Our Company
Vascular Closure Systems, Inc. is a privately held medical device company, based in part on the established intellectual property of CardioVascular Technologies, Inc. (http://cvtechinc.com), and is focused on the development and commercialization of the next generation vascular access closure technology for the Interventional Cardiology market. The company is comprised of several seasoned medical device professionals and world class physicians, with a proven record of innovation, clinical acumen, access to the industry and successful commercialization of multiple medical device technologies. Vascular Closure Systems, Inc. is ISO 13485 compliant.
The company is represented by Casey McGlynn (Wilson Sonsini Goodrich & Rosati).
The Market
There are more than 12 million endovascular procedures performed annually which require percutaneous access, primarily through the femoral artery. These vascular access punctures require rapid closure and careful management immediately following the procedure. The overall market for vascular closure is estimated to be over USD $2 billion. Due to an aging population and rapid increase in cardiovascular diseases, the catheter-based endovascular procedures market continues to grow. The growth rate of the vascular closure market is estimated at 10% to 15% annually. The current market is estimated to be only 30% to 35% penetrated.
Our Closure Technologies
Our technologies are based on more than fourteen issued and pending US and International patents (with priority dates going back prior to 2001), and has been engineered to be easier to learn, easier to use, and more cost effective (with a sales price of less than $150.) than current vascular closure systems. Our Intellectual Property (IP) covers more than four different types of sealing methods, including:
- Bioabsorbable Plug;
- Swellable and / or Bioabsorbable Tubular Plug;
- Self-Closing Nitinol Clip;
- RF Thermal Closure.
Our vascular access closure systems are designed to be guided and deployed using the existing procedural vascular introducer sheath.
Our sealing methods do not require an expandable internal vessel support component (such as a balloon, flexible bands, etc.) to deploy the sealing element. Additionally, our vascular access closure systems do not require a second device (deployment or infusion) to be inserted or reinserted into the arteriotomy. Each of the sealing method systems include versions designed for either temporary use (removable) - leaving nothing behind, or as a permanent implant. Our technology is scalable for use with multiple types and sizes of medical devices, such as vascular introducer sheaths, catheters, guide catheters, guide wires, etc., from less than 6 Fr. to larger than 20 Fr. The system could also be used for venous closure. Our vascular access closure system may be particularly beneficial and enabling for larger sized catheter-based percutaneous procedures, including aortic heart valve replacement (PAVR).
In addition, Intellectual Property (IP) available to the company also covers devices, systems and methods for minimally invasive Patent Foramen Ovale (PFO) closure - About 40 percent of patients who have an ischemic stroke have no known cause (called cryptogenic stroke). PFO is present and associated with an increase in stroke in about 40 percent of cases. Also, migraine headaches are more common in patients with PFO. The PFO closure systems include both implant and non implant (thermal closure) solutions.
Our Temporary Use / Removable nitinol clip system has been successfully tested during in vivo, pre-clinical studies. Acute hemostasis occurred as soon as the sealing element was deployed onto the vessel wall, and continued even after the sealing element was removed, several minutes later.
Our Bioabsorbable Closure System
Pre-Clinical (in vivo) testing is currently being conducted using our FastSeal® Bioabsorbable Vascular Access Closure System - the results have been very positive. Our Bioabsorbable System has only two components - a delivery capsule (with the absorbable sealing element pre-loaded) and an advancement plunger. The system design enables hemostasis within five seconds, while using the existing procedural introducer sheath - no second device insertion into the puncture site is required. In addition, our system is compatible with any (10 to 12 cm useable length) commercialized vascular introducer sheath - we don't force you to use a specific dilator / introducer sheath, to be able to use our system. Once the sealing element has been deployed, no external compression is required.
Both 6 Fr. and 8 Fr. systems have been designed, fabricated and successfully tested (see videos listed in the left margin of this page). When commercialized, the target sales price for this version of our vessel access closure system technology will be approximately $150. per set - even with a sales price as low as $100., we will still be able to realize typical medical device margins (60% to 80%), while pricing our system 40% to 50% less than other competitive systems.
Following are a few recent comments from important physicians, after using the latest version of our FastSeal® Bioabsorbable Vascular Access Closure System:
Dr. Antonio Colombo: "I can't believe it - it works so easily"
Dr. Charles Davidson: "The system really works great - I love the simplicity"
Dr. Corrado Tamburino: "This is the best closure system I have ever used"
Dr. Alessandro Bortone: "The system works wonderfully - congratulations"
COMPANY UPDATES
The Company is focused on securing CE Mark approval, for our Bioabsorbable Vascular Access Closure System, before the end of this year.
The Company has recently concluded an agreement for the licensing, manufacturing and distribution of our products for Australia, China (inc. Hong Kong), India, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Thailand and Taiwan. We are currently in discussions for the distribution rights to our products in several additional countries.
Dr. Richard Heuser has joined the Company as a Medical Advisor. Dr. Heuser will be assisting with our vessel access closure and transapical access closure projects. Dr. Heuser is the Director of Cardiology, St. Luke's Medical Hospital and Medical Center, and a Clinical Professor of Medicine, University of Arizona College of Medicine.
Our Company is currently looking to secure funding to complete product development and commercialize our advanced vascular access closure technology. Based on the comments from several important physicians (including those listed above), we believe that we have the optimum vascular access closure solution - safer, faster, much easier to learn, and much less expensive than any other system they have seen or used before. The Company will initiate a fourth round of funding during the month of July, 2010.
Contact Us for additional information.
The Vclosure website includes information for devices, systems, and methods covered in at least one of an Issued, Allowed, or Pending, US or International patent.
Please note that the company's devices have not yet been approved by the US FDA and are not for sale or use in the US.
