SynCardia Systems has filed an S-1 form with the U.S. Securities and Exchange Commission (SEC) regarding its initial public offering (IPO). The expected price range given in the filing was $10 to $12 for 2.5 million shares, with an overallotment option for an additional 375,000 shares. At the maximum price, the total offering is valued up to $34.5 million. According to the S-1, the company intends to list on the Nasdaq Global Market under the symbol TAHT. (Source: 24/7 Wall St.)
In this short animation showing how the world’s only FDA, Health Canada and CE approved Total Artificial Heart pumps blood in the body. The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed recovery of vital organs, making the patient a better transplant candidate. (Source: YouTube/SynCardia)
Based in Tucson, Arizona, SynCardia Systems, Inc. is the manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart for use 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 1,440 implants of the SynCardia Total Artificial Heart account for over 465 patient years of life on the device. Since January 2010 more than 600 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital to live at home and in their communities. The Freedom® portable driver has been used by more than 220 patients, accounting for over 140 years of patient support.
The FDA on June 26, 2014 approved the use of the Freedom® portable driver for all clinically stable U.S. patients on the SynCardia Total Artificial Heart. The Freedom® portable driver also is approved by Health Canada and has the CE Mark for use in Europe.
SynCardia is conducting an FDA-approved clinical study on the effectiveness of the SynCardia Total Artificial Heart and the Freedom® portable driver for use as destination therapy, also known as permanent use, in the United States.
The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use. (Source)
The underwriters for the offering are Roth Capital Partners, Maxim Group and Monarch Capital.
The net proceeds from the offering are intended to be used to fund the research and development activities and to build sales, marketing and distribution capabilities for the TAH-t system. The remainder will be used for working capital and general corporate purposes.
Note: Donald G. Isaacs, an employee of SynCardia, Systems, Inc., serves as vice chairman of the AZBio Board of Directors. The company has been a member of the Arizona Bioindustry Association since 2011 and was honored as the Arizona Bioscience Company of the Year in 2011. Only resources publicly available online were used in creating this article.