SynCardia Exceeds Best Year to Date
for Implants and Revenue
in the First Nine Months of 2012
Manufacturer of the World's Only Approved Total Artificial Heart Profitable for Sixth Straight Quarter
TUCSON, Ariz. – Oct. 11, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that revenue and implants for the first nine months of 2012 have exceeded the company's best 12-month totals to date. The quarter ended Sept. 30 marks SynCardia's sixth consecutive profitable quarter.
"Worldwide, SynCardia Certified Centers have performed nearly 100 implants of the SynCardia temporary Total Artificial Heart in 2012, which greatly exceeds any previous 12-month period," said Michael Garippa, SynCardia Chairman/CEO/President. "To date, the Freedom® portable driver has supported 53 Total Artificial Heart patients in the U.S. and more than 100 patients worldwide. In Q4, we will submit a Premarket Approval Supplement for the Freedom driver to the FDA."
Weighing 13.5 pounds, the Freedom portable driver allows stable Total Artificial Heart 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. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.
SynCardia's continuing success is evident in the 2012 U.S. News & World Report "Best Hospitals" issue published in August, which features Total Artificial Heart patient Michelle Johnson in its cover story. Among the top 50 centers honored in the "Best Hospitals" issue for cardiology and heart surgery, 25 have added or are in the process of adding the Total Artificial Heart to their programs. In addition, three pediatric centers that offer the Total Artificial Heart were honored among the Top 10 "Best Children's Hospitals" for cardiology and heart surgery.
There are currently 70 SynCardia Certified Centers worldwide spanning 15 countries, with an additional 29 hospitals currently undergoing SynCardia's certification process.
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 1,350 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.