia: pulsed dye laser with a compression handpiece versus intense pulsed light. Dermatol Surg. 2008 May;34(5):672-80.

3. Carniol PJ, Dzopa N, Fernandes N, Carniol ET, Renzi AS. Facial skin tightening with an 1100-1800 nm infrared device. J Cosmet Laser Ther. 2008 Jun;10(2):67-71.

4. Vascular lesions. Ting PT, Rao J. Curr Probl Derma-tol. 2011;42:67-80.

5. Kim S, Kang WH. Treatment of congenital nevi with the Q-switched Alexandrite laser. Eur J Dermatol. 2005 Mar-Apr;15(2):92-6.

6. Schwartz RJ, Burns AJ, Rohrich RF, Barton RE, Byrd HS. Long term assessment of CO2 facial laser re-surfacing: aesthetic results and complications. Plast Reconstr Surg. 1999;103:593-601.

7. Weiss RA, Weiss MA, Munavalli G, Beasley KL. Mono-polar radiofrequency facial tightening: a retrospective analysis of efficacy and safety in over 600 treatments. J Drugs Dermatol. 2006 Sep;5(8):707-12.

8. Yu CS, Yeung CK, Shek SY, Tse RK, Kono T, Chan HH. Combined infrared light and bipolar radiofre-quency for skin tightening in Asians. Lasers Surg Med. 2007 Jul;39(6):471-5.

9. David J. Goldberg, Alexander L. Berlin and Robert Phelps, Histologic and Ultrastructural Analysis of Melasma After Fractional Resurfacing, Lasers in Surgery and Medicine 2008;40:134138.

10. Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractio-nal radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.

Dr. Spero J. Theodorou, plastic surgeon, Manhat-tan, New York, is an expert in aesthetic plastic surgery and non-invasive laser, light and RF based cosmetic treatments. Dr. Theodorou is a member various organizations, including the American Anti-Aging Society, American Association for the Ad-vancement of Wound Care and American College of Surgeons. [email protected]. 212-517-5678 Dr. R. Stephen Mulholland is a plastic and recon-structive surgeon, certified by the Royal College of Physicians and Surgeons of Canada and by the American Board of Plastic Surgery. He cur-rently restricts and focuses his practice solely to Cosmetic Plastic Surgery. [email protected]. 416-642-1330 Dr. Michael Kreindel is the Founder and Chief Technical Officer of Invasix Ltd. Dr. Kreindel was previously involved in the development of laser, light and RF based products at Syneron Medical Ltd. And ESC/Sharplan and holds over 50 world-wide patients on medical and aesthetic devices. [email protected]. 905.707.6787

WINTER 2011 ANTI-AGING MEDICAL NEWS 33

1

FRACTORA: A NOVEL METHOD FOR DEEP RADIO-FREQUENCY FRACTIONAL RESURFACING AND TOTAL SKIN REJUVENATION

R. Stephen Mulholland, MD, FRCS(C), Michael Kreindel, Ph.D

Introduction

Carbon Dioxide laser skin resurfacing (LSR) gained great popularity in the 1990s because of impressive results seen with skin tightening, wrinkle reduction, improving skin texture and tone after a single treatment session. [1,2] One of the unique features of CO2 laser resurfacing is that it creates almost equal ablation, coagulation and residual sub-necrotic 50-100 micron thermal zones in the skin. [3] The main disadvantages of the procedure were relatively long downtimes with surface discharge followed by prolonged erythema and then long-term risks of hypopigmentation resulting from a poor reservoir of epidermal cells and melanocytes after deep skin ablation.

One of the significant advances in laser skin rejuvenation was the introduction of ablative fractional skin resurfacing [4-6], where small areas of skin, with depths in the range of 100-800 microns were treated with in a fractional fashion, leaving a proportion of the skin intact around the ablative thermal column, keeping this undamaged skin around for fast skin healing after the fractional ablative laser treatment. Over several years and multiple different lasers and wavelengths, the majority of laser manufactures have focused on Fractional CO2 resurfacing [7-8], either as a single aggressive treatment or in several more mild sessions, providing dramatic improvement in skin dyschromia, texture, wrinkles and acne scars, with relatively short downtime and a low rate of side effects that can be minimized by correct patient selection.

An alternative ablative technology is radio-frequency (RF) fractional skin resurfacing [8], which in published studies promotes more superficial ablation and is more focused on non-coagulative dermal residual heat. This relatively comfortable treatment demonstrates some level of improvement over a multiple treatment program. We believe that RF technology need not be limited by this superficial

ablative approach, but rather, it can be extended to CO2 like ablative results for effective resurfacing combined with simultaneous non-coagulative deep dermal heating.

