Ebers is a startup specialized in diabetic foot care and prevention. Our principal solution are smart insole that combines pressure, temperature and humidity measure with algorithm to alert early for any risk to diabetic patients.
2. [1] https://www.who.int/mediacentre/news/releases/2005/pr61/en/
Who we are
Ebers is a startup specialized in
diabetic foot care and prevention.
Our principal solution are smart
insole that combines pressure,
temperature and humidity measure
with algorithm to alert early for any
risk to diabetic patients.
The WHO establish that early
detection of foot problem
reduce 80% of amputation.1
80%
3. 2
Estimating the prevalence of limb loss in the United States: 2005 to 2050. Ziegler-Graham K1, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R.
3
Management of Diabetic Foot Ulcers. Kleopatra Alexiadou, John Doupis
4
Note méthodologique et de synthèse documentaire « Comment prévenir les réhospitalisations d’un patient diabétique avec plaie du pied ? ».
The Problem
ONLY BEHIND TRAUMATIC AMPUTATION.2
2º
amputation
cause
worldwide
2º
amputation
cause
worldwide
SENSIBILITY LOOSE
BECAUSE OF DIABETIC NEUROPATHY
IRRIGATION PROBLEM
CAUSED TO BAD SUGAR CONTROLS
OF DIABETICS HOSPITALIZATION
ARE DUE TO FOOT PROBLEM4
15-25%15-25%
LATE RESPONSE BY PATIENT AND DOCTOR
IN FRANCE THE COST FOR
AMPUTATIONS IN 2008 WAS ESTIMATED
AT 325 MILLION EUROS4
4. 17 PRESSURE
SENSORS
3 TEMPERATURE
SENSORS
Smart Insoles
Our insoles has a specialized sensor distribution
after one year probing it with patients and doctors.
After recollect data our application process and
compare this information with risk patterns.
Our algorithm combine the measures with times, risk
zones, walk patterns, etc. to determine if there is a
risk and how dangerous it is. In this way we give a
recommendation to the user.
5. Ebers Workflow
1 2
VS
3 4 5
COLLECT DIFFERENT
DATA FROM FOOT
PRESSURE POINTS
TEMPERATURE IN
SPECIAL ZONES
TIMES AND GAIT
ANALYSIS
TO COMPARE:
NORMAL PARAMETERS
HISTORICAL PATIENT
RECORDS
CREATE A USER
FOOT PROFILE
DAILY
RECOMMENDATIONS
INSTANT
ALERTS
DOCTOR NOTIFICATIONS
CLINICAL RECORDS
NUMBER OF ANOMALIES
6. Diabetes Foot Care Costs
THE COST OF THE
DIABETIC FOOT PER
PERSON DEPENDING
THE STAGE
IT IS THE COST ESTIMATED OF
AMPUTATIONS IN 20085
€1000-
20000
€325mm€325mm
5
Note méthodologique et de synthèse documentaire « Comment prévenir les réhospitalisations d’un patient diabétique avec plaie du pied ? ». Haute Autorité de santé novembre 2014. Cap. 2 Pag. 10.
6
Note méthodologique et de synthèse documentaire « Comment prévenir les réhospitalisations d’un patient diabétique avec plaie du pied ? ». Haute Autorité de santé novembre 2014. Cap. 2 Pag. 11.
THE COST PER
AMPUTATION IN 20056
€32000
Diabetes is not only a
social problem, it is also
extremely costly for health
system of all countries
and France is not the
exception.
VS
7. Market Analysis
IT’S EXPECTED TO BE THE
WORLDWIDE MARKET GROWTH
OF DIABETIC FOOT ULCERS AND
PRESSURE ULCERS BETWEEN 2016
AND 2024.
WILL REACH THE MARKET’S
VALUATION BY THE END OF 2024
SUFFERING FROM THIS PROBLEM
6.6-11%
1MM
THE TOTAL MARKET SIZE
€185MM
2015 - Diabetic foot market share Transparency Market Research.
