The document describes a medical device company called Flux Medical that is developing an innovative solution for treating atrial fibrillation using a stent-like implant. The implant uses magnetic induction heating of a coil to ablate the tissue and block abnormal electrical signals in the pulmonary veins. The summary is as follows: 1) Flux Medical is developing a stent-like implant that uses magnetic induction heating to ablate tissue and treat atrial fibrillation by blocking abnormal electrical signals in the pulmonary veins. 2) The implant aims to simplify the treatment procedure compared to current ablation treatments and reduce risks, costs, and need for follow-up treatments. 3) Flux Medical's research and development process involves engineering

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When nature fails, technology takes over:
Innovative Solutions by Flux Medical
CONFIDENTIAL
Ann-Rose Gustin
Chief Operation Officer Flux Medical
annerose.gustin@pandora.be
THEME 3 : HOW TO ORGANIZE FOR INNOVATION – BASED ON CASES

2. When nature fails, technology takes over:
Innovative Solutions by Flux Medical
in cooperation with Verhaert
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3. Glenn Van Langenhove, Chief Executive Officer and founder
MD, PhD, MBA
Interventional cardiologist, Middelheim Hospital
Medical Director Thermocore (2000-2009), technology successfully
licensed to Bristol Myers Squibb
President Belgian society of Interventional Cardiology
Expert in stenting business
Bruno Schwagten, Chief Scientific Officer and founder
MD, PhD
Cardiologist - Electrophysiologist, Middelheim Hospital
Entrepreneur in residence,
EP training Erasmus University, Rotterdam, The Netherlands
Co-founder of the Society of Cardiac Robotic Navigation
Expert in cardiac arrhythmias
Anne-Rose Gustin, Chief operations Officer
Manager of Safety & Prevention, Quality and Environment, Carestel
NV and Thermocore Medical Systems,
Managing partner Incubate Cardiac Solutions
Master degree in Eastern Languages/Sinology/Japanology
Special degree in Business Communication
Team
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4. Atrial fibrillation
Caused by abnormal electrical impulses originating in the pulmonary veins
Symptoms: palpitations, fainting, chest pain, decreased quality of life
Outcome: severe stroke and congestive heart failure leading to death
1 in 4 above 40 and increasing - currently 2.5 million patients treated in US
alone
High cost to society: 6.5 billion USD in US annually (Source: CDC)
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5. Atrial fibrillation
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6. Single invasive treatment
not requiring follow-up
medication
Successrate: 50 – 60%
10,000 EUR per procedure
(reimbursement in place in
Europe and US)
Complex:
- requires highly skilled
team
- dedicated electrophys lab
Recognised first line
treatment in new guidelines
in Europe and US
Chronic treatment with
medication
Successrate: 30-40%,
with frequent side effects
4,000 EUR per year per
person medication cost
1 in 3 patients do not
tolerate medication
Medication can induce
life threatening
arrhythmias
Ablation Medication
* ESC = European Society of Cardiology
ACC= American College of Cardiology
AHA= American Heart Association
AF treatments as per current ESC, ACC, AHA Guidelines
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7. Aberrant signals are blocked by creating a line of scar tissue between
the pulmonary source of the signal and the muscles of the left atrium
• Difficult lenghty procedures  special team required  10,000 EUR per patient
• Possible perforation of the vessel wall , damage to surrounding tissues / nerves, collateral
damage to the left atrium due to imprecise ablation
• Reconnection leads to invasive redo and is required in 50% of cases within 2-5 years
• Radiation exposure to patient and operator
Point by point treatment Single shot devices
Disadvantages adressed by the Flux system
Treatment principle
Treatment options
Current ablation treatments
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8. Procedure
• One stent-like device per pulmonary vein
• A circular heating coil in the stent touches the full circumference of the vein
• Externally applied magnetic energy heats the coil until the electrical
currents from vein to atrium are fully interrupted
• The stent includes a full set of safety features
Competitive edge over currently used ablation procedures
• A simple, low-risk, standard procedure compared to current ablation
treatments
• Reduced procedure time: increasing capacity of the cathlab
• Reduced collateral damage to surrounding tissues and atrium
• Reduced radiation damage to the operator and patient
• Repeat procedures are possible, non-invasive, quick and simple
• This procedure does not compromise future surgical intervention if needed
• Significant cost advantage to society
• High profit margins on the device and procedures
Medical device developed by Flux
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10. VIDEO
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11. IP protection
Search for investors
R&D:
• Engineering subcontractors
• Scientific path from modelling to first in man
• From concept to proof of concept
From Concept to Realisation:
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12. Verhaert NV - Belgium
Experience:
Leading engineering company with a track record in design of
satellite components, medical devices (orthopaedic), products
combining electronics with advanced material sciences
Provide to Flux:
Stent engineering - Magnet design development - CE certification
Feops NV - Belgium
Experience
Biophysics, modelling of physiological processes, prototyping
of virtual medical devices
Provide to Flux:
Prediction of the physical parameters and behaviour of the human pulmonary
veins
Anatomic and physhiological feasability analysis & definition of stent parameters
Contract Medical International (CMI) – Dresden Germany
Experience
Leading stent manufacturer
Provide to Flux:
Development and manufacturing of stent prototypes for animal
and human trials. Candidate for future stent production
Engineering Subcontractors
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13. Research phase Development phase Human trials
Animal model Animal trials First In Man
In vitro/in vivo In vivo In vivo
University of Ghent
Merelbeke
Paris