The current study demonstrates the results with a new fractional RF ablative rejuvenation technology providing a complete single treatment solution for aging patients.

Materials and Methods

15 patients with an age range of 34-65 years old and skin type I to V received a single full face, ablative fractional radiofrequency treatment using the Fractora hand piece of the BodyTite device (Invasix Ltd.). The Fractora hand-piece comes in an array of sharp RF conductive needles. Each needle is 600 microns long and 100 microns wide. There is a 60 Pin tip that provides 10% surface coverage and a 20 Pin tip for the upper and lower lid and lip lines for localized small lesions. The 20 Pin tip is a row of 20 bipolar Pins, while the 60 Pin tip has flat rail electrodes on either side of the needle array (see figure 1). The Fractora hand-piece is powered by the Bodytite platform and RF energy per pin, pulse sequencing and repetition rate is set on the device interface prior to treatment.

All patients were observed for a minimum of 4 months following the treatment. For pain control all patients underwent subcutaneous tumescent anesthesia with a mixture of 1 bottle of 1% lidocaine mixed in 1 liter of Ringers lactate and 2ml of epinephrine 1:1000. Approximately 150 cc of infiltrate was used on the forehead, cheek and lower face and another 100 cc if the neck was treated. Prior the tumescent anesthesia, Supra-orbital, Infra-orbital, Zygomatical-facial and temporal, and mental nerve blocks were performed with 10cc of 1% xylocaine.

After waiting 8-10 minutes for the epinephrine effect, a full face, single pass, ablative fractional RF treatment was applied using the 60 Pin Fractora

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Hand-piece. For those regions with deeper rhytides, such as the upper lips, lower lids or acne scars, a second pass was delivered. Lower lid, upper lid and deeper upper lip lines received a second pass with either the 60 Pin or 20 Pin tip.

Energy is applied to the skin through the matrix of sharp pins, each having length of 600 microns. Energy per pin was varied depending on skin type and thickness. For light and thick skin 50-62mJ/pin was applied, while for darker and thinner skin 30-40 mJ/pin were used. Figure 1 schematically shows RF current distribution between pins and side electrodes.

The Fractora Pins create a typical CO2 and laser like injury with a zone of vaporization (ablation), zone of coagulation and then zone of non-specific thermal stimulation. (Figure 1)

Figure 1 - Schematic distribution between pins and side electrodes.

With the Fractora electrode geometry, in addition to the typical ablative injury seen with CO2, Fractora Pins also act as bipolar electrodes and send radiofrequency energy from the tip of the ablative Pin and injury to the electrodes on two non-pin, flat electrodes on either side of the tip. This non-ablative, non-specific dermal matrix heating adds significant additional skin tightening, that one does not receive with traditional laser fractional ablative tissue injuries.

Antibiotic ointment was applied after the treatment. and the skin kept moist with Aquaphor for 3-4 days until camouflage make-up can be applied. Standard photographs were taken prior to the treatment and at the 6-month follow appointment Patients were advised to take a few days off following the treatment. Histology was taken immediately after treatment, 1 week and 3 weeks post treatment to analyze the characteristics of the ablative lesions and

the fractional wound healing process. Samples were stained with hematoxylin and eosin showed classic signs of fractional ablative coagulated tissue, phagocytosis and collagen remodeling.

Results and Discussion

Following the treatment and depending upon the parameters, intense edema and erythema were observed and lasted for up to 1 week, with a minor degree of edema being observed for up to 2 weeks. Small crusted dots, representing the ablated epidermaldermal tissue at the opening of the ablative crater, appeared the next day following the treatment and were observed for several days to 1 week after the procedure before flaking off. Histological images shown in Figure 1 presents treatment results and healing process after the Fractora fractional ablative RF treatment with energy settings of 60mJ/pin. Histological study demonstrated a typical, strong, ablation effect as shown in figure 2a. The crater depth (zone of ablation) is on average 500-600 microns deep going through the epidermis, the papillary dermis and to the mid- and deep reticular dermis. The architecture and shape of the zone of ablation is a typical upside down pyramid (smaller at the base) also seen with CO2 lasers. One can also see the zone of coagulation measuring 60-100 microns in width surrounding the ablation crater (zone of ablation). (Figure 2a) Figure 2b shows phagocytosis in the healing crater (zone of ablation) at 1-week follow-up and the initiation of neo-collagenesis with new collagen fibers being formed. Figure 2c shows the treated zone structure 2 weeks after the treatment. The phagocytosis is almost completed and new collagen was formatted in the healed crater and the surrounding area of non-ablative heating.

