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PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

Maui+Derm2017March19- 24,2017

Lasers,Lights,RadiofrequencyandMoreFatandAcne

AcademicAppointments

§ AssistantClinicalProfessor§ DepartmentofMedicine,DivisionofDermatology,Nashville,TNUSA

§ VanderbiltUniversitySchoolofMedicine:2006- 2014§ VanderbiltUniversitySchoolofNursing:2006- Present

§ AdjunctAssistantProfessor§ MeharryMedicalCollege:2013- Present

§ SchoolofMedicine,Nashville,TNUSA

§ VisitingProfessorofDermatology§ HuashanHospital,FudanUniversity(ShanghaiMedicalUniversity),Shanghai,China:

2006- Present§ TheFirstHospitalofChinaMedicalUniversity,Shenyang,China:2008- Present§ GuangdongProvincialPeople’sHospital,Guangzhou,China:2013– Present§ ThePeople’sHospitalofHunanProvince:2016- 2019

§ VisitingProfessorofPlasticSurgery§ FirstPeople’sHospitalofFoshanUniversity,Guangdong,China:2012- Present§ TheFirstAffiliatedHospitalofZhejiangUniversity,Hangzhou,Zhejiang:2013-

Present

§ Consultanttomanypharmaceutical,cosmeceutical,laserandenergy-baseddevicecompanies

§ Consultant,performsresearchandspeaksonbehalfofnumerouspharmaceuticalandmedicaldevicecompanies

§ Forthebenefitofthispresentation:consultant,investigator,speakerforLumenis,Syneron-Candela,Aerolase,Advantix,Invasix,Allergan(Kybella),Neothetics,Zeltiq,Zimmer,andSyneron-Candela

ConflictofInterest

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

AcneVulgaris&EBDs

• Laser/Lighttechnologyforthetreatmentofacnevulgaris

• Worktypicallyforacnevia3mainpremises:

• DestructionoftheP.acnes bacteria

• Destructionoftheentiresebaceousglandandsebaceousoutput

• ?DestroyP.acnes andpartialdestructionofsebaceousglands-- ALA-PDT

AcneVulgarisALA-PDTforAcne

ExpertReviewofDermatology2006

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AcneVulgaris

• Laser/Lighttechnology

• Lasers/lightsourcestoreducetheP.acnes population

• BlueLightSources- Blu-U(Dusa)

• IntensePulsedLightDevices– Quantum/Vasculight/LumenisOne/M22(Lumenis),,Ellipse(DDD),elosPlus(Syneron),BBL/Joule(Sciton),,HarmonyXL(Alma),Lumecca(Invasix)

• VascularLasers–Cynergy(Cynosure),V-BeamPerfecta(Candela),N-Lyte(ICN),AdvaTX(Advantix)

• Short-Pulsed650usec1064nm– AerolaseNeo

AcneVulgaris

• Blu-UdeviceFDAclearedforinflammatoryacne

• UsedoriginallyforALA-PDTtherapy

• Worksformildtomoderateinflammatoryacnevulgarisaswell

• 2004AADPosterPresentation;JDrugsDermatol2004– Gold,Goldman,Rao

• Blu-Umoreeffectiveininflammatoryacnelesionsthan1%clindamycinsolution

• Safetyandefficacyproved

BLU-UBlueLightPhotodynamicTherapyIlluminatorModel4170

OpenBLU-U ClosedBLU-U

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

IPLTechnology

AcneVulgaris

• Laser/Lighttechnology

• IntensePulsedLight(IPL)technologyforacne-manysystemsexist

• Quantum,VascuLight,LumenisOne,M22byLumenis

• Othersystems– HarmonybyAlma,BBLbySciton,IsolazbySolta,ElosPlusbySyneron,Lumecca(Invasix)

• ClearTouch,SkinStationbyRadiancy

• RossV(2002ASLMS)– 50%inflammatoryacnelesionimprovement

• ElmanM,LebzelterJ.Lighttherapyinthetreatmentofacnevulgaris.DermatolSurg2004;30:130-146.

