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© 2018 GAIA AG
Mario Weiss, MD, MBA
Founder & CEO
GAIA
Science I Technology I Therapy
www.gaia-group.com
Digital Therapeutics (DTx) – Disruption in Healthcare
© 2018 GAIA AG
GAIA is leading the next disruption in healthcare: Digital therapeutics (DTx).
Global pioneer in R&D for digital therapeutics, 1st successful launch in 2001.
 Delivering effective and fully automated treatments/interventions for
global medical needs.
Effect sizes similar or superior to drugs or medical devices (> 12 RCTs, > 10,000 pat.)
Strong R&D with a broad product pipeline of more than 15 non-chemical
compounds
Very experienced senior R&D staff (medical, psychology/psychotherapy,
computer science, regulatory affairs, digital trial management etc.) that develops
together for over 10 years
100+ employees; privately owned by management.
1
© 2018 GAIA AG
The “4 Ps” (Patients, Physicians, Payers, Policy makers) of today expect
more.
2
Drugs & Digital Therapeutics = bridging medicine to truly global therapeutic solutions
...or, in short:
Rx + DTx = global therapeutic solutions
© 2018 GAIA AG
Can digital therapeutics be as satisfying for the patients as a personal
consultation?
Psychotherapeutic consultation
 “How would you assess the quality of
elevida® compared to ‘real therapy’ (by a
human psychotherapist)?”¹
3
Orthopaedic consultation
 “How would you rate Dr. Beck® compared
to a real physician?”²
 84% patients say Dr. Beck® provides at least as
much support as their respective physician.
 2/3 of patients who suffer from back pain
state that Dr. Beck® helped them in
overcoming the pain.
 Patients describe Dr. Beck® as helpful,
informative, and likeable.
8%
69%
15%
8%
Definitely better
Rather better
Just as well
Rather worse
Definitely worse
Cannot evaluate
 GAIA is able to develop digital therapeutics that the majority of patients like / accept as much as a
personal interaction with their physician and psychotherapist
Digital therapeutics vs. personal consultation
¹Poettgen J et al. Abstract 135. Presented at: The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress; Oct. 7-10, 2015; Barcelona.
²Internal Aribus company valuation., Richard-Merten-Grant for quality management in healthcare.
© 2018 GAIA AG
Are digital therapeutics as effective as the personal consultation with a physician
or psychotherapist?
Example: Effectiveness of GAIA’s digital therapeutic deprexis® (depression treatment)
4
 GAIA’s digital therapeutic has the same effectiveness as personal consultations - even in the most
sensitive doctor patient interaction (psychotherapy). Proven in several published RCTs.
 Availability: 24/7 on mobile devices = unmet high demand for helpful consultations can be met
 Scalability: Hardly any production and distribution costs on global scale
RCT # of Patients Effectiveness (Cohen’s d)
Meyer (2009) 396 Medium 0.639
Berger (2011) 76 Large (0.853)
Moritz (2012) 210 Medium (0.433)
Schröder (2014) 78 Small (0.220)
Fischer (2015) 90 Medium (0.425)
Meyer (2015) 163 Medium (0.570)
Klein (2016) 1,013 Medium (0.386)
Beevers (2016) 376 Large (0.816)
2,402 Medium (0.544)
Digital therapeutics vs. personal consultation
¹Barth, J., Munder, T., Gerger, H., Nüesch, E., Trelle, S., Znoj, H., ... & Cuijpers, P. (2013). Comparative efficacy of seven psychotherapeutic interventions for patients with depression: a network meta-analysis. PLoS Med, 10(5), e1001454.
Personal psychotherapy consultation (CBT) Medium (0.50¹)
© 2018 GAIA AG
 Up to 80% of all MS patients suffer from fatigue symptoms¹.
 elevida® is built on the experience and quality of 10 years of
digital therapy research and development at GAIA
 RCT completed, publication expected in Q1/2018
 The majority of patients rate the quality of elevida
as high.
 Motivated by patient and physician need, GAIA developed
elevida® as a treatment option against fatigue in MS.
5
1 The National Multiple Sclerosis Society; online at nationalmsssociety.org from MAR 18th 2014
How would you assess the quality of
elevida compared to „real therapy“
(by a human psychotherapist)?
8%
69%
15%
8%
Definitely better
Rather better
Just as well
Rather worse
Definitely worse
Cannot evaluate
N=120
Product view – elevida®
elevida®: A digital therapeutic against fatigue – probably the major burden for
patients with multiple sclerosis (MS)
© 2018 GAIA AG
Results of ELEVIDA trial presented at the ECTRIMS
 ELEVIDA group shows significantly more
reduction in MS fatigue (ITT) measured by
Chalder fatigue scale after 3 and 6 months (-
4.5 / -4.7 points change on the Chalder Scale,
3 points = MCIC according to Chilcot et al.
