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TheCureforChronicWoundsE-QURECorp
OTCQB:EQUR
November2016
DISCLAIMER
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 2
Thisdocument isprovidedsolelyfortheconsiderationofeligibleinvestorswhohavetheknowledgeandexperienceinfinancialandbusinessmattersandthecapabilitytoconduct theirownduediligenceinvestigationinconnectionwiththeinvestmentoutlinedherein.ProspectiveinvestorsareurgedtoconductanindependentevaluationoftheCompany.
Thisdocument isstrictlyconfidentialandshouldbeused,distributed,orforwardedtothirdpartieswithoutanexplicitconsentofitsauthors.
WhiletheCompanybelievesthattheinformationcontainedhereinisaccurate,itexpresslydisclaimsanyandallliabilityforrepresentationsorwarranties,expressedorimplied,containedin,orforomissionsfromthisdocumentoranyotherwrittenororalcommunication transmittedormadeavailabletoprospectiveinvestors.Anyandallrepresentationsandwarrantiesregardingtheinformationdescribedinthisdocumentshallbeonlyassetforthinadefinitiveagreementifandwhensuchdefinitiveagreementisexecuted.AnyprospectiveinvestoracknowledgesitsresponsibilitytoperformaduediligencereviewpriortoconsummatingatransactioninvolvingtheCompany.
Thisdocument includesforward-lookingstatements,assumptionsandstatementregardinganticipatedfutureperformance.Suchstatementsarebasedonestimatesthataresubjecttoeconomicandcompetitiveuncertainties.TheCompanymakesnorepresentationorwarrantywithrespecttothestatementsandtherecanbenoassurancethatthefutureresultscanberealizedorthatactualresultswillnotbemateriallydifferentfromthoseprojected.TheCompanyundertakesnoresponsibilitytoupdateorreviseanyforward-lookingstatements.
TheCompanyanditsrespectiveaffiliates,directors,officers,employees,consultantsandrepresentativesexpressivelydisclaimanyandallliabilityrelatingtoorresultingfromtheuseofthisdocumentorsuchother informationregardingtheCompanybyaprospectiveinvestororanyofitsaffiliatesorrepresentatives.
OPPORTUNITY
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 3
• Hugemarketsize- $25Bworldwide
• Growingmedicalproblem– ChronicWounds>8%annualgrowthinthewesternworld
• Numeroustypesoftreatments- Norealsolution
• RealneedtoreducemedicaleconomicburdenbyNationalHealthSystems
• WorldwiderecognitionforourproprietaryElectricalStimulationtechnology
• SuccessfulClinicalstudiescompletedinIsraelandItaly
• Shorttimetomarket– immediateinmostcountries,and~3yearsintheUSA
• DefinedpathforFDAapprovalintheU.S.andcommercializationinselected internationalcountries
• Idealinvestment/returnprofile
E-QURECorp.(OTCQB:EQUR);proprietaryElectricQuickUlcerRemedy(E-QURE)BST.ElectricalStimulation(ES)treatmenthasbeenproventobethemosteffectiveforquick,painlessandfriendlyhealingofchronic,hard-to-healwoundsandulcers.
• Proprietarytechnology:USpat6,941,173,ValidUntilMay2021– Followingpatentswillcome
• Threemainshareholdersarethefounders- RonWeissberg,Ohad GorenandItsik BenYesha– Closepersonalmanagement.
• StrongScientificAdvisoryBoardandclinicalstudiessupportingmethodology– Clinicalvalidationprojectswillfollow
• MarketCap(July15,2016)- $3million– Hugeupsidevaluepotential
• Commercializationprocesshasbegun– Commercialindependencewithinfewyears
• Fundsavailableforoperation– untilQ4of2016– Needforlimitedfundinginthefuture.
• AdditionalInformation– www.e-qure.com
EXECUTIVEOVERVIEW
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 4
$25billionannuallyisspenttreatingwoundcareintheU.S.alone.Onaglobalscale,therearenoothersignificantplayersinprovidingElectricalStimulation(ES)treatmenttocurewoundsquickerandfaster.
