Tucson, Ariz. (PRWEB) February 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.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,100 implants of the Total Artificial Heart, accounting for more than 300 patient years of life.
Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
SynCardia Wins Two Gold Stevies® at 2012 American Business Awards
On June 18, 2012, SynCardia was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won "Company of the Year – Health Products and Services" and "Most Innovative Company of the Year – up to 100 Employees." See the full list of SynCardia Awards & Recognition, which includes accolades from Forbes, Fast Company and more.