Merit Medical Completes Enrollment in EVOLVE Study
October 19 2016 - 09:25AM
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer
and marketer of proprietary disposable devices used primarily in
cardiology, radiology and endoscopy, announced today that it has
completed enrollment in its EVOLVE study.
The EVOLVE study is a prospective, multicenter, single-blind,
randomized, FDA IDA-approved phase 3 study comparing Merit’s
EndoMAXX™ EVT fully-covered esophageal stent with valve to the
EndoMAXX™ fully-covered esophageal stent for malignant strictures
requiring stent placement across the gastroesophageal
junction. Sixty patients with strictures of the esophagus at
the junction to the stomach due to cancer have been enrolled at
seven sites. The study is investigating whether the unique
valve in the EndoMAXX™ EVT stent can facilitate swallowing by
treating the esophageal stricture while also limiting reflux.
“The prevalence of esophageal malignancy is increasing, and we
are pleased that our study is closer to completion,” said Fred P.
Lampropoulos, Merit’s Chairman and Chief Executive Officer.
“We are hopeful that this product can improve the quality of life
for suffering patients.”
The EndoMAXX™ EVT stent has a unique tricuspid valve designed to
simulate the natural valve at the gastroesophageal junction, the
only esophageal stent of its kind. It has been CE marked in
the EU since September 2013.
ABOUT MERITFounded in 1987, Merit Medical
Systems, Inc. is engaged in the development, manufacture and
distribution of proprietary disposable medical devices used in
interventional, diagnostic and therapeutic procedures, particularly
in cardiology, radiology and endoscopy. Merit serves client
hospitals worldwide with a domestic and international sales force
totaling approximately 200 individuals. Merit employs
approximately 4,000 people worldwide with facilities in South
Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern,
Pennsylvania; Rockland, Massachusetts; San Jose, California;
Maastricht and Venlo, The Netherlands; Paris, France; Galway,
Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil;
Markham, Ontario, Canada, and Melbourne, Australia.
Statements contained in this release which are
not purely historical, including, without limitation, statements
regarding Merit's forecasted plans, product releases, regulatory
approvals, clinical studies, financial results or anticipated
acquisitions, are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties such as those described in
Merit's Annual Report on Form 10-K for the year ended December 31,
2015. Such risks and uncertainties include risks relating to
Merit's potential inability to successfully manage growth through
acquisitions, including the inability to commercialize assets or
technology acquired through completed, proposed or future
transactions; product recalls and product liability claims;
expenditures relating to research, development, testing and
regulatory approval or clearance of Merit's products and risks that
such products may not be developed successfully or approved for
commercial use; greater governmental scrutiny and regulation of the
medical device industry; reforms to the 510(k) process administered
by the U.S. Food and Drug Administration; compliance with
governmental regulations and administrative procedures; potential
restrictions on Merit's liquidity or its ability to operate its
business in compliance with its current debt agreements; possible
infringement of Merit's technology or the assertion that Merit's
technology infringes the rights of other parties; the potential of
fines, penalties or other adverse consequences if Merit's employees
or agents violate the U.S. Foreign Corrupt Practices Act or other
laws and regulations; laws targeting fraud and abuse in the
healthcare industry; potential for significant adverse changes in,
or failure to comply with, governing regulations; the effect of
changes in tax laws and regulations in the United States or other
countries; increases in the prices of commodity components;
negative changes in economic and industry conditions in the United
States and other countries; termination or interruption of
relationships with Merit's suppliers, or failure of such suppliers
to perform; fluctuations in Euro and GBP exchange rates; Merit's
need to generate sufficient cash flow to fund its debt obligations,
capital expenditures, and ongoing operations; concentration of
Merit's revenues among a few products and procedures; development
of new products and technology that could render Merit's existing
products obsolete; market acceptance of new products; volatility in
the market price of Merit's common stock; modification or
limitation of governmental or private insurance reimbursement
policies; changes in health care markets related to health care
reform initiatives; failure to comply with applicable environmental
laws; changes in key personnel; work stoppage or transportation
risks; uncertainties associated with potential healthcare policy
changes which may have a material adverse effect on Merit;
introduction of products in a timely fashion; price and product
competition; availability of labor and materials; cost increases;
fluctuations in and obsolescence of inventory; and other factors
referred to in Merit's Annual Report on Form 10-K for the year
ended December 31, 2015 and other materials filed with the
Securities and Exchange Commission. All subsequent forward-looking
statements attributable to Merit or persons acting on its behalf
are expressly qualified in their entirety by these cautionary
statements. Actual results will likely differ, and may differ
materially, from anticipated results. Financial estimates are
subject to change and are not intended to be relied upon as
predictions of future operating results, and Merit assumes no
obligation to update or disclose revisions to those
estimates.
Contact: Anne-Marie Wright, Vice President, Corporate Communications
Phone: (801) 208-4167 e-mail: awright@merit.com Fax: (801) 253-1688
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