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Figure 2 - Treatment zone immediately after the treatment (a), 1 week after the treatment (b) and 2 weeks following the procedure (c).

Figure 3 shows a female patient before and 6 months after a Full Face Fractora treatment, together with lower lid and orbital-malar volumization with a Hyaluronic add gel. The Fractora treatment was delivered at 60MJ/pin and the before and after photographs demonstrate skin tightening, lower lid and peri-oral wrinkle reduction, and an overall improvement of skin quality.

Figure 4 shows a skin type IV patient before and 6 months after a Full Face Fractora only treatment. The

energy delivery was 50mj/pin and the treatment demonstrated a significant reduction of pigmented lesions comparable with IPL treatment, reduction of peri-oral lines and significant improvement of skin quality.

Patients with rosacea and facial telangiectasia were treated effectively with the Fractora, which also acted as an RF coagulator in improving these facial vascular lesions. (Figure 5)

Figure 3 - Female patient before the treatment and 6 months after the single full face Fractora treatment

2a 2b 2c

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Figure 4 - Female patient before the treatment and 64 months after a single full face treatment

Figure 5 - Nasal spider vessels before and immediately after Fractora treatment

Conclusion

The histology confirms the Fractora fractional ablative RF lesion reproduces many of the same characteristic features those seen with Fractional CO2 and ablative laser resurfacing. The Fractora has the additional benefit of a strong, bipolar RF non-ablative, non-coagulative dermal matrix stimulation not seen with ablative lasers.

Fractional Ablative Radiofrequency treatment with a deep needle based delivery system is a novel and unique fractional, ablative system in that acts as a Total Skin Rejuvenation system that can:

induce wrinkle reduction and skin tightening; deliver additional non-ablative, bipolar dermal

matrix thermal stimulation which provides

additional skin tightening over and above that seen with the ablation;

improves melanin lesions and dyschromia; removes superficial vascular lesions.

Fractora is a novel skin rejuvenation fractional ablative system that combines the best of the Intense Pulsed Light, non-ablative skin tightening and fractional ablative resurfacing as it delivers reduction in hemoglobin and melanin based lesions, while significant improvement in wrinkles, texture and skin tightening .

All patients re-epithelialized within 4-7 days. There were no cases of delayed healing, no significant adverse reactions and specifically, no hypo-pigmentation, post inflammatory hyper-pigmentation (PIH) and no hypertrophic or hypotrophic scars.

With seven different devices, 25 ap-plicators and the InMode platform with Fractora from InMode (Richmond Hill, Ontario, Canada), F. Victor Rueckl, M.D. a dermatologist and owner of Lakes Dermatology & The Spa at Lakes Dermatology (Las Vegas, Nev.) has an impressive selection of anti-aging treat-ment modalities from which to choose. However, in his experience, the Fractora has provided the best results from both a clinical and financial perspective.

I have found that Fractora is superi-or especially for ablative treatments, said Dr. Rueckl. It is far superior to modalities such as CO2 or erbium la-sers, not only because the results are better, but also because the recovery is dramatically easier, he explained. There is no pain after treatment, and post treatment redness is gone within a week.

According to users, Fractora pro-vides moderate to profound ablative results up to 3,000 microns deep. Radiofrequency (RF) energy heats the skin in a controlled method to re-model deep collagen and improve the appearance of the skin. This unique treatment allows physicians to provide precise, optimal skin contraction.

Fractora is a unique and very pro-ductive piece of equipment, Dr. Rueckl emphasized. It works extremely well and it generates money. In fact, within the first three months of having Fractora in his practice, Dr. Rueckl generated $90,000 solely from the use of that single piece of equipment. My staff and I performed 89 procedures using Fractora within the first 90 days of hav-ing the system, he said. Patients love

the results, and word-of-mouth referrals are common.

Dr. Rueckl uses Fractora in two ways high energy treatments, which he performs in his clinic; and lower en-ergy treatments in the spa portion of his practice, which his staff performs. The high energy treatments are accom-panied by local anesthesia, and one or two treatments typically suffice, while lower energy treatments are performed under topical anesthesia and are usu-ally provided in a series of three. Patients who opt for the low energy spa treatments tend to have dyschro-mia or early sun damage, as opposed to tremendous wrinkling or skin laxity.

