Transcript
Revolutionary Monitoring Technology for Vascular Health SIMPLE | NON-INVASIVE | EFFECTIVE | LOW COST
CSE: LNB │ OTCQB: LXGTF
LEGAL 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 or issue, or any solicitation of any offer to subscribe for or purchase any securities in the Company, nor shall it, or the fact of its communication, form the basis of, or be relied upon in connection with, or act as any inducement to enter into, any contract or commitment whatsoever with respect to such securities. The communication of this presentation in or to persons in certain jurisdictions may be restricted by law and persons who may receive communication of this presentation should inform themselves about, and observe, any such restrictions in advance of communication to them of this presentation. No securities exchange or affiliated service provider has reviewed or accepts responsibility for the adequacy or accuracy of the content of this presentation. The material contained in this presentation is provided solely for your general knowledge and is not intended to be a comprehensive review of all matters and developments concerning Lexington or its affiliates. Lexington has taken all reasonable care in producing the information contained in this presentation. This information may contain technical or other inaccuracies, omissions, or typographical errors, for which Lexington assumes no responsibility. Lexington makes no representation or warranty regarding, and assumes no responsibility for, the use, validity, accuracy, completeness, reliability or currency of any claims, statements or information in this presentation. To the extent permitted by law, Lexington BioSciences Inc. and its employees, agents, affiliates and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission. Statements in this presentation other 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 assumptions and are subject to the risks and uncertainties inherent in Lexington’s business, including risks inherent in early stage start up ventures and development. As a result, actual results may vary materially from those described in the forward-looking statements. Lexington disclaims any obligation to update any forwardlooking statements. This presentation was prepared to assist interested parties in making their own assessment of Lexington and its business plans and does not purport to contain all of the information that a prospective investor may desire. In all cases, interested parties should conduct their own investigation and analysis of the Company, 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 knowledge and no representation or warranty is made as to their accuracy and/or reliability. 2
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The First Sign of Heart Disease is Often a Heart Attack
• 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 4 CSE: LNB │ OTCQB: LXGTF
Core Cardiovascular Health Monitoring • HeartSentry is a simple non-invasive way to measure a patient’s core cardiovascular 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 prevented through proactive changes in lifestyle habits.
• Often the FIRST SYMPTOM of coronary artery disease is a heart attack.
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World Health Organization (WHO) Center for Disease Control (CDC), Atlanta 6 CSE: LNB │ OTCQB: LXGTF
Early Heart Disease Detection Is Critical 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.
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Endothelial Function Predicts Onset of Disease 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.
• 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 9 CSE: LNB │ OTCQB: LXGTF
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. 10 CSE: LNB │ OTCQB: LXGTF
Comparative Technologies
ULTRASOUND
ENDOPAT
HEARTSENTRY
Cost
~$50k-$200k / unit Varying hospital costs
~$27k / unit $40 per procedure
Inexpensive Minimal 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 measurements HeartSentry Testing: • 500% improved sensitivity over ultrasound • A consistently higher accuracy with lower variability than ultrasound • Faster and easier to use
HeartSentry Commercial Product Concept
HeartSentry First Prototype
HeartSentry Gen 1 Clinical Study Product
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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 13 CSE: LNB │ OTCQB: LXGTF
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 their instrument to assess endothelial function. Licensed to Lexington by Lawrence Berkeley National Laboratory in the field of cardiovascular vascular 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)
CSE: LNB │ OTCQB: LXGTF
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Robust Market Scope and Dynamics • • • • •
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
• 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
Stats: Global Industry Analysts, Inc.
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Chronology of Cardiovascular Diagnostic Products
Body mass
Temperature
Heart Rate
Blood pressure
Arrhythmias
Weight Scale (~2000 BC)
Body Thermometer (1625)
Physician’s Pulse Watch (1707)
Sphygmomanometer (1881)
Electrocardiograph (1901)
Cardiovascular Measurement Devices are Big Business Omron BP Units: Fitbit Bands: Apple Watches:
10 million 20 million 24 million
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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 biosensing technology 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 Stats: Global Industry Analysts, Inc.
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Lexington Has a Broad Spectrum of Potential Partners Traditional Medtech
Stats: Global Industry Analysts, Inc.
