Spectranetics (NSDQ:SPNC) yesterday said it plans to boost its research & development spend on the Stellarex drug-eluting balloon it acquired from Covidien early this year, aiming to expand its use into below-the-knee peripheral artery disease.
"Our team and global thought leaders believe the Stellarex DCB platform is ideally suited to treat BTK disease," president & CEO Scott Drake said in prepared remarks. "Accelerating this investment amplifies and elongates the impact of our powerful [drug-eluting balloon] program. Stellarex, in combination with our crossing solutions and laser atherectomy, establishes a comprehensive portfolio to treat peripheral artery disease generally and critical limb ischemia patients specifically."
The investment is expected to add $5 million to $6 million of product development, regulatory and clinical expense in 2015, the company said. A bid for an investigational device exemption from the FDA could lead to a U.S. clinical trial in mid-2016; Spectranetics said it hopes to win CE Mark approval in the European Union for the BTK indication during the 2nd half of next year.
Stellarex won CE Mark approval in the European Union last December, a month after Covidien announced the deal with Spectranetics. Covidien sold Stellarex for $30 million to appease anti-trust regulators ahead of its $50 billion merger with Medtronic (NYSE:MDT). The acquisition pushed Spectranetics much deeper into the red during the 1st quarter, the company said yesterday.
Spectranetics posted losses of -$27.3 million, or -65¢ per share, on sales of $57.4 million, widening losses by some 382.3% on 45.0% sales growth compared with Q1 2014. Adjusted to exclude 1-time items, losses per share were -30¢, missing Wall Street’s forecast by 7¢.
SPNC shares were down -24.6% to $26.15 apiece in mid-afternoon activity today.