Freedom® portable driver‡

*The 50cc SynCardia Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy and pediatric bridge to transplant. Prior to clinical use, a Humanitarian Device Exemption (HDE) application for each indication must be approved by the FDA.

‡The Freedom® portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

CAUTION – The Freedom driver and the 50cc Total Artificial Heart are investigational devices, limited by United States law to investigational use.

50cc SynCardia Total Artificial Heart*

- For adults with a BSA between 1.2 and 1.79m²

- For pediatric patients with a BSA between 1.2 and 1.7m²

Tiernee Gonzalez- Implanted: Nov. 9, 2012- Freedom® switch: March 19, 2013- Status: Waiting for a heart transplant

›› See Page 7

The SynCardia Total Artificial

Heart has made me feel the

best I have ever felt, and with

the Freedom portable driver,

I am able to live a more

normal and fulfilling life.

“

“

70cc SynCardia temporary Total Artificial HeartSimilar to a heart transplant, the SynCardia temporary Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular failure. ›› See page 9 for indications

Investigational 50cc SynCardia Total Artificial HeartThe investigational, smaller 50cc SynCardia Total Artificial Heart is designed for use in patients of smaller stature, including women and adolescents. ›› See page 9 for indications

Two Sizes Intended to Treat Most PatientsTogether, the 70cc and 50cc Total Artificial Hearts are intended to fit almost all adult men and women, and many adolescents, including patients with congenital conditions.

The Standard of Care for End-Stage Biventricular Heart Failure is Changing

Heart transplantation is the current standard of care for end-stage biventricular heart failure. However, due to the shortage of donor hearts, an increasing number of critically ill patients require a bridge to donor heart transplant.

End-Stage Biventricular Failure May be Accompanied by:Cardiomyopathy

n Restrictiven Infiltrativen Hypertrophicn Dilated

Refractory cardiogenic shock

Pediatric & adult congenital conditionsn Ventricular septal defectn Transposition of the great arteriesn Failed Fontan circulation

Transplant rejection Persistent ventricular tachycardia

Dono

r Hea

rt Tr

ansp

lant

s

Heart Transplants Reported by Year

1990

–

1991

–

1992

–

1993

–

1994

–

1995

–

1996

–

1997

–

1998

–

1999

–

2000

–

2001

–

2002

–

2003

–

2004

–

2005

–

2006

–

2007

–

2008

–

2009

–

5000 –4500 –4000 –3500 –3000 –2500 –2000 –1500 –1000 –

500 –0 –

North America Europe Other

Year Source: J Heart Lung Transplant. 2011 Oct; 30 (10): 1071-1132

Despite growing demand for heart transplants, the supply of donor hearts in the U.S. has remained flat and the supply in Europe has declined.

Both failing ventricles are removed.

The four native valves are removed.

The atria, aorta and pulmonary artery remain intact.

Quick connects are sewn into the atria, aorta and pulmonary artery.

The Total Artificial Heart (TAH) is implanted and attached via four quick connects.

When a donor heart becomes available, the TAH and quick connects are removed.

The donor heart is transplanted.

“The Total Artificial Heart has opened the flood gates in respect to the treatment possibilities for a quickly growing population of children in heart failure, including adolescents suffering

”

2

from chronic rejection of their transplanted heart, end-stage heart failure accompanied by multiple congenital defects and a chronic failed Fontan circulation.

CaUTiOn: The 50cc SynCardia Total artificial Heart is an investigational device, limited by United States law to investigational use.

David Luís Simón Morales, MD Chief of Pediatric Cardiothoracic Surgery Cincinnati Children’s Hospital Medical Center

Dr. David L.S. Morales plays foosball with his patient, 20-year-old Tiernee Gonzalez, the first SynCardia Total artificial Heart recipient at Cincinnati Children’s Hospital Medical Center.

Jordan Merecka, 18, was the first pediatric patient to be discharged from the hospital to wait for a matching donor heart at home using the Freedom® portable driver*. Jordan, pictured with his mother Suzanne,

received his donor heart transplant on Oct. 29, 2011, after 160 days of life with the Total Artificial Heart.

