The last phase of CLX's analysis and research process on the ThyroTest® product includes an in-depth analysis of competitive strengths and is part of an ongoing study of the product by a clinical laboratory affiliated with a major U.S. university. Data from the study is expected to be made available in the near term.
In addition to the acquisition of ThyroTest®, CLX Medical expects to enter into a co-development deal with ThyroTec, LLC to secure worldwide sales and marketing rights for 2 additional products in the medical diagnostic testing market.
"Our analysis of the potential market for ThyroTest indicates that it is much larger than the current estimated instance of hypothyroidism in the U.S.," stated Vera Leonard, chief executive officer of CLX Medical. "The wide range of symptoms, most of them very common in today's society, opens what we view to be a significant opportunity for a screening device like ThyroTest® that is CLIA waived and therefore allowed to be used in a wide variety of testing venues. We also believe that ThyroTest® is significantly superior to competitive products, and our marketing strategy for the product will include providing data that supports this contention."
CLX anticipates that Ms. Leonard will be providing additional follow-up information on ThyroTest®, as well as the opportunity presented by this product and the acquisition in the coming days.
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About CLX Medical, Inc.
CLX Medical, Inc. (www.clxmedical.com) holds a 51% equity interest in Zonda, Inc., which has developed rapid point of care tests for medical and non-medical markets, and CLX recently announced a letter of intent to acquire another rapid diagnostic device for the medical market. CLX has also invested, and holds a common stock position, in ActionView International, Inc. (www.actionviewinternational.com), a publicly traded global manufacturer and marketer of "smart" scrolling advertising billboards.
About ThyroTest®
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 doctor's offices in the U.S., as well as in any non-waived laboratory. The simple rapid diagnostic test is a qualitative measurement that allows physicians to screen adult patients for hypothyroidism in approximately ten minutes with a whole blood sample.
Hypothyroidism develops when the thyroid gland does not produce enough thyroid hormone to properly regulate the body's metabolism. A lack of thyroid hormone affects many body systems. The incidence of hypothyroidism tends to increase with age, with older people, especially women, at highest risk. Common symptoms include weight gain, fatigue, mood swings, weakness, dry and coarse skin and hair, hair loss, depression, decreased libido, trouble swallowing, increased cholesterol, heavy or irregular periods or trouble getting pregnant.
Approximately 120 million thyroid-related lab tests are performed in the United States each year. At an estimated average cost of $40 per test, the U.S. market is currently valued at nearly $5 billion. Approximately 45 million of those tests are conducted in order to diagnose thyroid dysfunction. CLX believes that ThyroTest® is an appropriate, cost-effective first-step for those 45 million diagnostic TSH tests. This current U.S. market opportunity is amplified by the CLIA waived status, which makes the opportunity to meet American Thyroid Association recommendations for screening every individual at age 35 and every five years thereafter a reality.
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.
Contact:
Contact: Gemini Financial Communications, Inc. A. Beyer 951-677-8073
Source: CLX Medical, Inc.
