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Page  Company Presentation CSF Dynamics
Introduction Key persons behind CSFDynamics A/S Page  MD, Dr.med.sci., University of Aarhus (1976), Specialist in Neurosurgery (1979). Currently employed as Chief Surgeon and Medical Director at PrivatHospitalet Danmark (1992-). Previously Dr. Børgesen was  employed as chief neurosurgeon at the University Clinic of Neurosurgery at Rigshospitalet (1988-02), consultant at Arbejdsskadestyrelsen (1987-99), assistant neurologist at Sikringsstyrelsen (1986-87), consultant at the department of neurosurgery at KAS Glostrup (1984-87), consultant at the department of neurosurgery at Borgaspitalin in Iceland (1982-82). Dr. Børgesen is author and co-author of 86 scientific articles Svend Erik Børgesen Niels Agerlin MD from the University of Copenhagen (1986), Ph.D. from the University of Copenhagen (1993). Currently employed as Chief Neurosurgeon at the Neurosurgical dept. at KAS Glostrup (2002-). Previously employed as senior resident physician at the Neurosurgical dept. at KAS Glostrup (1997-01), resident physician and senior resident physician at the Neurosurgical dept. and Neurological dept. at Rigshospitalet (1988-96)
Introduction History of the SinuShunt Page  Year Event 1993 The first animal experiment on dogs took place. 1994-95  Dr. Børgesen finished the first technical development of the SinuShunt and prepared the shunt ready for patenting. 26 Sep. 1996  An APCT application was filed for the USA, all of Europe, Japan, Hong Kong, Canada and Australia. 1997 The first SinuShunts were implanted. 1997-99  Clinical development and testing of the SinuShunt. 2000 The SinuShunt and the first results were presented at a neurosurgery world congress in Sydney. The interest was overwhelming.  At that congress, the first contacts were made with university hospitals in Europe which wanted to participate in the future testing. The development started of a new shunt for treatment of hydrocephalus for infants and young children. At the same time the shunt for treatment of AD was developed.  2001 CSFDynamics entered into a production agreement with Medical Rubber AB in Sweden, a family-owned company established in 1973. The company, which is ISO 9002 and EN 46002 certified and has clean room facilities (class 10,000), currently produces the SinuShunt.  2002 The SinuShunt achieved the CE approval. Pilot testing and clinical studies continued in selected university hospitals in Europe. Jun. 2003 Dr. Børgesen received the Pudenz Award for 2002 for “Excellence in Cerebrospinal Fluid Physiology”. The award was given to Dr. Børgesen for “his many contributions over the years to the understanding of factors underlying the clinical physiology of hydrocephalus and his recent innovative studies utilizing the ventriculo-cranial venous sinus methodology for treatment of this condition”.  End of 2003  Approx. 200 SinuShunts were implanted in selected hospitals 2007/2009 Development of a new and improved sinus-tube.
Introduction The SinuShunt  Page
Introduction Illustration of the SinuShunt  principle  Page
Introduction The SinuShunt vs. traditional shunts Page  SinuShunt Traditional shunts
Hydrocephalus Page
Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Hydrocephalus Causes and symptoms of Hydrocephalus  Causes Symptoms
Hydrocephalus Diagnosis and treatment of Hydrocephalus  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Diagnosis Treatment
Hydrocephalus Two types of Hydrocephalus  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Congenital stenosis of the Sylvius Aquaduct Obstruction of Foramen Magendi Hypoplasia of the Arachnoidal Granulation
Hydrocephalus Hydrocephalus market  Page  ,[object Object],[object Object],[object Object],[object Object],Competitive dynamics Geographical sales split Geographical sales split
Hydrocephalus Demand for Hydrocephalus  products  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Hydrocephalus Treatment alternatives  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Shunting is the preferred treatment
Hydrocephalus The shunting principle Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],SinuShunt Traditional shunts ,[object Object],[object Object]
Hydrocephalus Commonly acknowledged shortcomings of traditional shunts*  Page  Late complications ,[object Object],[object Object],Relatively short lifetime of current shunts ,[object Object],* FDA conference 8.1.1999 (www.fda.gov/cdrh/stamp)
Hydrocephalus Complications with traditional shunts Page  ,[object Object],[object Object],[object Object],[object Object],Overdrainage related complications 45%
Hydrocephalus Complications of overdrainage  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],Obvious complications ,[object Object],Other complications ,[object Object],Result
Hydrocephalus Dependency on posture Page  ,[object Object],[object Object],[object Object],Traditional shunts ShinuShunt 55-75 CM Supine Standing Supine Standing ,[object Object],[object Object],0-10 CM
