Friday , April 18, 2014

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.

CURRENT STATUS

We have completed a 100% successful First in Human (FIH) clinical trial (including 30-day follow-ups) with our 6 Fr. / 7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System. We are planning to begin commercialization (in countries that don't require regulatory approval for vessel closure devices), during the 1st quarter of this year, and CE Mark during the 2nd quarter of this year. We've also demonstrated in vitro proof of concept for our large diameter / large bore 18 Fr. system, designed for Transcatheter Aortic Valve Implants / Replacements (TAVI / TAVR) and Endovascular Aneurysm Repair (EVAR) procedures.

Fundraising

The Company has plans to close the current round of funding, in the near future, without advanced notice. 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, but not limited to, private funding, 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, Palo Alto, California).

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 thirty pending and issued, US and International patents (with some 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:

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 (TAVR - PAVR), as well as transapical access closure.

Our Bioabsorbable Closure System

Extensive pre-clinical (in vivo - acute and chronic) and First in Human (FIH) clinical testing has been conducted on our 6 Fr. / 7 Fr. 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 (such as Cordis, St. Jude Medical, Terumo, etc.). 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 in less than 30 days.

When commercialized, the target sales price for our 6 Fr. / 7 Fr. Bioabsorbable vascular access closure system 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 less than other vascular access closure systems.

RADIAL AND LARGE DIAMETER / LARGE BORE VASCULAR ACCEESS CLOSURE VERSIONS OF FastSeal® (For TAVI / TAVR and EVAR Applications)

Additional versions of our FastSeal® Bioabsorbable Vascular Access Closure system have been designed and developed specifically for use with radial artery access procedures, and a percutaneous vascular access closure system for the nonsurgical deployment of large diameter / large bore transcatheter therapeutic devices, such as Transcatheter Aortic Valve Implants / Replacements (TAVI / TAVR) and Endovascular Aneurysm Repair (EVAR) devices. The TAVI / TAVR market is rapidly growing, with multiple transcatheter valves already in the market (including CoreValve and Edwards Lifesciences), the procedure is proving to be a success. Other global giants and numerous small companies are developing transcatheter valves. Recent company acquisition activity in this market space is high - CoreValve ($750 million) and Ventor ($350 million) by Medtronic, Sadra ($450 million) by Boston Scientific - as large medical device companies look to get into and expand their market share. The TAVI market is projected to exceed $2 billion worldwide by 2015 with 20% annual growth. Our large diameter / large bore system is designed to reduce procedural complexity and eliminate the need for open field surgery. Both of these versions will enable us to offer solutions for these rapidly growing market segments, in addition to our main focus on the very large 6 Fr. / 7 Fr. vascular access closure market. The Company has also designed a non-absorbable closure system for transapical access procedures. All versions of our FastSeal® Vascular Access Closure systems have been designed in close collaboration with our world-class medical advisors. Click here for a video of our large diameter / large bore bioabsorbable vascular closure system sealing an 18 Fr. puncture.


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

(Most recent updates listed first)


The Company will begin a marketing test of our 6Fr./7Fr. FastSeal® Bioabsorbable Vascular Access Closure System, that will include up to 500 patients, in the near future.

Vascular Closure Systems, Inc. is pleased to announce that we have received a Notice of Allowance from the US Patent and Trademark Office, for our pending case titled, "Arteriotomy Closure Devices and Techniques". The Company currently has more than 30 issued and pending, US and International patents.

The successful First in Human (FIH) clinical results (including 30-day follow-ups) of our 6 Fr. / 7 Fr. FastSeal® system, was presented in Rome at the Joint Interventional Meeting (JIM on 15 February 2013 www.jim-vascular.com). Additionally,the chronic in vivo ovine test series results, including histological data, comparing our FastSeal® system to market leading vessel closure systems including Angio-Seal, FemoSeal, ExoSeal and ProGlide was presented. Our FastSeal® had the best results by far, with no adverse reactions (including inflammation) and normal vessel healing. Also, a video of our large diameter / large bore FastSeal® bioabsorbable vascular access closure system sealing an 18 Fr., pressurized simulated vessel puncture will be shown. Contact Us to request a copy of the presentation and / or the abstract.

