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Transcript of 160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor...
TheraSolve The Adherence Innovators
MemoPatch®- Innovation in
medication adherence
© TheraSolve 2016 - All Rights Reserved
Bram van Dijck, CEO
Health Valley Event 2016, Nijmegen
17 March 2016
1
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
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
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 bil l ion
© TheraSolve 2016 - All Rights Reserved 4
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
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
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!
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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.
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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
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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
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
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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
TheraSolve Manufacturing
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
“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
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
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
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TheraSolve The Adherence Innovators
TheraSolve NV
Agoralaan Abis
B-3590 Diepenbeek – Belgium
T +32 477 381 347
W www.therasolve.com
Partnership & Investment Information:
© TheraSolve 2016 - All Rights Reserved 16