Avita Corporate Presentation January 2017...

CorporatePresentation

January2017

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Disclaimer– ForwardLookingStatements

Thispresentationmayincludeforward-lookingstatements.Youcanidentifythesestatementsbythefactthattheyusewordssuchas“anticipate”,“estimate”,“expect”,“project”,“intend”,“plan”,“believe”,“target”,“may”,“assume”orsimilarexpressions.

Theseforwardlookingstatementsspeakonlyasatthedateofthispresentationandarebasedonmanagement’sexpectationsandbeliefsconcerningfutureevents.Forward-lookingstatementsarenecessarilysubjecttorisks,uncertaintiesandotherfactors,manyofwhichareoutsidethecontrolofAvitaMedicalthatcouldcauseactualresultstodiffermateriallyfromsuchstatements.

AvitaMedicalmakesnoundertakingtosubsequentlyupdateorrevisetheforward-lookingstatementsmadeinthisreleasetoreflecteventsorcircumstancesafterthedateofthisrelease.

Thispresentationisintendedtoprovidebackgroundinformationonlyanddoesnotconstituteorformpartofanofferofsecuritiesorasolicitationorinvitationtobuyorapplyforsecurities,normayitoranypartofitformthebasisof,orbereliedoninanyconnectionwithanycontractorcommitmentwhatsoever.



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OurSevenPointPlantoCreateValue

RegenerativeMedicinepioneerwithestablishedclinicaloutcomespoisedtoentertheUSmarket

Safe,simpleeffectivedevicealreadyvalidatedinhigh-valuewoundanddermatologymarkets

Robustclinicaldataandsubstantiallyde-riskedFDAapprovalprocess(PMAapprovalQ4’17/Q1‘18)

StrongIPpairedwithahighgrossmargin,single-usedevicebusinessmodel

RevampedBoardandManagementTeamwithtrackrecordofsuccess

Multiplenear-termmilestones:USmarketentrysupportedbyUSfederalfunding

Usingconservativepricingmodels,weprojectabaselinerevenueopportunityof$150M+infiveyears

2017 is a Pivotal Year for Avita

1

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4

3

5

6

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Market Opportunity



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SubstantialOpportunityTreatingComplexWoundsSelectedIndicationse.g.,excludesplasticandmaxillofacialsurgeries

Prevalence /Incidence (Patients)Percent

ApplicableMarketSize(assume1device

perpatient)US

pop.316M(11.4%diabetes1)

UK,FR, DE,ITpop.271M

(8%diabetes,avg1)

Auspop.23M

(5.1%diabetes1)

Chinapop.1.4B

(9.3%diabetes1)

ChronicUlcersprevalence

DFU2 9.0M 5.5M 0.3M 31.6M 20– 40% 9 – 19M

VLU3 3.2M 2.7M 0.2M 13.6M 60– 65% 12– 13M

Burnsannual admissions

40K4 42K5 8.6K6 3.4M7 90% 3.1M

Aestheticsannual procedures8 1.7M 585K 117K 157K 90% 2.3M

Vitiligoprevalence0.1%to2%ofpop.9 316K 271K 23K 1.4M 30% 0.6M

TOTAL* 14.3M 9.1M 0.7M 50.1M 35%-50% ~27-38M1InternationalDiabetesFederation(IDF)DiabetesAtlas,SixthEdition(2014)2[Lifetimeincidence:25%ofdiabetics]Singhetal."Preventingfootulcersinpatientswithdiabetes." JAMA 293,no.2(2005):217.3[Prevalence:1%ofpop.]Humphreysetal."Managementofmixedarterialandvenouslegulcers.“Br.J.Surg.94,no.9(2007):1104.4 AmericanBurnAssociation2013FactSheet(www.ameriburn.org)5Brusselaersetal."SevereburninjuryinEurope:asystematicreviewoftheincidence,etiology,morbidity,andmortality."CritCare14(5)(2010):R188.6 Australianhospitalstatistics.AustralianInstituteofHealthandWelfare.(2012)7 PeckMD.Epidemiologyofburninjuriesgloballywww.uptodate.com8 ISAPS2013InternationalSurveyonAesthetic/CosmeticProceduresPerformed(dermabrasion,resurfacing,facialrejuvenation)9 AlkhateebA,FainPR,ThodyA,BennettDC,SpritzRA."EpidemiologyofvitiligoandassociatedautoimmunediseasesinCaucasian probandsandtheirfamilies." PigmentCellResearch 16,no.3(2003):208-214.

