A novel implantable sensor for long-term continuous glucose - - PowerPoint PPT Presentation

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A novel implantable sensor for long-term continuous glucose measurement

Investor Presentation at

November 29th - 2019

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Lifecare AS is developing an implantable glucose sensor named SENCELL for positioning under the skin into the interstitial space.

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BGM versus CGM

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$ 5 CGM - sales in M$ Others Abbott Dexcom Medtronic $ 909 $ 594 $ 300 $ 1.415 $ 200 $ 899 $ 477 $ 221 2017 2018

• 1. H 2019

$ 68 $ 815 $ 418

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$ 502 Others Abbott Dexcom Medtronic $ 702 $ 111 $ 81 $ 853 $ 1.175 $ 192 $ 112 $ 539 $ 740 $ 125 $ 70 2017 2018

• 1. H 2019

CGM - sales in M$

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$ 76 RoW Europe U.S. $ 1.687 $ 702 $ 909 $ 2.728 $ 113 $ 1.753 $ 740 $ 899 2017 2018

• 1. H 2019

$ 137 $ 1.175 $ 1.415 WW CGM - sales in M$

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According to Harold Schnitzer Diabetes Health Center US presented at Diabetes Technology Meeting US 2017”, this is what the diabetes patient wants for a CGM (continuous glucose measurement) device; # 1) Simple & Affordable # 2) Covered by insurance # 3) Long wear time # 4) High usability with integration # 5) Excellent accuracy # 6) No calibration required # 7) No interference # 8) No compression artifact # 9) Inconspicuous (not readily visible to others) # 10) Safe & comfortable # 11) Accessible data

Competitive Landscape

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Help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management

• AI
• Big Data
• Robotics
• CGM

CGM: disruptive diabetes innovation today and near future

Meetin ting the needs ➢ Long-T erm rm use ➢ No body worn devices ➢ Convenient nt ➢ Lower cost of

• f care

➢ Actionab nable data ➢ Higher sensiv sivity ty ➢ Improved quality ty of

• f life

14 Double membrane patent 2004

• Composition of membranes
• A pressure sensor with a chamber on each side, where the two chambers have

individual semi-permeable membranes

• Applies in USA, Canada, India, China, Japan, Norway, EPO(1)

Augmented osmotic pressure patent 2009

• Apparatus for measuring augmented osmotic pressure
• Patent applies in US
• Approved EPO

Chemistry

• Active fluid composition and method of production and method of production of active

fluid, which can be used in a sensor for measurement of glucose concentrations in fluids

• Pending (Norway)

Dual sensor patent

• Implantable sensor with two chambers, each with a pressure sensor
• Pending

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Meeting the needs ➢ Long-Term use ➢ No body worn devices ➢ Convenient ➢ Lower cost of care ➢ Actionable data ➢ Higher sensivity ➢ Improved quality of life

Date: 25/11/2019 Number of investors: 311 Number of shares: 80 925 000 Holding Stake Name 15 032 030 18,57526 BECH INVEST AS 14 809 477 18,30025 TEIGLAND EIENDOM AS 10 658 301 13,17059 LACAL AS 7 634 920 9,42345 VERDIPAPIRFONDET NORDEA AVKASTNING 6 054 936 7,48216 SPAREBANKEN VEST 3 900 000 4,81928 STERNA HOLDING AS 3 787 879 4,68073 MP PENSJON PK 3 781 104 4,67236 Danske Invest Norge Vekst 1 812 500 2,23973 Deutsche Bank Aktiengesellschaft 1 587 358 1,96152 Rieber & Søn AS 1 515 152 1,87229 NORDA ASA 1 331 355 1,64517 CIMTER AS 710 012 0,87737 PROBE AS 689 379 0,85187 NEXUS MARKETING 590 625 0,72984 CLEARSTREAM BANKING S.A. 6 424 944 7,93938 Other 80 925 000 100

R&D R&D Progress

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Semi-permeable membrane Active fluid Encapsulant Electronic sensor Carrier Glucose molecule Transfer of data Power supply

1 Glucose molecules pass through the semi-permeable membrane and into the micro-sensor

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High concentrations of glucose induce ConA and Dextran dissociation and the formation of two new molecules: ConA / glucose and Dextran

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The active fluid contains two molecules, Concanavalin A (ConA) and Dextran, which will bind together in the absence of glucose

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The increase in osmotic pressure, equivalent to the number of bound glucose molecules, is measured as the difference in pressure between the active and reference fluid

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Pressure signals are conveyed to the electronic sensor and sent to an external reader

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The pressure sensor detects the increase in the osmotic pressure

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Illu lust stra ratio ion of step 2

a b Con A Dextran Glucose

Pressure sensor Pressure sensor Reference fluid Semi-permeable membrane

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Overview – Development Strategy

Macro Cell ll Sencell ncell Miniaturize iaturized Sensor nsor

Starting from a laboratory working cell (5 x 3 x 3 cm), the company has achieved significant miniaturization and has performed preclinical proof-

• f-concept with a small working

sensor model (2 x 1 x 0.5 cm)

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Pre -clinical

• Each system consists of four similar hand made sensor implants wired to a break-out box that collected

measurement data for the duration of the trial, and 1-2 Dexcom4 devices.

