Xcede Hemostatic Patch Clinical Trial Dossier Submitted to Groningen-based Medical Ethical Review Committee (MREC) in Anticipation of First-in-Human Clinical Trial

Friday, January 12, 2018 Clinical Trials News
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SEATTLE, 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., to execute the study and make the appropriate regulatory and ethical committee submission on behalf of Xcede Technologies.

Today's news followed shortly after on 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."

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.    

Safe Harbor  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, the success of efforts to fund 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," "expect," "estimate," "anticipate," "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, 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 Dynasil Corporation of America's Annual Report on Form 10 K, as filed on December 17, 2015 and from time to time in the Company's other filings with the Securities and Exchange Commission. Dynasil Corporation of America disclaims any intention or obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Dynasil Corporation of America 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 (Dynasil Corp of America)Xcede Technologies, Inc.P.O Box 75328Seattle, WA 98175Phone: (617) 668-6855pkehe@dynasil.com

 

Cision View original content:http://www.prnewswire.com/news-releases/xcede-hemostatic-patch-clinical-trial-dossier-submitted-to-groningen-based-medical-ethical-review-committee-mrec-in-anticipation-of-first-in-human-clinical-trial-300581732.html

SOURCE Xcede Technologies, Inc.



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