WOUNDCARE– HUGEMARKETOPPORTUNITY
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 5
Ø Chronic wounds (wounds that have not proceeded through a reparative process in three months)affect over five million Americans each year, resulting in over $20 billion in health care costs.
Ø Individuals with disabilities and diabetes, as well as the elderly, have the highest risk ofdeveloping chronic wounds. Patients afflicted with chronic wounds suffer from physical pain anddisabilities in addition to psychological and emotional stresses and poor quality of life.
Ø Current treatments for chronic wounds include cleansing, debridement, maintaining a moisttissue environment and in advanced cases amputation may become necessary.
Ø Death, especially in elderly patients, may result from sepsis that can be associated with chronicwounds.
Source: NIH (National Institute Of Health)
HEALTHCARECOSTSFORCHRONICWOUNDSTOP$20BANNUALLYINTHEUSAALONE
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 6
ü 60- 90minutesperdayü 45- 60daysoftreatmentü BothHomeandClinicCare
ü Complieswithstandardofcareü Painlessandeasytouseü ApprovedforuseinEurope(CE),pendingapprovalinAustralia,Canada&Israel.üDevice includesStimulusGeneratorandsoftsurfacedisposableelectrodes
ü Electrodesplacedonthesidesoftheulcerwheretheycanremainforupto3days.Electrodesarereplacedwhenbandagesarereplaced.
E-QURE SOLUTION– BIOELECTRICALSIGNALTHERAPY(BST)
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 7
IntroductionMovie
The “current of injury" measured during the natural healing process is absent or weakwith chronic wounds
ØA unique patented waveform signal that mimics the naturally occurring current ofinjury is transmitted to the skin surface around the wound site
Ø The BST signal enables both the stimulation of sensory nerves and direct stimulation ofthe ulcer tissues
Ø The nervous system interprets the transmitted pulse from the damaged area andinitiates healing activity to the wound tissues
E-QUREBSTDEVICE– HOWDOESITWORK
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 8
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 9
E-QUREBST TREATMENT– CASESAMPLECured DiabeticFootUlcerof27monthsWoundAgewithin60Days.
0
2
4
6
t0 t15 t30 t45 t60 t90
WoundArea(cm2)
Days of Treatment
CLINICALSTUDIES:ISRAEL&ITALY
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 10
ISRAEL:MultiCenter,Double-blind, Randomized,Placebo-controlled study(Monitored byHarrison Group)
In-patients,withstageIII,non-diabeticpressureulcerslasting≥90days,perNPUAPscoringsystem8weekstreatmentfollowedby12-weekfollow-up
Results:§ 5timesClosureratewithE-QURE– BSTvs.Controlgroup.
p=0.044§ TwiceFasterepitheliaprogressionwithBSTvs.Control
group.p=0.033§ Nounanticipatedadverseevents
Conclusion:studyhasestablishedcompletesafetyandefficacyresults
https://docs.google.com/file/d/0BzBBIZuLOk4iaWRqd2JHdEhaakk/edit?usp=sharing
TURIN,ITALY:ObservationalcaseseriestoevaluatetheeffectandtolerabilityofE-QUREBST(ProfRicci– JournalofWoundCare2010)
§ 9patientswith11ulcers(Woundage:18monthsto20years)§ E-QUREBSTtreatment30minutes,3timesaday, for60days
Results:§ Meanwoundsareareduction82.5%(SD=25.2%)§ Fullclosurerate(healing)45%withinthe60daysperiod
http://www.journalofwoundcare.com/cgi-bin/go.pl/library/article.cgi?uid=47278;article=JWC_19_3_96_103
CLINICALSTUDIES:ISRAEL&ITALY(CONT)
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 11
Prof. Fraccalvieri, 2008-2010 Observational case series to evaluate theeffect of E-QURE BST on Chronic wounds not responding for 3 months totraditional dressing, surgery or negative pressure therapies (NPWT).
