Vascular Closure Systems, Inc.:
The Company is pleased to announce the successful conclusion of Phase I
and Phase II of the First in Human (FIH) clinical trial for our 6 Fr. /
7 Fr. FastSeal® Bioabsorbable Vascular Access Closure System, achieving
a 100% success rate throughout both phases of the clinical trial, with
exceptional Time to Hemostasis (TTH) and Time to Ambulation (TTA). The
clinical trial included patients with challenging anatomy and vessel
condition. 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 process.
The post deployment follow-up evaluation (including echo doppler)
confirmed normal vessel healing, without inflammation, and complete
absorption of the FastSeal® sealing element.
The FIH clinical trial results are as follows:
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Phase I (10 patients, all diagnostic cases)
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TTH
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TTA
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(min:sec)
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(hrs:min)
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Time
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1:13
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6:40 Hrs.
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Std. Dev.
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0:40
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2:44
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Phase II (20 patients total, 15 PCI cases)
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TTH
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TTA
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(min:sec)
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(hrs:min)
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Time
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0:43
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2:14 Hrs.
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Std. Dev.
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0:34
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1:07
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The FIH clinical trial cases were performed by Prof. Alessandro Bortone,
and Prof. Emanuela de Cillis of the Policlinico di Bari, University of
Bari School of Medicine, Italy.
Videos of FIH cases are available to view at the following link: http://vclosure.com/fastsealvideos.php
The detailed Phase I and Phase II FIH clinical trial results will be
presented at multiple upcoming medical conferences.
The Company is planning to begin International commercialization
(outside the US, pending regulatory approval) of the 6 Fr. / 7 Fr.
system during the second quarter of 2013.
Additional Versions of Our FastSeal® System
An 18 Fr. version of our FastSeal® Bioabsorbable Vascular Access Closure
system has been designed, developed and successfully tested, 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. These additional versions of our technology will in the future
enable us to offer solutions for these rapidly growing market segments.
The Company has also designed and is developing a non-absorbable closure
system for left ventricle transapical access procedures. A video showing
our large bore vessel closure system sealing an 18 Fr. puncture, is
available to view at the following link: http://vclosure.com/fastseal_bioabsorb18wmv.php
All versions of our FastSeal® Vascular Access Closure systems have been
designed in close collaboration with our world-class medical advisors.
About the FastSeal® Product
Our FastSeal® Bioabsorbable Vascular Access Closure System is intended
for use following a diagnostic or therapeutic, interventional cardiology
or interventional radiology procedure. The 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 less than a minute 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 10 to 14 days. The remainder of the sealing element
is completely absorbed within 21 days. The FastSeal® system has the
ability to be removed after being deployed (if desired), without causing
trauma to the vessel or requiring a surgical intervention.
About Vascular Closure Systems, Inc.
Vascular Closure Systems, Inc. is a privately held medical device
company, based in part on the early and 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 and Interventional Radiology markets. 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.
The Company is currently exploring multiple strategic options to enhance
shareholder value, including, but not limited to, private funding, a
possible strategic alliance, a merger or sale of the Company. The
current funding round will close in the near future.
The Company is represented by Casey McGlynn of Wilson Sonsini Goodrich &
Rosati.
Jim Heslin (Wilson Sonsini Goodrich & Rosati) has taken the lead on the
maintenance and prosecution of the Company’s Intellectual Property (IP).
Please note that the Company`s devices have not yet been approved by the
US FDA and are not currently for sale or use in the US.
Additional information is available at the Company’s website: www.vclosure.com
CONTACTS :
Vascular Closure Systems, Inc.
Russ Houser, CEO, +1 925-371-1029
Investor Relations:
ir@vclosure.com
General Information:
info@vclosure.com, ,