Nexeon was originally founded in 2005 by Mark C. Bates, MD, DSci (Hon), a thought-leader in interventional cardiology and a medical device inventor with more than 50 issued and pending patents. Dr. Bates formed the Company with the goal of changing how innovative ideas in the medical device industry move from concept to reality. Pulsus Medical, LLC has since been formed as a spinout from Nexeon to focus on the ongoing development and commercialization of its proprietary balloon, catheter, and filter technologies used in precision medicine systems.
The company recently completed the phase I FastTrack research plan associated with this proprietary system. The phase II grant was awarded due to successful completion of corresponding phase I milestones, and it funded up to $600,000 of critical preclinical research and process development activities, including the completion of a pre-IDE meeting with the US Food and Drug Administration.
The technology in development under the FastTrack is a nanocomposite-based polymer balloon with microperforations that enables precise, pulse delivery of therapeutic drugs directly at the site of an intravascular lesion. Unlike present-day solutions, which are limited to certain drugs and utilize passive delivery only, this approach is hypothesized to enable more efficient drug delivery directly to the diseased site, reducing the potential for systemic toxicity from downstream drug loss.
In continuation to the above-mentioned development efforts, Nexeon MedSystems and a consortium of strategic partners have recently been awarded an additional € 1.4M to develop the IonCath Drug Delivery System.
The IonCath Drug Delivery System is a drug-coated balloon to reduce restenosis using iontophoresis and electroporation for greater, more effective, active drug delivery.
The following patents and applications relate to our micro-perforated balloon catheter system for use in the treatment of restenosis associated with hemodialysis.