The launch of a pivotal clinical trial next year for a “hybrid” procedure to treat atrial fibrillation patients will be an “inflection point” for cardiac surgical device maker AtriCure’s (NASDAQ:ATRC) U.S. business, its CEO said.
The pivotal clinical trial, which could lead to regulatory approval of the hybrid procedure to treat atrial fibrillation and is called DEEP AF, will involve expanding studies from six research centers to 35, CEO David Drachman said. The West Chester, Ohio company is in talks with a number of clinical centers regarding participation in the trial.
The hybrid procedure, which combines AtriCure’s minimally invasive surgical ablation devices with a catheter-based ablation system from BioSense Webster, holds a U.S. market potential of $2 billion, Drachman has previously said. A feasibility trial of the hybrid procedure enrolled its first patient late last year.
Drachman spoke with analysts in a conference call discussing AtriCure’s first-quarter financial results. The company’s quarterly loss narrowed to $1.3 million from $2 million in the year-earlier quarter. Last quarter, AtriCure reported its first-ever profitable quarter.
First-quarter revenue grew 12 percent to $15.6 million, highlighted by 21 percent growth in international sales.
The company reported sales of $1.5 million of its AtriClip device, a clip used during heart surgery to exclude the left atrial appendage. This exclusion helps protect atrial fibrillation patients from strokes. That was up from $1.3 million last quarter.
Drachman said the company plans to use the AtriClip device, which sells for an average of about $1,100, to “open new doors” and “pull through” sales of new ablation technologies the company is planning to launch. About 100 of the company’s top 250 accounts are stocking the device.