Company: SynCardia Systems, Inc.
Company Description: SynCardia Systems, Inc. is the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. Similar to a heart transplant, the SynCardia temporary Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure.
Nomination Category: Company / Organization Categories
Nomination Sub Category: Company of the Year - Health Products & Services

Nomination Title: SynCardia Systems, Inc.

Tell the story about what this nominated organization achieved since January 1 2011 (up to 500 words). Focus on specific accomplishments, and relate these accomplishments to past performance or industry norms. Be sure to mention obstacles overcome, innovations or discoveries made, and outcomes:

SynCardia Systems, Inc. is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart and the new Freedom® portable driver, the world’s first wearable power supply for the Total Artificial Heart.

Weighing 13.5 pounds, the Freedom portable driver allows stable Total Artificial Heart patients to be discharged from the hospital. For the first time in U.S. history, people who were once days, if not hours from death, are now leaving the hospital without human hearts to wait for a matching donor heart at home. Recovery at home greatly improves the patient’s quality of life and positively influences their physical, mental and emotional health.

Prior to the development of the Freedom driver, Total Artificial Heart patients in the U.S. were confined to the hospital for months, sometimes even a year or longer while they waited for a matching donor heart because the only FDA-approved driver for powering the Total Artificial Heart is the 418 pound “Big Blue” driver, which is hospital-based and the size of a washing machine. Life for a stable Total Artificial Heart patient confined to the hospital is emotionally, physically and financially draining for them, their family and the hospital. Discharge also eliminates most in-hospital costs for this portion of patient care while freeing up hospital resources to treat other critically-ill patients.

The Freedom portable driver is approved for commercial use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. To date, 34 patients have been enrolled in the study. Of these patients, 23 have been discharged from the hospital using the Freedom portable driver. This is more than 2/3 of the 30 discharge patients required by the FDA study.

In March 2011, Fast Company magazine named SynCardia #20 among the “World’s 50 Most Innovative Companies” for “giving mobility to artificial heart recipients.” In addition, last month, SynCardia was named “Arizona Bioscience Company of the Year” by the Arizona BioIndustry Association (AZBio). This award recognizes the for-profit bioscience company whose Arizona-based operations did the most to transform the world during the last 12 months.

The ability to discharge stable patients home using the Freedom portable driver has greatly increased interest in SynCardia’s Total Artificial Heart from transplant centers around the world and especially in the U.S. During the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the Total Artificial Heart, including leading transplant centers like Columbia/New York Presbyterian, Keck Hospital of USC and Texas Heart Institute, which performed four implants of SynCardia’s Total Artificial Heart in just 12 days this summer.

During Q2 and Q3 2011, SynCardia marked its first two profitable quarters in the company’s 10-year history. Through the first three quarters of 2011, SynCardia has recorded more than $16 million in sales, and is on track to do $20 million this year, which would double sales over 2010.

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Provide a brief (up to 100 words) biography about the leader of this nominated organization:

Michael Garippa joined SynCardia as President in July 2010, and by the end of 2010, his leadership had doubled sales over 2009. In May 2011, Mr. Garippa became CEO in addition to his role as President.

Prior to SynCardia, Mr. Garippa served as the CEO and President of TandemHeart, which had recruited him in 2002 as a turnaround expert. He took TandemHeart from an R&D firm that had lost an aggregate of $50 million and had no commercial sales, to a successful company with over $6 million in net income.