Among Fractoras capabilities is its ability to tighten skin on the neck. There really is nothing else that can safely and effectively tighten skin on the neck without surgery, Dr. Rueckl noted. Fractora can be used in ar-eas that demonstrate fine or deep wrinkles, scars or excessively discol-ored red and brown skin tone. The most common areas of treatment are the crows feet, fine lines around the mouth, smile lines, cheeks and neck. While the full face and neck are of-ten treated, it is also possible to treat smaller areas like cheeks and crows feet, where many people have local-ized wrinkling, he advised.

Remarkably, based only on Fractora, in just months Dr. Rueckl can cover the cost of the entire InMode plat-form, but Fractora is only one modality of the system, he pointed out. The results are wonderful, and it makes financial sense.

By Rochelle Nataloni, Contributing Editor

64 year old patient before Tx

64 year old patient eight weeks after one Fractora Tx session (two passes with 60 pin applicator, 211 pulses)Photos courtesy of F. Victor Rueckl, M.D.

Unique RF Device Considered Clinical and Financial Winner

F. Victor Rueckl, M.D.DermatologistOwnerLakes Dermatology & The Spa at Lakes DermatologyLas Vegas, NV

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Fractoras RF Technology Achieves Excellent Results with Less Downtime

F. Richard Noodleman, M.D.Board Certified DermatologistCampbell, CA

Jason B. Diamond, M.D., F.A.C.S.Board Certified Facial Plastic SurgeonBeverly Hills, CA

Fractora RF fractional rejuvenation by Invasix Ltd. (Yokneam, Israel) im-proves the appearance of aging skin while offering less downtime than previ-ous technologies. According to the com-pany, the Fractora achieves results that would normally require up to four differ-ent technologies. Benefits include stimu-lating collagen production, a smoother appearance of skin texture, evening of pigmented lesions and an improvement in fine lines and wrinkles.

For F. Richard Noodleman, M.D., a board certified dermatologist in Campbell, Calif. (in the Silicon Valley), Fractora is a new and very popular tech-nology. In his practice Dr. Noodleman and his staff perform about 75 proce-dures a month with this machine. Our Invasix device is being utilized all day every day, he stated.

Instead of using light or sound, like many other lasers, this technol-ogy uses heat in the form of radio-frequency (RF) in an innovative way, Dr. Noodleman explained. Depending on which of the modalities you are using, youre heating the entire skin from the epidermis down to the fat. This application of heat results in tis-sue shrinkage and tightening, which makes it fundamentally different from older technology.

Jason B. Diamond, M.D., F.A.C.S., a board certified facial plastic sur-geon in Beverly Hills Calif., prides himself on providing the most state-of-the-art treatments for his patients. He has also observed excellent and effec-tive results with Fractora.

It is one of the newest devices I have introduced to my patients, Dr. Diamond advised. This device

utilizes RF technology in a very safe and effective way.

Dr. Noodleman noted that, Fractora is resurfacing, just heated up. He also pointed out that his patients dont complain of pain like with earlier pro-cedures; they tell him it is gentler. Dr. Noodleman uses Fractora frequently for tightening along the jaw line and under the chin, but added that it is uniquely ef-fective for improving wrinkling in other areas, including the arms.

Nevertheless, Dr. Noodleman said there are other important reasons he likes the Fractora: When we do light-based resurfacing, there is often a somewhat unnatural change in the color or texture of the skin, and lines of demarcation. We dont get that with Fractora technology. Additionally, it is very friendly for darker skin types, he advised. Using a laser or intense pulsed light (IPL) procedure on Asian, southern European or Hispanic skin sometimes can worsen pigmentation indications, but this is not the case with Fractora RF.

Dr. Diamond agreed, adding, Fractora is effective in providing a non-surgical solution to people with any skin tone or type. With my varied patient popu-lation, I see a lot of darker skin tones, including Asian and Middle Eastern patients. With the Fractora, we can safely and effectively treat these skin types without ever having any side effects of hyperpigmentation. I dont have to turn away patients.

Significantly, Invasix also offers ad-ditional modalities on their device, in-cluding facial collagen skin contraction, body tightening and body contouring (invasive and non-invasive).

By Amy Di Leo, Contributing Editor

Before Tx

After Fractora TxPhotos courtesy of Jason B. Diamond, M.D., F.A.C.S.

