Merit Medical Systems, Inc. (NASDAQ: MMSI), a global leader of
healthcare technology, today announced positive 6-month findings
from the randomized arteriovenous (AV) fistula arm of its WRAPSODY
Arteriovenous Access Efficacy (WAVE) pivotal trial. The data were
shown at the Cardiovascular and Interventional Radiological Society
of Europe (CIRSE) during a FIRST@CIRSE presentation.
WRAPSODY is a cell-impermeable endoprosthesis which is intended
to extend long-term vessel patency in dialysis patients. Many
patients undergoing dialysis rely on a vascular access site created
in the arm called an AV fistula. The maintenance of adequate blood
flow through this site is crucial for patient survival.
The AV fistula arm of the WAVE trial enrolled 245 patients at 43
sites. Patients were randomized 1:1 to WRAPSODY or percutaneous
transluminal angioplasty (PTA). Target lesion primary patency in
patients treated with WRAPSODY was 27 percentage points higher than
patients in the PTA cohort (89.8% vs. 62.8%, p<0.0001).1 The
proportion of patients who experienced an adverse event was similar
between cohorts.2
“The superiority of the six-month efficacy data is compelling
and provides clinicians the chance to evaluate how WRAPSODY can
help us prolong the vascular access of our patients. WRAPSODY
should be the new standard of care for these patients,” said
Mahmood K. Razavi, MD, FSIR, FSVM, Interventional Radiologist and
Medical Director of Clinical Research at St. Joseph Heart and
Vascular Center in Orange, Calif., and Co-Principal Investigator of
the WAVE trial. “Meeting with colleagues at CIRSE to discuss the AV
fistula arm of the WAVE study was the first of what we hope to be
many productive discussions,” said Robert G. Jones, FRCR,
Consultant Interventional Radiologist at Queen Elizabeth Hospital
Birmingham in Birmingham, England, and Co-Principal Investigator of
the WAVE study. “The potential for WRAPSODY to help us safely
extend vascular access for our patients is a vital component of
care.”
“The data release of positive findings from the randomized AV
fistula arm of the WAVE study marks a major milestone for Merit,”
said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive
Officer. “This is an important next step in our continued efforts
to seek ways to improve care for patients requiring hemodialysis
treatment.”
The Merit WRAPSODY Cell-Impermeable Endoprosthesis is not
approved or available for commercial distribution in the United
States and may not be approved 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 US Food
and Drug Administration (FDA). Findings from the WAVE study 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 device is available in
Brazil and in the European Union. For additional information on
Merit Medical’s WAVE study, please visit:
https://clinicaltrials.gov/ct2/show/NCT04540302.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING
STATEMENTS
Statements contained in this release which are not purely
historical, including, without limitation, statements regarding
results, outcomes and applications of clinical trials, studies and
investigations involving Merit’s products, safety, efficacy and
patient and physician adoption of Merit’s products, Merit’s ability
to procure and maintain required regulatory approvals for its
products, forecasted plans, revenues and other operating and
financial measures, or future growth and profit expectations or
forecasted economic conditions, 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, 2023 (the “2023 Annual Report”) and other filings with
the SEC. Such risks and uncertainties include inherent risks and
uncertainties related to the safety, efficacy and patient and
physician adoption of Merit’s products, the ability to fully enroll
and the final results and outcomes of clinical trials and studies
involving the Merit’s products, the ability to obtain and maintain
reimbursement codes for Merit’s products, Merit’s ability to
procure and maintain required regulatory approvals for its
products, 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 generally, 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 – Department of
Health and Human Services; 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 Union 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;
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 other factors referenced in the
2023 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.
Financial estimates are subject to change and are not intended to
be relied upon as predictions of future operating results. Those
estimates and all other 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 and all other
forward-looking statements.
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 more than 700 individuals. Merit
employs approximately 7,000 people worldwide.
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
PR/Media Inquiries Sarah Comstock Merit Medical +1-801-432-2864
| sarah.comstock@merit.com
Investor InquiriesMike Piccinino, CFA, IRC Westwicke - ICR
+1-443-213-0509 | mike.piccinino@westwicke.com
1 The primary efficacy endpoint was defined as the freedom from
clinically driven target lesion revascularization or target lesion
thrombosis through 6 months.2 The primary safety endpoint was the
proportion of patients who experienced an adverse event in the 30
days following treatment that negatively affected the access or
venous outflow circuit and resulted in reintervention,
hospitalization, or death (not including stenosis or
thrombosis).
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