Significant Unmet Need in Key Approved Territories



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TheBurnProblem– ExpensiveOptions&PoorOutcomes

o Burnsvaryinsizeanddepthandtreatmentishighlyindividualizedo Managementofburninjuriesinvolvesachallengingtrade-offbetweentimeto

woundclosureversususeofskinautograftsharvestedfromthepatiento Autograft(usingthepatient’sownskin)hasbeenthestandardsince1964

o Requirespainfulharvestingandresultsinasecondwoundsiteo Healthyautograftisoftennotavailableforlargeburns,orifthepatientisachildo “Meshing”allowsgrafttostretchtocoverlargerareasbutresultsinpooraestheticoutcomeso Waitingcanresultinusingasmallergraft,butscarringisincreased

o Thecostburdenofsevereburnsonthehealthcaresystemissignificanto Estimatesforper-patienthospitalchargesrangefrom$27,000to$156,000forburns

affectinglessthan30%ofTotalBodySurfaceAreao Costscanexceed$500,000formoresignificantburns

A Different Approach is Needed



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Our Breakthrough Approach



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AUniqueSkinRegenerationPlatform

o 7000+usestodateinmultipleworldmarketsandnosafetysignalsobserved

o Single-usedisposable‘labinabox’;battery-poweredandambient-storable

o AnAutologousCellHarvestingDevicethatdeploysaproprietaryenzymeformulationandprocessingunit,andvalidatedapplicators

o Processisstraightforwardtolearn,andtakes30minutestoperform

o Designedbysurgeonsforsurgicaluse:anelegantmeanstoaddressthecomplexitiesofepithelialclosure

o 1sq.cmofskindelivers80sq.cmofwoundcoverage,drasticallysparingskinharvestingrequirementsrelativetoautografting

Fast, Simple, Safe, Effective

AcuteWoundsRepairwithlessdonorskin

ChronicWoundsRestarthealing

AestheticsRestorepigmentation

DeviceHighlights1. Easytolearn2. 30minstocreateRES™3. Treatmentareais80x

donorarea



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RES™inSkinRegeneration

o Autologoussamplesderivedfromhealthyareasoftheskincontainacompletemixofallskincells (non-cultured)andfactorstocatalysethehealingprocess

o Cellsinsuspensionarenolongercontact-inhibitedbyneighbouringcells(unlikeintacttissue)andundergophenotypicchangestopromoteclosure(free-edgeeffect)

o ApplicationofRESovercomestheusuallimitedavailabilityofhealthy,signallingcells

Trim&Quick.2015JWoundTech27:20-24.Singer&Clark.1999.NEJM.341(10):738.

Activated, Autologous, Available and Complete



1/6/1710

RegenerativeWoundTherapyLandscape

Avita’s Platform Covers a Range of Therapeutic Areas

Company MajorBrand(s) Technology SevereBurns DFU VLU

Dermatology(Vitiligo,scar,facial

rejuvenationOther

AvitaMedicalReCell®,

ReGenerCell®,ReNovaCell®

Autologouscelltherapyforskinregeneration ü ü ü ü

Alliqua BioMedical Biovance® Processeddehydrated,amniotic-basedallografts ü

CytoriTherapeutics

Cytori CellTherapy™ Adiposetissue-derivedstemcells ü ü ü

DermaSciences Amnioexcell®,Amniomatrix®

Amnioticextracellularmatrix;cryo-preservedplacenta-derivedliquid ü

Integra LifeSciences

Integra®DermalRegeneration

Matrix

Twolayersiliconefilmandcross-linkedfibermatrixskinsubstitute ü ü ü

MiMedx Group AmnioFix®,EpiFix® Processeddehydrated,amniotic-basedallografts ü ü ü

