TheCureforChronicWounds
E-QURECorp
OTCQB:EQUR
November2016
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OPPORTUNITY
• Hugemarketsize- $25Bworldwide
• Growingmedicalproblem– ChronicWounds>8%annualgrowthinthewesternworld
• Numeroustypesoftreatments- Norealsolution
• RealneedtoreducemedicaleconomicburdenbyNationalHealthSystems
• WorldwiderecognitionforourproprietaryElectricalStimulationtechnology
• SuccessfulClinicalstudiescompletedinIsraelandItaly
• Shorttimetomarket– immediateinmostcountries,and~3yearsintheUSA
• DefinedpathforFDAapprovalintheU.S.andcommercializationinselectedinternational
countries
• Idealinvestment/returnprofile
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EXECUTIVEOVERVIEW
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
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WOUNDCARE– HUGEMARKETOPPORTUNITY
$25billionannuallyisspenttreatingwoundcareintheU.S.alone.Onaglobalscale,thereareno
othersignificantplayersinprovidingElectricalStimulation(ES)treatmenttocurewoundsquickerand
faster.
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HEALTHCARECOSTSFORCHRONICWOUNDSTOP$20B
ANNUALLYINTHEUSAALONE
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 of
developing chronic wounds. Patients afflicted with chronic wounds suffer from physical pain and
disabilities in addition to psychological and emotional stresses and poor quality of life.
Ø Current treatments for chronic wounds include cleansing, debridement, maintaining a moist
tissue environment and in advanced cases amputation may become necessary.
Ø Death, especially in elderly patients, may result from sepsis that can be associated with chronic
wounds.
Source: NIH (National Institute Of Health)
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E-QURE SOLUTION– BIOELECTRICALSIGNALTHERAPY(BST)
ü 60- 90minutesperday
ü 45- 60daysoftreatment
ü BothHomeandClinicCare
ü Complieswithstandardofcare
ü Painlessandeasytouse
ü ApprovedforuseinEurope(CE),pendingapprovalinAustralia,Canada&Israel.
ü Device includesStimulusGeneratorandsoftsurfacedisposableelectrodes
ü Electrodesplacedonthesidesoftheulcerwheretheycanremainforupto3days.
Electrodesarereplacedwhenbandagesarereplaced.
IntroductionMovie
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E-QURE BSTDEVICE– HOWDOESITWORK
The “current of injury" measured during the natural healing process is absent or weak
with chronic wounds
Ø A unique patented waveform signal that mimics the naturally occurring current of
injury is transmitted to the skin surface around the wound site
Ø The BST signal enables both the stimulation of sensory nerves and direct stimulation of
the ulcer tissues
Ø The nervous system interprets the transmitted pulse from the damaged area and
initiates healing activity to the wound tissues
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E-QUREBST TREATMENT– CASESAMPLE
Cured DiabeticFootUlcerof27monthsWoundAgewithin60Days.
WoundArea
(cm2)
6
4
2
0
t0
t15 t30 t45 t60 t90
Days of Treatment
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CLINICALSTUDIES:ISRAEL&ITALY
ISRAEL:Multi Center, Double-blind, Randomized, Placebocontrolled study(Monitored byHarrison Group)
In-patients,withstageIII,non-diabeticpressureulcerslasting
≥90days,perNPUAPscoringsystem
8weekstreatmentfollowedby 12-weekfollow-up
Results:
§ 5timesClosureratewithE-QURE– BSTvs.Controlgroup.
p=0.044
§ TwiceFasterepitheliaprogressionwithBSTvs.Control
group.p=0.033
§ Nounanticipatedadverseevents
Conclusion:
studyhasestablished completesafetyandefficacyresults
TURIN,ITALY: Observational caseseriestoevaluatethe effectand
tolerability ofE-QUREBST(ProfRicci– Journal ofWound Care
2010)
§ 9patientswith11ulcers(Woundage:18monthsto20years)
§ E-QUREBSTtreatment30minutes,3timesaday, for60days
Results:
§ Meanwounds areareduction 82.5%(SD=25.2%)
§ Fullclosurerate(healing)45%withinthe60daysperiod
http://www.journalofwoundcare.com/cgibin/go.pl/library/article.cgi?uid=47278;article=JWC_19_3_96_103
https://docs.google.com/file/d/0BzBBIZuLOk4iaWRqd2JHdEhaakk/edit?usp=sharing
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CLINICALSTUDIES:ISRAEL&ITALY(CONT)
Prof. Fraccalvieri, 2008-2010 Observational case series to evaluate the
effect of E-QURE BST on Chronic wounds not responding for 3 months to
traditional dressing, surgery or negative pressure therapies (NPWT).