• 85%>50%improvement;15-20%non-responders

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

SoltaIsolaz

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Solta- ISOLAZInSideOutLightAmplifiedTxZone

• Multi-Application Platform• Acne therapy - iAC Therapy• Skin rejuvenation - iSR Therapy• Hair removal - iHR Therapy

• Only system to clear the pores from the dermis outward

• Only system FDA cleared to treat comedonal & pustular acne

• Proprietary iTM Technology• Accumulates 3x Energy in Deep Targets

While Keeping the Epidermis Cool• Uses iMP Multi-Pulse technology for

enhanced deep pore cleansing

PhotopneumaticTechnology:TheMechanism

•Hand piece is placed on treatment area

•Targets elevated closer to skin’s surface

•Blood concentration reduced

•Melanin concentration reduced

•Light applied to treatment area

•Targets are safely and painlessly destroyed

GoldMH,BironJ.JDrugsDermatol2008;7(2):139-145

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

AdvaTX

ADVATx DermatologicalLaser

Yellowlaser– theoptimalwavelengthTheyellowlaseristheoptimalchoiceoftherapybecauseitdepositsmoreenergyintothetargetregionpertreatmentthananyotherlaserwavelength.Atthesametime,theenergylossinthemelaninintheepidermisislowerat589nmthanat532nm.

HbO2

Melanin

Absorptio

n

Wavelength (nm)350 450 550 650 750

532

nm 589

nm

Highpowered,589nm,yellowlaser1319nm,infra-redlaser

Easy use andnodowntime

Noconsumables

Potentandefficienteliminationofacne

Effectivetreatmentforpsoriasis,scars,warts&wrinkles

Long-termreduction ofvascularconditions

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

AerolaseNeo

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LightPod Neo®

The Single Most Versatile Laser in the World. Period.

•650-microsecondtechnologyforupto255J/cm2inasinglepulseduration

•Morethan50FDAclearedmedicalaestheticindications

•Abilitytoperformanesthetic,gel&skincontactfreetreatmentonallskintypes

•Eliminatespain,burnsoradverseeffectsofthepreviousgenerationoflasers

•Nocostlyservicecontracts

AcneVulgaris

• Laser/Lighttechnology

• Laserstoreducethesebaceousglandsthemselves

• 810nmdiodelaserwithindocyaninegreen(Cynosure)

• 1450nmSmoothBeam laser(Candela-Syneron)

• 1320nmCoolTouchIII laser(CoolTouchCorp-Syneron)

• 1319nmScitonProfile laser(ScitonCorp)

AcneLaser– 1450nm

Significantreductioninacnecounts– 5.43to0.43– destructionofsebaceousglands

Smoothbeam-Candela

LaserTherapyofAcneVulgarisinAsiansPhotoderm,PhotoimmunPhotomed2009;25:3-7

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

FractorabyInvasixforAcne

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PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

FatReduction

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

KybellabyAllergan

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• KYBELLA™10 mg/mLis suppliedin2 mL,singlepatientusevials (4pack)

• Storeatroomtemperature20°Cto 25°C(68°Fto77°F)

• Excursionsarepermittedbetween59°Fto86°F

• Eachvialisforasinglepatientuse

• DonotdiluteoradmixKYBELLA™

• Discardunusedportion

KYBELLA™hasauniquehologramontheviallabel– Ifyoudonotseeahologram,donotusetheproductandcall1-844-KYTHERA(1-844-598-4372)KYBELLA™ Prescribing Information. KYTHERA Biopharmaceuticals, Inc. 2015.

IntroducingKYBELLA™(deoxycholicacid)Injection

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Please see complete KYBELLA™ (deoxycholic acid) injection Important Safety Information on slides 58 - 60.

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• KYBELLA™(deoxycholicacid)Injection

HealthyAdipocytes

Lysis of adipocytes

Submental fat

Wheninjectedintosubcutaneousfat,KYBELLA™causesthedestructionoffatcells.Oncedestroyed,thosecellscannotstoreoraccumulatefat

KYBELLA™isthefirstandonlyFDAapprovedinjectabledrugthatcontoursandimprovestheappearanceofsubmentalfullness

TreatmentwithKYBELLA™iscustomizedbythephysiciantothepatient’saestheticgoalsforanimprovedchinprofile

OncetheaestheticresponseisachievedwithKYBELLA™,retreatmentisnotexpected

ThuangtongRetal.DermatolSurg.2010;36:899-908.Dataonfile,KYTHERABiopharmaceuticals,Inc.Drugs@FDA. FDA Approved Drug Products. Available at: www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed May 21, 2015.KYBELLA™ Prescribing Information. KYTHERA Biopharmaceuticals, Inc. 2015.