Organogenesis Apligraf®,Dermagraft® Allogenic,bio-engineered,cell-basedtherapy ü ü

OsirisTherapeutics Grafix® Cryo-preservedhumanplacentalmembrane ü üVericel EpiCel® Culturedepidermalautografts ü ü



1/6/1711

ATTRIBUTESAVITARECELL®

CONVENTIONALSHEET/MESHEDAUTOGRAFT

MEEK/MICROAUTOGRAFT

CULTUREDEPITHELIALAUTOGRAFT

SKINSUBSTITUTE

AutograftSparing +/-

CapacitySingleUnit +/-

ShortTermOutcome- Healing +/- +/- +/- +/-LongTermOutcome- Scar +/- +/- +/-ClinicianEaseofUse +/- +/- +/-TotalPatientCareCost +/-

DevicePrice N/A

LimitationsforUse

TOTAL 8/8 1/8 5/8 3/8 3/8

WhereReCell® SitsamidstBurnTreatmentOptions

An Optimal Treatment Platform

ReCell®standsalonewithinthearrayoftreatmentsonoffertosurgeonsfortreatingacutewounds…

…Akeygoalistodeploythedeviceasanadjuncttoothermethods,suchasskingrafts,

togivesuperioroutcomes



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HowReCell®canDeliverSuperiorOutcomes

TreatmentDay

Day 7 Day 12 Day 21 3 months

o A12-year-oldgirlwithwidespreadfacialburnsduetoacarfire

o 62%TotalBodySurfaceAreaburninjuryo Insufficientdonorskinavailablefor

conventionalclosure,soReCell®usedunderCompassionateUse

o Dischargedin24days

CourtesyofDrJamesHHolmesIV,MDFACS,WakeForestNC



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ComparisontoConventionalAutografting

Split-Thickness,SkinGraft(Unmeshed)

ReCell

Contracturerelease

A Simple Way to Optimize Outcomes



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inBurns– PediatricScald

3 weeks post treatment 10 weeks post treatmentBefore treatment 10 months post treatment

Courtesy of Jeremy M Rawlins FRCS(Plast)

Pediatric Burns are a Key Treatment Focus

o CaseStudy:4-year-oldpediatricscaldo ReCell®-aloneeliminatedtherequirementforskingrafts,sonolargedonorsiteso Nocontracture(scarring)orsurgicalfollow-uprequired



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SuperiorOutcomesinWoundTreatment

Treatment: excision, and ReCell

Post-operation, Day 5Deep Partial Thickness Burn

Post-Operation, 4 months

Courtesy of Ms Isabel Jones, Chelsea and Westminster Hospital

Achieving Healing and Normal Appearance

o CaseReport:48-year-oldman,flameburninjuryfromanexplodingboilero Sub-optimaltouseskingraftsonfacialwoundso ApplicationofRES™triggeredwoundhealingo Reintroductionofmelanocytesclearlygivessuperiorcosmeticoutcome



1/6/1716

andMeshedAutograft– healingwithlessdonorskin

o Treatmentoflargesurface/deepburnswithlimiteddonorsiteusage• Addressesunmetneedinburncare• Designedforclinicaleffectivenesswithminimaldonorsiterequirement• Patientwith64%burn,hospitallengthofstay0.58daysper%TBSA(vs1.9±0.7daysfor

severitymatchedhistoricalcontrol)

Can reduce length of stay in large burns by 42%

HolmesJH.2016BiennialMeetingoftheInternationalSocietyforBurnInjuries,Miami,FL

“ReCell®allowedustograftagreaterareawithlessskin,therebyreducingthedonorsitemorbidity…Itwillbeavaluableadditiontoourgraftingarmamentarium.”Dr.JamesHHolmesIV

1Monthposttreatment

TreatmentRES™+Meshed

Autograft



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Current Partnerships and Clinical Trials