Treatment:
§ 21 patients for wound healing (up to 20 sqr cm)
§ 11 patients for wound related pain (Average VNS 8.7)
Results:
§ 87% full wound closure i n average time of 97 days (range 10 – 150
days)
§ 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 required
daily treatment with morphine painkillers. Both patients reported a
reduction of pain from 9.5 to 2.5 after 7 days and stopped morphine
painkillers in 14 days.
Prof. Ricci,June2009 Observationalcaseseriestoevaluatetheeffect
andtolerabilityofE-QUREBSTonextremelyhard-to-heal
(recalcitrant)wounds.
Treatment:
39patientswith40ulcers(Woundsage:6monthsto40years)
E-QUREBSTtreatment30minutes,3timesaday, for60days
Results:
§ Fullclosurerate(healing)45%
§ Partialclosure:25%ofwoundsshowareareduction>40%
§ Partialclosure:20%ofwounds showareareduction<40%
Source:
Electrical stimulation for difficult wounds: only an alternative procedure? International Wound Journal Marco
Fraccalvieri Marco Salomone Enrico M Zingarelli Filippo Rivarossa StefanoBruschi
DOI: 10.1111/iwj.12194
http://onlinelibrary.wiley.com/doi/10.1111/iwj.12194/abstract
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ADDITIONALCLINICALVALIDATIONS
ü Numerous publications and Meta-Studies endorsing Electrical Stimulations forwoundhealing.
ü Additional observational trials are planned forthenext fewyears forfurther clinical validation.
ü Conferences participations isplanned forBSTwide industry exposure.
ü Planned validation studies tobe completed byend of2017.
63Patients Randomized
Controlled Trial (RCT) in
Israel
9patients observational
study in Turin
90Patients Controlled,
Double Blinded, Placebo
Trial in USA
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39Patients observational
study in Italy
EfficacyObservational
trial inIsrael
31Patients study in Turin
Diabeticfoot ulcer Pilot
Trial in Germany
10Patients pilot trial in
Parma
Pilot Trial in Turin Italy
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4Patients Pilot trial in
Argentina
Pilot trial inBrazil
4Patients Observational
in Germany
Observational studyin
Poland
Pilot Trial in Colombia
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THE ULCERHEALING CONSENSUS INFAVOROFELECTRICAL
STIMULATION (ES)
Thereisaconsensus that:
NIHsiteexpressesastatementpreferringES:
electricalstimulation(ES)facilitateswoundhealing.
ESisrecommendedbyguidelinesissuedbybothEPUAPand
NPUAP(EUandUSPressureUlcersAdvisoryPanels)forthe
treatmentofrecalcitrantpressureulcers.
"ESistheuseofelectricalcurrenttostimulateanumber
ofcellularprocessesimportanttopressureulcerhealing.
ESappearstobemosteffectiveonhealingrecalcitrant
StagesIIIandIVpressureulcers.Thus,electrical
stimulationshould beconsideredfornon-healing
pressureulcers.“
http://www.ncbi.nlm.nih.gov/books/ NBK2650/#ch12.s20
http://www.epu ap.org/guidelines /Fin al _Quick _Treat ment.pdf
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REGULATORYAPPROVALSPATHWAY
ü CEMark – EUConformity Approval granted.
ü Pursuing Local registrations andMarketing approvals in various countries.