Themostcommonadversereactionsareedema/swelling,hematoma/bruising,pain,numbness,erythema,andinduration

KYBELLA™ (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

The safe and effective use of KYBELLA™ for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended. Please see complete KYBELLA™ (deoxycholic acid) injection Important Safety Information on slides 58 - 60.

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

Lipo202byNeothetics LIPO-202:PotentialBest-in-ClassNon-SurgicalProcedure

• SalmeterolXinafoate• Long-actingbeta-2adrenergicreceptoragonist

• TargetPatientsAreNotObese• Maintainstableweightandlifestyle• BMI<30kg/m2

• Once-WeeklyInjectionsfor8Weeks• MeasurableresultsassoonasWeek4

• 30-gauge,½- InchNeedle• Nonumbingagentrequired• Norecoveryordowntime

• FavorableSafetyandTolerabilityProfile• Similartoplacebo

LLIIPPOO--220022AAddmmiinniissttrraattiioonn

• 20injectionsspaced4cmapart• Drugdiffuses~2cminradius

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WellUnderstood,TargetedMechanismofAction

• Triggersbody’smetabolismofstoredtriglyceridesvianaturalprocessoflipolysis• Resultinginreductioninsize/volumeoffatcellsintreatmentarea

LIPO-202shrinksfatcellswithoutkillingthem

KeyHighlights

LIPO-202Phase 3 - Ready

Known Mechanism

CompellingData

505(b)(2)Regulatory

Pathway

Phase 3 in 2015

• Mimicsendogenousprocess• Stimulationoflipolysisviaβ2-adrenergicreceptor• Nofatcelldeathorapoptosis

• ~800patientsin6clinicalstudies• Statisticallysignificantandclinicallymeaningfulreductions• Safetyequivalenttoplacebo

• ReferenceablesafetyprofileofSXasSEREVENTDISKUS® ADVAIR®

HFAandADVAIRDISKUS®

• PivotalPhase3studiestobecompletedin2015• 2concurrentstudiesintheU.S.– 800patientseach(400LIPO-202,400Placebo)

• SalmeterolXinafoate(SX)forInjectionfornon-ablative,localizedfatreductionandbodycontouringincentralabdominalbulgingduetosubcutaneousfatinnon-obesesubjects

TheEmergingmarketforLipodissolving

• Sothisfieldischangingandchangingquickly

• UseonlyFDAapprovedproducts

CoolSculptingSystemandApplicators

Thenextevolutionoftheworld’s#1non-invasivefatreductiontreatment

CryolipolysisSeminCutanMedSurg32;31-34:2013

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ZeltiqCryoLipolysisLasersSurgMed2009;41:703– 708.

ZeltiqCryoLipolysisLasersSurgMed2009;41:785– 795.

Long-termefficacyfollow-upontwocryolipolysiscasestudiesJournalofCosmeticDermatology,15,561-564

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

CoolMiniSubmentalandOtherSmallAreaIndications

CoolMiniApplicator

• Designedforsubmentalfat

• Idealforsmallerbulges

• Treatnewareasofundesirablefat

ClinicalStudies

• SubmentalArea• IDEPilot– 15subjects(2013)• MexicoFeasibilityStudy– 32Subjects(Q32014)• USPivotalStudy– 60Subjects(Q1/Q22015)

• BrianZelickson– Minneapolis• SuzanneKilmer– Sacramento• JayBurns- Dallas

• EuropeanPilotEvaluation– 150+Subjects(current)• DistalThigh(AboveKnee)

• Multi-CenteredStudy– 40Subjects(current)• BrianBiesman– Nashville• JeffreyDover/MichaelKaminer– Boston• RoyGeronemus– NewYork• LeydaBowes- Miami

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MexicoFeasibilitySubject005MRIResults

Confidential– PropertyofZELTIQForInternalUseOnly 43

Baseline 10WeeksPost1Tx

Methods

• Multi-centerstudy:Drs.Burns,Kilmer,andZelickson• Studypopulation:n=60maleandfemalesubjects• Device:CoolMinismallvolumevacuumapplicator(prototype)• 60minutecycleat-10°C• 1treatmentcyclepervisit• Upto2treatmentvisits,6weeksapart• Finalfollow-up12weeksafterfinaltreatment

ApplicatorShapes

Surface ParallelPlate Cup

• Specialpurpose

• Non-pinchablefat

• Slowheatextraction

• Generalpurpose

• Mediumheatextraction

• Generalpurpose

• Fastheatextraction

• Enhancedcomfort• Thebasisforthenew

CoolAdvantageApplicators

What’sNext?