Hydrocephalus Technical details of the shunting  principle Page  Traditional shunts SinuShunt Traditional valves have large intervals for the intracranial pressure The SinuShunt does not have any interval for the intracranial pressure  ÷
Hydrocephalus Dependency on physical activity  Page  ,[object Object],[object Object],[object Object],[object Object],Traditional shunts SinuShunt ,[object Object],[object Object],[object Object]
Hydrocephalus Relatively short lifetime of current  shunts   Page  ,[object Object],[object Object],[object Object],[object Object],Copenhagen (N=870) +  Hakim     Orbissigma   Prudenz Survival of shunts Lund: Codman Medos (N=583) Survival of shunts
Hydrocephalus Clinical test of shunting to the sinus Page  Data on 156 implanted shunts Results ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Event Drain implant Total Drilled canal Direct No complications 26 9 35 Drain occluded 0 6 6 Infection 2 1 3 Intraventr. bleed-not shuntrelated 0 1 1 Total 28 17 45 Effect Hydrocephalus type Total Normal pressure High pressure Immediate 15 23 38 None 5 0 5 Transitory 1 1 2 Total 21 24 45
Hydrocephalus Surgical procedure with traditional  shunts  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Surgical procedure
Hydrocephalus Implanting the SinuShunt Page  1) Connector 2) Valves 3) Pre-chamber 4) Resistance tube 5) Drain for the transverse sinus  Incision marks Position of the transverse sinus
Hydrocephalus Surgical procedure with the  SinuShunt  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Surgical procedure SinuShunt advantages ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Same procedure as when implanting traditional shunts Simpler procedure than when implanting traditional shunts
Hydrocephalus The SinuShunt vs. other shunts  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Characteristics Codman Medos Miethke OSVII Pudenz Delta Cogni-Shunt Sinu-Shunt Type Pressure regulated X X Flow/pressure regulated X X X Passive X Opening pressure X X X X X Antisiphon device X X Resorption sites Peritoneum X X X X X Heart X X X X X Cranial Venous Sinus X Susceptible to posture Posture dependent X X X X X Posture independent X Complication possibilities Prox. drain occl. X X X X X Shunt house occl. X X X X X Distal drain occl. X X X X X X Distal drain disruption X X X X X Distal drain displacement X X X X X Overdrainage X X X X X Infection X X X X X X
Hydrocephalus General conclusions of shunting to the sinus  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Overall conclusions Survey of literature ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],* FDA conference 8.1.1999 (www.fda.gov/cdrh/stamp)
Alzheimer’s Disease Page
Alzheimer’s Disease  Causes and symptoms of AD  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],Causes Symptoms
Alzheimer’s Disease  Diagnosis and treatment of AD  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Diagnosis Treatment
Alzheimer’s Disease  Alzheimer’s patient development Page  ,[object Object],[object Object],[object Object],CAGR: 1.8% Source: OECD demographic report and SG Cowen report (march 2004) CAGR: 19.7% ,[object Object],[object Object],[object Object],[object Object],# of persons USDm Development in population above 65 years Development in AD products sales
Alzheimer’s Disease  Theory behind treating Alzheimer’s disease through shunting of CSF  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MiniShunt can possibly stop and may even reverse the progression of Alzheimer’s disease
Alzheimer’s Disease  Evidence from the CogniShunt Phase II clinical trial Page  AD patients seem to maintain their MDRS score when using the CogniShunt, whereas a substantial decrease in the MDRS score was recorded in the control group Mean MDRS score Delta mean MDRS score Treated Non treated Note: MDRS is by many considered as the primary efficacy endpoint for Alzheimer’s tests. The clinical study comprised 29 patients  Source: Assessment of low-flow CSF drainage as a treatment for AD, Silverberg et al. (2002) The difference between the control group and the treated patients is steadily increasing throughout the test period ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MDRS scores Delta MDRS scores
Alzheimer’s Disease  Shortcomings of traditional shunts in Alzheimer’s  Page  + ,[object Object],Late complications ,[object Object],[object Object],Relatively short lifetime of current shunts ,[object Object],Low CSF turnover Alzheimer’s disease Hydrocephalus
Alzheimer’s Disease  Pitfalls of normal csf-drainages  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],CSF shunting to peritoneal cavity only possible with high resistance shunts to avoid overdrainage Amount of CSF shunted is limited
Alzheimer’s Disease  Principle of the MiniShunt I  Page  CSF compartment Macromolecules Low ICP (<6-8 mmHg) Sinuses of the cranium Low pressure (4 mmHg) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Indicates high resistance Indicates low resistance
