Phase 0: Clinical Feasibility Trial (KTI 17074.1 PFLS)

Duration: 6 weeks

Patient Pop.: Single patient study

Status: Completed, August 2015

PI: Prof. Dr. Christian Benden (USZ)

Goals: To demonstrate the ability of prototype hardware and software to remotely,

and noninvasively, monitor a single patient’s adherence to the prescribed use

of two medical devices.

Outcomes: Demonstrated use of prototype hardware (eFlow positional sensor, Tobi

podhaler medicine use sensor) and prototype software platform.

Phase I

Phase 0

Phase I: Observational Data Gathering (KTI 19070.1 PFLS)

Duration: 2 weeks

Patient Pop.: Fewer than 5 patients

Status: Starts February 14

PI: Dr. Eli Goldberg

Goals: Incorporate patient feedback on current generation of hardware and software.

Outcomes: Anticipated outcomes include clinical-use ready hardware and software.

Phase II: Clinical Utility Study (KTI 19070.1 PFLS)

Duration: 6 months

Patient Pop.: Approximately 50 patients

Status: Scheduled for August 2017

PI: Prof. Dr. Christian Benden (USZ)

Goals: Evaluate hardware and software in a clinical setting; survey utility of hardware

and software to both physicians and patients; demonstrate an improvement

in perceived care management (patient) and ability to manage care

(physician) when using hardware and software.

Outcomes: Anticipated outcomes include survey feedback on utility of hardware and

software for both patients and physicians; improvement in perceived care

management (patient) and ability to manage care (physician) when using

hardware and software.

Phase II

Recruiting Assistance

Needed

Recruiting Assistance

Needed

Eli Goldberg PhD, MScCEO Aware Engineering GmbH

Sami Galal MscCTO Aware Engineering GmbH

Taking the guesswork out of staying healthy

AwareEngineering

Our Mission

“To go beyond the pill to improve the lives of those with chronic lung diseases by promoting adherence,

facilitating preventative care, and improving care management through real-time device monitoring.”

Technology Visualization Alerts and Prediction

To Market; Series A

aE Founded

Massbio Incubator

Utility Patent

CTI Feasibility Study (100K)

CTI Project(ca. $900k)

RegulatoryApproval

February 2018

Provisional Patent (Priority Date)

March 2012

March 2013

August 2013

March 2014

February 2015

Acceptance to CTI January 2014

Hard/SoftwareScaleup

March 2017

November 2016

Key resources in place.

Letters of intent to support & purchase:Cystic Fibrosis Foundation (CFF)IBM Watson HealthJohns HopkinsBrigham and WomensUniversity Hospital ZurichBaylor College of Medicine

September 2016

$1.2M - 2M Seed RoundJan. - Feb. 2017 Strategic

Partnership

August 2017

Dr. Markus FromherzFormer CIO of Xerox

Health

Dr. David Feigal, MDFormer FDA director of

CDRH and CDER

Dr. Carl Peck, MDFormer FDA Center

Director

Elsa Drews JacobsonFormer Director of Digital

Health at Stanford Health Care

Dr. Jordan McAfooseIBM Watson Ecosystem

Health Leader

Dr. Rishi Wadhera, MDClinical Fellow and

Instructor of Medicine at Harvard Medical School

Dr. Eli Goldberg, PhD, MScCEO

CF patient, data science, and modelling expert

Scott Luchau, MBACFO

Process engineering and analytics expert

Sami Galal, MScCTO

Data science, IT security, and database expert

Jacob Goldberg, RPCV, CAPMOperations LeaderClinical and project

management expert

World class team. World class advisors.

4 2$500k

Clinical ResearchPartners

Sales & GrowthPartnersGrants

Traction. Clinical & Growth Partner Network.

DoingTherapy

LivingLife

The everyday decision.

Staying healthy is hard

>1.5h

Adherence

>3

Devices

365

Every day

Self reporting, examination, & diagnostics

Behavior outside the hospital

10%

90%

Doctors can’t treat what they can’t see

“Your lung functions are down. I’m going to start you on antibiotics.”

?Repairs

A C B

SequenceRefills

Eli GoldbergPhD Candidate MSc ETHZ EngineeringaE Founder, CEO

... “Ok.”

Doctors treat symptoms, not behavior

Behavior

SelfAware: Taking the guesswork out of staying healthy

Monitoring. Management. Prevention. Intervention.

TechnologyOur tech measures your medical device activity.

VisualizationUnderstand your

adherence behavior in real-time.