2015)
 ELEVIDA group also reported significantly
improvements in anxiety and subjective
cognitive impairment
6
Chalder – pre/post / follow up, multiple imputation ANOVA
Randomized controlled trial , N=224
Focus on external validity: elevida® on top of standard care
vs standard care (control)
Details
Product view – elevida®
© 2018 GAIA AG
Results of ELEVIDA – Secondary Outcomes
 Significantly more reduction in MS fatigue
after 3 and 6 month
 Significantly more activity in daily life after 3
and 6 month
7
Fatigue Scale for Motor and Cognition (FSMC)
Frenchay Activity Index (FAI)
Product view – elevida®
© 2018 GAIA AG
velibra®: Aimed at patients suffering from anxiety disorders as primary diagnosis
or as one of the most common comorbidities for almost all chronic conditions.
 Based on scientific and therapeutic state of the art approaches
including:
 Individualised and evidence-based digital therapeutic for
patients with:
 Generalised anxiety disorder (primary or comorb.)
 Social phobia (primary or comorb.)
 Panic disorders (primary or comorb.)
 Transdiagnostic CBT model (Barlow)
 Mindfulness & acceptance (ACT, Hayes et al.),
 Self-compassion (Gilbert)
 Mental imagery (Holmes)
 Cognitive bias modification for interpretation (CBM-I; Holmes)
8
Product view – velibra®
 CE certification, FDA approval to be expected in 2018 latest
© 2018 GAIA AG
PI: Thomas Berger
GAIA independent RCT: Funded by the Swiss National Science Foundation
RCT: velibra® demonstrates high effectiveness and safety.
9
• Reliable effects on
several validated
anxiety measures
• Effects stable over
time
• High patient
satisfaction
• N = 139
• All diagnoses
confirmed by MD
“Healed”/Recovered: patients who no longer fulfilled
diagnostic criteria at post-treatment (i.e., recovery):
 Social phobia: 28.2% in velibra group vs. 4.7% in the
control group
 Panic disorder: 38.3% in the velibra group vs. 9.8%
in the control group
 Generalized anxiety disorder: 44.8% in the velibra
group vs. 0% in the control group.
 All these differences were statistically significant at
the p < .01 level.”
Product view – velibra®
© 2018 GAIA AG
Beside effectiveness and safety velibra® is well accepted by patients.
10
Product view – velibra®
Client Satisfaction
(Client Satisfaction Questionnaire; CSQ-8)
very
satisfied
somewhat
satisfied
somewhat
unsatisfied
dissatisfied
Mean: 3.19
(0.51)
Berger et al. (2016, Psychological Medicine):
“velibra is effective and significantly reduces anxiety among patients with anxiety disorders
(generalized anxiety disorder, panic disorder or social phobia)”
© 2018 GAIA AG
In addition to our own research activities, GAIA is cooperating with leading
scientific institutions in the development and evaluation of our digital
therapeutics.
11
Selection of R&D cooperation projects:
 HORIZON 2020: EU grant that is evaluating the
possibilities to combine GAIA products with
“wearable sensors”.
 IDEMS (MS society supported): Evaluating the
effects of deprexisMS® in the US and Europe.
 REACT: Evaluating the effect of Optimune® on
breast cancer patients.
 Healthy Metropolis: Evaluating the impact of
various GAIA software products in routine care.
Supported by the German Ministry of Health.
© 2018 GAIA AG
 Complex cognitive-functional interventions to modulate brain
functions and thought processes
 Individualised: Tailored provision of information and exercises based
on continuous identification of the patient’s needs and emotional
situation
 In-depth collection of individual patient data to trigger further
research and patient interaction
 Input from wearables used to drive further content and user
interaction
 100% mobile and cloud-based: for global 24/7 usage on any
connected device (PC, tablet, smartphone)
GAIA’s Artificial Intelligence (AI) software broca®4 simulates behavioral medicine
treatments otherwise delivered by empathetic physicians/therapists.
The “engine” for our digital therapeutics
12
Technologically supported by the Airbus Group
© 2018 GAIA AG13
Interested in partnering with us to build the bridge to the future of health care?