Singapore
Affiliated
Electrophysiology Centers
across Europe and VS
Efficient, nearby, low cost High quality, complete file Reliable and fast
Scientific path from modelling to first in man
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14. Question Workpackage Subcontractor Outcome
Anatomical variability
of pulmonary veins
• Literature
• FEA: CT scan of 100
pts
• PyFormex
• Slicer 3D
• >90% pts eligible for
implant
• custom made
implants
• presented at
Cardiostim 2012
• submitted JACC
From concept to ex vivo proof of concept
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15. Question Workpackage Subcontractor Outcome
Stretchability of
pulmonary veins
• Ex-vivo animal trial
•Prelevated specimens
of weight matched
sow hearts
• safe stretching x1.8
times
• huge safety margin
for implants
+ 120%+ 80%
From concept to ex vivo proof of concept
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16. Question Workpackage Subcontractor Outcome
Radial forces
required for vein
scaffolding and
implant fixation
• FEA: software
model used for
coronary artery
stenting, including
variables of vein
thickness and size,
strut size, implant
diameter and length
• feasible for self-
expanding device
• definition of device
design parameters
From concept to ex vivo proof of concept
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17. Question Workpackage Subcontractor Outcome
Selection of optimal
energy used by
implant
• Engineering study
on energy sources
• Iterative material
bench testing
• Multiple in vitro
trials
• Induction heating
by magnetic field
• Selecting optimal
alloy
• Magnet properties
and design
• Coil properties and
design
From concept to ex vivo proof of concept
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18. Question Workpackage Subcontractor Outcome
Device prototyping • Breadboarding
• Bench testing
• In vitro and ex vivo
testing
• Prototype ready for
in vivo animal trials
From concept to ex vivo proof of concept
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19. Question Workpackage Subcontractor Outcome
Controlled heating
of the implant
• Breadboarding of
control mechanisms
• Bench testing
• Incorporation in the
implants
• In vitro and ex vivo
testing
• Controlled heating
within range of 1
degree Celcius is
feasible
• Homogenous
lesion formation in
ablated tissue
From concept to ex vivo proof of concept
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20. •Long procedure
•Chance of repeat procedures due to incomplete conduction
block
•Surgeon exposure to X-Rays for visualisation of catheter
position
Current state-
of-the-art
•Single incision for placing implant
•Entire circumference of vein is treated at once
reducing procedure time
•Multiple veins can be treated simultaneously
reducing procedure time
•Repeat procedures are possible, quick and simple
•Ablation procedure can be performed without
the direct attention of a surgeon
Proposal
Goals:
•Technology investigation
•Initial feasibility of
technology
•Application ideation
Actions:
•Desk research
•Brainstorm sessions
•Initial patent screening
•Initial modelling
•Criteria exploration (regular
interaction with Flux Team)
Results:
•Morphological chart of
solution options
•First trade-off
•Hysteresis heating shows
potential for safe, controlled
heating – Further testing
required
•Joule heating and eddy
current heating as alternative
options
Phase 1 -
Feasibility
Goals:
•Practical verification of
hysteresis heating
•Material selection
•Parameter investigation
Actions:
•Breadboard testing of
various materials (Fe3O4 and
ZnFe2O4, 2x Ferrofluids)
•Testing parameter influences
(Frequency, field strength,
material mass)
•Initial thermal modelling
•Initial magnetic modelling
Effect of insulation (thermal &
electrical)
Results:
•First characterisation of
frequency, field strength and
mass effects
•Steady Sate and Transient
Thermal model
•Magnetic model
•Hysteresis heating achieved
(Fe3O4 and Ferrofluid show
potential, but efficiencies are
too low
• Refocus on Joule heating
with temperature sensing
Phase 2 –
Technology
breadboarding
Goals: (Current Phase)
•Ablation of tissue
•Temperature control
•Initial implant design
•Initial applicator design
•Formal risk assessment
Actions:
•Breadboard testing of
various implant designs and
temperature sensing
technologies (Bi-Metal switch,
PTC, Polyswitch, Digital
Thermostat...)
Results:
•Heating efficiency of Joule
heating is much higher
•Ablation of tissue samples
(pig heart vessels) achieved
•Temperature control
achieved in lab environment
• Implant design iterated
• Applicator concepts created
• Risk File
Phase 3 –
System
Breadboarding
Goals:
• Use all data and information
to build a demonstrator
• “Looks like real” – A
dimensionally correct model
to get the look and feel of the
final product
• “Works like real” – A fully
functional system model for
performing tests
Actions:
• Detailed system design of
equipment and implant
• Assembly of demonstrator
• Test campaign with
demonstrator
• Quality assurance
options
Phase 4 –
Demonstrator
Go/no-go
Goals:
• Use all data and information
to build a prototype
• Prototype to perform
ablations during clinical trials
•Application ideation
Actions:
• Detailed design of
equipment and implant
• Manufacture and assembly
of prototype
• Clinical trials with prototype
• Quality assurance
Phase 5 –
Detailed Design,
Prototype &
Clinical Trials
Go/no-go
Goals:
• Final design for production
• Production of first series
• Batch production
Actions:
•Detailed design of equipment
and implant taking into
account manufacturing
methods, materials and costs
• Manufacture and assembly of
product
• Quality assurance
Phase 6 –
Production
Go/no-go
Go/no-go
Proposal
Achieved
Confidential

21. BrainstormonImplantApplication Material on Implant
•How do we get the
active material in/on the
implant
Reduce Blood Cooling
Effect
•Difficult to control factor
is blood cooling of the
implant and active zone,
how can this be reduced
Other Foldable or
Flexible Mechanisms
•Are there other ways to
place the material apart
from or connected to a
stent
Out There
•Parking area for
miscellaneous and far
out of the box ideas
Confidential
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22. Slide 11
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Confidential
Blood Flow
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23. Confidential
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