the problem: current continuous glucose monitors (cgm) are invasive continuous glucose monitoring is...

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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

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Page 1: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

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

Page 2: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

THE SOLUTION: NON-INVASIVE CGM FOR DIABETICS

No non-invasive CGMs exist today in the marketplace!

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Page 3: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

PLATFORM TECHNOLOGY: ELECTROMAGNETIC IMPEDANCE TOMOGRAPHY & SPECTROSCOPY

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• TransTech is a 20 year old company with products sold in 50+ countries; BioSensors is a subsidiary

• $3.5M 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 BioSensors patent pending in 12 countries

Started here TodayPQI 380 SDG 200

Army Technology Development

Page 4: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

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 BioSensors Inc. is to be better than +/- 10%;

FDA present standard is +/- 20%; new ISO standard is +/- 15%

BUSINESS MODEL

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Page 5: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

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.

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Page 6: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

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%; BioSensors 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)

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Page 7: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

BioSensors 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

• BioSensors has a royalty free license for TransTech’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

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Page 8: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

BIOSENSORS TEAM

• Michael Dranichak, TransTech, Chairman• David Apkarian, TransTech, President & CEO• Chet Opalka, TransTech Board; AMRI co-founder• Jaret Morse, TransTech, Chief Operations Officer• Donald Colosimo, TransTech/BioSensors,

Engineering Manager• Sarah E. Pluta - Blue Lab Solutions, Inc., Principal

Investigator: Developer of the patented EMIT/EMIS models used by BioSensors

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Page 9: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

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

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Page 10: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

PROJECTIONS AND MILESTONES1. 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 2ND round investment efforts - Month 30

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Page 11: THE PROBLEM: CURRENT CONTINUOUS GLUCOSE MONITORS (CGM) ARE INVASIVE Continuous glucose monitoring is critical for some diabetics and very advantageous

SUMMARY AND CALL TO ACTION• Laboratory and animal data indicates the

innovative combination of tomography (proven in lab) and spectroscopy (in existing products) enables BioSensors 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.

• $4.8M required to accelerate development and generate human data for biomedical device and pharmaceutical company investment/licensing

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