NEWTON, Mass., Oct. 3, 2017 /PRNewswire/ -- Dynasil
Corporation of America (NASDAQ: DYSL) today announced that Xcede
Technologies, Inc. has completed the bulk of the required ISO
10993-1 Testing Program for the Xcede Hemostatic Patch. These
studies are based on the international standard for medical devices
that come into direct or indirect contact with the human body in
order to determine the potential for an unacceptable adverse
biological response. They include, but are not limited to,
nonclinical (in vitro and non-human) acute and long-term toxicity
studies as well as tests of mutagenesis, hemo- and
cyto-compatibility, sensitization, and irritation. Although
the chronic liver implantation study is still ongoing, we believe
the results to date from the cohort of studies demonstrate a
profile appropriate to initiate the filing for regulatory approval
to begin clinical trials. Subject to such regulatory approvals, the
Company anticipates starting clinical trials in the Netherlands in early 2018.
"We are very excited to announce these preclinical results,"
said Linda Zuckerman, Ph.D.,
President and CEO of Xcede Technologies., Inc. "We feel this
is a significant accomplishment in moving the Xcede Patch to the
clinical development phase of the product's life-cycle."
"At this point in time, we believe we are on track for clinical
trials in early 2018. However, further studies need to be
completed and regulatory approval obtained before the European
trials can begin. As mentioned on calls and other written
material, we remain very encouraged by the recent positive
results," added Peter Sulick,
Dynasil's Chairman and CEO.
About Xcede
Xcede Technologies, a subsidiary of Dynasil Corporation of
America is based in Seattle, WA
and began operations in October 2013
following a technology transfer from DBM. Xcede is committed
to the development and manufacturing of innovative hemostatic and
sealant products for surgical application including severe,
traumatic bleeding.
About Dynasil
Dynasil Corporation of America (NASDAQ: DYSL) develops and
manufactures optics and photonics products, optical detection and
analysis technology and components for the homeland security,
medical and industrial markets. Combining world-class
expertise in research and materials science with extensive
experience in manufacturing and product development, Dynasil is
commercializing products including dual-mode radiation detection
solutions for Homeland Security and commercial applications and
sensors for non-destructive testing. Dynasil has an
impressive and growing portfolio of issued and pending U.S.
patents. The Company is based in Newton, MA, with additional operations in MA,
MN, NY, NJ and the United Kingdom.
More information about the Company is available at
www.dynasil.com.
Forward-Looking Statements
This news release may contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. These forward-looking statements regarding future
events and our future results are based on current expectations,
estimates, forecasts, and projections and the beliefs and
assumptions of our management, including, without limitation, our
expectations regarding results of operations, the commercialization
of our technology, in particular the Xcede patch, our ability to
enter into and complete any financing or other strategic
transaction involving Xcede, positive outcomes of our pre-clinical
and planned clinical trials, regulatory approvals and the strength
of our intellectual property portfolio. These forward-looking
statements may be identified by the use of words such as "plans",
"intends," "may," "could," "expects," "estimates," "anticipates,"
"continue" or similar terms, though not all forward-looking
statements contain such words. The actual results of the
future events described in such forward-looking statements could
differ materially from those stated in such forward-looking
statements due to a number of important factors. These factors that
could cause actual results to differ from those anticipated or
predicted include, without limitation, our ability to develop and
commercialize the Xcede patch, including obtaining regulatory
approvals, our ability to identify and execute on strategic
opportunities involving Xcede, the size and growth of the potential
markets for our products and our ability to serve those markets,
the rate and degree of market acceptance of any of our products,
general economic conditions, costs and availability of raw
materials and management information systems, our ability to obtain
and maintain intellectual property protection for our products,
competition, the loss of key management and technical personnel,
our ability to obtain timely payment of our invoices to
governmental customers, litigation, the effect of governmental
regulatory developments, the availability of financing sources, our
ability to identify and execute on acquisition opportunities and
integrate such acquisitions into our business, and seasonality, as
well as the uncertainties set forth in the Company's Annual Report
on Form 10-K, as filed on December 21,
2016, including the risk factors contained in Item 1A, the
Company's Quarterly Reports on Form 10-Q and from time to time in
the Company's other filings with the Securities and Exchange
Commission. The Company disclaims any intention or obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contacts:
Patty
Kehe
Corporate Secretary
Dynasil Corporation of America
Phone: (617) 668-6855
pkehe@dynasil.com
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SOURCE Dynasil Corporation of America