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SynCardia Systems

Gold Stevie Award Winner 2012, Click to Enter The 2014 American Business Awards

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: Management Awards Categories
Nomination Sub Category: Maverick of the Year - Business Products Industries

Nomination Title: Michael Garippa, Chairman, CEO and President

Tell the story about what this nominee achieved since January 1 2012 (up to 525 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:

Michael Garippa is the Chairman, CEO and President of SynCardia Systems, Inc., the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart. When Mr. Garippa joined SynCardia as President in 2010, the company had never produced a profitable quarter in its nine-year history and had less than 40 customers worldwide, many of which were inactive. SynCardia had no sales team and revenue was stagnant. Mr. Garippa hand-selected an experienced sales force to aggressively target the top transplant centers around the world and establish the SynCardia temporary Total Artificial Heart as the “new standard of care” for end-stage heart failure affecting both sides of the heart (biventricular failure).

Thanks to Mr. Garippa’s leadership and experience, in 2012, SynCardia generated $25 million in revenue and a record-breaking 125 implants of the Total Artificial Heart at more than 50 Certified Centers, representing a 150% increase in implants over 2011. SynCardia has achieved over 400% revenue growth since 2009 and has been profitable for the past two years. Today, there are over 80 SynCardia Certified Centers worldwide spanning 15 countries and an additional 34 centers currently undergoing SynCardia’s four-phase certification program.

Mr. Garippa has played a pivotal role in recruiting hospitals to participate in the FDA-approved Investigational Device Exemption (IDE) clinical study of SynCardia’s Freedom® portable driver, the world’s first wearable power supply for the Total Artificial Heart. Weighing 13.5 pounds, the Freedom driver allows stable patients who meet discharge criteria to wait for a matching donor heart at home and in their communities instead of the hospital. Discharge speeds patient recovery, improves quality of life and eliminates most in-hospital costs for this portion of patient care.

Under Mr. Garippa’s leadership, minimum enrollment in the clinical study was completed on April 24, 2012, and on Feb. 14, 2013, the study data was submitted to the FDA. SynCardia hopes to receive commercial approval of the Freedom driver, which has supported over 125 patients worldwide, within the next six months.

Additional accomplishments in 2012 include:

• FDA approval of a Humanitarian Use Device (HUD) designation for the 70cc Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant
• FDA approval of the Companion 2 Hospital Driver for supporting patients from implant of the Total Artificial Heart until their condition stabilizes and they can be switched to the Freedom portable driver
• Surpassing 1,100 implants of the Total Artificial Heart worldwide

This January, the FDA approved two HUD designations for SynCardia’s new, smaller 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant. The 50cc Total Artificial Heart is designed for use in patients of smaller stature, including women and adolescents.

The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for each indication. Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapy and up to 4,000 pediatric patients to receive the device as a bridge to transplant. Currently, these patients have no other treatment options and are often referred to hospice.

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Provide a brief (up to 125 words) biography about the nominee:

Michael Garippa joined SynCardia as president in July 2010, became CEO in May 2011 and chairman of the board in January 2012. He is the former CEO and President of TandemHeart. He was recruited by TandemHeart in 2002 as a turnaround expert and stayed on as CEO and President. 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 in the 24 months prior to joining SynCardia. Before joining TandemHeart, Mr. Garippa served as CEO and President of Gateway Home Care. In addition, Mr. Garippa was Founder and CEO of Millennium HomeCare and The Prompt Care Companies.