Improvement in the Appearance of Cellulite Resulting from a Single Treatment with Acoustic Subcision: Findings from a Multi-Center Pivotal Trial Elizabeth L. Tanzi, M.D. FAAD Associate Clinical Professor of Dermatology George Washington University School of Medicine Washington, DC Director Capital Laser & Skin Care American Academy of Dermatology Annual Meeting 5/20/20


 
Disclosure • Allergan/Coolsculpting (SAB) • Beiersdorf • Cutera • Merz/Ulthera • Pulse Biosciences (SAB) • Sciton (SAB) • Soliton (SAB) • Solta • Syneron/Candela


 
Cellulite and Acoustic Subcision Cellulite Dimples Acoustic Subcision Smooth Epidermis Dermis Rapid Acoustic Pulses Fat cells Ruptured Fibrous septa fibrous septa Septa can contract and become sclerotic Rapid Acoustic Pulse (RAP) device emits rapid holding portions of the skin with a non- acoustic pulses (shock waves) that are transmitted flexible length of septa through the skin to rupture or “shear” the fibrotic septa (“Acoustic Subcision”) This results in areas of the skin being pulled down while adjacent sections bulge outward This causes the release of the septa resulting in resulting in dimples and ridges the smoothing of the skin dimples. Soliton has not yet received FDA pre-market clearance for the 3 cellulite indication


 
Rapid Acoustic Pulse Repetition rate and very short rise time provide microscopic mechanical disruption to the targeted cellular level structures and vacuoles High peak pressure and fast repetition rate exploit viscoelastic nature of tissue Compressed pulses from electronic filtering and reflector shape eliminate cavitation, heat and pain Physical Effects ! ECM/Fibrous Septa disruption (Acoustic subcision) ! Non-cavitation/non-thermal physical effects Biological Effects (from Mechanotransduction) ! Collagenesis Hydrophone measurements using an Onda Corporation AIMS III (Acoustic ! Angiogenesis Intensity Measurement System), using HNR-1000 Hydrophone; Z-Wave ! Lymphangiogenesis setup: Z-WavePro set to maximum output (185 mJ), using Z-Wave Handpiece 2.2 ! Inflammation inhibition "


 
Acoustic Disruption of Septa – Time/Dose Response #


 
Acoustic subcision device: Procedure ! 20-30-minute procedure can treat much of a single leg/buttock area ! Non-invasive: Real “incision-less” procedure. Skin never punctured ! No anesthetic required ! Physician oversight of delivery; delegable ! No recovery time $


 
Improvement in the Appearance of Cellulite Resulting from a Single Treatment with Acoustic Subcision Device: Findings from a Multi-Center Pivotal Trial Clinical Trial Sites Elizabeth Tanzi, MD Michael Kaminer, MD Brenda LaTowsky, MD Omer Ibrahim, MD Capital Laser & Skin Care SkinCare Physicians Clear Dermatology and Chicago Cosmetic Surgery Chevy Chase, MD 20815 Chestnut Hill, MA 02467 Aesthetics Center and Dermatology Scottsdale, AZ 85255 Chicago, IL 60654 Methods • A single arm, self-controlled, multi-center study was conducted with 62 participants to evaluate the safety and effectiveness of the acoustic subcision device for the temporary improvement of the appearance of cellulite. • After photographs (QuantifiCare), participants were treated with a single 19-33 minute RAP session comprising 1-2-minute RAP applications at each of 12-15 marked treatment sites. • Following treatment, adverse events and tolerability were recorded. 12-Week Assessment • Safety: Any adverse events • Efficacy: Photographic assessment by 3-blinded independent physicians using a 0 to 5-point validated simplified Cellulite Severity Scale (Table 1)* * Kaminer, M. S., Coleman, W. P., Weiss, R. A., Robinson, D. M., Coleman, W. P., & Hornfeld, C. (2015, March). Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite. American Soc of Derm Surg, 41(3).


 
RESULTS SUMMARY -- PARTICIPANTS !"#$%&'()!*(+&%)+#%!+' !"#$%%&' !"#$%%&'()"'(*#&)*&' ,- +$,* +$,*(*$(-$%%$./01($#(&23%0,4$")#5(3#4*&#4) . !6)%0)*&' !6)%0)*&'()*(78/.&&9, ,/ :3$0,*43(;0<34,4$"(;&,,4$" =4"0*&,(>=&)"((? ,*'(@ /012 ? ABC 34)&)3+%&5'+53' D&"'&# E&F)%& 6778 G)3& HI4*&JK)03),4)" 96198 :-#43)"(:F&#43)"JL%)39 :108 :,4)" 21/8 !*I"434*5 M$*(N4,1)"43JM$*(+)*4"$ 921.8 N4,1)"43J+)*4"$ ,1:8 :O&( =&)"((? ,*'( :217 ? CBC H&4OI*(>1$0"',@ =&)"((? ,*'( 6:91- ? 87B8 L=P =&)"((? ,*'( /:1.( ? 8BQ


 
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


 
RESULTS SUMMARY: SAFETY, TOLERABILITY AND SATISFACTION &%'";+'('"##)&LM(')N%+LO(+=;%&)$5;5+L()!*( ')+5'N)3+5=! ')N%+L !21&3*&'(:!, R(1)#*4341)"*,(((>=4"4F)%($#(F4%'( &#5*I&F)\( 9.1/8 -$%%430%4*4,\(10#10#)($#(1)4"@ ^"&21&3*&'(:!,( R(1)#*4341)"*,(( 7178 ;&#4$0,(:!, R(1)#*4341)"*,(( 7178 +=;%&)$5;5+L Z#$3&'0#&(_$%&#)<4%4*5 R(1)#*4341)"*, 901:8 W6&#)%%(1)4"(>U/7U(1)4"(,3)%&@( S0#4"O *#&)*F&"*(((>=&)"((? ,*'@ /1: ? 7BY PFF&'4)*&%5()-*&# *#&)*F&"*((>=&)"((? ,*'@ 712( ? UBQ '"$P%3+(')+5'N)3+5=! K&%%0%4*&()11&)#,(4F1#$6&'(( :O#&&()"'J$#(,*#$"O%5()O#&& 96198 M&0*#)% :108 S4,)O#&&()"'J$#(,*#$"O%5('4,)O#&& 21/8


 
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Summary • Acoustic Subcision represents a novel, non-invasive treatment to improve the appearance of cellulite • At 12-weeks, a single 20 to 30-minute acoustic subcision treatment provided a 1.16-point reduction in the CSS. On average, this represented a 32.5% reduction from the participants baseline CSS score. • The procedure is relatively painless without anesthesia and can easily delegated. • Side effects are minimal and transient; there is no down time. • Research continues into the use of acoustic subcision for cellulite as well as other aesthetic indications. 29