FIG. 2A illustrates a high-level plan view of a dilatation catheter that includes a carbon nanotube-reinforced balloon capable of delivering a fluidic therapeutic agent within blood vessel wall.
Nexeon MedSystems (formerly Paragon Intellectual Properties LLC) (Charleston, WV) has developed carbon nanotube-reinforced balloons for delivering therapeutic agents within or beyond the wall of blood vessels. Carbon nanotubes (CNT) are present in a concentration of less than 5% weight in the polymer. The nanotubes form a reinforcing web within the flexible balloon wall.
Nexeon MedSystems founder Dr. Mark C. Bates invented a dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure.
According to U.S. Patent Application 20100010470, in some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.
Paragon Intellectual Properties, LLC, in October 2008, restructured the company, moving from a limited liability company with seven subsidiaries to a single C-corporation to form Nexeon MedSystems, Inc. This restructuring was undertaken to prepare for pending clinical trials and commercialization of the company’s lead technologies.
In addition in 2008, the company completed a Series A equity funding round of $24 million with financing provided by SurModics, Inc. (Nasdaq: SRDX), Guidant Corporation (now Abbott Laboratories and Boston Scientific), and private investors.
Proceeds from the financing will be used to execute on development and clinical trial plans for the prohealing PROTEX™ Coronary Stent System. Additionally, Nexeon is using the funds to advance the development of its other lead technologies, including a family of innovative peripheral stents and nanotechnology-based medical devices. Worldwide, about 1.8 million stents are implanted into patients every year, with an annual US market of about $2.2 billion. Drug-eluting stents deliver drug locally, thereby requiring a lower dose of drug and minimizing systemic toxic effects.
