SOUTH JORDAN, Utah, May 26, 2020 (GLOBE NEWSWIRE) — 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, today announced that it received the CE mark for the WRAPSODY™ Endovascular Stent Graft System from the British Standards Institution (BSI). The WRAPSODY system is a flexible self-expanding endoprosthesis indicated for use in hemodialysis patients for the treatment of stenosis or occlusion within central veins as well as the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft.
Merit has worked for almost eight years to design, develop and establish the appropriate technology and manufacturing capabilities for this product. Merit recently completed enrollment and primary follow-up of its WRAPSODY FIRST study which included 46 patients in Europe. Merit submitted an IDE (Investigational Device Exemption) application to the FDA for its review and consideration prior to the initiation of its WAVE Pivotal Study. After completion of the WAVE pivotal study, Merit intends to submit a PMA (Pre-Market Approval) application to the FDA.
“We are pleased to receive this certificate and the opportunity to offer this unique product to the European community,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “I want to thank the principal investigators of the WRAPSODY FIRST study as well as our research and development, medical affairs and regulatory affairs staff members who worked tirelessly on this project.”
Merit intends to offer additional products utilizing this technology platform, subject to additional submissions and review by the FDA and the European Union notified body.
Recently Merit received three Breakthrough Device Designations covering indications and cohorts of the IDE for the WRAPSODY system which have been filed with the FDA.
Merit intends to systematically introduce the WRAPSODY system in Europe as procedures are resumed following the ongoing lockdown due to COVID-19. Additionally, Merit also plans to initiate registration activities associated with the system in Australia, Canada and certain countries in Latin America. The WRAPSODY system is complementary to other products that Merit produces or distributes, such as the HeRO® Graft, the Surfacer® Inside-Out® Access Catheter System and other vascular access products.
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 in excess of 300 individuals. Merit employs approximately 6,100 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; 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 clearances, approvals or activities, Merit’s forecasted plans, development and commercialization of new products, expansion of existing or future product lines, the potential impact, scope and duration of, and Merit’s response to, the coronavirus (COVID-19) pandemic and the potential for recovery from that pandemic, 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 (as amended by an Amendment No. 1 to Annual Report on Form 10-K/A, the “Annual Report on Form 10-K”) and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s internal models or the projections in this release; risks and uncertainties associated with the COVID-19 pandemic; 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; 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, including a potential 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; 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; 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 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.
| Date: | May 26, 2020 |
| Contact: | Anne-Marie Wright, Vice President, Corporate Communications |
| Phone: | (801) 208‑4167 e-mail: awright@merit.com Fax: (801) 253‑1688 |
