Slide 1: Progress of the Fully Implantable System
© 2013 Sunshine Heart, Inc. Progress of the Fully Implantable System TCT – October 2013 www.sunshineheart.com
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties. Various factors could cause actual results to differ materially from these st
Slide 3: C-Pulse II Overview
C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory CAUTION: Investigational device, limited by Federal (or United States) Law to Investigational Use C-Pulse II Overview
Slide 4: C-Pulse II Overview
C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory No percutaneous drive line CAUTION: Investigational device, limited by Federal (or United States) Law to Investigation
Slide 5: C-Pulse II Overview
CAUTION: Investigational device, limited by Federal (or United States) Law to Investigational Use C-Pulse II Overview: C-Pulse II - Fully Implantable System Internal electro-hydraulic converter eliminates the percutaneous drive line and associated infection risks. Non-blood contacting Non-obligatory
Slide 6: Freedom From VAD Exit Site Infection
Freedom From VAD Exit Site Infection 01/01/1996 to 12/31/2008 Entire Cohort [9.22 [s.18 [5.38 ‘Cumulative Proportion Free of infection 30 60 90 120 150 180 210 240 270 300 330 360 390 420 450 ‘Survival Time (days)
Slide 7: Eliminating the driveline is not a new idea... Circa 1985
Eliminating the driveline is not a new idea... © 2012 Sunshine Heart, Inc. Circa 1985
Slide 8: Arrow LionHeart LVAD First clinical TETS system
Arrow LionHeart LVAD First clinical TETS system
Slide 9: Arrow LionHeart LVAD First clinical TETS system
Arrow LionHeart LVAD First clinical TETS system
Slide 10: Arrow LionHeart LVAD First clinical TETS system
Arrow LionHeart LVAD First clinical TETS system
Slide 11: Where will clinical implementation of TETS technology first find traction?
© 2013 Sunshine Heart, Inc. Where will clinical implementation of TETS technology first find traction?
Slide 12: SUNSHINE HEART C-pulse juxta-aortic balloon
© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon
Slide 13: [LOGO]
[LOGO]
Slide 14: ?
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Slide 15: C-pulse juxta-aortic balloon: non-obligatory, no blood contact
© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon Non-obligatory No blood contact so...
Slide 16: SUNSHINE HEART C-pulse juxta-aortic balloon
© 2013 Sunshine Heart, Inc. SUNSHINE HEART C-pulse juxta-aortic balloon
Slide 17: SUNSHINE HEART C-pulse II
SUNSHINE HEART C-pulse II © 2013 Sunshine Heart, Inc.
Slide 18: SUNSHINE HEART C-pulse II
SUNSHINE HEART C-pulse II
Slide 19: Electrohydraulic pump...
] Electrohydraulic pump...
Slide 20: C-Pulse II – Leveraging powerful synergies
C-Pulse II – Leveraging powerful synergies Minnetronix Cirtec Medical Systems TEXAS HEART INSTITUTE at St. Luke’s Episcopal Hospital
Slide 21: Electrohydraulic pump
Electrohydraulic pump- Rapidly inflates and deflates the juxta-aortic balloon (reproduces C-I physiology) EKG synchronized to provide counter-pulsation Balloon passively empties in the event of pump or power failure (essential) Leverages the incompressibility of silicone oil Compliance reservoir inc
Slide 22: C-Pulse II – Important IP progress
C-Pulse II – Important IP progress
Slide 23: Cirtec Medical Systems Electrohydraulic pump
Cirtec Medical Systems Electrohydraulic pump-
Slide 24: How are we going to power it?
How are we going to power it? ll '
Slide 25: Trans-cutaneous Energy Transfer System (TETS)
Trans-cutaneous Energy Transfer System (TETS) DC battery pack outside the body DC current is put through an oscillator to make AC AC current is put through a large electro-magnetic coil (1o) to generate an oscillating magnetic field Oscillating magnetic field goes through the skin Oscillating magnet
Slide 26: Standard transformer
Standard transformer Cc SUNSHINE
Slide 27: Inductive coupling through an air-gap
Inductive coupling through an air-gap
Slide 28: Nikola Tesla
July 10, 1856 – January 7, 1943 Nikola Tesla
Slide 29: Newest TETS systems: smaller, more efficient, more tolerant
Newest systems are: Smaller size so easier to implant More energy efficient so improved battery life More tolerant of geometric misalignment © 2013 Sunshine Heart, Inc. Minnetronix Leaders in Transcutaneous Energy Transfer Systems (TETS)
Slide 30: Minnetronix Leaders in Transcutaneous Energy Transfer Systems (TETS)
Minnetronix Leaders in Transcutaneous Energy Transfer Systems (TETS)
Slide 31: Improvement in TETS component geometry and function
Improvement in TETS component geometry and function Minnetronix
Slide 32: Improvement in TETS component geometry and function
Improvement in TETS component geometry and function Minnetronix
Slide 33: Where are we going to test it?
Where are we going to test it? ~~ |
Slide 34: Texas Heart Institute at St. Luke’s Episcopal Hospital
TEXAS HEART INSTITUTE at St. Luke’s Episcopal Hospital
Slide 35: THI Cardio Vascular Research Lab ICU
THI Cardio Vascular Research Lab ICU
Slide 36: THI Cardio Vascular Research Lab ICU
THI Cardio Vascular Research Lab ICU
Slide 37: Surgical Implant and System Integration
Surgical Implant and System Integration THI’s Cardio Vascular Research Lab The premiere large animal cardiovascular research lab in the world Domain dominance in development and implementation of heart failure technology Successful acute system implantation (first generation) 36 © 2013 Sunshine Hear
Slide 38: Minimally Invasive Implantation
Minimally Invasive Implantation Small incision Sternal-sparing No cardiopulmonary bypass
Slide 39: In summary
The SUNSHINE HEART C-Pulse II has the potential to be the first completely self-contained therapy for heart failure since the bi-ventricular pacer Lack of blood contact and non-obligatory feature make it the most likely candidate to leverage TETS in a mechanical circulatory assist device Pump innova