Merit Medical Launches Super HeRO™ and HeRO™ Ally Products
October 18 2016 - 4:00PM
Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer
and marketer of proprietary disposable devices used primarily in
cardiology, radiology and endoscopy, announced today the launch of
the proprietary Super HeRO™ and HeRO™ Ally products, unique and
innovative additions to Merit’s expanding portfolio of dialysis
access products.
These products are designed to assist clinicians in preserving
existing fistulas or grafts that are in the process of failing
because of central venous stenosis. These first-of-a-kind
technologies expand upon the clinically-proven HeRO™ Graft by
allowing vascular surgeons to expand their repertoire of graft
options to include early cannulation grafts to bypass central
venous stenosis. By continuing to invest in innovative
research and development in the field of dialysis, Merit continues
to show its commitment to improving the clinical outcomes of
dialysis patients.
“During the last several months, we have relocated manufacturing
of the HeRO™ product line to our South Jordan facility, and now we
have expanded options for physicians and patients,” said Fred P.
Lampropoulos, Merit’s Chairman and Chief Executive
Officer.
The Super HeRO™ and HeRO™ Ally products are scheduled to be
introduced in the United States over the next 30 days, with
European release scheduled following receipt of the CE mark.
Merit intends to highlight the Super HeRO™ and HeRO™ Ally products
at the annual meeting of Controversies in Dialysis Access (CiDA)
being held October 20-21 in Austin, Texas.
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, 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
(including the HeRO™ product line); 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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