Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, today announced
the completion of enrollment in its WRAPSODY Arteriovenous Access
Efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective,
randomized, controlled, multicenter study comparing the Merit
WRAPSODY Cell-Impermeable Endoprosthesis (CIE) to percutaneous
transluminal angioplasty for treatment of stenosis/occlusion in the
venous outflow circuit in patients undergoing
hemodialysis.
Creation and maintenance of an arteriovenous fistula or graft
(AVF/AVG) to achieve long-term vascular access (access to blood
vessels) is required for patients undergoing hemodialysis. However,
progressive stenosis (narrowing) and/or occlusion (blockage) of
blood vessels where the AVF and AVG are located can prevent
delivery of hemodialysis, which can have life-threatening
consequences. WRAPSODY was developed to help physicians treat
patients with stenosis/occlusion in the vessels used for
hemodialysis.
The WAVE study enrolled 244 patients with AVFs and 113 patients
with AVGs across sites in Brazil, Canada, the United Kingdom, and
the United States. Merit intends to collect safety and efficacy
outcomes throughout the study follow-up period. Merit anticipates
filing primary outcomes with the U.S. Food and Drug Administration
(FDA) for Premarket Approval (PMA) after six months post-enrollment
completion. Merit intends to follow patients enrolled in the WAVE
study for 24 months following completion of enrollment.
“Given the inadequacy of therapeutic options to maintain
vascular access in hemodialysis patients, understanding WRAPSODY’s
overall performance—due to its unique cell-impermeable stent
covering in helping to maintain AV fistulas and grafts—is of high
value to physicians and the scientific community,” says Mahmood K.
Razavi, MD, FSIR, FSVM, medical director of clinical research at
St. Joseph Heart and Vascular Center in Orange, Calif.,
co-principal investigator of the WAVE study, and paid consultant of
Merit.
“The WAVE study has now completed the anticipated recruitment
thanks to the patients that participated and to the hard work of
all the global investigators and their respective teams,” says Rob
Jones, MBChB, MRCP, FRCR, consultant interventional radiologist at
Queen Elizabeth Hospital Birmingham in Birmingham, England,
co-principal investigator of the WAVE study, and paid consultant of
Merit. “I am looking forward to the data analysis and the next step
in this device’s journey in providing definitive management to AV
access patients.”
“Enrollment of the last patients in the WAVE
study represents an important milestone,” says Fred P.
Lampropoulos, Merit’s Chairman and CEO. “We believe it will enable
us to provide critical insight to our physician partners and
support our submission of a PMA Application to the Food and Drug
Administration.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not
approved, cleared, or available for commercial distribution in the
United States and may not be approved, cleared, or available for
sale or use in other countries. In the United States, the device is
being used under an Investigational Device Exemption (IDE) from the
Food and Drug Administration. Findings from the WAVE study are
expected to expand on results from the first-in-human study
(WRAPSODY FIRST) and support the Premarket Approval (PMA)
application to the FDA for commercial use in the United States. The
WRAPSODY device previously received the Conformité Européenne (CE)
Mark for commercial use in the European Union and is available in
Brazil. For additional information on Merit’s WAVE study, please
visit ClinicalTrials.gov here.
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,
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 more than 700 individuals.
Merit employs approximately 7,100 people worldwide.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTSStatements contained in this release which are not purely
historical, including, without limitation, statements regarding
Merit’s anticipated plans with respect to, or the regulatory,
therapeutic, commercial or other implications of, Merit’s WAVE
study, 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, 2022 (the “2022
Annual Report”) and other filings with the SEC. Such risks and
uncertainties include risks and uncertainties relating to Merit’s
expectations, forecasts or projections referenced in this release;
disruptions in Merit’s supply chain, manufacturing or sterilization
processes; reduced availability of, and price increases associated
with, commodity components and other raw materials; adverse changes
in freight, shipping and transportation expenses; negative changes
in economic and industry conditions in the United States or other
countries, including inflation; risks relating to Merit’s potential
inability to successfully manage growth through acquisitions,
including the inability to effectively integrate acquired
operations or products or commercialize technology developed
internally or acquired through completed, proposed or future
transactions; risks associated with Merit’s ongoing or prospective
manufacturing transfers and facility consolidations; fluctuations
in interest or foreign currency exchange rates; 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; consequences associated with a
Corporate Integrity Agreement executed between Merit and the U.S.
Office of Inspector General; difficulties, delays and expenditures
relating to development, testing and regulatory approval or
clearance of Merit’s products, including the pursuit of approvals
under the European Medical Device Regulation, and risks that such
products may not be developed successfully or approved for
commercial use; litigation and other judicial proceedings affecting
Merit; 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;
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;
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 U.S. Food & Drug
Administration or comparable regulatory authorities in other
jurisdictions; changes in tax laws and regulations in the United
States or other jurisdictions; termination of relationships with
Merit’s suppliers, or failure of such suppliers to perform;
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; dependance on
distributors to commercialize Merit’s products in various
jurisdictions outside the United States; 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; fluctuations in and obsolescence of inventory;
and risks and uncertainties associated with the COVID-19 pandemic
and Merit’s response thereto; and other factors referenced in the
2022 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. All 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 estimates
or any other forward-looking statements.
TRADEMARKS Unless noted otherwise,
trademarks and registered trademarks used in this release are the
property of Merit Medical Systems, Inc., its subsidiaries, or its
licensors.
Contacts: |
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PR/Media Inquiries:Sarah Comstock
Merit Medical Systems, Inc. |
Investor Inquiries:Mike
Piccinino, CFA, IRCWestwicke - ICR |
+1-801-432-2864 |
+1-443-213-0509 |
sarah.comstock@merit.com |
mike.piccinino@westwicke.com |
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