Sense capital and ipr 1

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Sense capital and ipr 1

  1. 1. ContiPress™Sense A/S DTU April 9. 2013 Lars Lading LL@sense-as.dk
  2. 2. Topics ContiPress™: The problem and our solution Sense history How to succeed? Some general comments about venture capital and IPR  IPR: • The procedure • What can you do yourself – and what not? • About claims, descriptions, figures • Publications and patents  Venture Capital: • Do you really need it? • Consequences Summary 2
  3. 3. The Challenge 3
  4. 4. Hypertension 25% of world populations suffers from hypertension 33% of these are being treated 1 out of 8 deaths are attributted to hypertension 4
  5. 5. Blood Pressure: Continuous measurementsare needed A strong need for continuous, non interfering blood pressure measurements: Ambulatory Blood Pressure Measurements (ABPM) No current commercial product satisfies this need First product focus is non-interfering 24 hours ABPM SBPSleep Dip 1 100% SBPWake Unhealthy Pressure Healthy Waken Sleep 24 hours 5
  6. 6. No interference! 6
  7. 7. Recommendations: HypertensionNICE guideline 34: Hypertension, August 20111.2.3 If the clinic blood pressure is 140/90 mmHg or higher, offer ambulatory blood pressure monitoring (ABPM) to confirm the diagnosis of hypertension. [new 2011]1.2.4 If a person is unable to tolerate ABPM, home blood pressure monitoring (HBPM) is a suitable alternative to confirm the diagnosis of hypertension. [new 2011]- In line with extensive investigations on the value of continuous BP measurements 7
  8. 8. Cost-effectiveness of Ambulatory BPKate Lovibond et al, Cost-effectiveness of options for thediagnosis of high blood pressure in primary care: a modelingstudy. www.thelancet.com published online August 24, 2011DOI:10.1016/S0140-6736(11)61184-7“Ambulatory monitoring was the most cost-effectivestrategy for the diagnosis of hypertension for menand women of all ages” 8
  9. 9. Solution forBlood Pressure 10
  10. 10. Continuous non-interferingblood pressure  Disposable patch/sensor band  Miniaturized electronics for excitation, collection, processing, and storage of data  Docking station for data transfer and charging  Dedicated software 11
  11. 11. Key Features Distension Stiffness No counter pressure No wire – or hose – connections to external devices Disposable patch: no cross-contamination The method is model based! Why is this not common practice? Because arterial distension is (has been) difficult to measure and Arterial stiffness has been almost impossible to measure at a single location 12
  12. 12. ContiPress consists of four partsPatch 21 3 4 Control panel Docking station (Charging/Transfer)
  13. 13. Usage 2 41 3 5 14
  14. 14. Graphical User Interface 15 15
  15. 15. Blood Pressure: How? Arterial distension (artery expansion with heart beat) from dynamic tissue response Arterial stiffness from Pulse Wave velocity The nonlinear stress-strain relation facilitates the mean arterial pressure from the pulse pressure and distensionCompare with a spring: If the increase in length (distension)as a result of an unknown force (pressure) is measured thenthe force can be calculated if the spring constant (stiffness)is known 16
  16. 16. The Circulatory System:Pump, vessels, capillaries, organs From: McDonald’s Blood Flow in Arteries 17
  17. 17. The circulatory systemMost important:  Transport (flow + content) according to needs: awake, work/rest, sleep  Can the pump deliver according to needs?  Can the vascular (arterial) system support flow and pressure?What affects the functioning of the cardiovascular system?  Psychological (white coat syndrome)  Physiological  Genetics, intake (salt), diseases + + +What is measured?  Pressure when flow is blocked (systolic)  At a single point in time, in doctors office: a psychological and a very strong physiological impact on the subject (e.g. inflating a cuff during sleep defeats the purpose)No current system complies with the need of continuousand non-interfering blood pressure measurements. 18
  18. 18. From ZYGOTE BODY19
  19. 19. Anatomy MR images 20
  20. 20. Arterial stiffness Highly nonlinear (Pressure) Central and periphal stiffnesses are different (Diameter) 21
  21. 21. Pulse Wave Velocity A good indicator of the state of the cardiovascular system – in particular of arteries High velocity large stiffness fragile arteries Typically measured over large stretches, e.g. heart to wrist Velocity depends on: o Stiffness o Diameter o Blood density o Wall thickness 22
  22. 22. Pulse reflections are important At bifurcations At localized depositions 23
  23. 23. Field Lines and tissue properties A simplified cross-section of an organ and the distribution of field lines Bioimpedance: See e.g. S. Grimnes and Ø. G. Martinsen, Bioimpedance and Bioelectricity Basics, AP Oxford 2008 24