ü Primary markets forthe company product include USA,Germany, Italy,Israel, SouthAmerica, Australia,
Canada France andEngland
ü Regulatory approvals forall major markets isexpected tobe completed byend of2018
CE MarkforEU
countries
16-Nov-16
Argentinian
Approval
Brazil andColombia
AMAR forIsrael
market
Canada CE
Australia Approval
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FDAPMA Approval
Korea and
Singapore
JapanFDA Approval
China and India
registration
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BUSINESSMODEL
§ BSTDevice isleased byclinics, hospitals and physicians tomaintain control ondevices location anduse.
§ Daysoftreatment isbeing sold bycharging forthe disposable electrodes. Electrodes designed for1,2or3
daysoftreatment.
§ Price isbased onpatient cost,considering reimbursement scheme.
§ Territories are managed byassigned distributors orbusiness partners, sharing revenues with the company
§ Strategic countries will behandled bythe company.
§ E-QURE target toposition 5000active devices byend of2018worldwide treating 20,000patients at
potential 1,000,000daysoftreatment.
§ Reaching economic break even by2019
Commencingsales in
Argentina
16-Nov-16
Marketpenetration in
Italy
Distribution agreements
in Germany
Commencingsales in
Israel
Distribution agreements
in other SouthAmerica
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Starting sales in other
selected countries
FDAPMA Approval
Commencingmarketing
activityin the USA
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USREGULATORYPATHWAY
ü Designed forPMAprocess. Nopredicate available
ü Discussions with FDAastotrial design andconduct isinfinal stages
ü Trial protocol synopsis
ü
ü
ü
ü
ü
ü
Primaryendpoints:completeclosurewithin60daysanddevicesafety.
90patientdoublearms,doubleblinded,controlledtrial.
45PatientswithBSTtreatment
45Patientswithshamplacebotreatment
Strictinclusionandexclusioncriteriatoensurehomogenouspopulation
Pressureulcers,in-patientsonlythathaveshownnoimprovementforatleast30days
ü Totalregulatory pathwayfortheBST device into 2017.
Pre -IDE
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Q-Sub
FDAMeeting
IDESubmission
Trial Approval
90Patients
Controlled, Double
Blinded, Placebo
Trial
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Trial Results
PMA Submission
FDAApproval
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REIMBURSEMENTFORESINTHEUSA
ExistingCMSReimbursementCode
•
•
•
•
HealthcareCommonProcedureCodingSystem(HCPCS)codeE0769
Reimbursementofupto$70perday
Reimbursementamounttothepatientisroughly$3,000(basedon60days)
Adjunctivetreatmenttostandardofcare(SOC) fornon-healingwounds
“TheuseofESandelectromagnetictherapyforthetreatmentofwoundsareconsidered
adjunctivetherapies,andwillonlybecoveredforchronicStageIIIorStageIVpressureulcers,
arterialulcers,diabeticulcers,andvenous stasisulcers.Chroniculcersaredefinedasulcersthat
havenothealedwithin30daysofoccurrence.ESorelectromagnetictherapywillbecovered
onlyafterappropriatestandardwoundtherapyhasbeentriedforatleast30daysandthere
arenomeasurablesignsofimprovedhealing.This30-dayperiodmaybeginwhilethewoundis
acute.”
Source:CMS
http://www.cms.gov /medic are-coverage-d atab ase/d etai ls/ncddetails.aspx?NCDId=131&ncdver=3 &DocID=270.1 &bc=gAAAAAgAAAAAAA%3D%3D&
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IP PROTECTION
USpat6,941,173 granted– 2005,Valid UntilMay2021
Claimno 1:
Amethodforthetreatmentofasore,themethodcomprisingthestepsof:(a)
situatingelectrodesinavicinityofthesoreofapatienttobetreated,and (b)
externallyinducing apercutaneous flowofelectricalcurrent betweensaid
electrodesby establishingatleastone voltagewaveformacrosssaidelectrodes,
whereinsaidatleastonevoltagewaveformincludesawaveformdesignedto
substantiallymimiccharacteristicnaturalvoltagewaveformemissionsofatleast
oneelectricallyactivesore.
