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160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor smb meeting tijdens hve 2016

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Presentation by Bram van Dijck, CEO TheraSolve on MemoPatch, an innovation in medication adherence. Presented during Science Meets Business meeting from SMB Life Sciences during Health Valley Event 2016.

160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor smb meeting tijdens hve 2016

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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
billion
© 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

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160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor smb meeting tijdens hve 2016

  • 1. 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
  • 2. 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