aclaris medical i-corps@nih 12-10-2014

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Wearable monitoring system to increase patient compliance and improve success rate of PTSD therapy Mark Bly Kent Lee Imad Libbus Founder Industry Expert Principal Investigator Mechanical Eng, MBA Biomedical Eng, MBA Biomedical Eng, PhD 12 yrs industry experience 13 yrs industry experience 12 yrs industry experience Team #2 Total Customer Interviews: 125 (80 facetoface)

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Page 1: Aclaris medical I-Corps@NIH 12-10-2014

Wearable monitoring system to increase patient compliance and improve success rate of PTSD therapy

Mark Bly Kent Lee Imad LibbusFounder Industry Expert Principal Investigator

Mechanical Eng, MBA Biomedical Eng, MBA Biomedical Eng, PhD12 yrs industry experience 13 yrs industry experience 12 yrs industry experience

Team #2

Total Customer Interviews: 125 (80 face‐to‐face)

Page 2: Aclaris medical I-Corps@NIH 12-10-2014

Existing PTSD Therapy 

• Re‐imagine traumatic triggers

• PTSD best treated by de‐sensitization to triggers

Image Source: The Hurt Locker (2008)

I don’t wantto experience this 

again

• No objective way to track engagement 

• Poor compliance, high drop‐out rate

Page 3: Aclaris medical I-Corps@NIH 12-10-2014

Wearable Monitoring System

Wrist Monitor

Smart phone or tablet

Cloud

Smart phone or tablet

Patient

Therapist

Page 4: Aclaris medical I-Corps@NIH 12-10-2014

Week 1 Canvas

Page 5: Aclaris medical I-Corps@NIH 12-10-2014

Customer Segments – VA/DOD psychologists appear to be initial customer segment

VA/DOD PTSD Psychologists (n=10)

VA/DOD Non‐PTSD Psychologists (n=5)

Community Psychologists (n=4)

Hypothesis:• Room for improvement in 

PTSD treatment and therapy compliance

Experiments:• Does improving 

compliance make a clinical difference?

Results/Next Steps• Therapy compliance and 

dropout limits PTSD improvement

• Potential first customer

Hypothesis:• Physiological monitoring 

is useful to other psychologists

Experiments:• What is the compliance 

of other therapies? • Other non‐PTSD pts?

Results/Next Steps• New segment ‐ Pain 

and anxiety disorders • Compliance and 

dropout are issues• Need more data

Hypothesis:• PTSD patients are 

treated in a community setting

Experiments:• What type of patients 

do community psychologists treat?

Results/Next Steps• Not focused on PTSD 

patients• Limited funds for new 

technology• Ignore for now

Page 6: Aclaris medical I-Corps@NIH 12-10-2014

“Prolonged exposure needs to be used more. 50% of patients drop out because it’s too intense, but those who finish therapy do better.”

“Decreasing dropout and increasing patient compliance during therapy are equally important tasks.”

Shannon Kehle‐ForbesPsychologist, Minneapolis VA Medical Center

Nishant PatelPsychologist, DC VA Medical Center

Page 7: Aclaris medical I-Corps@NIH 12-10-2014

Value Proposition CanvasCost Savings

Increased Likelihood of Recovery

Faster Recovery

Simplify Clinical Practice

30% Patient dropout

Patients don’t engage

Patients don’t comply

Treat PTSD patients

Alleviate symptoms

Improve patient 

quality of life

Time/Effort to attend sessions

Therapist

Patient

Payer

Therapist& Patient

Data Security

Page 8: Aclaris medical I-Corps@NIH 12-10-2014

Week 4 Canvas

Page 9: Aclaris medical I-Corps@NIH 12-10-2014

How do we deliver these value propositions?

Page 10: Aclaris medical I-Corps@NIH 12-10-2014

Critical Path – PTSD Application

• 5 years to collect evidence to support wide adoption in VA Medical Center

Monitoring System Development

2015 2016 2017 2018 2019

Clinical Trial – therapy vs. therapy + Aclaris System

Clinical Study to Evaluate Patient/ Therapist Use and gather data for 

Algorithm Development 

Updates, Fixes, Trial Support

MarketEntry

Page 11: Aclaris medical I-Corps@NIH 12-10-2014

“Could your technology be used for biofeedback? Current biofeedback devices are hard to use and expensive.”

Caryn SeebachPsychologist, DC VA Medical Center

Page 12: Aclaris medical I-Corps@NIH 12-10-2014

Biofeedback: An Existing Market• Clinical Applications

– Anxiety disorders– Chronic pain– Migraines and tension 

headaches

• Cumbersome system• Requires extensive training• Can be costly ($5,000+)

Page 13: Aclaris medical I-Corps@NIH 12-10-2014

MVP – Biofeedback System• A stepping stone to the long‐term opportunity

Wrist Monitor –collects physiological data such as HR and skin temperature

Smart phone or tablet – displays physiological data

Patient

Therapist

Page 14: Aclaris medical I-Corps@NIH 12-10-2014

Critical Path – Biofeedback Application

MVP Development

2015 2016 2017 2018 2019

Validation of Physiological Measurements in Clinical 

Setting

Time to market reduced by 3 years

Monitoring System Development

Clinical Trial – therapy vs. therapy + Aclaris System

Clinical Study to Evaluate Patient/ Therapist Use and gather data for 

Algorithm Development 

Updates, Fixes, Trial Support

Market Entry

MarketEntry

MarketEntry

Page 15: Aclaris medical I-Corps@NIH 12-10-2014

Validating our Biofeedback VPs

• Easy to use (<5 min to train user)

• Suitable for all patients (monitors multiple parameters)

• Meets data security requirements

Page 16: Aclaris medical I-Corps@NIH 12-10-2014

PTSD Exposure Therapist Early Adopters

PhD in PsychologyTrained in PE Therapy

VA/Military Base/AcademicTech‐Savvy

Male or FemaleAge 30 – 40 years

Customer Archetypes for MVP

Biofeedback Practitioners 

Masters in PsychologyCertified in Biofeedback

Hospital Clinic or Independent Clinic

Treat Pain, AnxietyMale or FemaleAge 45 – 55 years

Page 17: Aclaris medical I-Corps@NIH 12-10-2014

Week 10 Canvas

Page 18: Aclaris medical I-Corps@NIH 12-10-2014

Biofeedback is a Stepping Stone to PTSD Monitoring

MVP Development

2015 2016 2017 2018 2019

Validation of Physiological Measurements in Clinical 

Setting

Monitoring System Development

Clinical Trial – therapy vs. therapy + Aclaris System

Clinical Study to Evaluate Patient/ Therapist Use and gather data for 

Algorithm Development 

Updates, Fixes, Trial Support

Market Entry

Biofeedb

ack Mon

itor

PTSD

 Mon

itor

MarketEntry

MarketEntry

Page 19: Aclaris medical I-Corps@NIH 12-10-2014

SBIR Phase II Readiness• Status: Go with a nominal pivot

IRL 5

First Pass Canvas

Problem/Solution Validation

Low Fidelity MVP, Clinical Paths ID’d

Product/Market Fit

Left‐side of the Canvas

Business Case Defined

High Fidelity MVP

Path to Revenues, OP Plan, CustData points

Right‐side of the Canvas

IRL 2

Page 20: Aclaris medical I-Corps@NIH 12-10-2014

Lessons Learned Video

https://www.youtube.com/watch?v=f1eJ7Y7PauQ