• Let’smakeabigCoolMinifortheflanksandabdomen!• Prototype machinedmetalinsertmodifiedastandardparallelplateCoolCoreintoacooled,contouredcupapplicator

CoolAdvantageFamily

3–in–1Design• Threedifferentcontours

SingleApplicatorReplacesThreeApplicators• CoolCore• CoolCurve+• CoolFit

IntroducingtheCoolAdvantageFamilyofApplicators

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IntroducingtheCoolAdvantageApplicatorSeries

• Contouredcupcoolingsurface• Shortertreatmenttimes• Greatercomfort• Betterpatientexperience

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ItStartswith…YearsofResearch

ImprovedComfort

Greater Comfort• New cup design• Lower suction pressure for

gentler tissue draw

ItStartswith…YearsofResearch

FasterTreatmentTime

ColderTemperatures ShorterTime

Almosthalfthetime!

(35minutetreatmenttime)

BetterPatientExperience

EvendistributionofcoldGreaterversatilityMoretissueisincontactwiththecoldsurface

ItStartswith…YearsofResearch

StudyObjective

• Contouredcup,medium-sizedapplicatorwasdevelopedtocooltissuemoreefficiently

• increasetissuecontact• reducevacuumpressure• reducetreatmenttime

• EvaluateprototypeCoolAdvantagevs.standardCoolCoreapplicatorforsafety,efficacy,andpatientpreference

Methods

• Studypopulation:n=19maleandfemalesubjects• Randomizedleft/rightflanktreatmentstocompareapplicators• CoolCoreapplicatorvs.CoolAdvantage(prototype)

• CoolCore60minutesat-10°C• CoolAdvantage35minutesat-11°C

• 1treatmentcycle• Finalfollow-up12weekspost-treatment

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EquivalentEfficacy,ReducedPain,GreaterPatientPreference

• EquivalentEfficacy:Bilateralflanktreatmentsshowedsimilarefficacyby

• Ultrasoundfatlayerreductionmeasurements• Independentphotoreviewby3blindedphysicianevaluators

• 45%reducedprocedurediscomfortcomparedtostandardCoolCore

• 85%preferredCoolAdvantageinpatientsurveys

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PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

BeyondSubmentalFat

ZWavebyZimmer

RadialPulsedTherapy

The Handpiece & Software

ZimmerZ-WaveShockWaveTechnology

MajorUseinUS:AccelerationofRecuperation,DiminishedPain,QuickerRecoveryandImprovementofFatReduction

• CoolSculpt• Vanquish• Liposonix• Thermi• Liposuction

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

UltraShapeandthenewUltraShapePower

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UltraShapePower

Small U-Sculpt Transducer

(12gr)

New configuration with small transducer

WhyUSculpt Only?

• BestclinicaloutcomeeverarchivedwithUltraShapetechnologysofar(evenwhencomparingtomulti-focus)

• Betteruserexperience:• Lighter• Easiertomoveandmaneuveroncurvyareas

• Minimalimpactontreatmenttime

Small U-Sculpt Transducer

(12gr)

UserInterface&Usability

UserInterface&Usability

UserInterface&Usability

ProvenOutcomesThroughClinicalPublications

• 20+ClinicalPublishedStudiesandAbstractsPresented

• Over900StudySubjects

• 220,000+PatientTreatmentsperformedworldwide

• StudyFindingsConclude— HighSafetyProfile— Resultsvisibleasearlyas2weeksposttreatment— MRIimagesshowreductioninfatlayer

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UltraShapeClinicalStudiesAbdomen,FlanksandThighs