We are looking for…
…partners in the fields of
 Oncology
 Immunology
 Dermatology
 CNS
 Pain(management)
…we are open for licensing coorporations
and various forms of R&D partnerships
MARIO WEISS, MD, MBA
mario.weiss@gaia-group.com
Twitter: @mario_weiss
LinkedIn: Mario WeissFollow us:
LinkedIn: GAIA AG
Twitter: @GAIA_COM
www.gaia-group.com

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Digital Therapeutics (DTx) - Disruption in Healthcare

  • 1. © 2018 GAIA AG Mario Weiss, MD, MBA Founder & CEO GAIA Science I Technology I Therapy www.gaia-group.com Digital Therapeutics (DTx) – Disruption in Healthcare
  • 2. © 2018 GAIA AG GAIA is leading the next disruption in healthcare: Digital therapeutics (DTx). Global pioneer in R&D for digital therapeutics, 1st successful launch in 2001.  Delivering effective and fully automated treatments/interventions for global medical needs. Effect sizes similar or superior to drugs or medical devices (> 12 RCTs, > 10,000 pat.) Strong R&D with a broad product pipeline of more than 15 non-chemical compounds Very experienced senior R&D staff (medical, psychology/psychotherapy, computer science, regulatory affairs, digital trial management etc.) that develops together for over 10 years 100+ employees; privately owned by management. 1
  • 3. © 2018 GAIA AG The “4 Ps” (Patients, Physicians, Payers, Policy makers) of today expect more. 2 Drugs & Digital Therapeutics = bridging medicine to truly global therapeutic solutions ...or, in short: Rx + DTx = global therapeutic solutions
  • 4. © 2018 GAIA AG Can digital therapeutics be as satisfying for the patients as a personal consultation? Psychotherapeutic consultation  “How would you assess the quality of elevida® compared to ‘real therapy’ (by a human psychotherapist)?”¹ 3 Orthopaedic consultation  “How would you rate Dr. Beck® compared to a real physician?”²  84% patients say Dr. Beck® provides at least as much support as their respective physician.  2/3 of patients who suffer from back pain state that Dr. Beck® helped them in overcoming the pain.  Patients describe Dr. Beck® as helpful, informative, and likeable. 8% 69% 15% 8% Definitely better Rather better Just as well Rather worse Definitely worse Cannot evaluate  GAIA is able to develop digital therapeutics that the majority of patients like / accept as much as a personal interaction with their physician and psychotherapist Digital therapeutics vs. personal consultation ¹Poettgen J et al. Abstract 135. Presented at: The European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress; Oct. 7-10, 2015; Barcelona. ²Internal Aribus company valuation., Richard-Merten-Grant for quality management in healthcare.
  • 5. © 2018 GAIA AG Are digital therapeutics as effective as the personal consultation with a physician or psychotherapist? Example: Effectiveness of GAIA’s digital therapeutic deprexis® (depression treatment) 4  GAIA’s digital therapeutic has the same effectiveness as personal consultations - even in the most sensitive doctor patient interaction (psychotherapy). Proven in several published RCTs.  Availability: 24/7 on mobile devices = unmet high demand for helpful consultations can be met  Scalability: Hardly any production and distribution costs on global scale RCT # of Patients Effectiveness (Cohen’s d) Meyer (2009) 396 Medium 0.639 Berger (2011) 76 Large (0.853) Moritz (2012) 210 Medium (0.433) Schröder (2014) 78 Small (0.220) Fischer (2015) 90 Medium (0.425) Meyer (2015) 163 Medium (0.570) Klein (2016) 1,013 Medium (0.386) Beevers (2016) 376 Large (0.816) 2,402 Medium (0.544) Digital therapeutics vs. personal consultation ¹Barth, J., Munder, T., Gerger, H., Nüesch, E., Trelle, S., Znoj, H., ... & Cuijpers, P. (2013). Comparative efficacy of seven psychotherapeutic interventions for patients with depression: a network meta-analysis. PLoS Med, 10(5), e1001454. Personal psychotherapy consultation (CBT) Medium (0.50¹)
  • 6. © 2018 GAIA AG  Up to 80% of all MS patients suffer from fatigue symptoms¹.  elevida® is built on the experience and quality of 10 years of digital therapy research and development at GAIA  RCT completed, publication expected in Q1/2018  The majority of patients rate the quality of elevida as high.  Motivated by patient and physician need, GAIA developed elevida® as a treatment option against fatigue in MS. 5 1 The National Multiple Sclerosis Society; online at nationalmsssociety.org from MAR 18th 2014 How would you assess the quality of elevida compared to „real therapy“ (by a human psychotherapist)? 8% 69% 15% 8% Definitely better Rather better Just as well Rather worse Definitely worse Cannot evaluate N=120 Product view – elevida® elevida®: A digital therapeutic against fatigue – probably the major burden for patients with multiple sclerosis (MS)