Treatment:§ 21 patients forwound healing (up to 20 sqr cm)§ 11 patients forwound related pain (Average VNS 8.7)
Results:§ 87% full wound closure in average time of 97 days (range 10 – 150days)
§ 45% complete pain disappearance in 7 days (From 8.5 to 1.0)§ Other 36% Reduction in pain in 7 days (from 9.3 to 3.2)§ Remaining 19% (two patients) had very severe pain which requireddaily treatment with morphine painkillers. Both patients reported areduction of pain from 9.5 to 2.5 after 7 days and stopped morphinepainkillers in 14 days.
Source:Electrical stimulation for difficult wounds: only an alternative procedure? International Wound Journal MarcoFraccalvieri Marco Salomone Enrico MZingarelli Filippo Rivarossa StefanoBruschiDOI: 10.1111/iwj.12194
http://onlinelibrary.wiley.com/doi/10.1111/iwj.12194/abstract
Prof.Ricci,June2009ObservationalcaseseriestoevaluatetheeffectandtolerabilityofE-QUREBSTonextremelyhard-to-heal(recalcitrant)wounds.
Treatment:39patientswith40ulcers(Woundsage:6monthsto40years)E-QUREBSTtreatment30minutes,3timesaday, for60days
Results:§ Fullclosurerate(healing)45%§ Partialclosure:25%ofwoundsshowareareduction>40%§ Partialclosure:20%ofwoundsshowareareduction<40%
ü Numerouspublications andMeta-Studies endorsing Electrical Stimulations forwoundhealing.
ü Additional observational trialsareplanned forthenext fewyears forfurtherclinical validation.
ü Conferences participations isplanned forBSTwide industry exposure.
ü Planned validation studies tobecompleted byendof2017.
ADDITIONALCLINICALVALIDATIONS
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 12
90Patients Controlled,DoubleBlinded, Placebo
Trial inUSA
EfficacyObservationaltrial inIsrael
DiabeticfootulcerPilotTrial inGermany PilotTrial inTurin Italy Pilot trial inBrazil Observational studyin
Poland PilotTrial inColombia
63Patients RandomizedControlled Trial (RCT) in
Israel
9patients observationalstudy inTurin
39Patients observationalstudy in Italy 31Patients study inTurin 10Patients pilot trial in
Parma4Patients Pilot trial in
Argentina4Patients Observational
inGermany
Thereisaconsensus that:electricalstimulation(ES)facilitateswoundhealing.
ESisrecommendedbyguidelinesissuedbybothEPUAPandNPUAP(EUandUSPressureUlcersAdvisoryPanels)forthetreatmentofrecalcitrantpressureulcers.
http://www.epuap.org/guidelines /Fin al_Quick_Treatment.pdf
THEULCERHEALINGCONSENSUS INFAVOROFELECTRICALSTIMULATION (ES)
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 13
NIHsiteexpressesastatementpreferringES:
"ESistheuseofelectricalcurrenttostimulateanumberofcellularprocessesimportanttopressureulcerhealing.ESappearstobemosteffectiveonhealingrecalcitrantStagesIIIandIVpressureulcers.Thus,electricalstimulationshould beconsideredfornon-healingpressureulcers.“
http://www.ncbi.nlm.nih.gov/books/NBK2650/#ch12.s20
ü CEMark– EUConformityApprovalgranted.
ü PursuingLocal registrations andMarketing approvals invariouscountries.
ü Primarymarkets forthecompanyproduct include USA,Germany, Italy,Israel,SouthAmerica, Australia,CanadaFrance andEngland
ü Regulatory approvals forallmajormarkets isexpected tobecompleted byendof2018
REGULATORYAPPROVALSPATHWAY
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 14
CEMarkforEUcountries
ArgentinianApproval Brazil andColombia AMAR forIsrael
market CanadaCE Australia Approval FDAPMAApproval KoreaandSingapore JapanFDAApproval Chinaand India
registration
§ BSTDevice isleased byclinics, hospitalsandphysicians tomaintain control ondevices location anduse.
§ Daysoftreatment isbeingsoldbycharging forthedisposable electrodes. Electrodes designed for1,2or3daysoftreatment.
§ Price isbased onpatient cost,considering reimbursement scheme.
