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Continuous No-interference Peripheral vs. Central Individualized vs. General
Sense capital and ipr 1
ContiPress™Sense A/S DTU April 9. 2013 Lars Lading LL@sense-as.dk
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
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
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
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
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
ContiPress consists of four partsPatch 21 3 4 Control panel Docking station (Charging/Transfer)
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
The Circulatory System:Pump, vessels, capillaries, organs From: McDonald’s Blood Flow in Arteries 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
Arterial stiffness Highly nonlinear (Pressure) Central and periphal stiffnesses are different (Diameter) 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
Pulse reflections are important At bifurcations At localized depositions 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
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
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
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
Device Challenges Market needs and trends Basic method Algorithms Electronics Patches Design (aesthetic) and usability 37
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
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
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
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
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
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