2.8US Bn market
NORTH AMERICA
EUROPE
ASIA-PACIFIC
LATIN AMERICA
MIDDLE EAST AND AFRICA
Millons $194,00
Millons $267,00
Millons $523,50
Millons $805,30
Millons $1.064,00
https://www.who.int/diabetes/en/
US$4.9bn
8. Competitors - Global
MOVESOLE SIREN.CARE BONBOUTON EBERS
PRESSURE CONTROL
TEMP CONTROL
INSTANT ALERTS
PATIENT INFORMATION
DOCTOR INFORMATION
INSTANT MEDICAL ASSESSMENT
COMPACT PRODUCT
POSSIBILITY OF COMBINE
ORTOPHEDIC INSOLE
LONG TERM PREDICTION
COST No published price 20USD suscription No published price 150-200USD
MARKET
Nº SENSOR
Finland EEUU EEUU LatinAmerica-Europe
5 6 3 20
9. Competitors - France
NOT SPECIAL
FOR DIABETICS
A CANADIAN INSOLE THAT PARTNERSHIP
WITH ONDU - SANOFI PLATFORM
https://orpyx.com/orpyx-partners-with-onduo-to-offer-foot-ulcer-prevention-sensor-as-part-of-virtual-diabetes-program/
10. SHORT TERM ANALYSIS LONG TERM PREDICTION
Main Difference
6-8 MONTH STUDIO
HIGH SENSORS DENSITYTHAT ALLOWS US TO STUDY
BIOMECHANICS IN A MORE COMPLEX AND LONG-TERM WAY
THAN THE COMPETITION.
+300.00 BIOMECHANICS STUDIES COMBINED IN THE TEAM.
VS
11. Our product is classified as a Class I. This is really important because the regulatory
process is simpler as also the commercialization strategy
Normatives to sell our product in Europe
Regulatory Roadmap
DESIGN / PLANNING
COMPLEMENT QMS (ISO 13485)
COMPLEMENT TECHNICAL FILE (CER,
ESSAYS, IFUs, LABELING)
CONTRACT AN EC REP
HIRING A NOTIFYING AGENCY
CLASSIFY MD
DEFINE SPECIFIC REQUIREMENTS FOR MDR
SELECT ROUTE FOR CONFORMITY
EVALUATION
DESIGN ACTION PLAN
INITIAL AUDIT
SIGN DOC AND CE MARKING IN MD
REGISTER MD IN EUDAMED
IMPLEMENTATION EVALUATION
Quality management system
• ISO 13485
Risk management
• ISO 14971
Active medical device
• EN 60601-1
• EN 60601-1-2
Software
• EN 62304
• EN 62366
Insoles materials and design
• EN 62366
• ISO 10993-1
Insoles materials and design
• EN 62366
• ISO 10993-1
Manufacturer information
• EN 1041
• ISO 15223-1
Cybersecurity
GDPR
Document
52017PC0477R
MD: Medical Devices - MDR: Medical Device Regulation - QMS: Quality Management System - NO: Notified Organism - EC REP: Authorized Representant - CER: Clinical Evaluation Report - IFUs: Instruction For Use
12. Go To Market Strategy
As we know, the regulation process is complex and takes time,
so we partnered with Apexar
APEXAR IS AN ARGENTINIAN MEDICAL DEVICE COMPANY
WHICH IS GOING TO BE OUR CERTIFIED MANUFACTURER.
IT IS A STRATEGIC PARTNER THAT ALLOWS US TO
FACILITATE THE PRODUCTIVE AND REGULATORY PROCESS
TO LOWER UNCERTAINTY AND REACH THE MARKET IN A
SIMPLER AND FASTER WAY.