• The sensors were designed against requirements (size, materials, etc.) agreed with Sciema and MfD to

make them suitable for implantation

• Sensors were tested in Cambridge prior to shipping to Germany
• No sensor tests were undertaken on site prior to implantation

Dexcom 4 Dexcom 6

Experimental Analysis – Nanosensor Performance

60 µm 0.6 mm 1 mm

Micro Electrodes Membrane Window Optimal Sensorposition

Detail ils

• Stiff frame protects pressure SiN membrane
• Defined 140 nm thin Cr/Au microelectrodes (half-bridge)
• Membrane window with stress free membrane
• Two Membranes make up one full bridge (calibration, noise rejection)
• Optimal sensor position defined at bending edge

Stiff Frame

Calibration Protocol

• Measure Sensor Signal at -00 mbar pressure
• Measure Sensor Signal at -20 mbar pressure
• Measure Sensor Signal at -35 mbar pressure
• Measure Sensor Signal at -20 mbar pressure
• Measure Sensor Signal at -00 mbar pressure
• Measure Sensor Signal at -20 mbar pressure
• Etc….

R / kΩ 0 mbar 20 mbar 35 mbar 20 mbar 0 mbar

• 20 mbar
• 35 mbar

Measurement Curve

This protocol tocol yields

• Calibration Curve
• Signal Hysteresis

(Stability)

• Signal Stability

(Resolution)

Experimental Analysis – Nanosensor Performance

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Overview - Optimized Development Strategy

Preclinical I Preclinical II Laboratory Cell

Sencell

Needle Mounted Sencell

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Size Reduction

• Size Reduction
• Former: 11 mm³
• Current: 2 mm³
• Future: .0.5 mm3
• Allows Lean Implementation
• Needle Type Sensor
• Small Sencell Implant

R&D Progress - Layout of Glucose Sensing Unit

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R&D Progress - Layout of Glucose Sensing Unit

Layout

• Double chamber setup
• Noise free pressure measurements
• Full bridge sensor arrangement
• Drift free pressure measurements
• Just 4 wires necessary for two pressure sensors
• Lean and easy integration

Active chamber Passive chamber 4 Contact interfaces Semipermeable membrane Gold micro-electrodes Pressure sensing membranes

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R&D Progress - Layout of Needle Sensor

Needle Type Sensor

• Wired Interface
• Easy Signal Read-Out
• Sensor in Needle
• Protected
• Measuring Conditions
• Fully Controlled

Sensor Cutout Position of Sensor in Needle

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R&D Progress - Layout of Needle Sensor

Sensor Cutout

Needle Type Sensor

• Wired Interface
• Easy Signal Read-Out
• Sensor in Needle
• Protected
• Measuring Conditions
• Fully Controlled

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Assembly

• MEMS Body
• Carries Pressure Membrane
• Carries Gold Electrodes

Fabricated with MEMS Standard Technology

• Printing of 3D-Nano-Sensor
• Filling of Sensing Chamber with Liquid
• Microfluidic Liquid Application
• Glucose Permeable Membrane
• Attached to MEMS Body by Gluing Procedure

R&D Progress - Assembly of Glucose Sensing Unit

Glucose Permeable Membrane Adhesive Layer Micro Electrodes MEMS Body with Pressure Membrane

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Filling of Sensing Chamber with Active Liquid

• Filling with defined microfluidic process
• Capillary inner diameter 100 µm
• Defined application of liquid
• Defined filling of chamber
• High reproducibility
• Process scalable
• Automation possible

R&D Progress - Assembly of Glucose Sensing Unit

400 µm

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Sealing of Osmotic Pressure Chamber

• Application of UV glue via micro dispensing
• Defined volume of glue
• Restriction of gluing area
• Defined curing of glue (via UV exposure)

R&D Progress - Assembly of Glucose Sensing Unit

400 µm

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Experimental Study

• Burst Pressure Analysis
• Burst Pressure over 2 bar (threshold reached)
• Material change yields 1.6 times higher better mech. stability
• Membrane Deflection Measurements
• Vast increase in membrane deflection
• 3 times higher membrane deflection
• The smaller membrane (new material) is more sensitive

R&D Progress - Layout of Glucose Sensing Unit

New Mater eria ial l Old Mater erial New Mater eria ial l Old Mater erial

New Membranes Feature Enhanced Stability and Sensitivity

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Let’s Execute ute fo for Im Improved ved Val alue Cr Creat ation ion

Sencell cell - Driven by by Natur ture