revolutionary monitoring technology for vascular health · cse: lnb │ otcqb: lxgtf 4 • current...

RevolutionaryMonitoringTechnologyforVascularHealth

SIMPLE|NON-INVASIVE|EFFECTIVE|LOWCOST

CSE: LNB │ OTCQB: LXGTF

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Information contained in this presentation is the property of Lexington BioSciences (“Lexington” or the“Company”). This presentation does not constitute, or form part of, any offer or invitation to sell orissue, or any solicitation of any offer to subscribe for or purchase any securities in the Company, nor shallit, or the fact of its communication, form the basis of, or be relied upon in connection with, or act as anyinducement to enter into, any contract or commitment whatsoever with respect to such securities. Thecommunication of this presentation in or to persons in certain jurisdictions may be restricted by law andpersons who may receive communication of this presentation should inform themselves about, andobserve, any such restrictions in advance of communication to them of this presentation. No securitiesexchange or affiliated service provider has reviewed or accepts responsibility for the adequacy oraccuracy of the content of this presentation.The material contained in this presentation is provided solely for your general knowledge and is notintended to be a comprehensive review of all matters and developments concerning Lexington or itsaffiliates. Lexington has taken all reasonable care in producing the information contained in thispresentation. This information may contain technical or other inaccuracies, omissions, or typographicalerrors, for which Lexington assumes no responsibility. Lexington makes no representation or warrantyregarding, and assumes no responsibility for, the use, validity, accuracy, completeness, reliability orcurrency of any claims, statements or information in this presentation.To the extent permitted by law, Lexington BioSciences Inc. and its employees, agents, affiliates andconsultants exclude all liability for any loss or damage arising from the use of, or reliance on, any suchinformation, whether or not caused by any negligent act or omission. Statements in this presentationother than purely historical information, including statements relating to Lexington’s future plans,objectives or expected results, constitute forward-looking statements within the meaning of the U.S.federal and Canadian securities laws. Forward-looking statements are based on numerous assumptionsand are subject to the risks and uncertainties inherent in Lexington’s business, including risks inherent inearly stage start up ventures and development. As a result, actual results may vary materially from thosedescribed in the forward-looking statements. Lexington disclaims any obligation to update any forward-looking statements.This presentation was prepared to assist interested parties in making their own assessment of Lexingtonand its business plans and does not purport to contain all of the information that a prospective investormay desire. In all cases, interested parties should conduct their own investigation and analysis of theCompany, its assets and the information provided in this presentation. Any and all statements, forecasts,projections and estimates contained in this presentation are based on management’s current knowledgeand no representation or warranty is made as to their accuracy and/or reliability.

LEGAL


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• Current first line cardiovascular health diagnostics are insensitive at measuring heart disease development and progression

• Specialized cardiovascular diagnostics are highly invasive and expensive and generally catch cardiovascular disease AFTER it’s developed

...we need a simple way to proactively measure and monitor cardiovascular system health

BEFORE the development of heart disease

The First Sign of Heart Disease is Often a Heart Attack


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Core Cardiovascular Health Monitoring

• HeartSentry is a simple non-invasive way to measure a patient’s corecardiovascular system health.

• A large market already exists for cardiovascular monitoring products.

• Fast growing demand for personalized health measurement.

• Generated data integrates into broader “big data” health IT initiatives for clinicians and insurers.

Proposed design

Similar in look to a typical blood pressure cuff,

HEARTSENTRY represents a major leap forward in

cardiac health monitoring


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Undiagnosed Cardiovascular Disease Is a Killer

• 1 in 3 deaths annually are caused by heart disease and stroke.

• 1.5 million people suffer heart attacks annually in the U.S.

• Nearly 1/3 of the deaths could be preventedthrough proactive changes in lifestyle habits.

• Often the FIRST SYMPTOM of coronary artery disease is a heart attack.

1 World Health Organization (WHO)2 Center for Disease Control (CDC), Atlanta


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Knowing the core health of the cardiovascular system is critical to preventing future heart attacks and strokes

• Monitoring cardiovascular health changes over time is key to prevention via lifestyle modification, physician care and ongoing monitoring.

• Traditional measures of blood pressure and cholesterol measurements are only partial indicators of cardiovascular health.

Early Heart Disease Detection Is Critical


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Endothelial function measurement predicts when arteries are vulnerable to developing atherosclerosis

• Endothelium: a single layer of cells that line the heart, blood and lymphatic vessels.

