Contenu connexe Similaire à 160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor smb meeting tijdens hve 2016 (20) 160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor smb meeting tijdens hve 20162. Key
Information
1. Company
2. Therapy Non-Adherence
3. MemoPatch®Technology
4. Patient Benefits
5. Taylor to Therapy
6. Manufacturing
7. Clinical Development
8. Go-to-Market Roadmap
9. Business Model
10. Learnings of this start-up
11. Key Deliverables
12.TheraSolve on TV
© TheraSolve 2016 - All Rights Reserved 2
3. MemoPatch® is an innovative reminder
patch product to improve medication
adherence. Our technology is patient-
centric, simple, reliable and discreet.
Business Opportunity
High unmet need: despite e-health and
other solutions many patients still
forget to take their drugs timely.
Therapy non-adherence is a significant
problem resulting in medical burden for
patients and lost revenues for Pharma.
Product Solution
About
TheraSolve
TheraSolve is preparing a series B-
round to develop its technology to
market introduction, expand the
portfolio, and realize an exit.
Building Success
The innovative company with a
focus on medication adherence.
© TheraSolve 2016 - All Rights Reserved 3
4. Non-Adherence to Therapy
PREVALENCE FORGETFULNESS COST DEATHS
Estimated direct cost
annually worldwide.
On average,
50% of prescription
medications aren’t
taken as directed.
Estimated deaths in the
US caused by non-
adherence annually.
In 64% of cases people
cite forgetfulness as
major cause of non-
adherence to therapy.
50% 64%
Huge Impact
125,000+$100
billion
© TheraSolve 2016 - All Rights Reserved 4
5. PRIVACY POLICY
Has superior
significance
Your data will be deleted
immediately on request
There will be no transfer
of your data to third
parties
Your data will be treated
with the utmost care
and discretion
Our data protection
officer will respond
to all your questions
and concerns
DESPITE SYSTEMS
LIKE …
MANY PATIENTS
STILL FORGET …
© TheraSolve 2016 - All Rights Reserved
Too complex
Not working 24/7
Poor privacy
Limited effectiveness
Need to charge battery
Messaging overload &
confusion
5
6. MemoPatch®
Technology
MemoPatch® Backing with
Skin Adhesive
Developed for low-cost
mass production with
pharma quality.
Proprietary technology
protected by granted
patents and internal know-
how.
Fully automated pre-
programmed patch brings
optimal patient support.
2 years shelf life. No battery
to be charged.
Battery
Custom made
Microchip
Flexible Release
Liner
Full tactile signal
100% Silent
100% Invisible
Core Technology
Micro-electronics
Waterproof Pastille
Automatic Start
& Skin Detection
© TheraSolve 2016 - All Rights Reserved 6
Simple – Small – Smart
7. Patients
Benefit
© TheraSolve 2016 - All Rights Reserved - Confidential
MemoPatch® Features MemoPatch® Patient Benefit Alternatives (e.g., SmartPhone)
Fully automated, ‘button-free’ and pre-
programmed
User-friendly, Simple and Reliable Still too complex for many patients including
elderly in the real world setting
Self-adhesive, 24/7 active Works Anywhere, Anytime Not always in contact with or in close reach
of the user
100% tactile and discrete reminder signals* Minimally Invasive to Daily Life Classic audible, visual, vibration signals
=> privacy & effectiveness
Unique signals, no confusion with other
audible/visual signals
Fully Dedicated Medication Reminder Signal Multiple classic signals lead to messaging
overload and confusion
Ultra low power technology. No battery to
be charged, Just ‘Stick and Play’
Low Effort, High Benefit Batteries need to be charged far too often.
Low shelf life, low active life time
Combine/ Integrate with various drug
delivery forms, including transdermals
Treatment Solution Package offers optimal
patient support
Limited solution options
* MemoPatch® innovative reminder technology also supports elderly, hard of hearing,
and visual impaired patients!
7
8. Versatile MemoPatch® Technology
Multiple Programming Options congruent with Therapy Needs
“Pre-Programmed” Drug-MemoPatch® Packages:
=> MemoPatch® is fully pre-programmed at the patch
production site in line with the supported drug regimen (e.g.,
QD, BID, .., QxH).
Tailorable
To Therapy
© TheraSolve 2016 - All Rights Reserved - Confidential
“Customized” Programming and Applications:
=> MemoPatch® is programmed by the care provider, pharma
company, CRO or pharmacist congruent with the application
needs or physician’s prescription (e.g., 7am, 1pm, 6pm, 11pm).
Dedicated programming device currently used
in the Flanders’ care Pharmacists study.