§ Territories aremanaged byassigned distributors orbusiness partners, sharing revenues with thecompany
§ Strategic countries willbehandled bythecompany.
§ E-QURE target toposition5000active devices byendof2018worldwide treating 20,000patientsatpotential 1,000,000daysoftreatment.
§ Reaching economic break evenby2019
BUSINESSMODEL
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 15
Commencingsales inArgentina
Marketpenetration inItaly
Distribution agreementsinGermany
Commencingsales inIsrael
Distribution agreementsinotherSouthAmerica
Startingsales inotherselectedcountries FDAPMAApproval Commencingmarketing
activityin theUSA
ü Designed forPMAprocess.Nopredicate available
ü Discussions withFDAastotrialdesign andconduct isinfinal stages
ü Trial protocol synopsisü Primaryendpoints:completeclosurewithin60daysanddevicesafety.ü 90patientdoublearms,doubleblinded,controlledtrial.ü 45PatientswithBSTtreatmentü 45Patientswithshamplacebotreatmentü Strictinclusionandexclusioncriteriatoensurehomogenouspopulationü Pressureulcers,in-patientsonlythathaveshownnoimprovementforatleast30days
ü Totalregulatory pathwayfortheBSTdevice into2017.
USREGULATORYPATHWAY
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 16
Pre -IDE Q-Sub FDAMeeting IDESubmission TrialApproval
90PatientsControlled, DoubleBlinded, Placebo
Trial
TrialResults PMASubmission FDAApproval
REIMBURSEMENTFORESINTHEUSA
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 17
ExistingCMSReimbursementCode
• HealthcareCommonProcedureCodingSystem(HCPCS)codeE0769• Reimbursementofupto$70perday• Reimbursementamounttothepatientisroughly$3,000(basedon60days)• Adjunctivetreatmenttostandardofcare(SOC) fornon-healingwounds
“TheuseofESandelectromagnetictherapyforthetreatmentofwoundsareconsideredadjunctivetherapies,andwillonlybecoveredforchronicStageIIIorStageIVpressureulcers,arterialulcers,diabeticulcers,andvenous stasisulcers.Chroniculcersaredefinedasulcersthathavenothealedwithin30daysofoccurrence.ESorelectromagnetictherapywillbecoveredonlyafterappropriatestandardwoundtherapyhasbeentriedforatleast30daysandtherearenomeasurablesignsofimprovedhealing.This30-dayperiodmaybeginwhilethewoundisacute.”
Source:CMShttp://www.cms.gov/medic are-coverage-d atabase/detai ls/ncd-details.aspx?NCDId=131&ncdver=3&DocID=270.1&bc=gAAAAAgAAAAAAA%3D%3D&
IP PROTECTION
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 18
USpat6,941,173 granted– 2005,ValidUntilMay2021
Claimno1:Amethodforthetreatmentofasore,themethodcomprisingthestepsof:(a)situatingelectrodesinavicinityofthesoreofapatienttobetreated,and (b)externallyinducingapercutaneous flowofelectricalcurrentbetweensaidelectrodesbyestablishingatleastonevoltagewaveformacrosssaidelectrodes,whereinsaidatleastonevoltagewaveformincludesawaveformdesignedtosubstantiallymimiccharacteristicnaturalvoltagewaveformemissionsofatleastoneelectricallyactivesore.
https://www.google.com/patents/US6941173?dq=6,941,173&hl=en&sa=X&ei=oTdmUuziK-eO4ASQ8ICgAw&ved=0CDkQ6AEwAA
USPatentformethodoftreatment
USpatentforUlcerdiagnostic
PatentforproprietaryuseofSignal
PatentfornewgenerationBST
treatment
Patentforcombinationfor
treatmentgivenbyBSTwithothernovel
technology
FINANCINGNEEDSFORE-QURESTRATEGY:2017– 2019
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 19
PursueFDAapprovalintheU.S.Market
Commercialdevelopment
EuropeanMarket
EnhanceUSreimbursement
scheme
Receivemarketing
approvalinothermarkets
USmarketpenetrationwithstrategicpartners
Ø FDAApproval
Ø EuropeCommercialDevelopment
Ø USAMarketPenetration
Ø SouthAmericaCommercialDevelopment
Ø AsiaRegulationandCommercialDevelopment
Ø OtherFinancialNeeds
MANAGEMENTTEAM
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 20
• Mr. Ron Weissberg - Chairman - Over 20 years of executive experience in the Financial industry incompanies specializing in Real Estate, Insurance, Rating & Credit Agencies, and Investment Funds. Extensiveexperience in the Bio-Med industry around the world. Holds an MBA, New York University and BSc. IndustrialEngineering and Management, Cum Laude, Technion, Haifa, Israel.