• Function: Acts as a shield, preventing plaque from forming inside the artery wall, and produce substances that stop blood clots from developing in the vessel.

Endothelial Function Predicts Onset of Disease

• Monitoring endothelial function over time predicts the onset of heart disease long before symptoms begin.


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Current Standards are Complicated and Expensive

• Gold standard - ULTRASOUND• Measurement directly views arterial diameter

changes• Only at specialized diagnostic centers• Requires trained ultrasonographer• Expensive capital equipment needed

• Alternative method - ENDOPAT• Measurement uses a fingertip blood oxygen

sensor and laptop computer.

• Only at specialized diagnostic centers• Requires trained technician

Currently only used in specialized research centers by highly trained staff


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Simple and Elegant Solution

An easy-to-use product designed to easily and accurately measure endothelial function

HeartSentry stimulates a patient’s endothelium and then accurately measures the arterial response.

In healthy patients, arterial volume changes after endothelial stimulation are much greater than baseline levels, typically by more than 80%.

HeartSentry is compact and inexpensive enough for use in the professional clinic market as well as the home market.


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Comparative Technologies

ULTRASOUND ENDOPAT HEARTSENTRYCost ~$50k-$200k / unit

Varying hospital costs~$27k / unit$40 per procedure

InexpensiveMinimal operating costs

Training Ultrasonographer Specialized technician No specialized training

Location Clinic based Clinic Based Portable: Designed for clinic or home use

Time 1hr+ ~15 min 5 min

Method Imaging of large arteries in arm

Measures capillaries in fingertip

Directly measures endothelial function in large arteries in arm

IT data integration

None None Bluetooth results upload easily to cloud hosted database


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Compelling HeartSentry Research and Test Data

Early Clinical Research:• Initial results with 50 patients demonstrated a strong correlation to

standard ultrasound measurementsHeartSentry Testing:• 500% improved sensitivity over ultrasound• A consistently higher accuracy with lower variability than ultrasound• Faster and easier to use

HeartSentryFirstPrototype

HeartSentryCommercialProductConcept

HeartSentryGen1ClinicalStudyProduct


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HeartSentry U.S. Market Approval is Fast Tracked

HEARTSENTRY is an FDA regulated product that uses the expedited 510(k) premarket approval process

HeartSentry FDA Classification:• Class: II• Panel: Cardiovascular

Likely HeartSentry Predicates• Itamar Medical EndoPat 2000• iHealth Wireless Blood Pressure Monitor

International market approvals are also being pursued.

The 510(k) process demonstrates to the FDA that the device to be marketed is as safe and effective, and is substantially equivalent (SE) to an existing legally marketed predicate device

CSE: LNB │ OTCQB: LXGTF14

HeartSentry Technology Origin

Technology invented and developed over a fifteen year period by Thomas F. Budinger, M.D.Ph.D, and Jonathan S. Maltz, Ph.D, joint-winners of an international award in 2006 for theirinstrument to assess endothelial function.

Licensed to Lexington by Lawrence Berkeley National Laboratory in the field of cardiovascularvascular health diagnosis and monitoring.

The Lawrence Berkeley National Laboratory (Berkeley Lab) is synonymous with “excellence.”• Thirteen Nobel Prizes are associated with Berkeley Lab• Seventy lab scientists are members of the National Academy of Sciences (NAS)• Thirteen lab scientists have won the National Medal of Science• Eighteen lab engineers have been elected to the National Academy of Engineering• Three scientists have been elected into the Institute of Medicine (IOM)


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• Blood pressure monitor market forecast to exceed $2.6 billion by 2020 • Historical CAGR of 6.53% from 2012 to 2016 • Increasing prevalence of high and low blood pressure issues in patients • Market is fragmented and commoditized• Acquirers seeking high value differentiated features for premium product

offerings

Robust Market Scope and Dynamics

Stats:GlobalIndustryAnalysts,Inc.