https://www.google.com/patents/US6941173?dq=6,941,173&hl=en&sa=X&ei=oTdmUuziKeO4ASQ8ICgAw&ved=0CDkQ6AEwAA
USPatentformethod
oftreatment
16-Nov-16
USpatentforUlcer
diagnostic
Patentforproprietary
useofSignal
Patentfornew
generationBST
treatment
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Patentfor
combinationfor
treatmentgivenby
BSTwithothernovel
technology
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FINANCINGNEEDSFORE-QURESTRATEGY:2017– 2019
Ø FDAApproval
Ø EuropeCommercialDevelopment
Ø USAMarketPenetration
Ø SouthAmericaCommercialDevelopment
Ø AsiaRegulationandCommercialDevelopment
Ø OtherFinancialNeeds
PursueFDA
approvalinthe
U.S.Market
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Commercial
development
EuropeanMarket
EnhanceUS
reimbursement
scheme
Receive
marketing
approvalinother
markets
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USmarket
penetrationwith
strategicpartners
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MANAGEMENTTEAM
• Mr. Ron Weissberg - Chairman - Over 20 years of executive experience in the Financial industry in
companies specializing in Real Estate, Insurance, Rating & Credit Agencies, and Investment Funds. Extensive
experience in the Bio-Med industry around the world. Holds an MBA, New York University and BSc. Industrial
Engineering and Management, Cum Laude, Technion, Haifa, Israel.
• Mr. Ohad Goren - CEO – Over 20 years of experience in High-Tech and Bio-Tech Management. Former CEO
of Pollogen – Medical Device Company , Former CEO of LifeWave – Medical Device Company, Support Sales
Manager of Oracle Israel, Deputy Consul - Israel Foreign Ministry, Israeli Embassy-Washington DC. Holds a B.Sc In
Economics 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 from
Technion Haifa, and MBA, Cum Laude, Tel Aviv University , Israel.
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SCIENTIFICADVISORYBOARD
•Prof. Avi Ohry - Prof. Ohry is an expert in Rehabilitation Medicine, served as a Consultant to the Israeli Ministry
of Health, the Israeli Ministry of Defense, the Israeli Ministry of Foreign Affairs, IDF and other national and
international agencies and institutions. . From 1985-1999 he served as the director of the Department of NeuroRehabilitation ,at Sheba Medical Center, Tel Hashomer, Israel . Since 2000, he is a (full academic) Professor of
Rehabilitation Medicine at Tel Aviv University . Since 1999, he is the Chairman of the department of
Rehabilitation Medicine at Reuth Medical Center, Tel Aviv. Prof. Ohry served as Member of Biomedical Advisory
Board at LifeWave Ltd. In 2005, he was included in the project/book - “ Caring Physicians of the World “, On
behalf of the World Medical Association , as a representative of Israeli Medical Association. His main topics of
interest are: Rehabilitation Medicine, Spinal Cord Injuries, Medical humanities, history of Medicine, bio-ethics,
Polish-Jewish Medical 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. Weiner
joined the Office of the CEO and assumed the role of Chief R&D Officer. Dr. Weiner served as Group Vice
President - Global Products from April 2002 until January 2006. Previously, he served as Vice President - Research
and Development from 1986 to 2002. He received a Ph.D. in chemistry from the Hebrew University, where he
also earned B.Sc. and M.Sc. degrees. He conducted his post-doctorate research at Schering-Plough Corporation in
the United States. He was granted the Rothschild Prize for Innovation/Export two times, in 1989 for the
development of Alpha D3 for dialysis and osteoporosis patients and in 1999 for the development of Copaxone®
for multiple sclerosis.
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INVESTORINFORMATION
StateofIncorporation
Delaware
YearEnd
12/31
Symbol (OTCQB)
EQUR
RecentPrice(Nov2015)
$0.25
MarketCapitalization
~$6million
SharesOutstanding
~22million
SharesAuthorized
500million
TransferAgent
TransferOnline
Chairman oftheBoard
RonWeissberg
ChiefExecutiveOfficer
Ohad Goren
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E-QURECorp.Inc.
20West64thStreet,
Suite39G
NewYork,NY10023
https://www.e-qure.com
Phone: (972)8916-7333
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