MERIT MEDICAL RECEIVES TWO ADDITIONAL FDA BREAKTHROUGH DEVICE DESIGNATIONS
April 06 2020 - 9:25AM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary disposable devices used in
interventional, diagnostic and therapeutic procedures, particularly
in cardiology, radiology, oncology, critical care and endoscopy,
announced today that it has been granted two additional
Breakthrough Device designations by the U.S. Food and Drug
Administration (FDA) for the Merit WRAPSODY™ Endovascular Stent
Graft System. The WRAPSODY system is a flexible, self-expanding
endoprosthesis.
The new indications for use include treatment of
stenosis or occlusion within the dialysis outflow circuit,
including stenosis or occlusion 1) within the peripheral veins in
the arm of Arteriovenous Fistula (AVF) patients, and 2) within the
thoracic central veins, up to the superior vena cava, in
Arteriovenous Graft (AVG) patents. If the system is approved by the
FDA for these indications, Merit believes the expanded indications
will increase patient access to this life-saving technology.
The FDA Breakthrough Devices Program is intended
to help patients receive more timely access to breakthrough
technologies that have the potential to provide more effective
treatment or diagnosis for life-threatening or irreversibly
debilitating diseases or conditions. Under the program, the FDA
provides priority review and interactive communication regarding
device development and clinical trial protocols, through to
commercialization decisions. The WRAPSODY system is not currently
available for sale.
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, oncology,
critical care and endoscopy. Merit serves client hospitals
worldwide with a domestic and international sales force and
clinical support team totaling in excess of 300
individuals. Merit employs approximately 6,400 people
worldwide with facilities in South Jordan, Utah; Pearland, Texas;
Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts;
Aliso Viejo, California; Maastricht and Venlo, The Netherlands;
Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico;
Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia;
Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa;
and Singapore.
FORWARD-LOOKING STATEMENTS
Statements contained in this release which are
not purely historical, including, without limitation, statements
regarding prospective regulatory approvals and Merit’s future
product development and commercialization, 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, 2019 and subsequent filings with the
Securities and Exchange Commission. Such risks and uncertainties
include inherent risks and uncertainties relating to Merit’s
potential inability to successfully commercialize technology
developed internally or acquired through completed, proposed or
future transactions; negative changes in economic and industry
conditions in the United States or other countries, particularly
changes resulting from the ongoing COVID-19 pandemic; 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;
governmental scrutiny and regulation of the medical device
industry, including governmental inquiries, investigations and
proceedings involving Merit; restrictions on Merit’s liquidity or
business operations resulting from its debt agreements;
infringement of Merit’s technology or the assertion that
Merit’s technology infringes the rights of other parties; actions
of activist shareholders, including a proxy contest; product
recalls and product liability claims; changes in customer
purchasing patterns or the mix of products Merit sells; risks and
uncertainties associated with Merit’s information technology
systems, including the potential for breaches of security and
evolving regulations regarding privacy and data protection;
potential for significant adverse changes in governing regulations,
including reforms to the procedures for approval or clearance of
Merit’s products by the FDA or comparable regulatory authorities in
other jurisdictions; increases in the prices of commodity
components; 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 or regulations; laws
and regulations targeting fraud and abuse in the healthcare
industry; changes in tax laws and regulations in the United States
or other countries; increases in the prices of commodity
components; termination or interruption of relationships with
Merit’s suppliers, or failure of such suppliers to perform;
fluctuations in exchange rates; uncertainties relating to the LIBOR
calculation method and the expected discontinuation of LIBOR;
concentration of a substantial portion of Merit’s revenues among a
few products and procedures; development of new products and
technology that could render Merit’s existing or future 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 healthcare policies or markets related to
healthcare reform initiatives; failure to comply with applicable
environmental laws; changes in key personnel; work stoppage
or transportation risks; introduction of products in a timely
fashion; price and product competition; availability of labor and
materials; fluctuations in and obsolescence of inventory; and other
factors referenced in Merit’s Annual Report on Form 10-K for the
year ended December 31, 2019 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
CommunicationsPhone: (801) 208-4167
e-mail: awright@merit.com Fax: (801) 253-1688
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