8
9. Flexible Patch Electronics
Manufacturing
Status
© TheraSolve 2016 - All Rights Reserved
From Pilot Batch to High
Volume Production
Key Expertise Domains:
Electronics Core Tech
production partner
+
MemoPatch® assembly
and packaging partner
Subcontractors
Selected (Q1/16)
Product batch (25k) for use in Pilot
Programs with Pharma / Healthcare
in support of:
- Selected candidate drugs
- Targeted patient groups
Production Pilot
Batch (Q3/16)
Commercial Upscaling
(Q1/17)
High Volume Production and Pre-
Programming:
- Drug + MemoPatch® solutions
- Commercial treatment package
9
10. TS-104
N = 50
TS-201
Clinical
Development
TS-203
TheraSolve developed and validated
MemoPatch® reminder signals in 3
subsequent scientific studies with
hundreds of healthy volunteers, and
partners with Flemish Pharmacists in
the first MemoPatch® patient study.
Study in Senior Patients - Age 55+
TS-103
N =147
Studies in Healthy Adult Volunteers - Age 18-75
N = 146 N = 50 (recruitment ongoing)
5 effective and safe candidate
bi-polar signals selected.
Signals virtually independent
from patients biometrics.
Pulse Confirmation and Feedback
Study (autonomous PCB prototype
patches over 48 hours in real life
conditions.
Very high adherence rates i.e.,
SMS confirmation rates. Short
response times to reminder
signals.
High acceptability, satisfaction.
Good safety profile.
Pulse Optimization Studies (in laboratory using wired PCB patches
connected to external pulse generator device).
1 split bi-polar signal effective,
safe and appropriate identified.
Signals virtually independent
from patients biometrics.
Adherence Study (microchip
MemoPatches - 8 weeks in real
life conditions. Patient population
with various indications and
intake schedules.
This patient study is executed
in collaboration with the
Flemish Pharmacists. Results
are expected in Q3 2016.
Study papers published. Copy upon request. Pre-publication. Info under NDA. Study ongoing. Info under NDA.
© TheraSolve 2016 - All Rights Reserved 10
11. Go-to-Market
Roadmap
© TheraSolve 2016 - All Rights Reserved
Therapy Areas
Parkinson’s
Alzheimer’s
Epilepsy
OAB
HCV – HIV
Post-transplant
Oncology
…
Q2-Q3 2016
CE Mark
Small batch
Q3-Q4 2016
25k batch
and Pharma
Pilot
Q1 2017
Commercial
Application
Advanced BD Discussions with
Pharma Companies
Transdermal Companies
High Tech Companies
Deaf and Hearing Impaired Organization
Granted Patents in Key Markets
Europe
United States & Canada
Japan
China
India
11
12. Customers
Pharma Company:
Buy MemoPatch
Distribution, marketing
and sales.
TDS Company:
Buy MemoPatch Core
Co-develop / Integrate
1. Partnering / Licensing Agreements between TheraSolve and
its Pharma / TDS Customers as of 2016
2. Exit under consideration in 2017
Business
Model
End-Users
Patients that need Rx
adherence support
TheraSolveManufacturing
MemoPatch device
assembly partner
Electronic Core Tech
production partner
Owner of MemoPatch
Owner of MemoPatch
Core Technology
= “Standard MemoPatch“
= “Transdermal MemoPatch“
Patients that need
Transdermal Patch
adherence support
© TheraSolve 2016 - All Rights Reserved 12
13. “Never a dull moment”
Own experience ----> forget to take Rx----> device: no escape on remembering
Solution should be ----> simple- discreet- reliable
Challenges:
Small & fully automated device (microchip) ----> cross of IT & Pharma skills
In-house expertise = brains & outsourcing development = parts
Project funding
Deliver proof of concept
From design to manufacturability
Long lead times in pharma/ medtech business development
Manage expectations of VC funds/ Investors
© TheraSolve 2016 - All Rights Reserved - Confidential
Learnings of this start-up
13
14. PRODUCT DELIVERABLE
2016 2017 2018
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
“MemoPatch”
Patient Data
CE Label
Submission to FDA
1st Pharma Partnership
2nd Pharma Partnership
Go to Market > 2017
“Transdermal”
TDS Co-develop. Partner
Prototypes
Fulfill Reg./BioEquiv. Subm.
Go to Market > eo 2018
“Next Gen”
Concept Dossier
Tech Company Partner
Prototypes
Key
Deliverables
to Success
© TheraSolve 2016 - All Rights Reserved 14
15. TheraSolve in the spotlight at Life Tech Valley
January 2016
Life Tech Valley, a cluster organization of bio- and medtech companies and knowledge
institutions located in Belgian Limburg, is boosting life sciences and healthcare
development in the field of Healthy Aging.
TheraSolve's new MemoPatch® technology is a huge opportunity for senior patients
to stay longer independent and comply with their prescribed pharmaceutical
treatment regimens.
TV Limburg made a small introduction film about the companyTheraSolve and its
smart patch technology.
© TheraSolve 2016 - All Rights Reserved - Confidential
TheraSolve on TV
15
16. TheraSolve
The Adherence Innovators
TheraSolve NV
Agoralaan Abis
B-3590 Diepenbeek – Belgium
T +32 477 381 347
E bvd@therasolve.com
W www.therasolve.com
Partnership & Investment
Information:
© TheraSolve 2016 - All Rights Reserved 16