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When first introduced, CO2 based laser resurfacing emerged as the gold standard for skin rejuvenation. However, it quickly lost its appeal due to post-procedure re-covery issues and long-term side effects particularly loss of pigment. Recently, fractionated lasers restored the popularity of skin resurfacing by offering a more pal-atable recovery and reducing pigmentary loss. Unfortunately, the trade-off included shorter-term, less dramatic outcomes.

Now, practitioners are taking advan-tage of a new dimension in treatment: Fractora radiofrequency (RF) fractional resurfacing from Invasix Ltd. (Yokneam, Israel). Allowing greater flexibility for fractional RF ablative resurfacing through interchangeable tips that vary based on configuration (60, 20 and 126 pins), depth of penetration and density, this device overcomes the limitations of CO2, Erbium and certain other fractionated lasers. Coined Designer Dermis, physicians can tailor results based on skin tone, condition and patient recovery preferences.

Fractora delivers RF energy to the skin through an array of pins, which produce localized heat and small micro-lesion points in the treatment area. In addition to the fractional ablative injury, gentle heat generated at the end of the abla-tive pulse travels to the deeper dermal layers to the negatively charged side electrodes that promote collagen restruc-turing for skin rejuvenation and an over-all improved appearance. The fractional method scattering of micro-lesions allows the skin to heal faster than if the entire area were ablated.

In essence, I think Fractora does a better job because it goes deeper and combines ablative and non-ablative RF, said Thomas Loeb, M.D., a plastic sur-geon in New York, N.Y. RF influences all of the skin underneath, not just where

the pins penetrate and heat the skin. Traditional laser fractional therapy only influences the tissue under or next to the point of ablation. The secondary heat-ing next to this point is not as well con-trolled as with Fractoras RF method.

Invasix was founded in 2008 to pro-vide safe and effective in-demand solu-tions for aesthetic procedures. Michael Kriendel, Ph.D., the companys co-found-er and chief technology officer also the co-founder of Syneron and developer of els technology has overcome the limi-tations of light by complementing it with RF. As a result, Invasixs development team has established numerous patents and applications protecting unique, ad-vanced RF technologies. Other products include BodyTite and TiteFX. BodyTite is a surgical, RF-assisted form of liposuc-tion and TiteFX is a non-invasive body contouring procedure. Both have been cleared by Health Canada and are pending FDA approval.

Fractora is considered a non-invasive skin resurfacing and restoration treat-ment that has been approved by the FDA and Health Canada. It treats a wide-range of patient conditions, including acne scarring in patients with ethnic skin. I use this technology primarily to treat wrinkles, said Dr. Loeb. However, I am impressed by its versatility, enabling it be used for a variety of indications.

One of Fractoras key mechanisms of action, also not available from frac-tional laser technology, is a stimulating effect in the deep tissues. The tightening effects are due to deep RF being deliv-ered into the skin. It seems that the RF stimulation is optimal for initiating new collagen and thereby encouraging tight-ening, said Dr. Loeb. Again, tradition-al fractional does not do this as well or with the same consistency.

Fractoras RF Technology Achieves Effective Fractional Resurfacing

By Sean McKinney, Contributing EditorThomas Loeb, M.D. Plastic SurgeonNew York, NY

75 year old female before Tx

75 year old female after one Fractora Tx sessionPhotos courtesy of Thomas Loeb, M.D.

It seems that Fractoras RF stimulation is optimal for initiating new collagen and thereby encouraging tightening. Again, traditional fractional does not do this as well or with the same consistency.

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R. Stephen Mulholland, M.D., F.R.C.S.(C)OwnerSpaMedica Infinite Vitality ClinicsToronto, Canada

When radiofrequency (RF) fractional skin resurfacing meets thermal-based RF collagen remodeling in a single ses-sion, the result is a completely new facial treatment called FracTotal by Invasix (Yokneam, Israel). By perform-ing Fractora Firm skin tightening and Fractora skin resurfacing in succession, aesthetic physicians are able to success-fully address deterioration and descent two of the three Ds (deterioration, descent and deflation) in the aging face.

R. Stephen Mulholland, M.D., F.R.C.S.(C), owner of SpaMedica Infinite Vitality Clinics (Toronto, Canada), of-fers FracTotal Facial treatments and sees very positive patient response in textural smoothing with lifting and tight-ening. As co-developer of the original FotoFacial with intense pulsed light (IPL), I was looking for something with more clinically efficacious tightening and tex-tural outcomes, which has led to the FracTotal Facial. My treatment protocol begins with 20 minutes of Fractora Firms non-ablative RF tightening, followed im-mediately by 20 minutes of Fractora RF ablation, he explained.

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