NEWTON, Mass., Jan. 11, 2018 /PRNewswire/ -- The Xcede Patch
clinical trial dossier was submitted today to the Medical Ethical
Review Committee (MREC) Universitair Medisch Centrum Groningen
(Netherlands), in anticipation of
a first-in-human clinical trial. The clinical trial, which
outlines the treatment of up to 30 patients undergoing various
types of liver resection, will take place at two major liver
surgery centers in The Netherlands. Subject to the MREC
approvals, the Company anticipates that patients will be treated
with the Xcede Patch in the
Netherlands in early 2018. Xcede has contracted with
their manufacturer Cook Biotech Inc. (CBI), to execute the study
and make the appropriate regulatory and ethical committee
submission on behalf of Xcede Technologies.
Today's news followed shortly after Xcede's announcement of
completing their required ISO 10993-1 Testing Program. "We are very
excited to announce this clinical trial submission and significant
milestone in the development of the Xcede Patch," said Linda Zuckerman, Ph.D., President and CEO of
Xcede Technologies., Inc. "We continue to execute on our
development plan for the Patch."
"An extensive amount of testing and data analysis was necessary
to support this dossier, all of which was supervised by the CBI and
Xcede teams. While lengthy, this process was thorough and very
professionally done," said Peter
Sulick, Dynasil's Chairman and CEO. "We are encouraged by
this step and look forward to the successful completion of the
trials and eventual launch of the product, initially in
Europe."
Xcede is committed to the development and manufacturing of
innovative hemostatic and sealant products for surgical application
including severe, traumatic bleeding.
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.
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 20,
2017, 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