• HeartSentry initially targeted at the clinic based professional market, with the intention to market direct to consumer pending FDA approval

• Endothelial function monitoring will increase the demand for high value connected cardiovascular monitoring devices

• HeartSentry is marketable both as a capital investment as well as a pay per use model

• Potential reimbursement offers revenue sharing opportunities with clinics


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Chronology of Cardiovascular Diagnostic Products

Omron BP Units: 10 millionFitbit Bands: 20 millionApple Watches: 24 million

Body mass Temperature Heart Rate Blood pressure

Arrhythmias

Weight Scale(~2000 BC)

Body Thermometer

(1625)

Physician’s Pulse Watch

(1707)

Sphygmo-manometer

(1881)

Electro-cardiograph

(1901)

Cardiovascular Measurement Devices are Big Business


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Connected Biosensing is the Future of Medicine

iRhythm Technologies (NASDAQ:IRTC)

Founded in 2005 by physicians and engineers to remotely measure and diagnose cardiac arrhythmias

Cloud connected wearable biosensingtechnology as both device and service

Initially targeted at the professional marketplace

IPO in Oct 2016

Current Market Cap (10/17): $1.1B


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Market Evolving into Personal Health Management


Nokia/Withings, Apple, Google, all are creating integrated health platforms

Fitbit sells over 20 million devices annually

Endothelial function measurement for cardiovascular disease prediction is a critical missing measurement in all these portfolios


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Lexington Has a Broad Spectrum of Potential Partners


Traditional Medtech Information Technology


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Eric Willis, Chief Executive OfficerMr. Willis is an entrepreneurial healthcare technology executive with a track record of success inbringing products from initial concept to market. He is the past President and Chief OperatingOfficer of ParaPatch (2013–2015), where he was responsible for the development and launch of anover-the-counter women’s health product for the treatment of urinary incontinence. Prior to this,he served as President and CEO of InSite Medical Technologies (2008–2013) a venture backedstart-up medical device company that developed a new method for performing epiduralanesthesia. From 1994–2008 he served in a variety of executive and operational roles forcardiovascular medical device companies.

Nick Furber, Chief Financial OfficerNick Furber is a Chartered Accountant (US) and Chartered Financial Analyst who is currently theprincipal of NJF Consulting offering financial services growing public companies. Previously Nickhas over 10 years experience as Chief Financial Officer of a producing gold corporation listed onthe TSX and prior to which over 10 years accounting, Mergers & Acquisitions, valuation and duediligence experience gained in a variety of industries working for PricewaterhouseCoopers.

Nancy Lince, Regulatory and Clinical AdvisorNancy has over 25 years of experience in regulatory, clinical and quality affairs for medicalproducts. Nancy has written or overseen over 200 submissions, has conducted extensivenegotiations with FDA and International regulatory agencies, and developed regulatory strategiesresulting in significant cost savings and decreased time to market.

Scott Bluni - General Counsel, Intellectual PropertyScott Bluni is a Senior Principal with the firm Kacvinsky Daisak Bluni. His practice includes patentportfolio management and strategic counseling, licensing, product clearance, prosecution, dealdiligence and litigation. Previously, Scott was vice president and cardiovascular chief patentcounsel at Boston Scientific Corporation, a major global medical device company. Scott began hislegal career as a patent examiner with the United States Patent and Trademark Office whileattending evening law school, after which he was an associate at Kenyon & Kenyon, anintellectual property boutique, in Washington, D.C.

Executive Leadership


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Jonathan Maltz, Ph.D., Chief Scientific AdvisorDr. Maltz, received his PhD degree in Electrical Engineering from the University of California atBerkeley, and has over 16 years of experience designing new devices for assessing vascularfunction and evaluating these on human subjects. Dr Maltz is author of over 25 peer-reviewedpublications, and holds 18 granted US patents.

Jeffrey Olgin, M.D., Medical AdvisorDr. Jeffrey Olgin, a cardiologist and electrophysiologist, is co-director of the UCSF Heart andVascular Center and chief of Cardiology. A specialist in the treatment of arrhythmias, he hasdeveloped treatment techniques for irregular heartbeats and founded the UCSF Atrial ArrhythmiaClinic that provides comprehensive patient care and studies genetic links in atrial fibrillation.

Greg Robertson, M.D., Medical Advisor

Dr. Greg Robertson is chief of the Emory Heart and Vascular Clinic at Johns Creek. At the EmoryJohns Creek Hospital he is chief of cardiology and the medical director of the cardiaccatheterization laboratory and interventional program. He is board certified in Vascular Medicine,Endovascular Medicine, Interventional Cardiology and Cardiovascular Medicine. He is an associateprofessor of medicine at Emory University. Dr. Robertson’s clinical expertise has focused onpreventative care and using minimally-invasive vascular and cardiac treatment.