  • 7. © 2018 GAIA AG Results of ELEVIDA trial presented at the ECTRIMS  ELEVIDA group shows significantly more reduction in MS fatigue (ITT) measured by Chalder fatigue scale after 3 and 6 months (- 4.5 / -4.7 points change on the Chalder Scale, 3 points = MCIC according to Chilcot et al. 2015)  ELEVIDA group also reported significantly improvements in anxiety and subjective cognitive impairment 6 Chalder – pre/post / follow up, multiple imputation ANOVA Randomized controlled trial , N=224 Focus on external validity: elevida® on top of standard care vs standard care (control) Details Product view – elevida®
  • 8. © 2018 GAIA AG Results of ELEVIDA – Secondary Outcomes  Significantly more reduction in MS fatigue after 3 and 6 month  Significantly more activity in daily life after 3 and 6 month 7 Fatigue Scale for Motor and Cognition (FSMC) Frenchay Activity Index (FAI) Product view – elevida®
  • 9. © 2018 GAIA AG velibra®: Aimed at patients suffering from anxiety disorders as primary diagnosis or as one of the most common comorbidities for almost all chronic conditions.  Based on scientific and therapeutic state of the art approaches including:  Individualised and evidence-based digital therapeutic for patients with:  Generalised anxiety disorder (primary or comorb.)  Social phobia (primary or comorb.)  Panic disorders (primary or comorb.)  Transdiagnostic CBT model (Barlow)  Mindfulness & acceptance (ACT, Hayes et al.),  Self-compassion (Gilbert)  Mental imagery (Holmes)  Cognitive bias modification for interpretation (CBM-I; Holmes) 8 Product view – velibra®  CE certification, FDA approval to be expected in 2018 latest
  • 10. © 2018 GAIA AG PI: Thomas Berger GAIA independent RCT: Funded by the Swiss National Science Foundation RCT: velibra® demonstrates high effectiveness and safety. 9 • Reliable effects on several validated anxiety measures • Effects stable over time • High patient satisfaction • N = 139 • All diagnoses confirmed by MD “Healed”/Recovered: patients who no longer fulfilled diagnostic criteria at post-treatment (i.e., recovery):  Social phobia: 28.2% in velibra group vs. 4.7% in the control group  Panic disorder: 38.3% in the velibra group vs. 9.8% in the control group  Generalized anxiety disorder: 44.8% in the velibra group vs. 0% in the control group.  All these differences were statistically significant at the p < .01 level.” Product view – velibra®
  • 11. © 2018 GAIA AG Beside effectiveness and safety velibra® is well accepted by patients. 10 Product view – velibra® Client Satisfaction (Client Satisfaction Questionnaire; CSQ-8) very satisfied somewhat satisfied somewhat unsatisfied dissatisfied Mean: 3.19 (0.51) Berger et al. (2016, Psychological Medicine): “velibra is effective and significantly reduces anxiety among patients with anxiety disorders (generalized anxiety disorder, panic disorder or social phobia)”
  • 12. © 2018 GAIA AG In addition to our own research activities, GAIA is cooperating with leading scientific institutions in the development and evaluation of our digital therapeutics. 11 Selection of R&D cooperation projects:  HORIZON 2020: EU grant that is evaluating the possibilities to combine GAIA products with “wearable sensors”.  IDEMS (MS society supported): Evaluating the effects of deprexisMS® in the US and Europe.  REACT: Evaluating the effect of Optimune® on breast cancer patients.  Healthy Metropolis: Evaluating the impact of various GAIA software products in routine care. Supported by the German Ministry of Health.
  • 13. © 2018 GAIA AG  Complex cognitive-functional interventions to modulate brain functions and thought processes  Individualised: Tailored provision of information and exercises based on continuous identification of the patient’s needs and emotional situation  In-depth collection of individual patient data to trigger further research and patient interaction  Input from wearables used to drive further content and user interaction  100% mobile and cloud-based: for global 24/7 usage on any connected device (PC, tablet, smartphone) GAIA’s Artificial Intelligence (AI) software broca®4 simulates behavioral medicine treatments otherwise delivered by empathetic physicians/therapists. The “engine” for our digital therapeutics 12 Technologically supported by the Airbus Group
  • 14. © 2018 GAIA AG13 Interested in partnering with us to build the bridge to the future of health care? We are looking for… …partners in the fields of  Oncology  Immunology  Dermatology  CNS  Pain(management) …we are open for licensing coorporations and various forms of R&D partnerships MARIO WEISS, MD, MBA mario.weiss@gaia-group.com Twitter: @mario_weiss LinkedIn: Mario WeissFollow us: LinkedIn: GAIA AG Twitter: @GAIA_COM www.gaia-group.com