  24. 24. Electrical ImpedanceA macroscopic quantity 25
  25. 25. Permittivity and refractive index The permittivity relates to a materials ability to transmit (or "permit") an electric field. Complex permittivity ˆ ´ i Refractive index n r r 26
  26. 26. Electrical properties of tissue and blood Conductivities and permittivities are generally different for different types of tissues. They vary greatly with excitation frequency. Anisotropic. 1.8 1.6 1.4 1.2 Conductivity, muscle [S/m] 1 Conductivity, blood [S/m] 0.8 Conductivity, skin dry 0.6 Conductivity, skin wet 0.4 Conductivity, fat 0.2 0 1.00E+03 1.00E+04 1.00E+05 1.00E+06 1.00E+07 1.00E+08 1.00E+09 27
  27. 27. Permittivity 28
  28. 28. Impedance of a cross-section Finite element calculations Equivalent circuits 29
  29. 29. Sensor Band 30
  30. 30. Pulse Pressure and Waveforms30 year old healthy 20young male 10 0BMI = 24 kg/m2  10SBP = 126 mmHg  20 BP = 45 mmHg 112 113 114 115 116 117 Sec62 year old female 40 20BMI = 23 kg/m2  20 0SBP = 182 mmHg  40  60 BP = 85 mmHg 5 6 7 8 9 10 Sec52 year old male 20 10BMI = 46 kg /m2  10 0SBP = 186 mmHg  20 BP = 62 mmHg  30 2 3 4 5 6 7 Sec From a clinical study at Copenhagen Univ. Hospital: Tine Willum Hansen et al. 2011 31
  31. 31. Sense History 32
  32. 32. Sense History Established in 2000: A device for monitoring amount and quality of milk to prematurely born babies during breast feeding. Technology principles developed, but potential investors did not beleive in market. 2005: Similar technology for vascular transport monitoring: A new technology and a new application: Too much up-hill 2006-7: Non-interfering blood pressure 2008-9: A scheme identified and some very preliminary measurements (Innovation funding) 2009: Vækstfonden decides to invest jointly with Seed Capital 2010: Personnel hired (now 10 persons) 2010-now: Product development, key itereations, QA and regulatory, clinical trials 33
  33. 33. Sense IPRPatent appl. Status Priority Importance Action Freedom to from to Sense operate WO Pending 2006 Preventive Rejected; A successful appeal is Large2007/000164 considered very likely A2 WO2007 Granted in 2007 Small Maintain in Europe Large, can be DK00553 Europe affected by RFID patentsPCT/DK2009/ Pending 2009 Preventive Maintained at least until a Large 000241 Protection preliminary evaluation of 5 has been given Not 2010 Substituted Withdrawn before publication in Large publicized by 5 before order not to become prior art to being 5 publicized 5 Submitted 2011 Protection Submitted as a method Very large Feb. 2011 Prevention 6 In 2012 Protection Impedance sensing methods - Large preparation Prevention additional 34
  34. 34. How tosucceed? 35
  35. 35. How to succeed? There is no safe recipe! But a few things may help:  A need • Existing • Potential A unique solution (not a ”me too” product) Market access Financing IPR Avoid dead ends Keep it small – but not too small! And luck! 36
  36. 36. Device Challenges Market needs and trends Basic method Algorithms Electronics Patches Design (aesthetic) and usability 37
  37. 37. 38
  38. 38. Organizational Challenges Interdisciplinary  Physics  Electrical and mechanical  Medical – needs, clinical methods, anatomy, and physiology Engineering competences  Electronics  IT  Materials/mechanics Market Management  Financing  Accounting  Regulatory  Partnerships 39
  39. 39. IPR Time consuming Expensive Often frustrating But mandatory esp. for attracting venture capital Make it short! Claims and figures are most important Description should support claims but also contain material that prevents other applications threatening the freedom to operate. 40
  40. 40. Financing The valley of death Venture capital  Preferable to avoid  May strengthen milestones and plans  You loose control  There may be no other way Strategic partners  May pay for development conditioned by • Full right to product • Right to marketing • Right of first refusal Self financing  Slow growth  Higher risk  Potentially much higher return Crowd Funding 41
  41. 41. External ResourcesMedical  Rigshospitalet (the major university hospital in Denmark)  Odense Univ. Hospital  Frederiksberg HospitalMarket  LundbeckTechnology  DELTA, Electronics, Sound, and Optics  Danish Technological Institute  Technical Univ. of Denmark  Univ. of Southern Denmark  Ambu A/SIPR and Legal  Hegner and Partners  Law Firm Bech-BruunA strong international network 42
  42. 42. Summary Starting a company implies a lot of work, can be very frustrating but few other activities are more challenging and rewarding Market needs Idea: a relevant solution, novel, design and usability People: The right competences Money: Difficult with – impossible without! 43
  43. 43. Hale’s method for BPmeasurements 44

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