News | May 06, 2015

Spectranetics Accelerates Investment in Stellarex Drug-Coated Balloon Platform

Company expects below the knee peripheral vascular disease treatment market to reach $150 million by 2020

Stellarex, Spectranetics, investment, BTK, peripheral artery disease

May 6, 2015 — The Spectranetics Corporation 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.

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 U.S. in mid-2016. The commencement of the IDE trial is conditioned upon receipt of regulatory approval from the U.S. Food and Drug Administration (FDA).

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.

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