Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer
and marketer of proprietary medical devices used in interventional,
diagnostic and therapeutic procedures, particularly in cardiology,
radiology, oncology, critical care and endoscopy, announced today
positive results from a prospective, observational, first-in-human
study to evaluate the safety and effectiveness of the Merit
WRAPSODY Endoprosthesis. The WRAPSODY Endoprosthesis is a
self-expanding, cell-impermeable endoprosthesis designed for the
treatment of arteriovenous (“AV”) fistula access circuit stenosis
and AV graft access circuit stenosis.
The WRAPSODY FIRST Study enrolled 46 subjects with clinically
relevant stenosis, who were treated at three centers. The eligible
population consisted of patients undergoing hemodialysis through an
AV circuit with clinical and radiological evidence of stenosis at
the graft-vein anastomosis, in the peripheral outflow veins or in
the central veins up to the superior vena cava. The subjects did
not have clinically relevant secondary stenosis or thrombus in the
access circuit.
The study reported anatomical, clinical and procedural success
in all cases. The primary safety outcome measure was the proportion
of subjects without localized or systemic safety events affecting
the access circuit that resulted in surgery, hospitalization or
death during the first 30 days following device placement. All but
one subject was free from such a safety event in the first 30 days
following device placement (97.8%). The safety event was
adjudicated as not related to the device or study procedure. Over
the remainder of the study, there was one adverse event adjudicated
as possibly device-related.
The primary effectiveness outcome measure for the study was the
TLPP rate at 30 days following device placement, which was 100%. At
6 months following device placement, the TLPP rate was 97.7% and at
12 months following device placement, it was 84.6%. The 6- and
12-month ACPP rates were 84.4% and 65.9%, respectively. TLPP rates
were similar regardless of access type and lesion location or
whether subjects were treated with a single device or overlapping
devices. In all cases, reintervention at the target lesion was
successful in maintaining patency (12-month assisted TLPP rate of
100%.)
"Early first-in-human study results show that the Merit WRAPSODY
Endoprosthesis can be safely used to treat stenoses at key sites
within a dialysis access circuit,” said the study’s primary
investigator, James A Gilbert BMBS, MA (Ed), FRCS (Gen), FRCS Ed;
Consultant and Transplant & Vascular Access Surgeon, Vascular
Access Lead, Oxford University Hospitals. “Even more encouraging
are the very promising primary one-year target lesion patency rates
of 84.6% and access circuit patency rate of 65.9%. To my knowledge,
these are higher than any other published data and suggest that the
novel features of the WRAPSODY Endoprosthesis may have a key role
in preserving the longevity of precious dialysis access for our
patients.”
Merit is also conducting a large multinational, multicenter
study, identified as the WAVE Study, which it plans to use to
support a premarket approval application to the United States Food
& Drug Administration. Enrollment in the randomized WAVE Study
comparing the Merit WRAPSODY Endoprosthesis to percutaneous
transluminal angioplasty for treatment of venous outflow circuit
stenosis or occlusion in hemodialysis patients began in March 2021.
Merit anticipates that the WAVE Study will include 477
subjects.
“Merit has built its commercial legacy on innovative products
that benefit patients and advance standards of care,” said Fred P.
Lampropoulos, Merit’s Chairman and CEO. “We are encouraged by the
WRAPSODY FIRST Study’s positive results and excited to help shape
the future of arteriovenous access circuit stenosis treatment. We
look forward to assessing future study results regarding the Merit
WRAPSODY Endoprosthesis, and to making a positive impact in the
lives of patients suffering from kidney disease.”
ABOUT MERITFounded in 1987, Merit Medical
Systems, Inc. is a leading manufacturer and marketer of proprietary
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 6,300 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
STATEMENTSStatements contained in this release which are not purely
historical, including, without limitation, statements regarding
Merit’s plans and expectations with respect to the WRAPSODY FIRST
Study and the potential impact, scope, duration and outcome of that
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, 2020 (the “2020
Annual Report”) and other filings with the U.S. Securities and
Exchange Commission (the “SEC”). Such risks and uncertainties
include inherent risks and uncertainties relating to Merit’s
internal models or projections, including those related to the
WRAPSODY FIRST Study; risks and uncertainties associated with the
COVID-19 pandemic and Merit’s response thereto; disruptions in
Merit’s supply chain, manufacturing or sterilization processes;
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; 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; 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;
actions of activist shareholders; product recalls and product
liability claims; changes in customer purchasing patterns or the
mix of products Merit sells; 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; 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 countries; termination or interruption 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
2020 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
document are made only as of the date of this document, 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.
TRADEMARKSUnless 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.
1 References: Gilbert, J., Rai, J., Kingsmore, D. et al. First
Clinical Results of the Merit WRAPSODY™ Cell-Impermeable
Endoprosthesis for Treatment of Access Circuit Stenosis in
Haemodialysis Patients. Cardiovasc Intervent Radiol (2021).
https://doi.org/10.1007/s00270-021-02953-8
To learn more about the WRAPSODY Endoprosthesis, please visit:
https://www.merit.com/peripheral-intervention/access/renal-therapies-accessories/merit-wrapsody/
Disclaimer: The WRAPSODY Endoprosthesis is intended for sale
and/or use in the European Union, for use in haemodialysis
patients for the treatment of stenosis or occlusion within the
dialysis outflow circuit of an arteriovenous (AV) fistula or AV
graft. The WRAPSODY Endoprosthesis is not approved, cleared or
available for sale or use in the United States and may not be
approved, cleared or available for sale or use in
other countries. Before using any product, refer to the
Instructions for Use (“IFU”) for indications,
contraindications, warnings, precautions, and directions for
use.
Contacts: |
|
PR/Media Inquiries:Teresa Johnson
Merit Medical |
Investor Inquiries:Mike
Piccinino, CFA, IRCWestwicke - ICR |
+1-801-208-4295 |
+1-443-213-0509 |
tjohnson@merit.com |
mike.piccinino@westwicke.com |
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