Investigator YearPatient

Population

Average Circumference

Reduction ResultsTeitelbaum S. et al 1

US, UK, Japan2004-05 164 2.0 cm

(Single Treatment) 82% > 0.5 cm circumference reduction

Leal H. 2,3

Monterrey, Mexico2009 24 3.0-3.4 cm

(1 combo therapy Tx) 96% > 1.5 cm circumference reduction _100% patient satisfaction

Moreno-Moraga J 1

Madrid, Spain2006 30 3.95 cm 100% measurable and visual improvement

Ascher B. 1

Paris, France2007-08 25 3.58 cm 83% > 1.0 cm circumference reduction

Leal-Silva H. 2,3

Monterrey, Mexico2007-08 36 5.0 cm 100% measureable reduction

_94% patient satisfactionAd El D. 2,3

Beilinson Med, Israel2008 26 3.96 cm 90% > 2.0 cm circumference reduction

Mulholland S. 2

Toronto, Canada2008 21 3.48 cm 86% patient satisfaction

Inglefield C. 2

London, UK2005-06 148 6.3 cm 93% patient satisfaction

de Almeida G. 2

Sao Paulo, Brazil2007-08 20 5.4 cm 100% measurable reduction

_86% patient satisfactionBenchetrit A. 2

Montreal, Canada 2007-09 109 4.5 cm 96% measurable reduction

_86% patient satisfaction

1Published in peer-reviewed journal 2Presented in scientific conference 3Data on file

UltraShapeClinicalStudiesSummary

• Over600 patientsstudiedinclinicalstudies

• 3treatmentregimen

• Averagecircumferencereductionrangesfrom3.5to6.3cm

• Averageresponseraterangedfrom83%to100%

• Averagepatientsatisfactionrate86%to94%

Note: with UltraShape fat cell destruction is immediate and permanent

UltraShapeFlankStudyUSA– Dr.GoldJuly2016

SyneronCandelaProprietary- Confidential

ClinicalStudytoEvaluatethePerformanceoftheUltraShapeDeviceforFatReductionTreatmentintheFlankAreavs.Control

SyneronCandelaProprietary- Confidential

Methods• Multi-center study at 3 sites in the USA• 3 non-thermal, focused ultrasound treatments with small transducer (Usculpt)

at 2-week intervals to one randomized flank (contralateral flank served as untreated control)

• Measurements:• Fat thickness by ultrasound measurements• Fat thickness by skin caliper• Weight change

• Follow-up at 4 -, 8 -, and 16 weeks after the last treatment

ClinicalStudytoEvaluatethePerformanceoftheUltraShapeDeviceforFatReductionTreatmentintheFlankAreavs.Control

SyneronCandelaProprietary- Confidential

Results at Single Site (Dr. Gold)• 22 subjects (21 females) enrolled and received at least 1 treatment• Skin Type II-V• Age range: 21-60 years (Mean ± SD; 41.7±10.8)• BMI range: 22-29 (Mean ± SD; 24.7±1.9)• Weight range: 55-84 kg (Mean ± SD; 66.2±7.7)

Treatments• 63 treatment sessions (20 subjects had 3 txs, 1 subjects had 2 txs, 1 subject had 1 tx)• Mean treatment duration of 11±6 min • Mean focal treatment zones (FTZ): 2.0±0.6 • Mean discomfort with treatment: 0.2±0.6 (Scale of 0=no pain to 10)• Mild erythema post-treatments (17% of treatments)• Mild edema post-treatments (1.6% of treatments)• No adverse events

ClinicalStudytoEvaluatethePerformanceoftheUltraShapeDeviceforFatReductionTreatmentintheFlankAreavs.Control

SyneronCandelaProprietary- Confidential

Results at Single Site (Dr. Gold)• Weight increase of 1.3% at the 8-week follow-up and 1.9% at the 16-week visit • Significant fat reduction in ultrasound measurements of treated flanks• Difference of 23.4% fat reduction between the treated and control flanks at 16 weeks• Difference of 2.1mm fat reduction between the treated and control flanks at 16 weeks

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Clinicalstudy

• ClinicalStudyDesign• ClinicalOutcome• Before&Afters

ASingle-Center,ControlledStudytoAssesstheEffectivenessandSafetyoftheUltraShapePowerSystemfor