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TheBARDAContract

BARDA contributes resources and validation

o AtotalofUS$61.9M committedunderthefive-yearcontractawardedSept29,2015andcontractaddendumJune27,2016

o BARDAwillpay$27.9MtocompletetheFDA-PMAprocess,ensureAvitaismarket-ready,andbuyaninitial$8Minventorytobestockpiled

o BARDAcouldspend$34Mmoreonlargerprocurement,apediatrictrialandvariousstrandsofpost-marketentrysupport

o AvitaisalsoengagedwithotherbranchesoftheUSFederalgovernment:thedevicehasgreatpotentialformilitaryuse

o AvitaisnowusingBARDAfundstostrengthenitsoperationsandbuildawarenessintheburnscommunityinadvanceofaUSlaunch



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U.S.FDAPivotalTrialofReCell®Goal:EvaluatesafetyandeffectivenessofReCell®incombinationwithmeshedskingraftfortreatmentofbroadrangeofacuteburninjuries

*Additionalproceduresaidingwoundclosureallowedwithininitial8weeks;**ReCellexpansionratio:controlexpansion>1

Co-PrimaryEndpoints:1. Expansionratio(donor:treatmentarea) attimeoftreatment:Superiority**ofReCell/Meshcomboversus

graftalone2. Incidenceofcompleteclosurerateofrecipientsiteat8weeks*:Non-inferiorityofReCell/Meshcomboversus

graftaloneSecondaryEndpoints(3):Week24Subjectpreference,BlindedObserverscarrating,Patientscarrating

RES™incombinationwithprotocol-definedwidermeshedautograft

Conventionalskingraft

o SampleSize:25o Targetenrollment(N):30o Age:≥5yrso Allburnsrequiringskingrafts(2nd&3rd

degree)o Treatmentarea:300+cm2 /areao %Burn:5-50%TBSAo Centers:7

CTP001-6

Qualifyingburnareabisectedtorandomize1:1foreachpatient

Active

Control

All Patients Enrolled and Treatment Complete



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ProjectedU.S.ReCell® BurnsApproval:~Endof2017

InitiateCTP001-6

CompleteU.S.enrollment

EstimatedFDAApproval

ClinicalStudyReport,PMA

Submission

6months

1Q2015 1Q2016 1Q2018

LastSubjectLastFollow-up

1Q2017

FDAAdvisoryPanel

CompleteInitialPMAReview

Program on Track, now in Safety Period

RecentpositiveinteractionswithFDA:

Ø December‘15:grantedExpeditedAccessPathwaydesignation

Ø May‘16:approvalofContinuedAccesstoReCell®inUSburnstrial

Ø October‘16: approvalofincreasedCompassionateUsepatientcasesandsites

üü



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Clinical Pipeline



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PilotTrialforReGenerCellinVenousLegUlcers(CTP003)

Aim:EvaluationoftheefficacyofReGenerCellincombinationwithstandardcompressiondevicevsstandardofcarealonefortheclosureofvenouslegulcers(VLU)

*Ulcerclosuredefinedascompletere-epithelializationwithoutdrainage

Endpoints:1. Incidenceofulcerclosure*at12weeks2. Rateofre-epithelialization(woundsize)3. Patientreportedpain&qualityoflife4. TreatmentcostdifferentialbetweenReGenerCellandcontrol5. Adverseeventprofile;safetyofReGenerCellinVLU

#ReGenerCellpatientsareeligibleforrepeatReGenerCelltherapyatstudyweek6-7iftheextentofwoundepithelializationis<85%but>15%

Multi-Center VLU Study Completed Q1-2016

CTP003ReGenerCellSusp#+SoC(Multi-Layer

CompressionTherapy)

StandardofCare(Multi-LayerCompressionTherapy)

o SampleSize:65(~30pts/arm)o Age≥18yrso Venousrefluxandulcero treatedfor≥4wkso DocumentedVLUbutno

exposedboneortendono Treatmentarea:2-80cm2

o Centers:7

1:1randomization

2WeekObservationRun-InPeriod

Control

Active



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o Statisticallysignificantimprovementsshowninwoundsize,painandhealth-relatedqualityoflife

o Positivetrendsbothinhealingtimeandincidenceofclosure,particularlyinlargeulcers(over10cm2)whichcomprisethemajorityofVLUs

o Treatmentusingautologouscellsuspensiondefinitivelyplacesthewoundsonahealingtrajectory

PilotTrialforReGenerCellinVenousLegUlcers- RESULTS

Strong Results Support Progression to US Pivotal Trial



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ClosingWoundswhereotherroutesFailed

CaseStudy1:67yearoldfemalewithperipheralarterialdisease,controlledtypeIIdiabetesVLU(10cm2)onrightlateralmalleolusopenfor46weeks beforetreatmentwithReGenerCell.