3

Eliminates the symptoms & source of end-stage biventricular heart failure Replaces the left and right failing heart ventricles

Replaces the tricuspid, pulmonary, mitral and aortic valves

Eliminates native heart complications No diseased heart valves

No ventricle dysfunction/failure or need for inotropes

No arrhythmias or need for pacemaker/defibrillator

Provides immediate, safe blood flow of up to 9.5 L/min through each ventricle Immediately restores normal Cardiac Index (CI)

Helps restore normal Central Venous Pressure (CVP)

Overcomes high Pulmonary Arterial Pressure (PAP)

Restores normal hemodynamics and organ perfusion

Unlike a donor heart, the SynCardia Total Artificial Heart Is immediately available at SynCardia Certified Centers

Does not require expensive, immunosuppressant medication, which can cause subsequent complications

Provides consistent quality and reliable performance

Donor Heart Transplant

VenaeCavae

VenaeCavae

RightAtrium

RightAtrium

Pulmonary Artery Pulmonary Artery

LeftAtrium

LeftAtrium

LeftVentricle

LeftVentricle

RightVentricle

RightVentricle

Aorta Aorta

Similar to a heart transplant, the SynCardia Total Artificial Heart is the only device that:

Jordan Merecka UNITED STATES

First of 3 Consecutive Pediatric Patients Bridged to Transplant

*The Freedom portable driver is CE approved for use in Europe and undergoing an FDa-approved investigational Device Exemption (iDE) clinical study in the U.S.

CaUTiOn – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

Implanted: May 22, 2011Freedom® discharge: Aug. 31, 2011

Transplanted: Oct. 29, 2011

4.0 –

3.5 –

3.0 –

2.5 –

2.0 –

1.5 –

1.0 –

0.5 –

0 –

Patients Recover Rapidly with the SynCardia Total Artificial Heart Safe Blood Flow of Up to 9.5 Liters per Minute

Data from the 10-year pivotal clinical study of the Total Artificial Heart, published in the New England Journal of Medicine

Pre -Implant At Implant

1.9 2.9 Cardiac Index (L/min/m2)92.8 121.7 Systolic Arterial Pressure (mm Hg)19.7 13.6 Central Venous Pressure (mm Hg)48.6 67.5 Organ Perfusion Pressure (mm Hg)

Pre-Implant At Implant

1.9 2.9 Cardiac Index (L/min/m2)92.8 121.7 Systolic Arterial Pressure (mm Hg)19.7 13.6 Central Venous Pressure (mm Hg)48.6 67.5 Organ Perfusion Pressure (mm Hg)

Cardiac Index

Days

0 – 1 – 2 – 3 –

4 – 5 – 6 – 7 – 8 – 9 –

10 –

11 –

12 –

13 –

14 –

40 –

70 –

-1 –

L/m

in/m

2

Immediate Improvement in Hemodynamic Status with the SynCardia Total Artificial Heart

4

2.9L/min/m2

Implanting the Total Artificial Heart helps make patients healthier transplant candidates: n Immediately increases Cardiac Index (CI)n Helps restore normal Central Venous Pressure (CVP) n Overcomes high Pulmonary Arterial Pressure (PAP)n Restores normal hemodynamics and organ perfusion

Prior to implant, patients in need of the Total Artificial Heart had a baseline cardiac index of 1.9 L/min/m2.

Immediately following implant, the patient’s cardiac index increased to an average of 2.9 L/min/m2.

(N Engl J Med 2004; 351:859-867)

The SynCardia Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high cardiac output helps recover the vital organs, including the kidneys, liver, GI tract and brain.

Data from the 10-year pivotal clinical study of the Total Artificial Heart, published in the New England Journal of Medicine

(N Engl J Med 2004; 351:859-867)

Organ Recovery

Physical Recovery

Post-Operative Day 5: Approximately 65% of Total Artificial Heart patients were out of bed.

Post-Operative Day 14: 60% of Total Artificial Heart patients were walking more than 100 feet.

Liver function at two weeks had returned to normal Kidney function at two weeks had improved significantly, trending to normal

Kidney FunctionLiver Function

Able to Walk > 100 FeetAble to Get Out of Bed

DaysDays

DaysDays

-1 – 0 –

2 –

5 –

8 –

11

–

14 –

35 –

56 –

77 –-1

– 0 –

2 –

5 –

8 –

11

–

14 –

35 –

56 –

77 –

2 – 5 – 7 – 14 –

21 –2 – 5 – 7 – 14 –

21 –

Crea

tinin

e (m

g/dL

)

Tota

l Bili

rubi

n (m

g/dL

)

3.5 –

3.0 –

2.5 –

2.0 –

1.5 –

1.0 –

0.5 –

0 –

3.5 –

3.0 –

2.5 –

2.0 –

1.5 –

1.0 –

0.5 –

0 –

100% –

80% –

60% –

40% –

20% –

0 –

100% –

80% –

60% –

40% –

20% –

0 –

5

End-Stage Biventricular Failure

With the Total Artificial Heart

In 2008, Leroy Haynes received a HeartMate II left ventricular assist device (LVAD). However, in April 2012, his condition began to rapidly deteriorate. Over several

weeks, he experienced persistent ventricular tachycardia and continuous shocks from his defibrillator. To save his life, doctors removed his LVAD and implanted the SynCardia Total Artificial Heart.

