CE Marking for Centros® Dialysis Catheter
CE Marking for HepaSphere™ with Irinotecan Indication
510(k) Clearance for Prelude SNAP™ Splittable Hydrophilic Sheath
510(k) Clearance for Elation® Wireguided Balloon Dilation Catheter with Biliary Indication
SOUTH JORDAN, Utah, Nov. 09, 2015 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, today announced that it has received four new regulatory approvals.
Merit received the CE Marking (Conformité Européenne) in the European Union to market the Centros® Dialysis Catheter, which includes proprietary technology and has been marketed in the United States for the past few years. Revenues for this product are up approximately 76% year-to-date worldwide, excluding Europe, and we believe this approval will continue to enhance growth prospects for some time to come.
Merit also received the CE Marking for HepaSphere™ Microspheres with Irinotecan indication. We believe this indication will help to complement the doxorubicin indication in Europe and will be a segue for additional regulatory filings in the future.
Merit received 510(k) clearance from the FDA for the Prelude SNAP™ Splittable Hydrophilic Sheath, which we believe will complement the uncoated sheath which has already gained substantial acceptance worldwide. Merit has recently received orders from a major OEM customer, and we expect additional customer commitments in the near future.
Merit also received 510(k) clearance for the Elation® Wireguided Balloon Dilation Catheter with biliary indication. We believe this will complement Merit’s existing esophageal indication in our fastest-growing division. We have recently added two additional production lines to keep up with customer demand.
“We believe each of these approvals enhances an exciting cavalcade of new products and opportunities for Merit,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer. “A special thanks goes out to our skilled research and development personnel and the professionals of our regulatory staff who have worked tirelessly to bring these products to market.”
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 and diagnostic procedures, particularly in cardiology, radiology and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 200 individuals. Merit employs approximately 3,700 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; and Rockland, Massachusetts.
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's future performance, 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, 2014. Such risks and uncertainties include risks relating to product recalls and product liability claims; potential restrictions on our liquidity or our ability to operate our business by our current credit agreement, and the consequences of any default under that agreement; possible infringement of our technology or the assertion that our technology infringes the rights of other parties; the potential imposition of fines, penalties, or other adverse consequences if our employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; expenditures relating to research, development, testing and regulatory approval or clearance of our products and the risk that such products may not be developed successfully or approved for commercial use; greater governmental scrutiny and regulation of the medical device industry; reforms to the 510(k) process administered by the U.S. Food and Drug Administration (the "FDA"); laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or our failure to comply with, governing regulations; increases in the price of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination or interruption of relationships with our suppliers, or failure of such suppliers to perform; our potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future acquisitions; costs and expenses associated with our pursuit of a strategic plan to grow through acquisitions; fluctuations in Euro and GBP exchange rates; our need to generate sufficient cash flow to fund our debt obligations, capital expenditures, and ongoing operations; concentration of our revenues among a few products and procedures; development of new products and technology that could render our existing products obsolete; market acceptance of new products; volatility in the market price of our common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in health care markets related to health care reform initiatives; failures to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; uncertainties associated with potential healthcare policy changes which may have a material adverse effect on Merit; introduction of products in a timely fashion; price and product competition; availability of labor and materials; cost increases; fluctuations in and obsolescence of inventory; and other factors referred to in our Annual Report on Form 10-K for the year ended December 31, 2014 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.