COLORADO SPRINGS, Colo., April 23, 2015 (GLOBE NEWSWIRE) -- The Spectranetics Corporation (Nasdaq:SPNC) today announced it is accelerating investments in the Stellarex drug-coated balloon angioplasty (DCB) platform for treatment of Below the Knee (BTK) peripheral artery disease. The Company estimates this will represent a $150 million market opportunity by 2020.
"Our team and global thought leaders believe the Stellarex DCB platform is ideally suited to treat BTK disease," said Scott Drake, President and CEO. "Accelerating this investment amplifies and elongates the impact of our powerful DCB program. Stellarex, in combination with our crossing solutions and laser atherectomy, establishes a comprehensive portfolio to treat peripheral artery disease (PAD) generally and critical limb ischemia (CLI) patients specifically."
Spectranetics estimates that treatment of BTK disease will become a meaningful segment of the global market for drug-coated balloons, representing a potential market opportunity of $150 million. The Company anticipates the global market for DCBs to reach between $700 million and $1 billion over the next seven years. Spectranetics is targeting CE mark approval for the Stellarex DCB BTK platform in the second half of 2016.
"Wound healing is always a concern in the treatment of BTK disease. Robust patency and coating stability with minimal flaking is critical in those situations," said William Gray, MD, Columbia University Medical Center, New York. "The Stellarex DCB was designed to optimize drug delivery to the treatment site while minimizing downstream drug loss through the unique coating formula and manufacturing process. The unique coating coupled with the strong clinical data on the Stellarex DCB platform set the stage for an ideal application in treatment of BTK disease."
The acceleration of the investment in the BTK program is expected to represent an incremental $5 to $6 million of product development, regulatory and clinical expense in 2015. The Company expects to commence enrollment in an Investigational Device Exemption (IDE) clinical trial in the US in mid-2016. The commencement of the IDE trial is conditioned upon receipt of regulatory approval from the FDA.
About the Stellarex™ DCB Platform
The Stellarex DCB platform is designed to treat peripheral arterial disease. Stellarex uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. It is not approved for use in the United States.
SPNC develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company's products are sold in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
The Company's Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee as well as the AngioSculpt(R) scoring balloon used in both peripheral and coronary procedures. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.
Safe Harbor Statement
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CONTACT: COMPANY CONTACT The Spectranetics Corporation Guy Childs, Chief Financial Officer (719) 633-8333 INVESTOR CONTACT Westwicke Partners Lynn Pieper (415) 202-5678 firstname.lastname@example.orgSource:The Spectranetics Corporation