Leroy Haynes UNITED STATES

Safe Blood Flow of Up to 9.5 Liters per MinuteThe SynCardia Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high cardiac output helps recover the vital organs, including the kidneys, liver, GI tract and brain.

Implanted: June 8, 2012Freedom® discharge: Sept. 13, 2012

Status: Waiting for a heart transplant

Patie

nts (

%)

Patie

nts (

%)

Patie

nts (

%)

Patie

nts (

%)

Patie

nts (

%)

Patie

nts (

%)

Months

Months

Patients

Months

Months

Results at 12 Months

Results at 12 Months

Results at 12 Months

0 – – – –

12 – – – –

24 – – – –

36 – – – –

48 –

0 – – – –

12 – – – –

24 – – – –

36 – – – –

48 –

0 – – – –

12 – – – –

24 – – – –

36 – – – –

48 –

100 –

80 –

60 –

40 –

20 –

0 –

100 –

80 –

60 –

40 –

20 –

0 –

100 –

80 –

60 –

40 –

20 –

0 –

SynCardia Total Artificial Heart*ALL (BTT Listed and Likely to be Listed)

Biventricular Assist Devices (BiVADs)*

Left Ventricular Assist Devices (LVADs)*

*Primary Prospective Implants: June 23, 2006 - September 30, 2012

6

Tran

spla

nted

Tran

spla

nted

Tran

spla

nted

11.6%

22%

56%

18.1%

36%

18%

Dea

th

Dea

thD

eath

1% E

xpla

nted

Aliv

e on

Dev

ice

Aliv

e on

Dev

ice

2% E

xpla

nted

Aliv

e on

Dev

ice

100 –

80 –

60 –

40 –

20 –

0 –

100 –

80 –

60 –

40 –

20 –

0 –

100 –

80 –

60 –

40 –

20 –

0 –

70.3%

39%

25%

Number of Patients at Risk

0 6 12 18 24 30 36 42 48 54 60

141 30 12 7 7 3 3 3 3 1 1

Alive on Device

Alive on Device

Transplanted

Transplanted

Transplanted

11.6%

56% Alive on Device

22%

18.1% Death

18% Death

36% Death

2% Explanted

1% Explanted

70.3%

25%

39%

INTERMACS: Competing Outcomes for the Total Artificial Heart, BiVADs and LVADs

INTERMACS: Competing Outcomes for the Total Artificial Heart, BiVADs and LVADs

INTERMACS (www.intermacs.org) INTERMACS is the national registry for patients with FDA-approved mechanical circulatory support (MCS) devices that treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA), in conjunction with the University of Alabama at Birmingham (UAB) and United Network for Organ Sharing (UNOS).

7

As a child, Tiernee Gonzalez suffered from kidney cancer, which led to the removal of one kidney and chemotherapy, which weakened her heart. She received a heart transplant in 2006, but over

the next few years, her body rejected the donor heart and she progressed to end-stage kidney failure. Two months after receiving the Total Artificial Heart, Tiernee was scheduled to receive a permanent catheter, but the day

before the surgery, she began producing urine for the first time in months. She now has normal function in her kidney.

Tiernee Gonzalez UNITED STATES

Transplanted Alive on Device DeathTAH 70.3% 11.6% 18.1%

BiVADs 39% 22% 36%

LVADs 25% 56% 18%

INTERMACS 12-Month Competing Outcomes for the TAH, BiVADs and LVADs

According to Q3 2012 INTERMACS data, despite the fact that prior to implant Total Artificial Heart patients were in the sickest groups of patients, their survival was comparable to less sick LVAD patients and surpassed survival for BiVAD patients.

Survival

Source: Q3 2012 inTERMaCS data

Implanted: Nov. 9, 2012Freedom® switch: March 19, 2013

Status: Waiting for a heart transplant

*The Freedom portable driver is CE approved for use in Europe and undergoing an FDa-approved investigational Device Exemption (iDE) clinical study in the U.S.

CaUTiOn – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

Long-Term SupportAt 12 months, 12 of 144 Total Artificial Heart patients were still on support. By 48 months, only one patient remained on support with the other 11 patients transplanted. For this data set, no Total Artificial Heart patients died from Month 12 through Month 48. Although this cohort is small, it could indicate effectiveness for long-term support.

