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The Cure for Chronic Wounds E-QURE Corp OTCQB: EQUR November 2016

The Cure for Chronic Wounds E-QURE Corp Web Presentation - Nov 2016.pdf · The Cure for Chronic Wounds E-QURE Corp OTCQB: EQUR ... may resultfrom sepsis that can beassociated with

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Page 1: The Cure for Chronic Wounds E-QURE Corp Web Presentation - Nov 2016.pdf · The Cure for Chronic Wounds E-QURE Corp OTCQB: EQUR ... may resultfrom sepsis that can beassociated with

TheCureforChronicWoundsE-QURECorp

OTCQB:EQUR

November2016

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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.

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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

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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

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$25billionannuallyisspenttreatingwoundcareintheU.S.alone.Onaglobalscale,therearenoothersignificantplayersinprovidingElectricalStimulation(ES)treatmenttocurewoundsquickerandfaster.

WOUNDCARE– HUGEMARKETOPPORTUNITY

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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

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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

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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

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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

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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

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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%

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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

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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

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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

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§ 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

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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

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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&

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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

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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

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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.

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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.

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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