Revolutionary Monitoring Technology for Vascular Health SIMPLE | NON-INVASIVE | EFFECTIVE | LOW COST
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 2
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. Proposed design • Intellectual property protected by multiple pending and issued patents and trademarks. Similar in look to a typical blood pressure cuff, • FDA 510(k) approval pathway for efficient path to HEARTSENTRY represents a major leap forward in market launch. cardiac health monitoring • Large existing market for cardiovascular monitoring products • Resultant data integrates into broader “big data” Health IT initiatives for clinicians and insurers 3
Undiagnosed Cardiovascular Disease Is a Killer 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. • 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 4
Unmet Medical Need: Early Disease Detection 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 only 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. 5
Key to Early Disease Detection: Measurement of Endothelial Function 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. • Healthy endothelial cells release nitric oxide (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. 6
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 offices. 7
Current Standard of Care 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. • 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 of 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. 8
Comparative Technologies ULTRASOUND ENDOPAT • Inexpensive • ~$50k to $200k / • ~$27k / unit • Portable: Designed for clinic unit • ~$40 in consumables per test or home use • Operating costs vary • Price point means low • Operating cost: N/A adoption • Requires trained • No training required • Facility Based - Requires personnel • Test time: <5 min Technician • Clinic based • Test time: ~15 min + clinic • Bluetooth results upload • Test time: 1hr + access easily to cloud hosted clinic access database • Only measures small vessels – • Measures endothelial not major arteries where dangerous plaque buildup is function in larger arteries. prevalent. 9
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 10
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). 11
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 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 International market approvals are also being pursued. 12
Market Scope and Dynamics • 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 • Lexington BioSciences plans to create a proprietary device that measures overall 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 13 Stats: Global Industry Analysts, Inc.
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