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 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 Technology

Our technology is based on more than ten 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 primary 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.

Pre-Clinical (in vivo) testing is currently being conducted using the
Bioabsorbable Plug System - the results have been very positive.

The Company is currently discussing potential strategic opportunities
with multiple medical device companies.

Dr. Antonio Colombo has joined the Company as a Medical Advisor
Dr. Colombo is one of the top interventional cardiologists in the world.

Vascular Closure Systems, Inc. is currently establishing the US and International distribution network.

The company may consider a strategic alliance, partnership, joint venture, sub-licensing of intellectual property (depending on the technology), as well as other potential business development opportunities.

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.