Merit Medical Appointed Global Distributor for Micro Guide Wire
10 May 2016 - 11:30PM
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
signed a distribution deal with PIOLAX Medical Devices, Inc. of
Yokohama, Japan for a product known in Japan as the Labyrinth Noah™
Micro Guide Wire. The deal covers all global markets, with
the exception of Japan, and is subject to certain minimum order
requirements.
“We believe this guide wire is a great product to complement
Merit’s Maestro® and SwiftNINJA® microcatheters,” said Fred P.
Lampropoulos, Merit’s Chairman and Chief Executive Officer.
“Subject to obtaining registration, we plan to sell this guide wire
as a component of these catheters and as a stand-alone product as
well.”
“This micro guide wire is currently being sold in Japan and was
recommended to Merit by a number of Japanese physicians who use the
wire on a daily basis,” Lampropoulos continued. “For some
time now, we believe we have been at a disadvantage compared to
companies that offer microcatheters with a wire included.
This changes the game.”
Merit intends to begin registration procedures immediately with
a goal of introduction in late 2016.
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 hospitals, acute care facilities and
clinics worldwide, with a domestic and international sales force
totaling approximately 200 individuals. Merit employs
approximately 3,900 people worldwide with facilities in South
Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern,
Pennsylvania; Rockland, Massachusetts; Maastricht and Venlo, The
Netherlands; Paris, France; Galway, Ireland; Beijing and Hong Kong,
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 revenues, net income, financial
results or anticipated acquisitions or other business arrangements,
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 and other filings
with the U.S. Securities and Exchange Commission. Such risks
and uncertainties include risks relating to Merit's potential
inability to successfully manage growth through acquisitions,
including the inability to commercialize assets acquired through
completed, proposed or future transactions, such as the
distribution arrangement described in this release; 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,
including Merit’s Form 10-Q for the three-month period ended March
31, 2016. 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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