AbdominalNon-InvasiveCircumferenceReduction

StudySiteIn-house clinic – Dr. Ruthie Amir

Study Design • 43 subjects enrolled (41 female, 2 male; Fitzpatrick Skin Types I-V;

mean age 48±8 years, range 30-65 years) with mean baseline weight = 73±14 kg and body mass index (BMI) 27.36±4.21, range 20.64-38.06

• 3 biweekly treatments to the abdomen with a single pass, using the 12 gram transducer (660W/cm2)

• 6 biweekly assessments at 2-12 weeks after the 3rd treatment

Measurements • Fat thickness by ultrasound imaging• Abdominal circumference measurements • Caliper fat thickness • Weight • Patient comfort & satisfaction

ASingle-Center,ControlledStudytoAssesstheEffectivenessandSafetyoftheUltraShapePowerSystem

for AbdominalNon-InvasiveCircumferenceReduction

Resultsatfollow-up• Allsubjects(n=43)completedall3treatments• Significantfatlayerreduction(mean32.3%)onultrasoundimaging(at12wkFU)• Significantcircumferencereduction(midlinemean2.62cmat12wkFU)• 80%ofclinicalstudypatientsreportedanimprovementalready2weeksafterthetreatmentphase

• Meanreportedpainlevelof0.68onascaleof0-10• Noadverseevents

ClinicalTrialResultsShowed:

Treatments were accompanied with none to minimal discomfort (mean 0.68 on 0-10 scale)

2.62cm average abdominal circumference reduction after 3 sessions

32% average fat layer reduction after 3 sessions

No safety issues

3.26cm average abdominal circumference reduction in patients with BMI>28

PatientSatisfaction

• 100%ofclinicalstudypatientsreportedtheyfeltcomfortableduringtreatment

• Nodowntimeorvisiblesignsoftreatment,unlikeotherfatdestructionmethods.

• Themostpainlesstreatment– Averagereportedpainlevelof0.68onascaleof0-10.

• 80%ofclinicalstudypatientsreportedanimprovementalready2weeksafterthetreatmentphase

• Customizableforeachpatient- Theonlyfatdestructionprocedurethatcanbeadjustedtoindividualbodyareasandshape,includingBMI>28.

• Patientproven– Morethan350,000treatmentsworldwide

FatLayerMeasurementExample

Photos courtesy of Ruthie Amir, M.D.

Δ US reduction: -26%

Before Post Tx

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FatLayerMeasurementExample

Before 6 wk FU after 3rd tx

Δ US reduction: -27.2%

6.71m9.2mm 6.71m6.7mm

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

BodyFX&MiniFXbyInvasix

BodyFx

• ONLYnon-invasivebodycontouringdeviceproveninpeerreviewedandpublishedhumanstudiestobothpermanentlykilladiposetissueANDtightenskin.

• LSMFebruary2014• Lask,Nelson,Divarisetel• 30%adiposecellsAPAF-1at2.5cmdepth• 13.7%newcollagen

BODYFX&MINIFX

PresentedbyMichaelH.Gold,MDGoldSkinCareCenter,TennesseeClinicalResearchCenterNashville,TNUSA

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TheBodyFxMechanism

• HowdoesiteffecttheAdipocyte?

• RF#1=BasicRF• Heatsadiposetissue• Increasemetabolicrate• LOWERSIREthreshold• Makeelectroporationeasier• LIKEELOSconcept

• RF#2=HVP• Electroporation• IRE• Apoptosis

AClinicalandBiologicalEvaluationofaNovel,Non-invasiveRadiofrequencyDevicefortheLong-TermReductionofAdiposeTissue

Authors:SylvieBoisnic- MD,MarcDivaris- MD,AndrewA.Nelson- MD,NimaM.Gharavi- MD,PhDandGaryP.Lask-MD

Viewfullarticlehere:http://inmodemd.com/wp-content/uploads/2014/02/PeerRev_JCEDR_TiteFX.pdf

Clinical&ExperimentalDermatologyResearch

Objective:Anovel,non-invasivetechnology,utilizingsuction-coupledradiofrequency(RF)heatingandultra-shortpulseduration,high-voltageelectricalpulseswasstudiedforitsefficacyandsafetyonadiposetissuereduction.

Method:21subjectsunderwenttreatmentoftheirabdominalfatonceweeklyfor6weeks.BiopsiesfromtheRF-treatedanduntreatedsideswereharvestedduringabdominoplastyandcultured;measurementsofadipocytesizeandshape,rateofapoptosis,collagenproduction,anddermalthicknessweredetermined.