Alzheimer’s Disease  Physics of the MiniShunt Page  Traditional shunts High pressure differential requires much higher resistance MiniShunt Low pressure differential enables much larger outflow with no overdrainage risk
Alzheimer’s Disease  Production of CSF Page  ,[object Object],[object Object],[object Object],CSF production without the MiniShunt CSF production with the MiniShunt ,[object Object],[object Object],[object Object]
Alzheimer’s Disease  Benchmarking AD products  Page  Drugs Traditional shunts MiniShunt Effect Cost  Patient convenience Side effects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Patient compliance ,[object Object],[object Object],[object Object]
Alzheimer’s Disease  Conclusions regarding the  MiniShunt  Page  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Benefits of the MiniShunt Drawbacks of the MiniShunt

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Csf Presentation 2009

  • 1. Page Company Presentation CSF Dynamics
  • 2. Introduction Key persons behind CSFDynamics A/S Page MD, Dr.med.sci., University of Aarhus (1976), Specialist in Neurosurgery (1979). Currently employed as Chief Surgeon and Medical Director at PrivatHospitalet Danmark (1992-). Previously Dr. Børgesen was employed as chief neurosurgeon at the University Clinic of Neurosurgery at Rigshospitalet (1988-02), consultant at Arbejdsskadestyrelsen (1987-99), assistant neurologist at Sikringsstyrelsen (1986-87), consultant at the department of neurosurgery at KAS Glostrup (1984-87), consultant at the department of neurosurgery at Borgaspitalin in Iceland (1982-82). Dr. Børgesen is author and co-author of 86 scientific articles Svend Erik Børgesen Niels Agerlin MD from the University of Copenhagen (1986), Ph.D. from the University of Copenhagen (1993). Currently employed as Chief Neurosurgeon at the Neurosurgical dept. at KAS Glostrup (2002-). Previously employed as senior resident physician at the Neurosurgical dept. at KAS Glostrup (1997-01), resident physician and senior resident physician at the Neurosurgical dept. and Neurological dept. at Rigshospitalet (1988-96)
  • 3. Introduction History of the SinuShunt Page Year Event 1993 The first animal experiment on dogs took place. 1994-95 Dr. Børgesen finished the first technical development of the SinuShunt and prepared the shunt ready for patenting. 26 Sep. 1996 An APCT application was filed for the USA, all of Europe, Japan, Hong Kong, Canada and Australia. 1997 The first SinuShunts were implanted. 1997-99 Clinical development and testing of the SinuShunt. 2000 The SinuShunt and the first results were presented at a neurosurgery world congress in Sydney. The interest was overwhelming. At that congress, the first contacts were made with university hospitals in Europe which wanted to participate in the future testing. The development started of a new shunt for treatment of hydrocephalus for infants and young children. At the same time the shunt for treatment of AD was developed. 2001 CSFDynamics entered into a production agreement with Medical Rubber AB in Sweden, a family-owned company established in 1973. The company, which is ISO 9002 and EN 46002 certified and has clean room facilities (class 10,000), currently produces the SinuShunt. 2002 The SinuShunt achieved the CE approval. Pilot testing and clinical studies continued in selected university hospitals in Europe. Jun. 2003 Dr. Børgesen received the Pudenz Award for 2002 for “Excellence in Cerebrospinal Fluid Physiology”. The award was given to Dr. Børgesen for “his many contributions over the years to the understanding of factors underlying the clinical physiology of hydrocephalus and his recent innovative studies utilizing the ventriculo-cranial venous sinus methodology for treatment of this condition”. End of 2003 Approx. 200 SinuShunts were implanted in selected hospitals 2007/2009 Development of a new and improved sinus-tube.
  • 5. Introduction Illustration of the SinuShunt principle Page
  • 6. Introduction The SinuShunt vs. traditional shunts Page SinuShunt Traditional shunts
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  • 19. Hydrocephalus Technical details of the shunting principle Page Traditional shunts SinuShunt Traditional valves have large intervals for the intracranial pressure The SinuShunt does not have any interval for the intracranial pressure  ÷
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  • 24. Hydrocephalus Implanting the SinuShunt Page 1) Connector 2) Valves 3) Pre-chamber 4) Resistance tube 5) Drain for the transverse sinus Incision marks Position of the transverse sinus
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  • 37. Alzheimer’s Disease Physics of the MiniShunt Page Traditional shunts High pressure differential requires much higher resistance MiniShunt Low pressure differential enables much larger outflow with no overdrainage risk
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