ARDEN HILLS, Minn.--(BUSINESS WIRE)--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 the Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring (CDM) device. The Centauri combines event recording with wireless transmission of patient data allowing physicians to continuously monitor patient cardiac events remotely.
Mark S. Gorder, president and chief executive officer at IntriCon said, “With rising health care costs, we are excited to offer a device that will not only improve patient quality of life, but also reduce treatment costs by providing the ability to identify asymptomatic cardiac events remotely. The Centauri follows current industry trends of shifting patient care from expensive health-care settings to the home which not only reduces costs but improves patient comfort.”
The Centauri device provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. With continuous monitoring, automatic arrhythmia detection and wireless transmission of the recorded cardiac activity to a licensed physician for review, Centauri offers flexibility and comfort not found in traditional devices.
Given the timing of the FDA clearance, IntriCon expects to release the product in the third quarter of 2011 and anticipates modest revenue contributions in the 2011 fourth quarter.
About IntriCon Corporation
Headquartered 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 Statements
Statements 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 government approval of the debt
ceiling, risks related to the company’s strategic alliances and joint
venture, possible non-performance of the Centauri, Scenic, Overtus, APT,
Sirona, PhysioLink, 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.