CLX Medical, Inc. Issues CEO Comment on Status of Company With Ownership and Planned Distribution of FDA Cleared ThyroTest(R) Product
Ms. Leonard has been instrumental in the process of identifying the ThyroTest® product as a potential acquisition for CLX Medical and completing the close of the transaction in early December 2008. CLX Medical is currently implementing its ThyroTest® marketing program and is seeking to establish distribution of the product with a national U.S. distributor. ThyroTest® is FDA cleared and has also achieved CLIA waived status, so the test can be administered in the more than 100,000 CLIA waived doctors' offices in the U.S., as well as in any non-waived laboratory.
Ms. Leonard stated, "CLX Medical has been afforded a rare opportunity to bring under management a product that has no remaining regulatory hurdles for it to be sold in the United States. We believe that ThyroTest® can be introduced into the U.S. market within the next several months, and we look forward to announcing nationwide distribution in the first calendar quarter of 2009.
"With an estimated 13 million undiagnosed hypothyroidism cases in the U.S., the market opportunity is attractive, especially for a company like CLX Medical, which is focusing the vast majority of its attention on the successful distribution of this product. Also working in the company's favor is that there has been an increased awareness of the need to screen for hypothyroidism, including high profile celebrities that have been diagnosed with the condition bringing additional media attention. This increased awareness offers an opportunity for success that did not exist as strongly in the past.
"The U.S. market is clearly large enough to grow distribution of ThyroTest® and to generate significant revenue numbers, but we will also seek to utilize CLX Medical's distribution relationship with Leti Laboratories for the European market and potentially other international markets.
"ThyroTest® provides the opportunity to screen for elevated TSH in the doctor's office with a 10-minute result, offering significant savings to the healthcare system while delivering practice management efficiencies to the health care practitioner. With growing concerns of hypothyroidism at the same time that healthcare costs have become problematic for both consumers and health care professionals, this type of test is exactly what the medical community needs. With effective marketing, we believe that significant and growing revenues can be generated from the sale of ThyroTest®.
"Beyond ThyroTest®, we believe that CLX Medical is positioned to seek out additional diagnostic products that also offer cost savings and convenience to the healthcare industry. There is no reason that the same system for identifying and closing acquisitions, as well the subsequent marketing and distribution program that we expect to implement for ThyroTest®, cannot be applied to other products as well.
"These factors, taken together, place CLX Medical in a relatively good position at a time when many business strategies have been compromised due to changing economic conditions and industry shifts. We look forward to executing CLX Medical's strategy successfully and taking the company to an entirely different level from a value standpoint."
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About CLX Medical, Inc.
CLX Medical, Inc. (www.clxmedical.com) holds a 51% equity interest in Zonda, Inc. (www.zondaincusa.com), which has developed several rapid point of care tests for medical and non-medical markets, including a rapid test for chlamydia. CLX has also recently closed its acquisition of ThyroTest®, a rapid thyroid stimulating hormone (TSH) screening device used for the detection of hypothyroidism in adults, a common thyroid disease. CLX Medical is focused on the successful worldwide distribution of these and any additional products it may acquire or license.
All statements included in this release, including statements regarding potential future plans and objectives of CLX Medical, Inc. are forward-looking statements. Such statements are necessarily subject to risks and uncertainties, some of which are significant in scope and nature beyond CLX Medical's control. There can be no assurance that such statements will prove accurate. Actual results and future events could differ materially from those anticipated in such statements depending on many factors. Historical results are not necessarily indicative of future performance.
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