Spectranetics is accelerating investments in the Stellarex drug-coated balloon angioplasty platform for treatment of below-the-knee peripheral artery disease. The company estimates this will represent a $150m market opportunity by 2020.
“Our team and global thought leaders believe the Stellarex platform is ideally suited to treat below-the-knee disease,” said Scott Drake, president and chief executive officer. “Accelerating this investment amplifies and elongates the impact of our powerful drug-coated balloon programme. Stellarex, in combination with our crossing solutions and laser atherectomy, establishes a comprehensive portfolio to treat peripheral artery disease generally and critical limb ischaemia patients specifically.”
Spectranetics estimates that treatment of below-the-knee disease will become a meaningful segment of the global market for drug-coated balloons, representing a potential market opportunity of US$150m. The company anticipates the global market for drug-coated balloons to reach between US$700m and US$1bn over the next seven years. Spectranetics is targeting CE mark approval for the Stellarex platform in the second half of 2016.
“Wound healing is always a concern in the treatment of below-the-knee disease. Robust patency and coating stability with minimal flaking is critical in those situations,” said William Gray, Columbia University Medical Center, New York, USA. “The Stellarex drug-coated balloon was designed to optimise drug delivery to the treatment site while minimising downstream drug loss through the unique coating formula and manufacturing process. The unique coating coupled with the strong clinical data on the Stellarex platform set the stage for an ideal application in treatment of below-the-knee disease.”
The acceleration of the investment in the programme is expected to represent an incremental US$5–6m of product development, regulatory and clinical expense in 2015. The company expects to commence enrolment in an investigational device exemption (IDE) clinical trial in the USA in mid-2016. The commencement of the IDE trial is conditioned upon receipt of regulatory approval from the FDA.