THE PROBLEM CURRENT CONTINUOUS GLUCOSE MONITORS CGM ARE
THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous for others… But, the only devices available require the insertion of a needle sensor or a finger stick, which decreases patient compliance
THE SOLUTION: NON-INVASIVE CGM FOR DIABETICS No non-invasive CGMs exist today in the marketplace! 2
PLATFORM TECHNOLOGY: ELECTROMAGNETIC IMPEDANCE TOMOGRAPHY & SPECTROSCOPY PQI 380 SDG 200 Started here Today Army Technology Development • Trans. Tech is a 20 year old company with products sold in 50+ countries; Bio. Sensors is a subsidiary • $3. 5 M revenue, 18% growth/yr over 5 years • 8 products from concept to market; instrumentation products (PQI/SDG) use our platform technology • 15 issued US patents, 7 pending; primary Bio. Sensors patent pending in 12 countries 3
BUSINESS MODEL Biosensors’ focus is the development of its CGM technology to the point where it can be licensed to large pharmaceutical or biomedical device company that will bring it to market. Realistic accuracy goal of Bio. Sensors Inc. is to be better than +/- 10%; FDA present standard is +/- 20%; new ISO standard is +/- 15% 4
MAJOR MARKET FOR DEVELOPMENT OF REVENUE: • Royalty income from licenses to major pharmaceutical and biomedical companies. • 25. 8 Million in US and 350 Million Worldwide. • The Royalty Income from the Potential Worldwide Glucose Monitoring Market is in excess of $20 -Billion • In U. S. alone, Estimated Annual Royalty Revenues to exceed $70 -Million 5 years after product introduction with 8% penetration rate and $150 million 7 years after with 10% penetration rate. 5
CGM COMPETITION • Invasive approaches are on the market Medtronic, Dexcom, Abbott Labs, and Animas (J&J) $7 -Billion Finger Stick Market - NIH 2007 • Industry accuracy rate +/- 20%; Bio. Sensors accuracy rate to be better than +/- 10% • Minimally invasive - at least 20 organizations are working in this area, many doing basic research • Noninvasive - Presently NONE, the most advanced is Biovotion (Andreas Caduff) 6
Bio. Sensors Competitive Advantage • We think outside of the biomedical device box • We already commercialize construction products, using our platform technology, for asphalt (PQI) and soil (SDG) worldwide with a focus on innovations in sensor system design, model/algorithm development, signal processing, and problem solving • Bio. Sensors has a royalty free license for Trans. Tech’s platform technology, as well as its own primary patent pending in 12 countries • Laboratory in vitro tests and animal in vivo tests have proven technical feasibility for biomedical use 7
BIOSENSORS TEAM Michael Dranichak, Trans. Tech, Chairman David Apkarian, Trans. Tech, President & CEO Chet Opalka, Trans. Tech Board; AMRI co-founder Jaret Morse, Trans. Tech, Chief Operations Officer Donald Colosimo, Trans. Tech/Bio. Sensors, Engineering Manager • Sarah E. Pluta - Blue Lab Solutions, Inc. , Principal Investigator: Developer of the patented EMIT/EMIS models used by Bio. Sensors • • • 8
STATUS AND TIME LINE • Demonstrated technical feasibility with in vitro laboratory testing and in vivo animal testing; • The plan calls for a 24 -month technical program to carry out 2 rounds of human testing; and • Upon completion of the technical program, focus on securing a licensing agreement or second round investment 9
PROJECTIONS AND MILESTONES 1. Design and fabricate sensor arrays and supporting electronics for tomographic human testing - Month 6 2. Complete tomographic human testing, prepare for spectrographic human testing, and start licensing efforts - Month 11 3. Complete spectrographic human testing and accelerate licensing efforts - Month 22 4. Complete data analysis and model/algorithm update - Month 24 5. Finalize licensing or 2 ND round investment efforts - Month 30 10
SUMMARY AND CALL TO ACTION • Laboratory and animal data indicates the innovative combination of tomography (proven in lab) and spectroscopy (in existing products) enables Bio. Sensors to rapidly and non-invasively measure changes in glucose levels • Technology may also measure lactic acid, hydration levels, hemorrhage extent, lithium salt levels for bipolar disorder patients, and more. • $4. 8 M required to accelerate development and generate human data for biomedical device and pharmaceutical company investment/licensing 11
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