Slide 1: The Emperor Total Artificial Heart: A Next Generation, Fully Implantable Total Artificial Heart
SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All rights reserved. The Emperor Total Artificial Heart: A Next Generation, Fully Implantable Total Artificial Heart Duffy Elme
Slide 2: Disclaimers
Disclaimers SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All rights reserved. General Picard Medical, Inc. (“PMI”) is making this presentation available in connection with
Slide 3: The SynCardia Total Artificial Heart (STAH)
The SynCardia Total Artificial Heart (STAH) Over 2,100 Implants and Only FDA Approved Total Artificial Heart SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All rights reserve
Slide 4: The SynCardia STAH Replaces Both Sides of a Failing Heart
The SynCardia Total Artificial Heart Replaces Both Sides of a Failing Heart 4 Each patient is implanted with a pair of ventricles driven by either the Companion C2 Driver or the Freedom Home driver, depending upon the situation of the patient. The STAH is intended to replace a failing or failed huma
Slide 5: Clinically Validated: Peer-Reviewed Outcomes Demonstrate STAH Survival Advantage
Survival Rate to transplantation (vs. 46% in control group) 1 79% Survival Rate at one year (vs. 31% in control group) 1 70% 75% Survival Rate at one year after heart transplant 2 Over 2,100 SynCardia Total Artificial Heart Implants 3 Over 7.5 Years Longest Living patient on the STAH 3 Clinically Va
Slide 6: Implantation Procedure
Diseased native heart Planned surgical excision of native cardiac chambers (dotted lines) Partial excision (X) of native cardiac chambers, ascending aorta, and proximal pulmonary artery Complete excision of ventricular chambers, ventral atrial chambers, and great vessels Inflow right and left atrial
Slide 7: Mechanism of Action: Partial Fill – Full Eject
Diastole Air is evacuated from behind the diaphragm, allowing blood to refill through the inflow valve Systole Air pressure is applied to the diaphragm, pushing blood through the outflow valve Mechanism of Action: “Partial Fill – Full Eject” Autoregulation Based on the Frank - Starling Law Source: S
Slide 8: The Emperor (ETAH): Fully Implantable TAH in Development
The Emperor Total Artificial Heart (ETAH) Fully Implantable TAH in Development as Alternative to Heart Transplantation SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All righ
Slide 9: Emperor – A Fully Implantable, Driver-less Version of the SynCardia STAH
Source: SynCardia information Emperor Total Artificial Heart – A Fully Implantable, Driver - less Version of the SynCardia Total Artificial Heart • Identical placement and connections • Identical components and materials • Equivalent mechanism of action • Equivalent hemodynamics • No transdermal dri
Slide 10: Emperor – Identical Placement and Connections
Source: SynCardia information Emperor – Identical Placement and Connections STAH Anatomical Placement Identical Anastomoses Emperor Anatomical Placement SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc.
Slide 11: Emperor – Equivalent Mechanism of Action
Mechanical Actuation Preserves “Partial Fill – Full Eject” Autoregulation • Volume displacement diaphragm pump with one - way valves • Partial fill enables Frank - Starling preload response • Full ejection enables volume displacement afterload independence Emperor – Equivalent Mechanism of Action Sy
Slide 12: Emperor – Benchtop Prototype
Emperor – Benchtop Prototype (1) Crosby et al., ASAIO J. 2015 May - Jun; 61(3):274 – 281 Source: SynCardia Systems, LLC SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All rig
Slide 13: Emperor – Hemodynamics Equivalent to the STAH
Emperor TAH shows increased cardiac output at a constant beat rate in response to increased inflow right atrial pressure, demonstrating autoregulation in response to changing hemodynamics. Testing was conducted at a rate of 125 beats/min. • Identical chamber and stroke volume • Identical max flow ra
Slide 14: Emperor – Hemodynamics Equivalent to the STAH
Emperor – Hemodynamics Equivalent to the STAH Emperor Exhibits Frank - Starling Autoregulation Source: SynCardia information SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. Al
Slide 15: Emperor – First-in-Animal Feasibility Testing
Emperor – First - in - Animal Feasibility Testing SynCardia's products are approved for sale in the U.S. and Canada only. SynCardia Systems, LLC is a wholly owned subsidiary of Picard Medical Inc. © SynCardia Systems, LLC. All rights reserved. • Successfully implanted in three porcine models, each s
Slide 16: Emperor – A Fully Implantable, Driver-less Version of the SynCardia STAH
Source: SynCardia information Emperor Total Artificial Heart – A Fully Implantable, Driver - less Version of the SynCardia Total Artificial Heart • Identical placement and connections • Identical components and materials • Equivalent mechanism of action • Equivalent hemodynamics • No transdermal dri
Slide 17: About SynCardia Systems, LLC
About SynCardia Systems, LLC SynCardia Systems, LLC, a Picard Medical Company, is headquartered in Tucson, AZ. We manufacture and distribute the world’s f irs t and only US Food and Drug Administration (FDA) and Health Canada approved total artificial heart. The SynCardia Total Artificial Heart is t