Merit Medical Receives FDA “Breakthrough Device Designation” for Embosphere® Microspheres for Use in Genicular Artery Embolization for Symptomatic Knee Osteoarthritis
08 March 2022 - 1:25AM
Merit Medical Systems, Inc. (NASDAQ: MMSI), announced today that it
has received “breakthrough device designation” from the U.S. Food
& Drug Administration (FDA) for Embosphere® Microspheres for
the Genicular Artery Embolization (GAE) indication.
GAE is a procedure intended to reduce pain and disability caused
by knee osteoarthritis by reducing blood flow to the knee,
minimizing the inflammatory process. As a market-leading solution
in embolotherapy, Embosphere Microspheres are the most clinically
utilized and clinically studied spherical embolic. With more than
20 years of clinical experience, Embosphere Microspheres have been
used in more than 250,000 procedures and featured in more than 200
clinical articles.
The FDA Breakthrough Devices Program is intended to provide
patients and healthcare providers with more timely access to
breakthrough technologies that have the potential for more
effective treatment or diagnosis of life-threatening or
irreversibly debilitating diseases or conditions. Under the
program, the FDA has undertaken to provide priority review and
interactive communication regarding device development and clinical
trial protocols, through commercialization
decisions.
This breakthrough designation for the new indication adds to the
innovative history of the product. “We are pleased with the
recognition and partnership of the FDA, making it possible for new
and innovative products to reach the market faster,” said Fred P.
Lampropoulos, Merit Medical’s Chairman and CEO. “Merit’s
embolotherapy platform of products has provided consistent and
predictable results for effective embolization. We believe this
breakthrough designation allows us to accelerate our programs to
study and obtain FDA clearance for the GAE indication for
Embosphere Microspheres, ultimately expanding treatment options for
patients.”
ABOUT MERIT MEDICAL Founded 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 500 individuals. Merit employs approximately 6,500 people
worldwide with facilities in South Jordan, Utah; Pearland, Texas;
Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo,
The Netherlands; Paris, France; Galway, Ireland; Beijing, China;
Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne,
Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg,
South Africa; and Singapore.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS Statements contained in this
release which are not purely historical, including, without
limitation, statements regarding Merit’s forecasted plans, the FDA
approval process and the potential for FDA approval of Merit’s
products, are forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended, 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,
2021 (the “2021 Annual Report”) and other filings with the SEC.
Such risks and uncertainties include risks and uncertainties
associated with the COVID-19 pandemic and Merit’s response thereto;
disruptions in Merit’s supply chain, manufacturing or sterilization
processes; reduced availability of, and price increases associated
with, commodity components; risks relating to Merit’s potential
inability to successfully manage growth through acquisitions
generally, including the inability to effectively integrate
acquired operations or products or 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; 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;
governmental scrutiny and regulation of the medical device
industry, including governmental inquiries, investigations and
proceedings involving Merit; litigation and other judicial
proceedings affecting 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; product recalls
and product liability claims; changes in customer purchasing
patterns or the mix of products Merit sells; 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; 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; 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; changes in tax laws and regulations in the United
States or other countries; termination of relationships with
Merit’s suppliers, or failure of such suppliers to perform;
fluctuations in exchange rates; 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; failure to introduce 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 the 2021 Annual Report and other
materials filed with the SEC. 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. Forward-looking
statements included in this release are made only as of the date of
this release, and except as otherwise required by applicable law,
Merit assumes no obligation to update or disclose revisions to
forward-looking statements.
TRADEMARKS Unless noted otherwise, trademarks and
registered trademarks used in this release are the property of
Merit Medical Systems, Inc. and its subsidiaries in the United
States and other
jurisdictions. CONTACTS PR/Media
Inquiries Sarah Comstock Merit Medical+1-801-432-2864 |
sarah.comstock@merit.com Investor Inquiries Mike
Piccinino, CFA, IRC Westwicke - ICR +1-443-213-0509 |
mike.piccinino@westwicke.com
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