13. Commercial Strategy
• Pharmacy
• Medical device store
• Pharmacy
• Medical device store
• Supermarket
• All kind of market
• Visit doctors to make
prescription
• Visit pharmacist to
explain the product
• Visit pharmacist to
explain the product
• Make a lot of
communication for patien
and medical person
SELLING PLACE
STRATEGY
PUBLIC
HEALTH
INSURANCE
(STATE)
REFUND
PRIVATE
HEALTH
INSURANCE
REFUND
YES YES
NO
NO
14. B2C Business Model
Product And Service Model
• FREE APLICATION USE FOR
1 PERSON AND 1 DOCTOR
• AUTOMATIC ALERTS
• DATA SYNCHRONIZATION
• LOWER INITIAL
PURCHASE COST
PRODUCT SERVICE - MONTHLY SUBSCRIPTION
1 YEAR
+ ASSOCIATED SERVICES: DOCTOR 24 HOURS A DAY,
CONSULTATIONS AT THE MOMENT, AMONG OTHERS
60€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
10
€
180€
annually
15. Clínica Santa Catalina
Neurorehabilitiación
Clínica
To fulfill our objectives it is essential to
work with prestigious institutions that
endorse our path and support us in
the different aspects of the project.
• Today we are incubated within the
Argentine Foundation of
Nanotechnology surrounded by an
ecosystem of technological startups
of international level.
• Apexar Technologies is a medtech
that is partner with us in the
production and regulatory strategy.
• We also work with prestigious
hospitals in the country such as the
Hospital Italiano from Buenos Aires
and we are going to start working
with the Israelite Albert Einstein
Hospital in Brazil.
Our Partners
16. Ebers + Biogaran
Biogaran shares with Ebers
the struggle to improve the
lives of people by adding
value to their daily life.
Diabetes is a global problem,
which increasingly causes
more complications in
millions of people and we
can fight it together.
For Ebers to be able to work
with a company with the
knowledge and experience of
Biogaran is a before and after,
as it was this first month
working with our mentors.
Undoubtedly it is a possibility to
continue growing and showing
that technology is changing the
way medicine is made.
WE ARE CONFIDENT THAT
WORKING TOGETHER WE ARE
CLOSER TO MEETING OUR
GOAL OF PROVIDING A
UNIQUE SOLUTION TO
COMBAT AMPUTATIONS.
17. Our startup is supported by multiple
institution around the globe.
This support is fundamental to
continue growing and let us work with
specialist from different areas.
We receive different supports, from
technical to financial and also from
business creation from institution like
entrepreneurs organization.
All this achievement were only in the
last year. For this we spect to start
clinical trial and normative probation
in Argentina and start it in Europe.
Awards and
International Recognition
We already won this prizes
18. Road Map
MAR 2019
WERE WE ARE NOW?
JUN 2019
START REGULATORY
PROCESS
OCT 2019
END OF FINAL
PRODUCT DESIGN
JUN 2020
CLINICAL RESULTS
OCT 2020
MARKET LAUNCH
• Validating the 20
prototypes for final tests
• Looking for strategic
partnership in Brazil and
Europe
• Planification and
beginning of final
product design
• Begin the documents for
clinical trials
• Begin the regulatory
process in Argentina and
Europe
• Present files before the
necessary authorities
• Find the investment
needed for this stage
• Finish insole design to
complete all regulatory
process
• Start first product
manufacturing
• Analyze the results of
the clinical tests.
• Finalize the regulatory
process in Argentina and
Europe
• Search distributors in
Europe
• Start product sale in
Argentina and possibly in
France and Spain
19. NEGRI MARIANO
MBA - COLUMBIA UNIVERSITY
BIANCOTTI PAOLO
BUSINESS MANAGER - UNC
MENTOR
Team
Advisors
VILLARES BERNARDO
INDUSTRIAL DESIGNER - UNLP
NOYA FACUNDO
BIOMEDICAL ENG. - UNC
CARRASCO MARINA
UCLA-UBA MEDICAL SPECIALIST
IN FOOT AND ANKLE SURGERY
ALEJANDRO THALASSELIS
BIOMECHANICS SPECIALIST
RUIZ CAMILA
BIOMEDICAL ENG. - UNSAM
CAPRICCIO FLORENCIA
SOCIAL SCIENCE - UNC
20. Thank youINNOVATION FOR YOUR FEET
ebers.com.ar
info@ebersmed.com
+5493517055265
/ebersinsole