ClearTracTechnologies.com

Because 58 million patients and 12,000 urologists*

need a better way to diagnose and treat lower urinary tract symptoms.

* US only

CarePath is the first and only remote patient monitoring system for urology.

Why is this such a big idea?

Hand-written voiding diaries were the best we had.

They were terrible!

Nobody wants a commode hat.

CarePath is the first and only remote patient monitoring system for urology.

Why is this such a big idea?

Or instructions.

Or they blew it off completely.

CarePath is the first and only remote patient monitoring system for urology.

Why is this such a big idea?

Patients were homebound with a commode hat.

Before we continue, you want to know:

FDA cleared? Yes.

IP? 33 issued patents.

Management? Same team that sold AUS to MDT in 2014.

Competition? None.

Reimbursable? More than 60% of patients covered under four codes.*

regulatorycompet.market analysis

market sector

teamdemoipreimb.

Market Sector

$52Billion

$0

$15

$30

$45

$60

Medical Devices Systems / software Services

Bill

ion

s

2017 2022

246%Increase

* Deloitte, Pew Research, Rand Report 2019

Digital Health Market Analysis

– Dr. Neil Evans, Chief Officer Connected CareVeterans Administration

“Remote patient monitoring… is the very future of healthcare delivery in America.”

Fastest growing segments? Telehealth, virtual care, connected care, and remote patient monitoring (RPM)

$50B market (2022)

The perfect storm?

Senior pop. primed for tech solutions for prevalent, non-lethal diseases

90% of urologists ready for connected care/RPM

Internet of Medical Things*

Market Analysis

Changes in Initial Expenditures for BPH Evaluation in the Medicare Population, J Urol. 2012 May ; 187(5): 1739–1746BPH: Epidemiology, Economics and Evaluation, Can J Urol 2015; 22 (Suppl 1): 1-6

58 Million Americans Suffer From LUTS

• Frequency• Urgency• Nocturia

Lower Urinary Tract Symptoms (LUTS)

• Urge Incontinence• Retention

Source: Research & Reports in Urology, 2016; MedScape, 2018

>60% Of Sufferers

Consult Medical Professionals

>16% OAB Symptom

Prevalence Worldwide

<10% OAB Sufferers

Properly Diagnosed/Treated

Sources: Journal of Urology, 2016; Asian Journal of Urology, 2017; British Journal of Urology, 2009, GlobalData, Outcome CapitalReview of the Epidemiology of Overactive Bladder, Research and Reports in Urology, 6 June 2016

• >60% have overactive bladder (OAB) or benign prostate hyperplasia (BPH) • Represent the largest unmet need in all of healthcare• LUTS impact on QOL = cancer or AIDs

Benign Prostatic Hyperplasia (BPH)

Patients with

LUTS

• 70% over age 60 have BPH with LUTS• 12M actively managed with BPH• 67 % have mod-severe symptoms

men (U.S.) with BPH/LUTS>15M

>$13 BNGlobal LUTS Treatment Market

Competition

Product Deficiencies

Paper Diaries Plastic Commodes Un-connected Apps Connected Apps

X Illegible

X Unreliable

X Prone to loss

X Retrospective fulfillment

X Poor, low quality design

X Lifestyle restricting

X Additive to work of voiding

X Requires good vision to interpret

X Relies on plastic commode

X Variable reporting

X Non-HIPPA compliant

X Impaired time-stamp accuracy

X Relies on plastic commodeX ExpensiveX Difficult to cleanX Not portableX Minimally innovative

Voiding Diary Competition Landscape

Competition

X Unnatural setting/specimen X Static, single-void UF analysisX Not portable – confined to clinic or home commodeX Limited data collection – can only perform uroflowsX Expensive

✓ Home-based use by patient& remote analysis ✓ Completely portable✓ Multi-void selection/comparison✓ Comprehensive & actionable reporting✓ Capable of performing uroflows & voiding diaries

Uroflowmeter Competition Landscape

Standard Uroflowmeters

Limitations Advantages

Vs.

Easy FloFLOWSTAR Danflow 2000

• No other uroflow device is compact, completely portable, designed for patient use at home or in the ambulatory setting• CarePath is more accurate then full size uroflowmeters costing 10 tens as much• Formidable IP protection prevents direct competition in the market

Regulatory

*www.accessdata.fda.gov

Regulatory Overview

Device Class II

Device Description

Uroflowmeter, Urinometer, Mechanical, Electrical Measuring, Non-Electrical, Disposable Urine flow or volume measuring system

Regulatory Description

Urine flow or volume measuring system

Regulation Medical Specialty

Gastroenterology/ Urology

Premarket ReviewOffice of Device Evaluation, Division of Reproductive, Gastro-Renal and Urological Devices

Regulation Number 867.1800

GMP Exemption No

I have reviewed all the relevant FDA materials, including the Federal Food, Drug and Cosmetic Act, FDA regulations, and FDA guidance regarding how the FDA would classify the “CarePath” medical device. I have concluded CarePath device would be a Class II medical described in 21 C.F.R. §876.1800 and exempt from premarket notification procedures in 21 C.F.R. Part 807… and will be able to market … without 510(k) premarket clearance notification or pre-market approval application.

