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September
2016
Neurostimulation Transformed
2
Urinary Incontinence – Underserved Patient Population
People in the UK suffer from Urinary Incontinence1
(over 200 Million people worldwide)
1. http://www.nhs.uk/conditions/Incontinence-urinary/Pages/Introduction.aspx (accessed 31/8/2016)
2. Irwin DE, Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int.
2006 Jan;97(1):96-100.
3. Turner DA et al, The cost of clinically significant urinary storage symptoms for community dwelling adults in the UK. BJU Int. 2004 Jun;93(9):1246-52.
3-6 Million
Of patients with OAB and Incontinence suffer from Depression2
40% Patient report: social anxiety, withdrawal from day to day activities
3
£536M NHS cost to treat urinary incontinence (1999/2000 prices)3.
Sacral Nerve Stimulation: Effective, but Complex and Expensive
(source: MDT InterStim Clinical Summary)
Lifetime NHS cost of Sacral
Nerve Stimulation1, not
taking into account
complications
£24,000
Of patients required
surgical intervention due to
adverse event
%15-42%
1. Assuming 2 device replacement over lifetime: £10482 per initial implant and £6700 for each replacement
4
BlueWind System – Minimally Invasive Neurostimulation
Small Passive Implant
External
Control Unit
Physician
Programmer
• The implant is a micro (0.3cc) neuro-
stimulators placed at the desired
treatment site, adjacent to the target
nerve.
• The implant is then
wirelessly powered
and controlled by an
external device
Closed
loop RF
energy and
data
transfer
5
Clinical Improvement: UI Response
6
36 patient study conducted in the UK and Belgium
BlueWind OAB clinical results
are comparable to competing
neurostimulation solutions,
without the invasive pelvic
procedure
6.7
3.9 4.1 3.9
3.1
2.1 2.1 2.2
1.8
1.4 1.2 1.10
1
2
3
4
5
6
7
8
Baseline (n=29) Month 1 (n=28) Month 3 (n=29) Month 6 (n=29)
Perday
Leaks/day
Pads change/day
Leaks severity
7
Cost Drivers
 Simplified procedure, 30 min under local Anesthesia
 Lower complication rate
 1/36 required surgical intervention
 No batteries  no replacement procedures
 Treatment efficacy  lower ongoing treatment cost
Conclusion
A study investigator:
“All patients were given the option of enrolling
in this BlueWind study or receiving a Sacral
neurostimulation device. 100% chose the
BlueWind device.”
8
Sep 2016
Thank You

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BlueWind Medical

  • 3. Urinary Incontinence – Underserved Patient Population People in the UK suffer from Urinary Incontinence1 (over 200 Million people worldwide) 1. http://www.nhs.uk/conditions/Incontinence-urinary/Pages/Introduction.aspx (accessed 31/8/2016) 2. Irwin DE, Impact of overactive bladder symptoms on employment, social interactions and emotional well-being in six European countries. BJU Int. 2006 Jan;97(1):96-100. 3. Turner DA et al, The cost of clinically significant urinary storage symptoms for community dwelling adults in the UK. BJU Int. 2004 Jun;93(9):1246-52. 3-6 Million Of patients with OAB and Incontinence suffer from Depression2 40% Patient report: social anxiety, withdrawal from day to day activities 3 £536M NHS cost to treat urinary incontinence (1999/2000 prices)3.
  • 4. Sacral Nerve Stimulation: Effective, but Complex and Expensive (source: MDT InterStim Clinical Summary) Lifetime NHS cost of Sacral Nerve Stimulation1, not taking into account complications £24,000 Of patients required surgical intervention due to adverse event %15-42% 1. Assuming 2 device replacement over lifetime: £10482 per initial implant and £6700 for each replacement 4
  • 5. BlueWind System – Minimally Invasive Neurostimulation Small Passive Implant External Control Unit Physician Programmer • The implant is a micro (0.3cc) neuro- stimulators placed at the desired treatment site, adjacent to the target nerve. • The implant is then wirelessly powered and controlled by an external device Closed loop RF energy and data transfer 5
  • 6. Clinical Improvement: UI Response 6 36 patient study conducted in the UK and Belgium BlueWind OAB clinical results are comparable to competing neurostimulation solutions, without the invasive pelvic procedure 6.7 3.9 4.1 3.9 3.1 2.1 2.1 2.2 1.8 1.4 1.2 1.10 1 2 3 4 5 6 7 8 Baseline (n=29) Month 1 (n=28) Month 3 (n=29) Month 6 (n=29) Perday Leaks/day Pads change/day Leaks severity
  • 7. 7 Cost Drivers  Simplified procedure, 30 min under local Anesthesia  Lower complication rate  1/36 required surgical intervention  No batteries  no replacement procedures  Treatment efficacy  lower ongoing treatment cost
  • 8. Conclusion A study investigator: “All patients were given the option of enrolling in this BlueWind study or receiving a Sacral neurostimulation device. 100% chose the BlueWind device.” 8

Editor's Notes

  1. Expand platform to new indications