GOLD Lasers web - Maui Derm€¢ No recovery or down time ... • Final follow-up 12 weeks after...
Transcript of GOLD Lasers web - Maui Derm€¢ No recovery or down time ... • Final follow-up 12 weeks after...
3/18/17
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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