Revolutionising Glucose Testing

JOURNEYS OF HEALTH TECH INNOVATION: PRODUCT TO MARKET

30 | November | 2015

Chris Thomas, Ph.D.

Ollie MitchellMarketing Director

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Changes to glucose testing over the decadesUrinary Glucose Testing• 1500 BC Egyptians first to

mention diabetes.– Tested in medieval times by

appearance, taste• 1838 George Rees, Guy’s

Hospital isolated glucose as sugar responsible• 1945 Clinitest (Ames)

Blood Glucose Testing• 1957 Dextrostrips – Clinitest

chemistry on 50-100 uL of blood• 1970 – First benchtop meter,

reflectance based• 1980 – First home meter:

Dextrometer and Ames Glucometer

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Changes to glucose testing over the decadesBiosensors (Enzyme Based)• 1987 ExacTech (MediSense,

Cranford and Oxford Universities)– 1991-2000 – smaller meters

• 1999 Cygnus Glucowatch Biographer– 2006 DexCom– 2008 Abbott FreeStyle

Navigator– Medtronic

• 2014 Abbott Flash Glucose Monitoring System

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Unmet needs in glucose testingCurrent methods have significant issues• Traditional Blood Glucose Monitoring

(BGM)– Current standard, widely available– Pain, hassle and inconvenience of

fingersticks limits data points– Overnight data is impractical

• Continuous Glucose Monitoring (CGM)– Addresses data density issue– Globally, <4% of glucose monitoring

category due to cost and lack of reimbursement

– Data interpretation challenges• An alternative to both BGM and CGM for

a broad population was needed

Liberation from the hassles of glucose monitoring• No more routine finger pricks*• Painless, 1-second scan• Discreet – Anytime, anywhere even through

clothing**• Accurate over 14 days• No finger prick calibrations• Designed to replace BGM – Use for day-to-

day therapy decisions

* A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycaemia or impending hypoglycaemia is reported by the System or when symptoms do not match the System readings.** The reader can capture data from the sensor when it is within 1 cm to 4 cm of the sensor.

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The FreeStyle Libre Sensor• Small size (35mm x 5mm)• Wear for up to 14 days• No finger prick calibrations• Water resistant* – swim, shower

and exercise• Most agree it is painless to apply

and wear**• Automatically measures,

captures, and stores readings day and night• Fully disposable

*Sensor is water-resistant in up to 1 metre (3 feet) of water. Do not immerse longer than 30 minutes.** Data on file, Abbott Diabetes CareSensor is approximately the size of a 2 Euro coin

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Addressing the data density issue withAmbulatory Glucose Profile (AGP)

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FreeStyle Libre Flash Glucose Monitoring Summary• Painless, 1-second scan of the reader over the sensor to collect

glucose data• 14 day sensor wear, fully disposable, small, low profile sensor• Factory calibrated so no finger prick calibrations required• Accurate, stable and consistent performance over 14 days – 11.4%

MARD• AGP-based reports to visualize comprehensive glucose data• On-going RCTs focus on reimbursement through improved outcomes

with the use of FreeStyle Libre

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Our JourneyPivot to strips• 1997 TheraSense founded to

commercialise sensor technology– Ca. $120MM venture capital

• 1999 Pivoted to strips to enable earlier revenue stream• 2001 Went public – Supported sales force necessary

to compete in strip market• 2004 Bought by Abbott to form

Abbott Diabetes Care, $1.2 Billion– Two strip platforms, FreeStyle

and Precision

Reemergence of sensor portfolio• Ca. 2008 narrowed focus to

insulin dependent diabetics (T1 and T2)– Price pressure in strips, low cost

competitors• 2009 withdrew Navigator from

US market– Inclusion of 510k product in PMA

increases regulatory challenges in 510k products.

• As a result, started FreeStyle Libre program to replace strip testing for our target population• 2014 – CE mark for FreeStyle

Libre