Merit Medical Systems Announces Four Regulatory Approvals
Posted on February 20, 2020 by Medtech[y] Staff
SOUTH JORDAN, Utah, Feb. 20, 2020 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced today that regulatory clearances have been issued with respect to four products Merit owns or holds the rights to distribute.
Merit received clearance from the China National Medical Products Association (NMPA) to market the Swift Ninja™ Steerable Microcatheter in China. This device previously received clearance in the United States as well as the European Union (CE mark). The Swift Ninja has received strong reviews for its time efficiency as well as the ability to employ its steerable characteristics to access difficult or tortuous anatomy.
Secondly, the NMPA also gave Merit clearance to market in China the InQwire® Amplatz Guide Wire, which has been selling successfully in the United States and Europe.
“Although it has taken some time to receive these approvals, they are complementary to our peripheral product offering, especially our embolic products,” said Fred P. Lampropoulos, Merit’s Chairman and CEO.
Thirdly, Merit received the CE mark for its Cianna Scout® Surgical Guidance System. Initial procedures utilizing the Scout Surgical Guidance System have been completed in Great Britain with preparations to launch the Scout Surgical Guidance System throughout the EU over the next several weeks.
“In an environment where international approvals are becoming more difficult to obtain, we are pleased to add these to our product portfolio,” Lampropoulos said.
Finally, Merit received notice from BlueGrass Vascular Technologies, Inc. (Bluegrass Vascular) that the FDA has granted to Bluegrass Vascular a De Novo classification order for its Surfacer® Inside-Out® Access Catheter System. Merit owns approximately 19% of the common equity of BlueGrass Vascular and has been the worldwide exclusive distributor of the system for the last three years. Merit has the option to acquire the remaining equity of Bluegrass Vascular within the next two months. Merit plans to evaluate the Surfacer Inside-Out System in several U.S. accounts and feature the system at the Society of Interventional Radiology (SIR) meetings scheduled to take place in Seattle March 28-April 2. Additional information about the Surfacer Inside-Out System can be obtained by visiting https://bluegrassvascular.com/.
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 6,400 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; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
Statements contained in this release which are not purely historical, including, without limitation, statements regarding the issuance of regulatory clearances and anticipated consequences of Merit’s sale of products authorized thereby, the commercialization, marketing, evaluation and sale of medical devices owned or distributed by Merit, or Merit’s rights with respect to Bluegrass Vascular and its products, 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, 2018 and subsequent filings with the Securities and Exchange Commission. Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s potential inability to successfully commercialize technology developed internally or acquired through completed, proposed or future transactions; 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; 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; 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; 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; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States or other countries; litigation or other judicial proceedings affecting Merit, its operations or its financial condition; termination or interruption 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; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; 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 referred to in Merit’s Annual Report on Form 10-K for the year ended December 31, 2018 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.
|Contact:||Anne-Marie Wright, Vice President, Corporate Communications|
|Phone:||(801) 208-4167 e-mail: [email protected] Fax: (801) 253-1688|