The Company is pleased to announce the conclusion of the First in Human (FIH) clinical trial of the FastSeal® Bioabsorbable Vascular Access Closure System, achieving a 100% success rate throughout both Phase I and II of the clinical trial, with exceptional Time to Hemostasis (TTH Mean Time = 42.9 seconds) and Time to Ambulation (TTA Mean Time = 2 hrs. and 14 seconds) times, including patients with challenging anatomy and vessel condition. The 7 and 30 day post deployment follow-up evaluation (including using echo doppler) confirmed normal vessel healing, without inflammation, and complete absorption of the FastSeal® sealing element. Additionally, the patient comfort with the system was excellent, with no groin pain during the deployment of the sealing element, immediately after, and throughout the vessel healing and sealing element absorption process, and without any residual lump at the sealing element deployment site that is common with other vessel closure systems. Click here for a copy of the press release.

A video of our large diameter / large bore FastSeal® vascular access closure system sealing an 18 Fr. vessel puncture was shown, and the successful First in Human (FIH) clinical results of our 6 Fr. / 7 Fr. FastSeal® system, was presented during the Transcatheter Cardiovascular Therapeutics (TCT) conference (Miami, 22 - 26 October, 2012). Presentations featuring our FastSeal® technologies, will be made at several important medical conferences during 2013.

Jim Heslin has taken the lead on the maintenance and prosecution of our Intellectual Property (IP). For more than 20 years, Jim has focused on helping medical device companies protect and enforce their domestic and international intellectual property rights. In addition, Jim has extensive experience in investor due diligence, portfolio evaluation, licensing matters, and the preparation of patent validity and infringement opinions. He also counsels clients regarding in-house intellectual property protection programs.

Click here to view our FastSeal® Bioabsorbable Vascular Access Closure system being used during two First in Human (FIH) clinical cases.

The 7 and 30-day follow-up results for the Phase I FIH clinicals have been perfect, as confirmed by doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal® sealing element. During the follow up, no adverse events were observed - no hematoma, pseudoaneurysm or fistula were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at seven and thirty days after the procedure. Click here for a copy of the press release.

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. With the Time To Hemostasis (TTH) being as low as 20 seconds. Test Results Demonstrate Superior Safety, Ease of Use, Performance, Patient Comfort and Cost Effectiveness. Click here for a copy of the press release.

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).

Our manufacturing facility has been set up and is producing FastSeal® Bioabsorbable Vascular Access Closure systems. Initially, the units being produced are for clinical testing to support regulatory submissions. Once regulatory approval has been granted, the units being produced at this site will be for commercial use.

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.

Dr. Richard Heuser has joined the Company as a Medical Advisor. Dr. Heuser will be assisting with our 6 Fr. / 7 Fr. vascular access closure system, as well as our 18 Fr., large diameter / large bore vascular access closure systems for such minimally invasive procedures including Transcatheter Aortic Valve Implants (TAVI), Endovascular Aneurysm Repair (EVAR), and transapical access closure devices, that require larger introducer sheaths. 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 distribution agreements for the distribution rights for our FastSeal® Vascular Access Closure system products in Austria, Belgium, Czech Republic, Egypt, Holland, Italy, Luxembourg, Portugal, Saudi Arabia, Spain, Slovakia, South Africa, Switzerland, Turkey and the United Arab Emirates. 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.


COMPANY UPDATES
Click here




Large Bore Version of our FastSeal® Bioabsorbable Vascular Access Closure System (18 Fr.)
  MWV Video




Click here to view our FastSeal® Bioabsorbable Vascular Access Closure system being used during First in Human (FIH) clinical cases.



COMPARISION ANIMATIONS

Deployed Profile Comparison Between the Market Leading System and our FastSeal® System
QuickTime Video
  WMV Video



PROCEDURAL ANIMATIONS

FastSeal® Bioabsorbable Vascular Access Closure System
QuickTime Video
  WMV Video

FastSeal® Swellable, Bioabsorbable Tubular Plug System
QuickTime Video

FastSeal® Self-Closing Nitinol Clip System
QuickTime Video



BIOABSORABLE SYSTEM DEPLOYMENT VIDEOS

FastSeal® Bioabsorbable Plug System Being Used During a Pre-Clinical Study
 WMV Video

6 Fr. FastSeal® Bioabsorbable Plug Deployed into a Carotid Artery (pressure tested to over 250 mm Hg)
QuickTime Video
  WMV Video

8 Fr. FastSeal® Bioabsorbable Plug Deployed into a Carotid Artery (pressure tested to over 250 mm Hg)
QuickTime Video
  WMV Video

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