160317 presentatie memo patch® innovation in medication adherence (bram van dijck therasolve) voor...

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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

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

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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.

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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

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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 …

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Too complex Not working 24/7 Poor privacy Limited effectiveness Need to charge battery Messaging overload &

confusion

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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

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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

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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.

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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

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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

E [email protected]

W www.therasolve.com

Partnership & Investment Information:

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