HeartWare International (NSDQ:HTWR) got a bump today after revealing preliminary 4th-quarter sales numbers that beat expectations. The Framingham, Mass.-based company also said it launched a long-planned thoracotomy trial for its implantable heart pump.
HeartWare said it expects to report that 4th-quarter sales grew 38% to roughly $73 million, topping Wall Street’s forecast of $71.24 million, and put full-year 2014 revenues at about $278 million up 34% over 2013.
"Our full-year revenue growth of 34% for 2014 above 2013 reflects the strong market penetration we have experienced to date for the HeartWare ventricular assist system in both the U.S. and international markets," president & CEO Doug Godshall said in prepared remarks. "In international markets, the 6-month follow-up period concludes next month for our clinical trial in Japan, a future growth market, and I am pleased to report that submissions of our CE Marking Trial Application to regulatory authorities are underway requesting approval to commence a trial to evaluate our next-generation MVAD System."
In a separate announcement, HeartWare said it launched an investigational device exemption trial of its left ventricular assist device using a thoracotomy approach for implantation rather than open heart surgery. The HVAD Lateral study is slated to enroll 120 patients with end-stage heart failure who have not responded to standard medical management and who are eligible for cardiac transplantation, according to a press release.
It’s the 1st trial to examine a full-support LVAD implantation other than sternotomy, HeartWare said.
"The thoracotomy implant technique holds considerable promise for making implantation easier for the surgeon and better tolerated by the patient," co-principal investigator Dr. Ed McGee of the Loyola University Chicago Stritch School of Medicine said in a statement. "Implantation via thoracotomy allows for preservation of a sternotomy for a heart transplant, making that subsequent surgery less difficult for the bridge-to-transplant patient."
HTWR shares were up 1.7% to $803.0 apiece in mid-afternoon trading.