Forbes Ranks SynCardia Among
"America's Most Promising Companies"
for Second Straight Year
SynCardia Sets New Monthly Record for Total Artificial Heart Implants in January
TUCSON, Ariz. – Feb. 14, 2013 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has been selected by Forbes as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was ranked #69, moving up eight spots from its #77 ranking last year.
“2012 was a record-breaking year for the SynCardia temporary Total Artificial Heart with a 200% increase in implants over 2010 and over 400% revenue growth since 2009,” said Michael Garippa, SynCardia Chairman/CEO/President. “That momentum has continued into the new year with year-to-date implants representing a 40% increase over the same time period last year. In addition, this week we will submit our premarket approval supplement to the FDA for the Freedom® portable driver.”
In 2012, SynCardia achieved several regulatory milestones, including:
- Completing the required patient enrollment in the FDA-approved Investigational Device Exemption (IDE) clinical study of its Freedom portable driver, the world’s first wearable power supply for the SynCardia Total Artificial Heart
- FDA approval of a Humanitarian Use Device (HUD) designation for the 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
For the Most Promising list, Forbes reviewed thousands of applications over the course of six months. The final assessment is based on growth (both in sales and hiring), quality of the management team and investors, margins, market size and key partnerships.
To view the complete the list of America's Most Promising Companies, please visit http://www.forbes.com/most-promising-companies/list/
SynCardia's profile can be viewed at http://www.forbes.com/companies/syncardia-systems/
CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by 175 patients, accounting for over 100 years of support.