KarmelSonix Limited KarmelSonix Ltd. (KSX) Suite 2, 1233 High Street PulmoSonix Pty, Ltd. 336A Glenhuntly Road KarmelSonix (Israel) Ltd. 5 Palyam Avenue Armadale VIC 3143 Australia Elsternwick VIC 3185 Australia Haifa, Israel COMPANY ANNOUNCEMENT WIM-PC™ Receives FDA Approval HIGHLIGHTS • FDA clears the WIM-PC™ for marketing in the USA • Marketing and sales process of WIM-PC™ to commence in the USA • Approval for acoustic pulmonary function testing based on quantification of wheeze • WIM Holter and Personal Wheezeometer accelerated development process reaffirmed by the FDA approval of the WIM-PC™ • Next regulatory steps are the European (CE mark) and Australian (TGA) approval process 7th November 2007: KarmelSonix Ltd (KSX) Israeli-based subsidiary, KarmelSonix Israel Ltd, is pleased to announce that it has received regulatory clearance from the US Food and Drug Administration (FDA) for its first product, the WIM-PC™. The clearance allows the marketing and use of the WIM-PC™ in the United States and constitutes an important milestone in the process of commercialization of the product. The FDA Clearance is based on extensive scrutiny of scientific and technical data which demonstrate that the device is both safe and effective for its intended use. KarmelSonix CEO, Dr. Reuven Regev states: “The FDA approval is a significant strategic milestone achieved by the company which now positions the company strongly in its marketing and partnership distribution plans and negotiations". In addition to commencing sales operations, the FDA approval reaffirms the KSX decision to accelerate the development of the Company’s future planned products, the WHolter and Personal Wheezeometer. The WHolter will provide a diagnostic tool for overnight study of asthma – nocturnal asthma as well as other ambulatory applications - and the Personal Wheezeometer will be a home-based asthma diagnostic tool”. KarmelSonix Limited KarmelSonix Ltd. (KSX) Suite 2, 1233 High Street PulmoSonix Pty, Ltd. 336A Glenhuntly Road KarmelSonix (Israel) Ltd. 5 Palyam Avenue Armadale VIC 3143 Australia Elsternwick VIC 3185 Australia Haifa, Israel Below is the formal statement of indications for use as cleared by the FDA. “Indications for Use Statement: The WIM-PC™ is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PC™ is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.” Chief Medical Officer, Prof. Noam Gavriely stated that “The FDA approval covers a broad range of applications of the KarmelSonix acoustic technology, making the test a critical component in positively establishing the diagnosis of asthma. The use of the WIM-PC™ will be particularly applicable in the detection and quantification of wheeze in patients who cannot properly perform standard spirometery tests such as children, the elderly and others who make up to 30% of the tested population.” KarmelSonix Chairman Peter Marks stated “The FDA clearance marks the full transition of KarmelSonix Ltd from a technology company to the next phase of commercial activities. The Company can now confidently mobilize products to clinical sites for regular clinical use and market acceptance through the comprehensive clinical engagement plan that has been developed in the USA and around the world." KarmelSonix will now immediately submit the WIM-PC™ for European approval (CE mark) followed by the Australian market (TGA) approval”. For additional information, please contact: Mr. Peter Marks, Chairman, 03 9824 8166 Email: [email protected] Dr. Reuven Regev, CEO +972 546 54 3318 Email: [email protected]
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