Revolutionary Monitoring Technology for Vascular Health SIMPLE | - - PowerPoint PPT Presentation

Revolutionary Monitoring Technology for Vascular Health

SIMPLE | NON-INVASIVE | EFFECTIVE | LOW COST

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• The first sign of a 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 often

highly invasive and expensive and generally catch cardiovascular disease AFTER it’s developed ...there needs to be a simple and easy way to measure and monitor cardiovascular system health BEFORE the development of heart disease

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Core Cardiovascular Health Predictive Assessment

• HeartSentry is a simple noninvasive and relevant

product for measuring a patient’s core cardiovascular system physiological health.

• Targeted initially at the professional market but also

designed for simple & easy use in consumer markets.

• Technology extensively tested with published

clinical data.

• Intellectual property protected by multiple pending

and issued patents and trademarks.

• FDA 510(k) approval pathway for efficient path to

market launch.

• Large existing market for cardiovascular monitoring

products

• Resultant 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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Heart (cardiovascular) disease and stroke are the No.1 killers world-wide.1

• Nearly 1 in 3 deaths in the United States each year are caused by heart

disease and stroke. Of the approximately 1.5 million people suffering heart attacks annually in the U.S., more than 250,000 will die within one hour of their incident.

Undiagnosed Cardiovascular Disease Is a Killer

• Nearly 1/3 of the ~ 600,000 annual cardiovascular

disease deaths in the U.S. could be prevented through changes in lifestyle habits.2

• Unfortunately, for up to 50% of these individuals, 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 health of the underlying cardiovascular system is critical to preventing future heart attacks and strokes

• Early assessment is key to prevention through proactive lifestyle modification,

physician care and ongoing monitoring.

• Traditional measures of blood pressure and cholesterol measurements are
• nly partial indicators of cardiovascular health.
• Most cardiovascular disease is related to plaque buildup and inflammation

within the arteries (atherosclerosis).

• Cholesterol levels and blood pressure tests do not show plaque build up.

Unmet Medical Need: Early Disease Detection

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Assessing endothelial function detects that arteries are vulnerable to developing atherosclerosis

• The endothelium is the single layer of cells that line various organs and

cavities, especially the heart, blood and lymphatic vessels.

• These cells act as a shield, preventing plaque from forming inside the artery

wall, and produce substances that stop blood clots from developing in the vessel.

Key to Early Disease Detection: Measurement of Endothelial Function

• Healthy endothelial cells release nitric
• xide (NO), which is responsible for critical

protective functions of the artery.

• In an at-risk individual, the endothelial

cells do not produce enough NO, or the NO produced is deactivated by chemicals in the bloodstream before it can prevent deposits from forming in the arterial wall.

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The Solution:

An easy-to-use product that accurately measures endothelial function

• HeartSentry measures increases in arterial volume which occurs when the

endothelial cells of the artery are stimulated and the muscles in the wall of the artery relax.

• A proprietary blood pressure cuff and algorithm senses the ability of the

brachial artery to dilate before and after an applied vascular stimulus. In a relaxed, dilated artery, the volume change over the cardiac cycle is much greater than baseline levels, typically by more than 80% in healthy subjects.

• The HEARTSENTRY unit is outwardly

identical to a standard blood pressure cuff, but is differentiated by its advanced firmware and software which operates a patent-protected measurement protocol.

• The fully automated device is compact and

inexpensive enough for commercial use in the home market and primary care physician

• ffices.

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Current Standard of Care

• The current standard for arterial endothelial

assessment requires a visit to a diagnostic center where an ultrasonographer using high-resolution ULTRASOUND will take approximately an hour to perform the diagnostic imaging and measurements

• f the brachial artery.
• A newer, but less common system is ENDOPAT,

(Itamar Medical) that also requires a visit to a dedicated facility for a supervised assessment undertaken by a trained technician. This technique measures endothelial function using a fingertip blood oxygen sensor and laptop computer. Today, candidate patients must consult with their physician, book an appointment, and visit a specialized facility in order to undergo an assessment with a trained technician.

