Healthcare Industry News: Merit Medical Systems
News Release - July 1, 2013
Merit Medical Announces Multiple Regulatory ApprovalsSOUTH JORDAN, Utah, July 1, 2013 -- (Healthcare Sales & Marketing Network) -- Merit Medical Systems, Inc. (MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received multiple regulatory approvals from various regulatory bodies.
The basixTOUCH(TM), Merit's most advanced high-pressure inflation device, has received 510(k) clearance from the FDA. The "Touch," which attained the CE mark early in the second quarter of 2013, has had substantial success in the first two months of its European release. The "Touch" eliminates the need to use multiple inflation devices in some advanced interventional cases because of its high pressure range. The Company also received initial acceptance of a number of claims from its U.S. patent application.
"We believe the introduction of the basixTOUCH clearly places Merit in the worldwide leadership position for inflation devices which are used in numerous interventional and peripheral procedures," said Fred P. Lampropoulos, Merit's Chairman and Chief Executive Officer. "The features of this device can also be applied to other inflation products such as the Blue Diamond(TM) digital inflation system. This device and its derivatives have the potential, when combined with other devices such as our hemostasis valves, to become the largest single revenue producing product in Merit's history."
Merit also announced that it has been notified by its embolic business partner in Japan, Nippon Kayaku, that it has received approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for Embosphere(R) and HepaSphere(TM) Microspheres as medical devices for the purpose of arterial embolization in patients with hypervascular tumors and arteriovenous malformations.
"We are pleased with the substantial efforts of our partner to bring this highly needed product to the people of Japan," Lampropoulos said. "Initial shipments are scheduled to begin in the third quarter of 2013."
Merit also announced that it has received 510(k) clearance for its Bearing(TM) nsPVA Embolization Particles.
"This embolic product, which was developed in our French facility, adds an additional product to our portfolio to complement our Embosphere, HepaSphere and QuadraSphere(TM) product offering," Lampropoulos said. "The Bearing nsPVA has broad appeal worldwide and has also received the CE mark."
Finally, the China Food and Drug Administration (CFDA) has renewed its clearance of Merit's Embosphere product line.
"We believe the efforts of our regulatory staff and business partners worldwide will enhance our business prospects and growth moving forward," Lampropoulos said.
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 2,750 people worldwide with facilities in Salt Lake City and South Jordan, Utah; Angleton, Texas; Richmond, Virginia; Malvern, Pennsylvania; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Copenhagen, Denmark; and Rockland, Massachusetts.
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted revenues, net income, financial results or anticipated acquisitions, 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, 2012. Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through recent, proposed or future transactions; product recalls and product liability claims; 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; 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; compliance with governmental regulations and administrative procedures; potential restrictions on Merit's liquidity or its ability to operate its business by its current debt agreements; possible infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; 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 and regulations; laws targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in, or failure to comply with, governing regulations; the effect of changes in tax laws and regulations in the United States or other countries; 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 Merit's suppliers, or failure of such suppliers to perform; fluctuations in Euro and GBP exchange rates; Merit's need to generate sufficient cash flow to fund its debt obligations, capital expenditures, and ongoing operations; concentration of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing 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 health care markets related to health care reform initiatives; failure 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 Merit's Annual Report on Form 10-K for the year ended December 31, 2012 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 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.
Source: Merit Medical Systems
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