Results:Significantclinicalimprovements(P < 0.05)wereobservedforthereductionofabdominalcircumference(113.4–110.7 cm).Withintheadiposetissueofthetreatedareas,increasedlevelsofadipocyteapoptosiswereobservedimmediatelyfollowingthetreatmentseries,withapproximately20%ofalladipocytecellsstainingpositiveforAPAF-1,avalidatedmarkerofapoptosis.Atday14ofculture,fatcellapoptosishadfurtherincreased(30%ofadipocytesstainingpositiveforAPAF-1)withintheRF-treatedadiposetissue.Additionally,asignificantincreaseincollagensynthesis(neocollagenesis)representinganaverageincreaseof13.7%wasobservedaftertreatmentbytheRFdevice,withameancollagenlevelof57.6mg/mginthetreatedzoneversus49.7mg/mginthenon-treatedzone,asdeterminedbytheSpectrocolorimetricmethod.

PeerReviewedJournal

FaceTite/BodyTite

• Deliversurgicalresultstopatientswithoutthescalpelorscars.

• Mini-facelift,neck-lift,brachioplastylikeresultsusingRFALaccessedthrough16gaugeneedleentryport.

• Significantlytightenabdominalarea,flanks,bra-line,innerthighandotherareaswithunheraldedoutcomes.

• ImprovesurgicaloutcomeswithRFALforamorecompleteandnaturallookinexcisionalprocedures

InModeRFALIntendedUse

• InModeRFALstandsforRF AssistedLipolysisbycoagulationofsofttissue.FDAapprovalwasbasedonfatcoagulationdatasubmittedbythecompany.Devicecanbemarketedforanyprocedurewheretreatmentoutcomeisaresultofsofttissuecoagulation.

• By-productofsubcutaneousfatcoagulationisheatingoffibrousseptaandpapillarydermissurroundingfatclustersupto70oCprovidingsignificantcollagencontraction.

RFALTechnology:DirectionalThermalProfile

BodyTiteFaceTite

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UniformSkinTemperature TissueElectricalProperties

Tissue Conductivity,S/m@1MHz

Conductivity,S/m@460KHz

Skin 0.221 0.175Fat 0.025 0.025Muscle 0.503 0.443Blood 0.822 0.745

Clinicalresults Plastic&ReconstructiveSurgery

RFALislegitimizedasastandardliposuctionoption,withagoodsafetyrecordandupto47percentcontraction.

Withincreasedfocusonone’saestheticappearance,liposuctionhasbecomethemostpopularcosmeticprocedureintheworldsinceitsintroductioninthe1980s.Forthepresentarticle,asystematicreviewoftherelevantliteratureregardingpatientworkup,tumescentfluidtechniques,medicationoverview,andoperativetechniquewasconductedwithapracticalapproachthatthereaderwillpossiblyandclinicallyapplicable.Recenttrendsregardingenergy-assistedliposuctionandbodycontouringlocalanesthesiauseareaddressed.Deepvenousthromboembolismprophylaxisismentioned,asareothercommonandlesscommonpossiblecomplications.Thearticleprovidesaliterature-supportedoverviewonliposuctiontechniqueswithanemphasisonpreoperativeassessment,medicinesused,operativetechnique,andoutcomes.

Evidence-BasedMedicine:LiposuctionArticleType:MaintenanceofCertification(MOC)– CME

Authors:ChristopherT.Chia,MDRyanM.Neinstein,MDSperoJ.Theodorou,MD

PeerReviewedJournal

Viewfullarticlehere:http://www.invasix.com/upload/ARTICLES/PeerReviewed_APS_3DTightening.pdf

AestheticSurgeryJournal

Objectives: Theauthorinvestigatesthedegreeofskincontractionresultingfromtreatmentwithradiofrequency-assistedliposuction(RFAL)andattemptstodeterminewhether,afterlong-termfollow-up,theclassificationofupperarmdeformitiesandtheircorrespondingtreatmentprotocolscanberefinedtoofferpatientswithprominentskinlaxityanalternativetotraditionalbrachioplasty.