CaseStudy2:70yearoldmalewithperipheralarterialdisease,controlledtypeIIdiabetes.RightmedialVLU(13cm2)openfor212weeksbeforetreatmentwithReGenerCell.

Baseline Week1 Week6 Week10 Week14

“Changed within a month, could see the change, getting smaller and not so deep. Pain was reduced after thecells were applied, no pain at all after week 4”

“[It’s] just a miracle. Got my life back, can go out and socialise. Three years ago I couldn’t walk 10 yards”



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SimpleSolutionforSkinRepigmentationo Repigmentationofhypo-pigmentedskinduetovitiligo,oldage,injury,skintreatments

• Mostsignificantunmetmedicalneedinaestheticdermatologyo Currentinadequatetreatmentoptionsforrepigmentation

• Non-surgicaloptions“lotions&potions”andlighttherapyonlysometimesefficacious• Lab-basedmelanocytetransferissolesurgicalchoicebutexpensiveandtimeconsuming

o ReNovaCellistheonlysimpleandcost-effectivesolutionforskinrepigmentationo OngoingcollaborationwithrenownedNetherlandsInstituteforPigmentDisorders

Baseline 18weekspostReNovaCellKomenL,Vrijman C,Wietze vanderVeenJP,deRie MA,Wolkerstorfer A.ObservationsonCO2 laserpreparationofrecipientsitefornoncultured cellsuspensiontransplantationinvitiligo.JCutan Aesthet Surg 2016;9:133-135



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Commercialization Strategy & 2016-2017 Outlook



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Outcomes-DrivenHealthEconomicsForReCell®

TargetTraumaCenterswithXX

beds

Clinical&HealthEconomicDataDemonstrateSuperiorityofReCellOverSoC

25%

30% 32%

34%

42%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0

10000

20000

30000

40000

50000

60000

2 5 10 15 20

%Savingsachievedwith

ReC

ell

CostofT

reatmen

t(£)

TotalBodySurfaceArea(%)

%Savings COSTSOC COSTRC

N=22;PinderfieldsHospitalBurnsUnitinternaldata;2011

o ShorteningacutesurgerydurationwithReCellindependentlypredictsthelengthofstayintheburncenter1,2

o PatientswithReCellsurgerywerelikelytohaveashorterlengthofstaycomparedtopatientswithsplitskingrafting(SSG)surgeryalone2

o Reduceddonorsitemorbidityandbetterfunctional andaestheticscaroutcomesmakeReCellapreferredchoice3

o ReducedcostswithReCellsaved29%comparedtoconventionaldelayedsurgeryfornon-healingwounds3

o DevelopinghealtheconomicmodeloftheUSburncarepathwayshowingcosteffectivenessandpayer-budgetimpact(underwrittenbyBARDA)

1Limetal.2013. Isthelengthoftimeinacuteburnsurgeryassociatedwithpooreroutcomes?2Parketal.2013.Doesthetypeofskinreplacementsurgeryinfluencetherateofinfectioninacuteburninjuredpatients?3J.A.Dunne.2013.Earlypaediatricscaldsurgery—Acosteffectivedermalpreservingsurgicalprotocolforallchildhoodscalds.