Alerts and PredictionState-of-the-art machine

learning relates your behavior to your health.

Nebulizers Sterilizers Powder Delivery

Makes existing devices smarter.

Heat. Light. Current. Voltage. Motion.

Autonomous data syncing, visualization, and analytics.

Real-life example. Information anywhere.

Location in Beijing Treatment

Day 3

Pulmozyme

NaCl 7%

Syncing

This is the # of times I failed to keep the nebulizer upright during this treatment

60%

Adherence

Day 1

6m

30s

4m

30s

25

11

Day 2

6m10

s

4m42

s

11

8

Day 4

4m

48s

5

Day 5

6m

10s

4m37

s

8

2

5

Days in China

IP and Technology Barrier: Patent pending platform capable of using adher-ence data to predict health outcomes. AE is the first company to develop and employ predictive analytics derived from patient device use for interventional care for chronic lung diseases.

Regulatory Barrier: SelfAware platform is the first Class II monitoring platform with clinical evidence to substantiate our claims. This forces entrants to meet this same standard to compete.

Endorsements:

Patient - Engineer - Scientist: I am uniquely placed to lead our effort to build a device that effectively predicts health outcomes without interfering with day-to-day life of patients.

Sustainable Competitive Advantage

Initial Target Market: Cystic Fibrosis

1 of > 200M with COPD 1 of > 300M with AsthmaEli GoldbergPhD Candidate MSc ETHZ EngineeringaE Founder, CEO

CEO & CF Patient1 of > 70k with CF

Christian Benden MD FCCP

Division of Pulmonary Medicine University Hospital Zurich

Raemistr 100 CH-8091 Zurich

Switzerland Grant Review Board Commission for Technology and Innovation (CTI) Effingerstrasse 27 CH – 3003 Bern, Switzerland

06 March 2016

RE: Letter of Intent to Participate in CTI Project Improving adherence in cystic fibrosis: monitoring patient behavior through a smart network of sensors attached to patients' medical equipment.

Project Manager: Eli Goldberg, ETHZ

Dear CTI Grant Review Committee,

This letter is documentation of our Division of Pulmonary Medicine’s intention to participate in the project: Improving adherence in cystic fibrosis: Investigation of the feasibility of monitoring patient behavior through a smart network of sensors attached to patients' medical equipment, should it be funded. Should the project study not be funded, this letter is effective for a term not to exceed six months from the letter date. The six-month term may be extended, provided the project is under active negotiation and/or active research is ongoing.

Our Research Group within the Division of Pulmonary Medicine collaborates strongly with lung transplant programs around the world and plays an active role in national and international professional societies and collaborations. Major research focus areas include diagnosing, monitoring, and understanding and treating chronic lung allograft dysfunction (CLAD). Explicit in these research directions is the desire to improve clinical management and procedure with regards to establishing best practices, optimizing patient self-management and adherence, and increasing health outcomes for lung transplant patients and patients with cystic fibrosis before and after lung transplantation.

This project proposes an innovation in telemedicine that is particularly well aligned with the strategic direction of the group; to improve clinical management procedures with regards to improving health outcomes for lung transplant and CF patients. Our competencies of specific importance to this project are our medical expertise and research experience, which will be employed to identify, and validate, clinically relevant outcomes of this project.

Sincerely,

Christian Benden MD FCCP Date: 06 March 2016

National Office 6931 Arlington Road, Suite 200, Bethesda, Maryland 20814 301.951.4422 800.FIGHT.CF Fax: 301.951.637 www.cff.org email: info@cff.org

October 21, 2015 Cystic Fibrosis Foundation 6931 Arlington Road, 2nd floor Bethesda, MD 20814 Dr. Eli Goldberg SelfAware Engineering Austin, TX CC: Grant Review Board, Commission for Technology and Innovation (CTI) Effingerstrasse 27 CH – 3003 Bern, Switzerland RE: Letter of Intent to Potentially Purchase

Improving adherence in cystic fibrosis: monitoring patient behavior through a smart network of sensors attached to patients' medical equipment.