Results: OneyearaftertreatmentwithRFAL,themeansurfaceareareductioninthevolarupperarmregionwas33.5%bilaterally.Themeandegreeofpendulousvertical“hang”shorteningwas50%bilaterally.StatisticalanalysisshowedaPvalueof>.001forbothmeasurements.

Conclusion:TreatmentwithRFALachievedstatisticallysignificantskincontractionintheupperarmregion.Patientsincategories2band4weresuccessfullytreatedwithRFALinsteadoftraditionalbrachioplasty(whichisrecommendedbythecurrentclassificationsystem).Category3patients,however,didrequireashort-scarbrachioplastyproceduretoobtainsatisfactoryresults.

ImprovingOutcomesinUpperArmLiposuction:AddingRadiofrequency-AssistedLiposuctiontoInduceSkinContraction

Authors:Dr.DianeDuncan

Viewfullarticlehere:http://inmodemd.com/wp-content/uploads/2016/08/peerrev_asj_rfalarms_dd1.pdf

PeerReviewedJournal

AestheticPlasticSurgery

Excerpt:“Linearcontractionobservedat3monthsfollow-upweremuchmoresignificantthanreportedwithanyothertechnologyandvariedfrom12.7%upto47%dependingonpatientandtreatmentvariables.”Abstract:Theuseofradiofrequencyenergytoproducecollagenmatrixcontractionispresented.Controllingthedepthofenergydelivery,thepowerapplied,thetargetskintemperature,andthedurationofapplicationofenergyatvarioussofttissuelevelsproducessofttissuecontraction,whichismeasurable.Thistechnologyallowsprecisesofttissuemodellingatmultiplelevelstoenhancetheresultachieved.Conclusion: ThemechanismofsubcutaneouscollagencontractionduringRF-assistedliposuctionissimilartothatwitnessedinothertypesofcollagen,inthatthecontractionprocesshasthermalcontractionthresholdsintherangeof60–70°C.ThisRFALthermalprocessandcontractioncanbeeffectivelyappliedduringaliposuctiontreatmentinselectedcases,improvingpatientsatisfactionandextendingliposuctionprocedurestohigher-weightpatientsandpatientswithcompromisedskinconditions.

ThreeDimensionalRadiofrequencyTissueTightening:AProposedMechanismandApplicationsforBodyContouring

Authors:M.Paul,G.Blugerman,M.Kreindel,S.MulhollandViewfullarticlehere:http://www.invasix.com/upload/ARTICLES/PeerReviewed_APS_3DTightening.pdf

PeerReviewedJournal

3/18/17

17

Plastic&ReconstructiveSurgery

Background: Thepurposeofthisstudyistoreportourexperienceusingradio-frequency-assistedliposuction(RFAL)forneckandfacecontouring.Methods: FromNovember2009toNovember2013,55patientswhounderwentRFALtreatmentwereenrolledinthestudy.Postoperativepatientsatisfactionsurveyswereconducted,and2independentplasticsurgeonsevaluatedcontourandskinqualitywithrandomizedpreoperativeandpostoperativephotographsat6monthspostoperatively.Ourlongestfollow-upwas4years.Results: Allpatientswerefollowedupforaminimumof6months.Eighty-fivepercentofpatientsweresatisfiedwiththeircontouringresultanddegreeofskintightening(48/55patients).Twoindependentplasticsurgeonsconsideredtheimprovementincontouringanddegreeofskintighteninggoodtoexcellentin52of55cases.Conclusion: Inappropriatelyselectedpatients,RFALneckandfacecontouringrepresentasafeproceduretoachievesignificantimprovementoftheskinlaxityandfatdepositsofthecervicomentalzoneandjowls.

Radiofrequency-assistedLiposuctionforNeckandLowerFaceAdipodermalRemodelingandContouring

Authors:EvangelosKeramidas,MD,StavroulaRodopoulou,MDViewfullarticlehere:http://www.invasix.com/upload/Downloads/file_47.pdf

PeerReviewedJournal

Lasers,Lights,RadiofrequencyandMore

• WehavenovelEBDsthatworkwellforthetreatmentofacnevulgarisandweneedtoconsiderusingthemforourpatients

• Wehavegreattechnologyforfatreduction==withincreasingsafetyandefficacyforourpatients

• ThisisanexcitingtimeforEBDsinourworld