• Mr. Ohad Goren - CEO – Over 20 years of experience in High-Tech and Bio-Tech Management. Former CEOof Pollogen – Medical Device Company , Former CEO of LifeWave – Medical Device Company, Support SalesManager of Oracle Israel, Deputy Consul - Israel Foreign Ministry, Israeli Embassy-Washington DC. Holds a B.Sc InEconomics and Business Management from the University of Maryland USA.
• Mr. Itsik Ben Yesha - CTO - Over 30 years of experience in High-tech and Bio- Tech R&D and Management.Former CTO & Executive VP of LifeWave, CFO & Executive VP of Valor, Founder and Partner in Hisense(BabySense), CFO of Innowave (Tadiran Wireless Telecom). Hold a B.Sc in Aeronautical Engineering fromTechnion Haifa, and MBA, Cum Laude, Tel Aviv University , Israel.
SCIENTIFICADVISORYBOARD
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 21
•Prof. Avi Ohry - Prof. Ohry is an expert in Rehabilitation Medicine, served as a Consultant to the Israeli Ministryof Health, the Israeli Ministry of Defense, the Israeli Ministry of Foreign Affairs, IDF and other national andinternational agencies and institutions. . From 1985-1999 he served as the director of the Department of Neuro-Rehabilitation ,at Sheba Medical Center, Tel Hashomer, Israel . Since 2000, he is a (full academic) Professor ofRehabilitation Medicine at Tel Aviv University . Since 1999, he is the Chairman of the department ofRehabilitation Medicine at Reuth Medical Center, Tel Aviv. Prof. Ohry served as Member of Biomedical AdvisoryBoard at LifeWave Ltd. In 2005, he was included in the project/book - “ Caring Physicians of the World “, Onbehalf of the World Medical Association , as a representative of Israeli Medical Association. His main topics ofinterest are: Rehabilitation Medicine, Spinal Cord Injuries, Medical humanities, history of Medicine, bio-ethics,Polish-JewishMedical establishments between the World wars. Long term sequelae of disability , and captivity
• Dr. Ben Zion Weiner - Dr. Weiner has been with Teva Pharmaceuticals since 1975. In January 2006, Dr. Weinerjoined the Office of the CEO and assumed the role of Chief R&D Officer. Dr. Weiner served as Group VicePresident - Global Products from April 2002 until January 2006. Previously, he served as Vice President - Researchand Development from 1986 to 2002. He received a Ph.D. in chemistry from the Hebrew University, where healso earned B.Sc. and M.Sc. degrees. He conducted his post-doctorate research at Schering-Plough Corporation inthe United States. He was granted the Rothschild Prize for Innovation/Export two times, in 1989 for thedevelopment of Alpha D3 for dialysis and osteoporosis patients and in 1999 for the development of Copaxone®for multiple sclerosis.
INVESTORINFORMATION
16-Nov-16 Confidential E-QURECorp. www.e-qure.com 22
StateofIncorporation Delaware
YearEnd 12/31
Symbol (OTCQB) EQUR
RecentPrice(Nov2015) $0.25
MarketCapitalization ~$6million
SharesOutstanding ~22million
SharesAuthorized 500million
TransferAgent TransferOnline
ChairmanoftheBoard RonWeissberg
ChiefExecutiveOfficer Ohad Goren
E-QURECorp.Inc.20West64thStreet,Suite39GNewYork,NY10023
https://www.e-qure.comPhone: (972)8916-7333