Merit Medical Announces Multiple Regulatory Approvals
December 10 2014 - 9:30AM
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer
and marketer of proprietary disposable devices used primarily in
cardiology, radiology and endoscopy, today announced that it has
received 501(k) clearance for three products: the ReSolve® Biliary
Locking Drainage Catheter, the ONE Snare® Endovascular Microsnare
System and the AEROmini™ Tracheobronchial Stent System.
"These products are scheduled to be launched in the United
States at the beginning of 2015," said Fred P. Lampropoulos,
Merit's Chairman and Chief Executive Officer. "They all help to
fill out our product lines and will be a continued source of growth
for Merit."
ABOUT MERIT
Founded in 1987, Merit Medical Systems, Inc. is engaged in the
development, manufacture and distribution of proprietary disposable
medical devices used in interventional and diagnostic 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 3,000 people worldwide, with facilities in South
Jordan, Utah; Pearland, Texas, Richmond, Virginia; Malvern,
Pennsylvania; Maastricht and Venlo, The Netherlands; Paris, France;
Galway, Ireland; Beijing, China; and Rockland, Massachusetts.
Statements contained in this release which are not purely
historical, including, without limitation, statements regarding
Merit's forecasted revenues, net income, 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,
2013. Such risks and uncertainties include risks relating to
Merit's potential inability to successfully manage growth through
acquisitions, including the inability to commercialize 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, 2013 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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