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 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. 2
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Cardiovascular Disease is Highly Prevalent and Poorly Diagnosed • 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 clinical management or lifestyle • Often the FIRST SYMPTOM of coronary artery disease is a heart attack. 1 World Health Organization (WHO) 2 Center for Disease Control (CDC), Atlanta 4 CSE: LNB │ OTCQB: LXGTF
The First Sign of Heart Disease is Often a Heart Attack • Current front line cardiovascular health diagnostics are insensitive at measuring heart disease development Specialized cardiovascular diagnostics • are highly invasive and expensive and generally only 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 5 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. 6 CSE: LNB │ OTCQB: LXGTF
Monitoring Endothelial Health Predicts Onset of Heart Disease Endothelial function tests measure 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. 7 CSE: LNB │ OTCQB: LXGTF
Current Endothelial Function Measurement Tools 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 8 CSE: LNB │ OTCQB: LXGTF
Lexington Has a Simple and Elegant Solution An easy-to-use product designed to easily and accurately measure endothelial function HeartSentry stimulates the 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 . 9 CSE: LNB │ OTCQB: LXGTF
Technology Comparison ULTRASOUND ENDOPAT HEARTSENTRY Cost ~$50k-$200k / unit ~$27k / unit Inexpensive Varying hospital costs $40 per procedure Minimal operating costs Training Ultrasonographer Specialized technician No specialized training Location Clinic based Clinic Based Portable: Designed for clinic or home use ~15 min Time 1hr+ 5 min Method Imaging of large arteries in Measures capillaries in Directly measures endothelial fingertip function in large arteries in arm arm IT data None None Bluetooth results upload easily to integration cloud hosted database 10 CSE: LNB │ OTCQB: LXGTF
Compelling HeartSentry Research and Test Data Early Prototype Clinical Research: • Initial results with 50 patients demonstrated a strong correlation to standard ultrasound measurements • 500% improved sensitivity over ultrasound • 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 11 CSE: LNB │ OTCQB: LXGTF
HeartSentry Technology Origin 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 12
HeartSentry U.S. Market Approval is Fast Tracked HEARTSENTRY is an FDA regulated product that will use the 510(k) premarket notification process HeartSentry FDA Classification: • Class: II • Panel: Cardiovascular Likely HeartSentry Predicate Devices • 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
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