Ross C. D'EmanuelePartner, FDA and Regulatory Consultant5/15/2019

CarePath is exempt from Pre-Market approval application or 510(K) requirement• CarePath is manufactured in strict adherence to FDA GMP in FDA qualified production facility• All FDA labeling requirements are met• Complete design files and documentation prepared for CE Mark submission requirements

Reimbursement

• >60% of target patient market is covered by CMS• Patient survey (by CTT) showed 100% of men and 80% of females would pay directly for CarePath if recommended by their physician• Contracted with Marksman Consulting for full HC economics analysis & develop formal plan to obtain coverage by commercial payers• Formal clinical utility study to begin April 2020 to demonstrate impact of CarePath on patient outcomes and HC system costs• Major US healthcare systems interested in providing CarePath to improve access to urology services

Intellectual Property

Extensive Patent Estate Prevents Direct Competition in Marketplace

Item No.US Patent

Application No. Title (claim focus) US Status OUS Status Ownership

1 16/297,192Uroflowmeter (Utility Application for Female Device and Male Device, brief descriptions of Data Transfer System and Test/Calibration Apparatus)

Pending PCT filed on same date ClearTrac

2 16/297,417Urinary Event Detection, Tracking and Analysis (Utility Application for Data Transfer and Communicationincluding Physician and User Interface Applications)

Pending PCT filed on same date ClearTrac

3 16/296,647Testing Device for a Uroflowmeter (Utility Application for Test/Calibration Apparatus)

Pending PCT filed on same date ClearTrac

4 29/649,761Uroflowmeter (Design Application for Original FemaleProduct)

AllowedRegistered in Europe, China, Japan and Canada

ClearTrac

5 29/656,567Uroflowmeter (Design Application for Original Male Product)

PendingRegistered in Europe, China, Japan, and Canada

ClearTrac

6 29/682,876Uroflowmeter (Design Application for Current Versions of Both Female Product and Male Product)

PendingRegistered in Europe; Allowed in Japan, Pending in Canada and China

ClearTrac

• Total patents filed = 53, patents issued to date = 33, challenges raised to claims = 0• Freedom to Operate established• TM authorized – USA, Canada, EU, Japan (China pending)

Lee Osman, Senior Partner IP, Dorsey & Whitney, LLP Denver, CO

Rotary hall sensor

Magnet in-float arm

Float arm

Float arm rotation

OUTFLOW

INFLOW

Research & Development Premium Product Development Partners

ClientsOverview

Headquarters: Boulder, CO

Founded: 2009

ISO13485 certified

Specializations:- Technical validation- Product development- User experience/human factor assessment- Volume manufacturing

Combining Clinical Experience With Expert Medical Device Engineering

, but we’re feeling pretty darn sure about CarePath.

There’s no such thing as a sure thing?

Unmet need

58M patients

Management

33 patents

Reimbursable

Okay pretty darn sure about CarePath., but we’re feeling

FDA cleared

Better diagnoses

12K urologists

No competition

Lower HC costs

Data Source: Weighted samples from the 2018 AUA Annual Census

There were less than 8,000 practicing general urologists in 2018.

The Growing Shortage of Urologists

Near-future Impact of Retirement on the Urologic WorkforceResults from the AUA Urological Association CensusUrology, Volume 94, August 2016 pg 85-89

More than 50% of Practicing Urologists are over 55 years of age

Urologists planning to retire in the next 5 years

= 27%

The Growing Shortage of Urologists

Back

Appendix: Telehealth and UrologySupply & Demand – we face a major urologist shortage.

* ChildStats.gov US Census Bureau 1970 to 2017: 65 years and older

Supply will decline: 27% of urologists retire (next 5 years).

Demand will grow: 22% of population is 65+ by 2040.

… this will have a impact on patient care!

Patients• Longer consultation wait times

• Treatment delays

• Lower satisfaction

Urologists• Increased clinical demands

• Burnout

Danflow 2000FLOWMASTER Easy Flo

Uroflow Technology

Standard Uroflow Graph

Limited Data and accuracy