Information Technology
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Executive Leadership Eric Willis, Chief Executive Officer Mr. Willis is an entrepreneurial healthcare technology executive with a track record of success in bringing products from initial concept to market. He is the past President and Chief Operating Officer of ParaPatch (2013–2015), where he was responsible for the development and launch of an over-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 backed start-up medical device company that developed a new method for performing epidural anesthesia. From 1994–2008 he served in a variety of executive and operational roles for cardiovascular medical device companies. Nick Furber, Chief Financial Officer Nick Furber is a Chartered Accountant (US) and Chartered Financial Analyst who is currently the principal of NJF Consulting offering financial services growing public companies. Previously Nick has over 10 years experience as Chief Financial Officer of a producing gold corporation listed on the TSX and prior to which over 10 years accounting, Mergers & Acquisitions, valuation and due diligence experience gained in a variety of industries working for PricewaterhouseCoopers. Nancy Lince, Regulatory and Clinical Advisor Nancy has over 25 years of experience in regulatory, clinical and quality affairs for medical products. Nancy has written or overseen over 200 submissions, has conducted extensive negotiations with FDA and International regulatory agencies, and developed regulatory strategies resulting in significant cost savings and decreased time to market. Scott Bluni - General Counsel, Intellectual Property Scott Bluni is a Senior Principal with the firm Kacvinsky Daisak Bluni. His practice includes patent portfolio management and strategic counseling, licensing, product clearance, prosecution, deal diligence and litigation. Previously, Scott was vice president and cardiovascular chief patent counsel at Boston Scientific Corporation, a major global medical device company. Scott began his legal career as a patent examiner with the United States Patent and Trademark Office while attending evening law school, after which he was an associate at Kenyon & Kenyon, an intellectual property boutique, in Washington, D.C. 20 CSE: LNB │ OTCQB: LXGTF
Scientific Advisors Jonathan Maltz, Ph.D., Chief Scientific Advisor Dr. Maltz, received his PhD degree in Electrical Engineering from the University of California at Berkeley, and has over 16 years of experience designing new devices for assessing vascular function and evaluating these on human subjects. Dr Maltz is author of over 25 peer-reviewed publications, and holds 18 granted US patents. Jeffrey Olgin, M.D., Medical Advisor Dr. Jeffrey Olgin, a cardiologist and electrophysiologist, is co-director of the UCSF Heart and Vascular Center and chief of Cardiology. A specialist in the treatment of arrhythmias, he has developed treatment techniques for irregular heartbeats and founded the UCSF Atrial Arrhythmia Clinic 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 Emory Johns Creek Hospital he is chief of cardiology and the medical director of the cardiac catheterization laboratory and interventional program. He is board certified in Vascular Medicine, Endovascular Medicine, Interventional Cardiology and Cardiovascular Medicine. He is an associate professor of medicine at Emory University. Dr. Robertson’s clinical expertise has focused on preventative care and using minimally-invasive vascular and cardiac treatment. James Wall, M.D., Medical Advisor Dr. James Wall is a practicing Pediatric Surgeon at Stanford University. He is an alumnus of the Stanford Biodesign program and holds a Master's degree in Bioengineering. His current research interest is in the design, development and analysis of health technology as well as the emerging field of surgical endoscopy. James currently leads the surgical endoscopy program at Lucile Packard Children’s Hospital and is the Assistant Director of the Biodesign Innovation Fellowship for Stanford Biodesign. 21 CSE: LNB │ OTCQB: LXGTF
Board of Directors Doug Janzen, Chairman Mr. Janzen has 20 years of experience in life sciences with leadership experience in corporate finance, business development, and operational management of life sciences companies. Mr. Janzen is currently Co-Founder and Managing Director of Northview Ventures. He serves as Chairman and CEO of Aequus Pharmaceuticals (AQS-TSXV), a company that was founded within Northview. 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 in licensing deals, and led a partnership with Merck to bring Cardiome’s lead product, Brinavess, through to clinical approval and marketing in Europe. Rocco Rossi, Director A successful entrepreneur and business executive, champion fundraiser, and dedicated public servant, Rocco Rossi is currently President and CEO of Prostate Cancer Canada. His unique blend of experience intersects general management, philanthropy, public policy, politics, business strategy, and new media. As CEO of the Heart and Stroke Foundation – one of Canada’s largest non-profit organizations – from 2004 to 2009, Rossi oversaw four consecutive years of record fundraising raising over $500 million in total and launching many new, life-saving initiatives. Bryan Disher, Director, Audit Committee Chair Mr. Disher (CPA, CA) spent 38 years with PricewaterhouseCoopers in Canada, Australia and Ukraine. He was admitted to partnership in PwC Canada in 1991 and from 2011 until his retirement in June 2015 was a partner with PwC Central and Eastern Europe, where he served as both Managing Partner of its 400+ person Ukrainian practice and leader of its Ukrainian audit and assurance group. Donald A. McInnes, Board Advisor Mr. McInnes is a co-founder and principal at Oxygen Capital Corporation, where he applies his over twenty years’ experience building companies from the ground up. He serves as Chairman of the Clean Energy Association of British Columbia and is a director of Prostate Cancer Canada, the Duke of Edinburgh’s Award-British Columbia and Yukon Division and is a Governor of the British Columbia Business Council. CSE: LNB │ OTCQB: LXGTF
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Lexington Capitalization and Financials
Capitalization Issuer: Security: Symbol(s): Issued & Outstanding: Reserved for Issuance: Options: Warrants:
Lexington Biosciences Inc. Common Shares CSE: LNB│OTCQB: LXGTF 32,355,901 9,054,100 1,800,000 7,254,100
End Q2 2017 Financial Snapshot Cash on hand: CDN$360,000
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Milestones
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.
2019
b. Define regulatory & clinical data strategy for market approval.
2018
2017
a. Develop 1st generation product for distribution into clinical studies.
g. Product development advances toward industrial design, consumer and commercial strategies.
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Summary • • • • •
• •
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. 25 CSE: LNB │ OTCQB: LXGTF
Lexington BioSciences, Inc. Contact +1 (800) 320-2640
[email protected] CSE: LNB│OTCQB: LXGTF
