January 11, 2018
Newton, MA. Jan 11, 2018 – 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.
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.
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.