SOUTH JORDAN, Utah, March 28, 2016 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it received notification of substantial equivalence from the FDA for the Corvocet™ Biopsy System, which is intended for use in obtaining core biopsy samples from the liver, kidney, prostate, breast, lung and various other soft tissue tumors.
The proprietary device comes in stand-alone packaging and also as a component in certain kits to provide convenience for hospitals and physicians. It offers features and performance characteristics which were designed from clinician input to reduce sound levels and provide one-handed use.
"The Corvocet™ Biopsy System is Merit’s first entry into the biopsy market and is the first of several biopsy devices we expect to introduce in the future," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. “We believe the introduction of the Corvocet, a new line of One-Step™ Centesis Catheters, the SwiftNINJA™ Steerable Microcatheter, the Elation™ Balloon Dilator, and several other products slated for release will provide support for our projected growth and profit expectations for 2016 and beyond.”
The Corvocet is scheduled to be introduced in the United States over the next thirty days or so, with European release following receipt of the CE mark. Merit will highlight the new biopsy system at the annual meeting of the Society of Interventional Radiology (SIR) being held April 2-7 in Vancouver.
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 3,850 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada, and Melbourne, Australia.
Statements contained in this release which are not purely historical, including, without limitation, statements regarding our 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 our Annual Report on Form 10-K for the year ended December 31, 2015. Such risks and uncertainties include risks relating to 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; 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; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or our failure to comply with, governing regulations; availability and pricing of commodity components; negative changes in economic and industry conditions in the United States and other countries; termination, modification or interruption of our relationships with our suppliers, or failure of such suppliers to perform; 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, 2015, and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to our company or persons acting on our 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 we assume no obligation to update or disclose revisions to those estimates.