From Months 12 through 48, the risk of death for LVAD and BiVAD patients increased the longer they were on support.

Additional Benefits of the SynCardia Total Artificial Heart

8

Total Artificial Heart: 30 Years of Proven Reliability Longest supported Total Artificial Heart patient, 1,374 days (nearly 4 years) prior to transplant

The valves in the Total Artificial Heart have never failed

The diaphragm has a failure rate of less than 1% over 2,200+ diaphragms

1,100+ implants of the Total Artificial Heart account for more than 300 patient years of life on the device

No right ventricular dysfunction/failureNo reported cases of acquired von Willebrand syndrome

Right Ventricular Dysfunction/Failure after LVAD ImplantHeartWare® HVAD - ADVANCE Clinical Study Results of patients developed right heart failure requiring either a Right Ventricular Assist Device (RVAD) or inotropic support*

HeartMate II® LVAD - Premarket Approval Results of patients developed right heart failure during the premarket approval of the HeartMate II**

22%

19%

*Source: Evaluation of the HeartWare HVAD Left Ventricular Assist System for the Treatment of Advanced Heart Failure: Results of the ADVANCE Bridge to Transplant Trial; Keith Aaronson, Mark Slaughter, Edwin McGee, et al. for the HeartWare ADVANCE Investigators; American Heart Association Scientific Sessions November 2010

**Source: HeartMate II FDA Summary of Safety and Effectiveness http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060040b.pdf

SynCardia Total Artificial Heart PatientsPreviously Supported with an LVAD

# of Patients

1 – 2 – 3 – 4 – 5 – 6 – 7 – 8 – 9 –

2009 –

2010 –

2011 –

2012 –

Q1 2013 –

2

2

6

9

3

The SynCardia Total Artificial Heart powered by the Freedom® portable driver

Generic left ventricular assist device (LVAD)

Source: SynCardia implant/Explant Database

New Products & Indications70cc SynCardia temporary Total Artificial Heart

FDA approval: Oct. 15, 2004 European CE Mark: May 16, 2005 Health Canada: Oct. 27, 2005

Bridge to Transplant: Indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Destination Therapy: The FDA has approved a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart to be used for destination therapy.

Patient Selection Criterian At risk of imminent death from non-reversible biventricular heart failuren Not eligible for cardiac transplantn Body surface area (BSA) ≥ 1.7m2

50cc SynCardia Total Artificial HeartBridge to Transplant: SynCardia plans to conduct an Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart as a bridge to transplant in the U.S. The study will feature two arms: a premarket approval (PMA) arm for adult patients and a Humanitarian Device Exemption (HDE) arm for pediatric patients.

Patient Selection Criterian At risk of imminent death from non-reversible biventricular heart failuren BSA between 1.2 and 1.79m²

Destination Therapy: The FDA has approved a Humanitarian Use Device (HUD) designation for the 50cc Total Artificial Heart to be used for destination therapy. SynCardia plans to conduct an Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart for destination therapy in the U.S.

Humanitarian Device Exemption (HDE) ApplicationsOnce approved, the HDEs will allow:

n Up to 4,000 U.S. patients annually to receive the 70cc Total Artificial Heart as destination therapyn Up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapyn Up to 4,000 U.S. pediatric patients annually to receive the 50cc Total Artificial Heart as a bridge to transplant

Current Approvals and Expanding Indications

9

Pietro Zorzetto, pictured wearing the Freedom® portable driver in the Backpack, is the world’s longest supported Total Artificial Heart patient at 1,374 days.

He received his matching donor heart after nearly four years of support.

Pietro Zorzetto ITALY Implanted: Dec. 6, 2007

Discharged: Feb. 4, 2008 Transplanted: Sept. 9, 2011

World’s Longest Supported Total Artificial Heart Patient 1,374 Days

50cc SynCardia Total Artificial Heart

70cc SynCardia Total Artificial Heart

*The Freedom portable driver is CE approved for use in Europe and undergoing an FDa-approved investigational Device Exemption (iDE) clinical study in the U.S.

CaUTiOn – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

European CE Mark: July 25, 2011 FDA Approval: July 5, 2012

The Companion 2 (C2) Driver provides pneumatic power to the SynCardia temporary Total Artificial Heart inside the hospital and on hospital grounds.

Hospital Cart For implant surgery through initial patient recovery, the C2 Driver is docked in the Companion Hospital Cart. The Hospital Cart features sturdy support handles and locking casters to assist patients in standing and walking during early recovery.

