IntriCon Receives FDA 510(k) Marketing Clearance For Sirona Cardiac Diagnostic Monitor
IntriCon Corporation (NASDAQ: IIN), a designer, developer,
manufacturer and distributor of miniature and micro-miniature body-worn
devices, today announced it has received 510(k) marketing clearance from
IntriCon Corporation (NASDAQ: IIN), a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA), for its Sirona Event and Holter Recorder. Sirona is the company’s second-generation cardiac diagnostic monitoring (CDM) device, allowing physicians to monitor patient cardiac events remotely. The device combines event and holter recording, with IntriCon’s PhysioLink ® wireless technology. PhysioLink enables audio and data streaming to ear-worn and body-worn applications over distances of up to five meters. Additionally, PhysioLink technology consumes less power than Bluetooth radios, which results in more compact devices. “The FDA’s approval of Sirona further solidifies our commitment to the CDM market space,” said Mark S. Gorder, president and chief executive officer of IntriCon. “Sirona is the first device to incorporate PhysioLink—a core technology with tremendous potential. Similar to Centauri, Sirona follows current industry trends of shifting patient care from expensive health-care settings to the home. This not only reduces costs but improves patient comfort.” Sirona provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. The device’s platform is essentially two products in one design since it can be used as an event recorder and a holter monitor. Additional features include its small size, rechargeable battery, and spray- and splash-proof design. The company expects to release the product in the first quarter of 2012 and anticipates modest revenue contributions in the 2012 year. About IntriCon CorporationHeadquartered in Arden Hills, Minn., IntriCon Corporation designs, develops, manufactures and distributes miniature and micro-miniature body-worn devices. The company is focused on three key markets: medical, hearing health, and professional audio communications. IntriCon has facilities in the United States, Asia and Europe. The company’s common stock trades under the symbol “IIN” on the NASDAQ Global Market. For more information about IntriCon, visit www.intricon.com. Forward-Looking StatementsStatements made in this release and in IntriCon’s other public filings and releases that are not historical facts or that include forward-looking terminology such as “may”, “will”, “believe”, “anticipate”, “expect”, “should”, “optimistic” or “continue” or the negative thereof or other variations thereon are “forward-looking statements” within the meaning of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, without limitation, statements concerning prospects in the miniature body-worn device arena, new products and their timing, strategic alliances, future growth and expansion, expansion into new manufacturing facilities, market fundamentals, future financial condition and performance, prospects and the positioning of IntriCon to compete in chosen markets and the Company’s planned investments in research and development. These forward-looking statements may be affected by known and unknown risks, uncertainties and other factors that are beyond IntriCon’s control, and may cause IntriCon’s actual results, performance or achievements to differ materially from the results, performance and achievements expressed or implied in the forward-looking statements. These risks, uncertainties and factors include, without limitation, risks related to the current economic crisis, the risk that IntriCon may not be able to achieve its long-term strategy, weakening demand for products of the company due to general economic conditions, risks related to the manufacturing agreement with hi HealthInnovations, risks related to the company’s strategic alliances and joint venture, possible non-performance of developing the Centauri, Scenic, Overtus, APT, Sirona, PhysioLink, Lumen, wireless glucose monitor and situational listening device products and other technological products, the volume and timing of orders received by the company, changes in the mix of products sold, competitive pricing pressures, the cost and availability of electronic components and commodities for the company’s products, ability to create and market products in a timely manner, competition by competitors with more resources than the company, government regulation and review of products, foreign currency risks arising from the company’s foreign operations, ability to satisfy and maintain compliance with the covenants under the company’s loan facility, the costs and risks associated with research and development investments and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2010. The company disclaims any intent or obligation to publicly update or revise any forward-looking statements, regardless of whether new information becomes available, future developments occur or otherwise.