SynCardia Systems yesterday withdrew its plans for an initial public offering that was slated to fetch $27.5 million at the midpoint.
“The registrant submits this request for withdrawal as it does not intend to pursue the contemplated public offering at this time,” the Tucson-based artificial heart maker said in an SEC filing. Syncardia had planned to float 2.5 million shares at $10 to $12 apiece.
Syncardia’s TAH-t device is approved in the U.S. as a bridge to transplant for heart failure patients. A destination therapy trial won FDA approval in January. SynCardia is also running a trial for a bridge-to-transplant indication for a smaller version of its device sized for women and children.
The company is working to address a Class I recall of the driver for some of its devices it initiated after a single incident in which a patient briefly lost consciousness but suffered no permanent injury. The malfunction was caused by a supplier’s unauthorized rework of a component, the company said last month.
In June, Syncardia sent a letter to surgeons warning them about issues with a component of its artificial heart in patients who received pre-implantation circulatory rescue interventions.