Companion 2 (C2) Hospital Driver

implant Driver for Powering the SynCardia Total Artificial Heart

The C2 Driver docked in the Driver Caddy

The C2 Driver docked in the Hospital Cart

Driver CaddyOnce the patient is out of bed and ambulatory, the C2 Driver can be docked in the Companion Driver Caddy to provide greater mobility within the hospital. The Driver Caddy makes it easier for patients to move and exercise, which helps rebuild their strength and improve their health.

The color LCD touch screen display allows for the adjustment of the beat rate, left/right pressure, left/right vacuum and percent systole. Clinicians can monitor the performance of the C2 Driver and the Total Artificial Heart via three line graphs showing pressure, flow and cardiac output.

Three Operating Modesn Operating Room – all features and functions are available

n Intensive Care Unit – full access to alarm modes and monitoring of critical functions

n Ambulatory – heart rate & drive pressures need no adjustment

Switching to the Freedom® Portable DriverOnce stable, eligible patients can be switched to the smaller, wearable Freedom® portable driver. Patients who meet discharge criteria can then leave the hospital to wait for a matching donor heart at home and in their communities.

10

LCD Touch Screen

Freedom Portable Driver Experience (as of April 4, 2013)

128 patients supported worldwide

55 patient years of support 85 patients discharged

Freedom Driver Featuresn Weighs 13.5 pounds (~6 kg), including two onboard lithium-ion batteries and power adaptor

n Batteries are recharged using a standard electrical outlet or the cigarette lighter adaptor in a car

n Worn by the patient in the Backpack or Shoulder Bag

n Uses a “dark cockpit” design, meaning the driver only flashes a light and sounds an alarm when something requires the user’s attention

Benefits of Dischargen Frees stable Total Artificial Heart patients from the hospital

n Improves patient quality of life/helps speed patient recovery

n Eliminates most in-hospital costs for this portion of patient care

n Frees up in-hospital resources to serve additional critically ill patients

European CE Mark: March 1, 2010 Health Canada: May 25, 2011 FDA: Premarket approval supplement submitted Feb. 14, 2013*

Freedom® Portable Driver*

Portable Driver for Powering the SynCardia Total Artificial Heart

The Freedom portable driver and the SynCardia temporary Total artificial Heart

The Freedom portable driver in the Shoulder Bag

The Freedom portable driver in the Backpack

11

Hiking up to six miles every day isn’t for the faint of heart. Luckily for Chris Marshall, he didn’t have one. Mr. Marshall hiked 607 miles while he waited for his matching donor heart using the Freedom portable driver to

power his Total Artificial Heart. He was often accompanied by his wife Kathy and their golden retriever Gracie.

Chris Marshall UNITED STATES Implanted: Feb. 6, 2012

Freedom discharge: March 21, 2012Transplanted: Sept. 12, 2012

Man Hikes 607 Miles Wearing Freedom Portable Driver

*The Freedom portable driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

The Freedom portable driver is the world’s first wearable power supply for the SynCardia Total Artificial Heart. It allows stable patients who meet discharge criteria to leave the hospital and resume their lives at home and in their communities while they wait for a matching donor heart.

1992 E. Silverlake Rd. | Tucson, AZ 85713Phone: +1 520-545-1234 | Fax: +1 520-903-1783info@syncardia.com | www.syncardia.com

Bad Oeynhausen, Germany | europe@syncardia.comPhone: +49 700 SYNCARDIA (796227342) Fax: +49 911 308 44 66266

70cc SynCardia Total Artificial Heart

FDA approval: Oct. 15, 2004 European CE Mark: May 16, 2005 Health Canada: Oct. 27, 2005

Bridge to Transplant: Indicated for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.

Destination TherapyThe FDA has approved a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart to be used for destination therapy. ›› See Page 9

50cc SynCardia Total Artificial Heart

Bridge to Transplant: SynCardia plans to conduct an Investigational Device Exemption (IDE) clinical study of the 50cc Total Artificial Heart as a bridge to transplant in the U.S. ›› See Page 9

Destination TherapyThe FDA has approved a Humanitarian Use Device (HUD) designation for the 50cc Total Artificial Heart to be used for destination therapy. ›› See Page 9

Humanitarian Device Exemption (HDE) ApplicationsOnce approved, the HDEs will allow:n Up to 4,000 U.S. patients annually to receive the 70cc Total Artificial Heart as destination therapyn Up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapyn Up to 4,000 U.S. pediatric patients annually to receive the 50cc Total Artificial Heart as a bridge to transplant

*

SynCardia Total Artificial HeartTwo Sizes Intended to Treat Most Patients