Significant Unmet Clinical Need:
Vascular disease is often treated via the implantation of stents that are designed to expand the vessels and remain in place. Many stents are combined with drugs (Drug-Eluting Stents, or DES) to prevent endothelialization and vessel restenosis. The scientific literature, however, has been reporting high incidence of restenosis with both stents and DES within 10 years of implantation. Thus, for many patients, it is not feasible to implant stents. Other complications can include thrombosis (clot formation).
To address the complications and short lifespan of stents and DES, interventional science has experienced a trend toward ‘Directional’ atherectomy technologies that scrape or drill the plaque out of the vessels, in the effort to restore vessel integrity organically. Regrettably, these new Directional methods lack any kind of intuitive architecture that afford physicians the physiologic intelligence and intuitive command of vessel integrity to mitigate adverse events. Effectively, they exert too much concentric force and/or linear translation upon the vessel. These mechanical side effects compromise the structural integrity of the vessel, resulting in vessel perforation, pseudo-aneurysm, stroke and even death.
AngioCure was founded to deliver an entirely new class of interventional tools called ‘Smart Balloon Catheters’, such as TOP-C, which possess the physiologic intelligence and device characteristics that not only advance physicians’ intra-operative skills but also their intuitive command of vessel integrity to deliver safe, reproducible results across the broad spectrum of diverse and challenging patient populations.
No Regulatory Hurdles:
The AngioCure TOP-C ‘Smart Balloon Catheter’ will follow the 510(k) regulatory path. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is “equivalent” to a device already placed into one of the three classification categories. “Class 1” predicate devices are already in the U.S. market. This means that AngioCure expects to be able to quickly gain clearance to market TOP-C in the United States.
Favorable Medical Economics:
Cardiovascular intervention procedures are shifting away from Drug Eluting Stents (DES) toward Drug Eluting Balloons (DEB). While effective, DEB performance includes the following: 10% of the drug may be lost during catheter placement; 80% of the drug is transferred off the balloon during inflation, but most is lost downstream. Consequently, only about 20% of the drug is transferred to vessel wall membranes.
Drug Eluting Balloons are desirable because they are easy to use and leave nothing implanted in the patient at the end of a procedure. The market for Drug Eluting Balloons is expected to be $127M USD by 2017, at an annual growth rate of 8.1%. Drug Eluting Balloons are expected to be used in 90%+ of all peripheral percutaneous vascular procedures. A growing need for peripheral intervention procedures, significant incidence of restenosis after stenting, and bifurcated lesions point to a market of nearly $8 billion for the AngioCure’s TOP-C Smart balloon Catheter.
Validated Product Concept:
(How can we communicate that TOP-C “works?”)
Extensive IP Protection:
AngioCure has numerous patents and patents pending for its Smart Balloon Catheters. Specific details are subject to restricted access.
Significant Competitive Advantages:
AngioCure’s intellectual properties safeguard its development of an all-new class of semi-compliant Smart Balloon Catheters, comprised of: (1) A proprietary physiologic metric and biofeedback technology system, PhysioSense™; (2) its new class of Plug-N-Play Surgical Camera, AngioCam™; and (3) its proprietary extravasated drug delivery platform, NanoVas™. These patent-protected assets afford AngioCure a dramatic, next-generation advantage in the commercialization of sophisticated, physiologically intelligent devices. Like nothing else available in the market, AngioCure’s technologies are designed to empower surgeons with an entirely new armamentarium of medical devices that advance physicians’ intra-operative skills along with their intuitive command of vessel integrity to help them deliver safe, reproducible results across the broad spectrum of diverse and challenging patient populations.
Experienced, Successful Leadership:
Stephen C. Schimpff, M.D., is Chairman of the AngioCure Scientific Advisory Board. Dr. Schimpff is the retired CEO of the University of Maryland Medical Center. Dr. Schimpff is a consultant to the United States Army on mechanisms to interdigitate high technology into improved patient safety in the “operating room of the future.” He has been consultant to the Battelle Memorial Institute in techniques to assist states or institutions to increase translational research. He continues as a voluntary Professor of Medicine at the University of Maryland.
Attractive Exit Validation:
C. R. Bard’s Peripheral Vascular Division acquired Lutonix for $325 million. Maquet Vascular acquired Atrium Medical for $680 million. Medrad Interventional, a unit of Bayer AG, acquired Pathway Medical for $125 million. Medtronic acquired Invatec for $350 million. Terumo acquired Arterial Remodeling Technologies for $144 million.