Med 11 AG
MED-11 AG ANNOUNCES COMPLETION OF FDA REVIEW OF LUNG CANCER TEST PRE-IDE APPLICATION
Med 11 AG / Miscellaneous Release of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer / publisher is solely responsible for the content of this announcement. ---------------------------------------------------------------------- MED-11 AG ANNOUNCES COMPLETION OF FDA REVIEW OF LUNG CANCER TEST PRE-IDE APPLICATION. ZUG, Switzerland -- Swiss-based MED-11 AG (Frankfurt Stock Exchange: WKN: A0LGDQ), the holder of two US patented cancer screening test kits for various cancerous and precancerous conditions, has been notified by the USA Food and Drug Administration (FDA) that they have reviewed Med-11’s Lung Cancer Screening Test 'Investigative Device Exemption' (IDE) application. The FDA informed Med-11 that there are no other non-invasive screening tests for Lung Cancer. Med-11 will now conduct a small Clinical Trial as submitted to the FDA to confirm the sensitivity and specificity of the Lung Screening Test when compared with lung biopsies from existing cancer patients. This clinical trial is expected to take six months and will consist of 485 subjects made up of 196 lung cancerous subjects and 289 non-lung cancerous. Following the Clinical Trial, Med-11 will submit a Pre-Market Approval (PMA) to the FDA as a Class III medical diagnostic device. This application will request an accelerated review by the FDA as lung cancer is a leading cause of death in the USA. Early assessment and prevention can eliminate a large percentage of these deaths; consequently there is an urgent need and vast market potential for this product. Market research indicates that the annual sales of the Cancer Screening Tests for Lung Cancer in the US alone, once approved by the FDA, should exceed $1 Billion a year. About MED-11 (www.med-11.ch, www.med-11diagnostic.com and www.med-11.com) MED-11 AG is medical service company with a wide range of patented medical products in different market segments. These include Cancer Screening Tests, Cancer Preventive Dietary Supplements; Personal Care Products; and prepackaged Modular Medical Clinics. The Company identified ‘medical diagnostics’ and ‘preventive health care’ as sectors of the medical service industry that were experiencing strong growth. As a result of management’s background and experience in the United States pharmaceutical, nutraceutical and retail industry, MED-11 made several investments and acquired the United States and Japanese patents to, Screening Tests for Colon Cancer, Lung Cancer and Breast Cancer; the worldwide Licenses to manufacture and distribute certain Cancer Preventive Dietary Supplements; the worldwide Licenses to manufacture and distribute Modular Medical Clinics; and distribution agreements for various Personal Care Nutraceutical Products. Through the provision, by Medical Practioners, of evidence-based clinical proof of each products safety and efficacy, the Company aims to acquire a major position in this expanding market. For further information contact: Ulrike Dickmann, Investor Relations: Phone: +49-1577-631-55-88 or Email: u.dickmann@med-11diagnostics.com or Mail to: MED-11 AG, Alpenstrasse 7, CH-6300, Zug, Switzerland. 04.07.2008 Financial News transmitted by DGAP ----------------------------------------------------------------------
Aktuelle News
Aktuelle Berichte
Keine Berichte gefunden
Anstehende Events
Keine Events gefunden
Webcasts
Keine Webcasts gefunden