Dear CTI Grant Review Committee, The mission of the Cystic Fibrosis Foundation is to cure cystic fibrosis and to provide all people with the disease the opportunity to lead full, productive lives by funding research and drug development, promoting individualized treatment, and ensuring access to high-quality, specialized care. The mission of the Cystic Fibrosis Foundation is fueled by a dedicated group of scientists, caregivers, donors, volunteers and people with CF and their families who are united by a common goal: to find a cure for this devastating disease and help those with CF live longer, healthier lives. The project, Improving adherence in cystic fibrosis: monitoring patient behavior through a smart network of sensors attached to patients' medical equipment, and the potential of the resultant innovation, SelfAware, to improve communications with patients, to gain insight into patient behavior, to improve patient adherence, and to prevent adherence-related hospitalizations and readmissions is of significant interest to us. In support of this project, this letter is evidence of our interest in potentially purchasing the innovation for use and/or research should it be fully realized. However, this letter does not constitute a purchase order. The Cystic Fibrosis Foundation or its affiliates are not obligated, under any circumstances, to purchase the resultant innovation.

Sincerely,

Bruce C. Marshall, M.D. Senior Vice President of Clinical Affairs Cystic Fibrosis Foundation

Cynthia George, MSN, FNP Senior Director of Patient Engagement Cystic Fibrosis Foundation

November 6, 2015 Grant Review Board Commission for Technology and Innovation (CTI) Effingerstrasse 27 CH – 3003 Bern, Switzerland RE: Letter of Support

Improving adherence in cystic fibrosis: monitoring patient behavior through a smart network of sensors attached to patients' medical equipment.

Dear CTI Grant Review Committee,

The Johns Hopkins Adherence Research Center (JHARC) is an early adopter of new electronic medication monitoring devices and is an international leader in the development of device-specific quality control procedures. For almost three decades, JHARC has conducted investigator-initiated studies of adherence measurement and promotion interventions. There is specific interest and expertise in behavioral studies to reduce health disparities, disseminating interventions to community settings, and using technology to improve the quality and sustainability of interventions.

As the co-Director of JHARC and as an experienced and well-funded adherence research investigator, I can personally attest to the research community’s desire and need for remote behavioral monitoring systems, such as the one being proposed here. Existing devices are not reliable, flexible enough to work across many therapeutic delivery devices, and often intrude on existing behavioral habits, thus making them unacceptable to patients, clinicians, and researchers alike. For decades I have worked with companies attempting to make a viable device, yet they have failed, particularly for respiratory treatments. With emerging technologies, passionate developers, and a focus on the end-user experience, I think we may be on the verge of changing adherence measurement and our capability to provide tailored, cost-effective interventions to help overcome the personal and societal burden of nonadherence. Furthermore, the emergence of health-related wearables and tracking devices throughout all areas of our lives is leading to patient and healthcare provider expectations that this detailed and nuanced data will be available to support healthcare decision-making.

Sincerely,

Kristin A. Riekert, PhD

Kristin A. Riekert Ph.D Associate Professor Co-Director, Johns Hopkins Adherence Research Center (JHARC) Director, Cystic Fibrosis Adherence Program Division of Pulmonary and Critical Care Medicine 5501 Hopkins Bayview Circle, JHAAC 3B.37 Baltimore, MD 21224 410-550-7755 T 410-550-2612 F kriekert@jhmi.edu

September 11, 2016 Dr. Eli Goldberg CEO, SelfAware Engineering 8715 West Highway 71 Austin, TX 78735 RE: Intent to establish clinical research partnership - SelfAware Engineering adherence monitoring platform Dear Dr. Goldberg: I am Director of the Center for Pediatric Abdominal Pain Research at Baylor College of Medicine/Texas Children's Hospital. Our research focuses on elucidating the causes of, and developing treatments for, functional abdominal pain disorders in children. SelfAware Engineering’s technology platform, SelfAware, offers the possibility to further our research goals by incorporating real-time monitoring of abdominal function, as well as other physiologic parameters (e.g., bowel sounds, galvanic skin resistance, skin temperature, vibration, orientation, breathing and heart rate). These data are critical in improving our understanding of the relationship between physiologically measurable biomarkers and functional abdominal pain disorders in children. It is my intent to jointly conduct research utilizing SelfAware to commence mid-2017 pursuant to the development of a research protocol to be mutually agreed upon, or pursuant to an accompanying grant application. Together, I believe that SelfAware Engineering and the Center for Pediatric Abdominal Pain Research have a unique opportunity to significantly improve our understanding of functional abdominal pain disorders in children and consequently, move towards novel treatment paradigms. Sincerely,

Robert J. Shulman, M.D. Professor of Pediatrics Director, Center for Pediatric Abdominal Pain Research Children's Nutrition Research Center Baylor College of Medicine

CHILDREN’S NUTRITION RESEARCH CENTER Department of Pediatrics 1100 Bates Street Houston Texas 77030-2600 713 798-7000

Texas Children's Hospital