2
When nature fails, technology takes over:
Innovative Solutions by Flux Medical
CONFIDENTIAL
Ann-Rose Gustin
Chief Operat...
When nature fails, technology takes over:
Innovative Solutions by Flux Medical
in cooperation with Verhaert
3.3 3.4 3.5 3....
Glenn Van Langenhove, Chief Executive Officer and founder
MD, PhD, MBA
Interventional cardiologist, Middelheim Hospital
Me...
Atrial fibrillation
Caused by abnormal electrical impulses originating in the pulmonary veins
Symptoms: palpitations, fain...
Atrial fibrillation
6
Single invasive treatment
not requiring follow-up
medication
Successrate: 50 – 60%
10,000 EUR per procedure
(reimbursement...
Aberrant signals are blocked by creating a line of scar tissue between
the pulmonary source of the signal and the muscles ...
Procedure
• One stent-like device per pulmonary vein
• A circular heating coil in the stent touches the full circumference...
10
VIDEO
11
IP protection
Search for investors
R&D:
• Engineering subcontractors
• Scientific path from modelling to first in man
• Fr...
Verhaert NV - Belgium
Experience:
Leading engineering company with a track record in design of
satellite components, medic...
Research phase Development phase Human trials
Animal model Animal trials First In Man
In vitro/in vivo In vivo In vivo
Uni...
Question Workpackage Subcontractor Outcome
Anatomical variability
of pulmonary veins
• Literature
• FEA: CT scan of 100
pt...
Question Workpackage Subcontractor Outcome
Stretchability of
pulmonary veins
• Ex-vivo animal trial
•Prelevated specimens
...
Question Workpackage Subcontractor Outcome
Radial forces
required for vein
scaffolding and
implant fixation
• FEA: softwar...
Question Workpackage Subcontractor Outcome
Selection of optimal
energy used by
implant
• Engineering study
on energy sourc...
Question Workpackage Subcontractor Outcome
Device prototyping • Breadboarding
• Bench testing
• In vitro and ex vivo
testi...
Question Workpackage Subcontractor Outcome
Controlled heating
of the implant
• Breadboarding of
control mechanisms
• Bench...
•Long procedure
•Chance of repeat procedures due to incomplete conduction
block
•Surgeon exposure to X-Rays for visualisat...
BrainstormonImplantApplication Material on Implant
•How do we get the
active material in/on the
implant
Reduce Blood Cooli...
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Innovation day 2013 3.1 ann-rose gustin (flux medical) - when nature fails, technology takes over

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Innovation day 2013 3.1 ann-rose gustin (flux medical) - when nature fails, technology takes over

  1. 1. 2 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. 2. When nature fails, technology takes over: Innovative Solutions by Flux Medical in cooperation with Verhaert 3.3 3.4 3.5 3.5 3.6 3.6 3.73.4 3.4 3.5 3.6 3.9 4.2 4.6 2.9 5.0 2.4 2.3 2.4 2.7 3.0 3.3 3.6 2.1 1.2 1.4 1.6 1.8 2.1 2.4 0.8 1.0 3
  3. 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 4
  4. 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) 5
  5. 5. Atrial fibrillation 6
  6. 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 7
  7. 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 8
  8. 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 9
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  10. 10. VIDEO 11
  11. 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: 12
  12. 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 13
  13. 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 14
  14. 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 15
  15. 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 16
  16. 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 17
  17. 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 18
  18. 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 19
  19. 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 20
  20. 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. 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 23
  22. 22. Slide 11 Ref : 31/01/2013  322 2242 0 2 16 Rz IRr Q    mcdTdQ  Confidential Blood Flow Blood Flow 24
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