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.
Our Company is currently in the process of securing funding to complete the regulatory and clinical requirements to enable the commercialization of our advanced vascular access closure technology. Based on the results of extensive testing, as well as the comments from several important physicians (including those listed below), we believe that we have the optimum vascular access closure solution - safer, faster, much easier to learn, and at a much lower cost per use than any other system. In addition to the Preferred shares being offered, there are also a limited number of Common shares being made available. The Company will close the current round of funding, before the end of this month. A new funding round will then be initiated, with a higher company valuation. The Company is also currently exploring multiple strategic options to enhance shareholder value, including a possible strategic alliance, merger or sale of the company. Contact Us for additional information.
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 sixteen pending and issued, US and International patents (with priority dates going back prior to 2001), and have been engineered to be safer, provide tactile feedback during deployment, easier to learn, easier to use, and much 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 vascular access closure sealing methods, including: 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 vessel puncture site. Our self-closing nitinol clip systems include versions designed for either temporary use (removable) - leaving nothing behind, or as a permanent implant. Each of our cardiovascular access closure technologies is designed to be easily 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. Our cardiovascular access closure systems may be particularly beneficial and enabling for larger sized catheter-based percutaneous procedures, including aortic heart valve replacement (PAVR), as well as transapical access closure.
Our Bioabsorbable Closure System
Extensive pre-clinical (in vivo - acute and chronic) testing has been conducted on our FastSeal® Bioabsorbable Vascular Access Closure system - the results have been very positive. Our Bioabsorbable System is packaged and used as a single piece unit, with no assembly required prior to use, and no separate deployment device is needed to be inserted into the puncture site. Simply insert the FastSeal® system into the hub of the procedural introducer sheath, and advance the attached plunger. The system design enables hemostasis within five seconds after the non-collagen sealing element has been deployed. Our system doesn't require the use of a specific type or brand of vascular introducer sheath, and is compatible with any commercialized vascular introducer sheath with a useable length of between 10 to 12 cm. Once the sealing element has been deployed, no external compression is required. The inner vessel section of the sealing element is absorbed within 14 days. The remainder of the sealing element is completely absorbed within 30 days.
Both 6 Fr. and 8 Fr. systems have been designed, fabricated and successfully tested (see the videos listed in the left margin of this page). When commercialized, the target sales price for our Bioabsorbable vascular access closure system will be less than $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 from 40% to more 60% less than other vascular access closure 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.
The FastSeal® Vascular Access Closure System has the potential to replace all others"
Dr. Alessandro Bortone: "The system works wonderfully - congratulations"
COMPANY UPDATES
The clinical trials to support the CE Mark submission, will begin during the last week of May. This clinical testing is in addition to the FIH test series.
Vascular Closure Systems, Inc. Announces Conclusion of Phase I of the First in Human (FIH) Use of the FastSeal® Bioabsorbable Vascular Access Closure System - 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition. Test Results Demonstrate Superior Safety, Ease of Use, Performance, Patient Comfort and Cost Effectiveness. Click here for a copy of the press release. Contact Us to view a video of one of the Phase I FIH clinical cases. Phase II of the FIH test series will begin before the end of this month (May).
The company expects to begin the International (Outside the US) commercialization of the FastSeal® Bioabsorbable Vascular Access Closure System during 2012.
January 2012 Endovascular Today article, "Vascular Closure Update"
Packaged single unit FastSeal® Bioabsorbable Vascular Access Closure System
(Actual Size: 12" long, 3.75" wide and .5" thick).
10-unit carton of FastSeal® Bioabsorbable Vascular Access Closure Systems
(Actual Size: 12.75" long, 4" wide and 3.5" in height).
Intellectual Property (IP) outside the field of use of vascular access closure applications, may be available to sublicense. This IP includes, but is not limited to, minimally invasive cardiovascular, gastrointestinal, oncology, neurological, reproductive, lymphatic, respiratory, orthopedic, combination or other medical applications.
Contact Us for specific details.
A scientific paper featuring the detailed chronic pre-clinical test series results, of our FastSeal® Bioabsorbable Vascular Access Closure system, compared to several current market leading closure systems, will be published in a major peer reviewed journal in the near future.
The FastSeal® Bioabsorbable Vascular Access Closure system has been successfully tested during in vivo pre-clinical studies, using vascular introducer sheaths,
from 5 Fr. through 11 Fr.
The results of the 30, 60 and 90 day chronic in vivo tests confirm the benefits and advantages of our FastSeal® Vascular Access Closure system - no inflammation at or near the deployment site, and the inner vessel section of the sealing element was fully absorbed within two weeks. Also confirmed in this series of tests is our system's ability to be removed after deployment, atraumatically and without requiring a surgical intervention. Detailed pictures (including histology) of the test results are available upon request.
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. These larger sized versions of our access closure systems, are very important and enabling for Transcatheter heart valve replacement procedures. 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.
The Company has 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. Vascular Closure Systems, Inc. has also concluded a
Rights of First Negotiation (ROFN) agreement for the distribution rights for our FastSeal® Vascular Access Closure system products in Austria, Belgium, Czech Republic, Holland, Italy, Luxembourg, Portugal, Spain, Slovakia and Switzerland. We are currently in discussions for the distribution rights to our products in several additional countries.
The Vascular Closure Systems, Inc. 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.