GreaterTheBurnSurface-MoreTheCostEffectivenessofReCellTherapy



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CommercialStrategyfortheUS:BuildingonExperience

1.CompellingClinicalData

2.KOLRecruitment

3.CenterofExcellenceModel

4.HealthEconomics

5.Reimbursement

6.RobustTraining

7.Stake-holderEngagement

Experienceinex-USmarketshastaughtusthatrecurrentsalesofabreakthroughmedicaldevicerequireamulti-layeredapproach

WearebuildingupourUSoperationstodeliveronthisstrategy:

o The127burncentersintheUSmakethisadefinedmarketnichethatiseasilyreachable

o Alreadyengagedwithmanyofthe300burnssurgeonsintheUS

o Earlyadoptionat15centersthroughCompassionateUseandContinuedaccess

o QuintilesIMS developingourHEModel

o WellstaffedwithReimbursementManager,ClinicalProductStrategyDirectorandBurnsEducationManageralreadyonboard

o TrainingmaterialspreparedandE-learningmoduletobelaunched

o Discussionswithstrategicpartnersunderway

Key US Launch Elements in Place



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PRODU

CT

/REG

ULATO

RYCLINICAL

/HEA

LTHECON

INFR

ASTR

UCTURE

/COMMER

CIAL

OCT-DEC16 JAN-MAR17 APR-JUN17 JUL-SEP17 OCT-DEC17 JAN-MAR18

Burns

Chronics

Pigmentation

LAOfficeExpansionComplete

InitialPre-EUAActivityComplete

U.S.BurnsCarePathwayStorybook

VLUManuscriptsubmission

Non-SegmentalVitiligo Studystarts

KeyU.S.Hiresrecruited

U.S.BurnsEducationRoll-out

U.K.BurnsStudyforNICEMTAC

U.S.BurnsCareHEPathwayModel

DFUFeasibilitycompleterecruitment

DFUPilotcommence VLUAustralia/US1st

stagePivotal

U.S.SalesTeamrecruited

BurnsPMAsubmission

BurnsPMAApproval

VLUPre-IDE

ContinuedAccessComplete

USConditionofApproval

$8MBARDABaseProcurement

CommercialStrategyfortheUS;BuildingonExperience

2017 is a Pivotal Year for Avita

MilestoneCalendar



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FinancialOverviewFinancialRecap

Tickers: ASX:AVHOTCQX:AVMXY

MarketCap:Jan3,2017 A$80.6MM

CashPosition:Sep30,2016 A$10.6MM

CashBurn: A$2.3MM/quarter

Debt: A$0MM

Annual Revenue: FY15-16 A$3.5MM

US Focus in 2017



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STRATEGICIMPERATIVE ACTIVITIES EXPECTED

COMPLETION

1. DevelopPayerValuePropositionforReCell®

• Identifyandaddressevidencegapsforburnandwoundcare• IdentifyspecialpopulationsthatwouldbenefitfromReCell®

• Developvaluedossiertosupportclinicalandeconomicvalueproposition• Validatevaluepropositionwithkeystakeholders

Q22017

2. EnsureAdequatePayment

• Determinewithphysicianspecialtysocietiesoptimalcodingstrategy• ApplyforCPT®andICD-10-PCScodesifnecessary• Developmaterialstosupportpaymentinthefield

Q42017

3. FavorablyInfluencePayerPolice

• Establishcoverageforexpandedindicationstoensurepatientaccess• Developprivatepayerstrategiesfocusedonintermediate-risk• LeverageevidencestrategicallytoprepareforNCDreconsideration

Q22018

4. DevelopToolsforHospitals

• Providefieldteamwithcustomerfacingtoolsandresources• Facilitatebestpracticesharingamonghospitals Q12018

USReimbursementStrategicRoadmapfor2017/2018

Reimbursement is being actively addressed



1/6/1732

SeniorLeadershipTeam

Name Position Joined Avita YearsExperience Affiliations

AdamKelliher CEO April,2015 20

TimRooney CFO October,2012 25

TroyBarring COO June,2016 23

AndrewQuick Sr.VPClinicalDevelopment July,2010 21

RossSaunders VPSales&Marketing July,2016 20

David Fencil VPGlobal Operations January,2012 30

LouPanaccio Board Chairman July,2014 30

JeremyCurnock Cook Director October,2012 40

Dr.MichaelPerry Director February,2013 25

LouisDrapeau Director January,2016 45

DamienMcDonald Director January,2016 25

Prof.SuzanneCrowe Director January,2016 24



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AvitaMedical– RecentAccomplishmentsandtheRoadAhead

