|C.R. Bard's Lutonix Drug Coated Balloon|
C.R. Bard ($BCR) provided more clarity around the launch strategy of the first FDA approved drug-coated balloon, the Lutonix 035 Drug Coated Balloon Catheter, during its third quarter earnings call today.
"I think the Lutonix DCB is a great example of how you fight against price [pressure] over time by having really differentiated technology," said COO John Weiland, according to the Seeking Alpha transcript.
The device has been available for use in Europe since 2012, and helped power a 9% increase in the company's line of peripheral percutaneous transluminal angioplasty (PTA) devices. And Weiland said the device was being operated in the U.S. the day after its Oct. 10 FDA approval for the reopening of narrowed or blocked arteries in the knee or thigh in patients with peripheral artery disease (PAD).
Bard acquired the product through acquisition in December 2011, and made a $100 million milestone payment to the product developer upon the approval, as per the terms of the transaction.
CEO Timothy Ring gave an update on the company's clinical trials to expand Lutonix's indication for patients with PAD below the knee (BTK), in-stent restenosis, and hemodialysis patients requiring an arteriovenous access point.
"Frankly, BTK is a tough enrolling study. Some of that we think is a little bit of chill effect based on the recall of the competitive product that was on the market. And so that's--enrollment in that study is slower than we'd like for sure, although we're making good progress. We've continued to try to work through FDA and work with investigator to find the appropriately patient mix to drive reasonable enrollment," he said, adding that the in-stent restenosis trial is also experiencing enrolment challenges, while the trial for hemodialysis patients is enrolling quickly.
"To complement our Lutonix launch, we received clearance and are rolling out our new Ultraverse 035, family of PTA balloons with our new Geoalign technology. Geoalign is a new marking system on the catheter that's designed to simplify placement and track catheter movement to reduce procedure time and radiation exposure," said John DeFord, senior vice president of Science, Technology and Clinical Affairs, during the call.
For the quarter, the company reported earnings of $131.3 million (up 41% year-over-year) on net sales of $830 million (up 9%). Net U.S. sales were $565.4 million (up 13%) and international sales were $264.6 million (up 3%). The surgical specialty unit experienced the fastest growth, with net sales of $135 million, a 15% increase, while oncology grew the slowest, with sales of $229 million, a 7% increase.