James Wall, M.D., Medical AdvisorDr. James Wall is a practicing Pediatric Surgeon at Stanford University. He is an alumnus of theStanford Biodesign program and holds a Master's degree in Bioengineering. His current researchinterest is in the design, development and analysis of health technology as well as the emergingfield of surgical endoscopy. James currently leads the surgical endoscopy program at LucilePackard Children’s Hospital and is the Assistant Director of the Biodesign Innovation Fellowshipfor Stanford Biodesign.

Scientific Advisors


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Doug Janzen, ChairmanMr. Janzen has 20 years of experience in life sciences with leadership experience in corporatefinance, business development, and operational management of life sciences companies. Mr.Janzen is currently Co-Founder and Managing Director of Northview Ventures. He serves asChairman and CEO of Aequus Pharmaceuticals (AQS-TSXV), a company that was founded withinNorthview. Prior to Northview Ventures, he was President and CEO of Cardiome Pharma (NASDAQ:CRME) During this time he raised over $300 million from investors, completed over $1 billion inlicensing deals, and led a partnership with Merck to bring Cardiome’s lead product, Brinavess,through to clinical approval and marketing in Europe.

Rocco Rossi, DirectorA successful entrepreneur and business executive, champion fundraiser, and dedicated publicservant, Rocco Rossi is currently President and CEO of Prostate Cancer Canada. His unique blendof experience intersects general management, philanthropy, public policy, politics, businessstrategy, and new media. As CEO of the Heart and Stroke Foundation – one of Canada’s largestnon-profit organizations – from 2004 to 2009, Rossi oversaw four consecutive years of recordfundraising raising over $500 million in total and launching many new, life-saving initiatives.

Bryan Disher, Director, Audit Committee ChairMr. Disher (CPA, CA) spent 38 years with PricewaterhouseCoopers in Canada, Australia andUkraine. He was admitted to partnership in PwC Canada in 1991 and from 2011 until hisretirement in June 2015 was a partner with PwC Central and Eastern Europe, where he served asboth Managing Partner of its 400+ person Ukrainian practice and leader of its Ukrainian audit andassurance group.

Donald A. McInnes, Board AdvisorMr. McInnes is a co-founder and principal at Oxygen Capital Corporation, where he applies hisover twenty years’ experience building companies from the ground up. He serves as Chairman ofthe Clean Energy Association of British Columbia and is a director of Prostate Cancer Canada, theDuke of Edinburgh’s Award-British Columbia and Yukon Division and is a Governor of the BritishColumbia Business Council.

Board of Directors


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CapitalizationIssuer: Lexington Biosciences Inc.Security: Common SharesSymbol(s): CSE: LNB│OTCQB: LXGTFIssued & Outstanding: 32,355,901Reserved for Issuance: 9,054,100

Options: 1,800,000 Warrants: 7,254,100

End Q2 2017 Financial SnapshotCash on hand: CDN$360,000

Lexington Capitalization and Financials


Milestones20

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2018

2019

a. Develop 1st generation product for distribution into clinical studies.

b. Define regulatory & clinical data strategy for market approval.

c. Establish Scientific Advisory Board.

d. Create 1st gen. clinical data demonstrating correlation to results obtained by competing technologies.

e. Create clinical data to support product FDA approval.

f. Obtain full US market approval for HeartSentry measurement.

g. Product development advances toward industrial design, consumer and commercial strategies.

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• Lexington BioSciences (CSE: LNB) (OTCQB: LXGTF) is developing the HeartSentry, a new non-invasive diagnostic tool for accurately measuring and monitoring cardiovascular health.

• The HeartSentry measures the function of the endothelium – the critical inner lining of a person’s cardiovascular system.

• The core research and IP portfolio has been exclusively licensed to the company.

• Lexington is in final stages of releasing the product into clinical studies for FDA approval.

• The cardiovascular diagnostic market is growing fast and evolving into personalized medicine.

• The goal is to make HeartSentry the standard of care for cardiologists, general practitioners, and ultimately patients first line evaluation of cardiovascular health.

• We seek the participation of dedicated stakeholders and committed partners who share our vision of the future of cardiovascular personalized medicine.

Summary

Lexington BioSciences, Inc.

Contact+1 (800) 320-2640

[email protected]

CSE: LNB│OTCQB: LXGTF

revolutionary monitoring technology for vascular health · cse: lnb │ otcqb: lxgtf 4 • current...

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