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Comparative Technologies

ULTRASOUND

• ~$50k to $200k /

unit

• Operating costs vary
• Requires trained

personnel

• Clinic based
• Test time: 1hr +

clinic access

ENDOPAT

• ~$27k / unit
• ~$40 in consumables per test
• Price point means low

adoption

• Facility Based - Requires

Technician

• Test time: ~15 min + clinic

access

• Only measures small vessels –

not major arteries where dangerous plaque buildup is prevalent.

• Inexpensive
• Portable: Designed for clinic
• r home use
• Operating cost: N/A
• No training required
• Test time: <5 min
• Bluetooth results upload

easily to cloud hosted database

• Measures endothelial

function in larger arteries.

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Research and Test Data

• Research:
• Initial results with 50 patients demonstrated a strong measurement

correlation to the current standard of care (ultrasound)

• The diagnostic value of the endothelial function measurement is

supported by a large number of published peer-reviewed studies

• HeartSentry Testing:
• 500% improved sensitivity over the current standard (ultrasound in a

clinic with a trained technician) for endothelial function measurement

• A consistently higher accuracy with lower variability

HeartSentry First Prototype HeartSentry Commercial Product Concept HeartSentry Clinical Study Product

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HeartSentry Technology Origination

The underlying technology has been licensed to Lexington by Lawrence Berkeley National Laboratory in the field of cardiovascular vascular health diagnosis and monitoring. This ground-breaking technology was 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.

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), one of the highest honors for a scientist in the United States. Thirteen lab scientists have won the National Medal of Science, our nation’s highest award for lifetime achievement in fields of scientific research. Eighteen lab engineers have been elected to the National Academy of Engineering, and three scientists have been elected into the Institute of Medicine (IOM).

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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:

• Product Code: 74 DQK
• Regulation No: 870.1425
• Class: II
• Panel: Cardiovascular

Likely HeartSentry Predicates

• iHealth Wireless Blood Pressure Monitor
• Itamar Medical EndoPat 2000

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

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• The global blood pressure monitoring and measurement instruments market is

forecast to exceed $2.6 billion by 2020 and grew at CAGR of 6.53% from 2012 to

• 2016. Increasingly concentrated in the high-growth home segment.
• A key factor contributing to market growth is the increasing prevalence of high

and low blood pressure issues in patients.

• Blood pressure measurement market is increasingly commoditized and is looking

for high value differentiated features for premium product offerings

Market Scope and Dynamics

Stats: Global Industry Analysts, Inc.

• Lexington BioSciences plans to create

a proprietary device that measures

• verall cardiovascular system

health by measuring and monitoring a user’s endothelial function.

• Initially targeted at the clinic based

professional market, the product ultimately will be marketed direct to consumers.

• Endothelial function monitoring will

increase the demand for high value cardiovascular monitoring devices

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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

• ver-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 20 years of experience in regulatory, clinical and quality affairs for medical

• products. Nancy has written over 160 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.

Executive Leadership

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Jonathan S. 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.

Scientific Advisors

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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. His passion for public policy has led him to stand for election both for the position of Mayor of Toronto and for MPP. 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. Eric Willis, Chief Executive Officer 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.

Board of Directors

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Lexington Biosciences aims to rapidly and efficiently capitalize the core science

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non-invasive endothelial health measurement to capture a significant market share in the rapidly growing preventative health sector.

• Because of the mature state of the technology development and the ready

market, we believe we can turn a moderate capital investment into a sustainable business model capable of impressive and ongoing returns within a reasonably short timeline.

• We have the product, the knowledge and the dedication to succeed. We

have proven our ability to create a market opportunity where none existed before, and to actively move decisively forward to position ourselves as leaders in the sector.

• We seek the participation of dedicated stakeholders and committed

partners who appreciate our vision of the future of user-based diagnostic vascular monitoring.

Summary

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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 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

• bserve, 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

• ther than purely historical information, including statements relating to Lexington’s future plans,
• bjectives 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 forward- looking 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.

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