o MultiplepositiverecentcommercialandregulatorydevelopmentsintheUSo BARDA’sUS$61Mcontractforlate-stagedevelopmentandpurchaseunderpinsUSbuild-out

o NewCaliforniaofficenowthehubofclinical,regulatoryandfinancialactivities

o ActivelybuildingmultipleoperationalteamsinadvanceofUSlaunch

o MultipleClinicalProgramsforgingaheado RecentFDAapprovalsforCompassionateUse(twiceexpanded),andContinuedAccess

o FDAExpeditedAccessPathway(EAP)designationforburnso PositiveresultsinVenousLegUlcers(VLU)haveinformedaUSstrategyonchronicwounds

o DFUstudynowunderwayintheUK

o StrengthenedBoardandManagementtoaccelerateUScommercializationo Maintainingglobalreachandfocusedonaddingtoclinicaldataseto EuropeandAsia-PacificmarketexperienceinformsaclearandcomprehensiveUS

commercializationstrategy

A Motivated Company on the Move



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Formoreinformation

www.avitamedical.com



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Appendix



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IntellectualPropertyProtectiono Originalepithelialsuspension&methodforproduction– expirationdate2022o Originalapparatusforproducingepithelialsuspension– expirationdate2022o Augmentedepithelialsuspensionandmethodofproduction– expirationdate2033o Automatedapparatusandmethodofproduction– expirationdate2033-2034o Augmentedregenerativeepithelialsuspension– expirationdate2037

Country/Region OriginalSuspension&Method

OriginalApparatus

AugmentedSuspension&Method

AutomatedApparatus&Method

Australia Granted Granted Granted Granted

U.S. Granted Pending Pending Pending

Europe Granted Granted Pending Pending

Japan Granted Granted Pending Pending

Brazil Pending Pending Pending Pending

Canada NA NA Pending Pending

China NA NA Pending Pending

HongKong Granted Pending Pending Pending

Comprehensive Patent Portfolio in Key Markets



1/6/1737

ClinicalEvidence– SomeHighlights

Positive Clinical Evidence in Multiple Indications

o Earlyproductapprovalsbasedoncaseseries,60+presentationsandpublicationso Todaypursuingrobust,randomizedcontrolledclinicaltrials

ClinicalIndication RCT Readout

Burns ReCelladjuncttowidelyexpandedautografts,fortreatmentofmixed-depth(incl.full-thickness)burninjuries(US,CTP001-6)

PMAsubmissionearly2017

ChronicWounds ReGenerCellfortreatmentofhard-to-healvenouslegulcers(UK,CTP003)

PresentedEWMA2015,manuscriptinprep

ChronicWounds ReGenerCellfortreatmentofchronicwounds(China)

published2015,BritishJSurg

Aesthetics/Repigmentation

ReNovaCellforrepigmentationofsegmentalvitiligo/piedbaldism(Netherlands)

published2015,JAmerAcadDermatol

Aesthetics/Repigmentation

ReNovaCellforrepigmentationofhypopigmentedscar(Germany)

Published2016,Burns(JournalofInt’lSocietyforBurnInjuries)



1/6/1738

EarlyExperienceinChronicWounds

DeAngelisB,MignerA,LucariniL,AgovinoA,CervelliV.Theuseofanon-culturedautologouscellsuspensiontorepairchroniculcers.InternationalWoundJournal2013;doi:10.1111./iwj.12047[Epub]

o 70%ofulcershealedwithin60daysoftreatmento Meandurationofulcers=18monthso Meanageofpts=70years

14 of 20 (70%)

5 of 20(20%)

1 of 20(5%)*

0

4

8

12

16

20

100% 80% 50%

Num

ber o

f Sub

ject

s

Percent Re-epithelialization

Healingat60daysAverageUlcerDuration:18.3months

* Ulcer duration: 32 months; co-morbidity:

psoriasis

3(within50days)

1

0

2

4

100% 80% Num

bero

fSub

jects

PercentRe-epithelialization

DFUHealingat60daysAverageUlcerDuration:28monthsAverageRectangularArea:8.7sqcm

Compelling Early Results in VLU and DFU

Avita Corporate Presentation January 2017...

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