CAESAREA, Israel, March 24, 2015 /PRNewswire/ --
Asaf Alperovitz, Allium Medical CEO: “The FDA confirmed that Gardia successfully achieved all of the clinical endpoints of the WISE clinical study already at this early stage of recruitment of half the number of patients planned for the full study cohort. This is a significant milestone for us in the process towards obtaining FDA approval”.
Allium Medical (TASE: ALMD): An Israeli medical devices company specializing in minimally invasive technologies, announced that the FDA confirmed Gardia successfully achieved all the clinical study objectives at the early stage of recruitment of half the number of patients (120 patients out of 240), based on the interim results. According to the study protocol, in order to meet the primary end-point of the study, which is the safety profile, already at this early stage, the Company was required to meet very stringent statistical criteria in relation to the statistical criteria required for the full study. In view of the successful compliance with all clinical trial objectives at this early stage, the Company decided to stop recruiting additional patients.
Asaf Alperovitz, CEO of Allium: “FDA confirmation that Gardia successfully met all the clinical trial endpoints at this early stage of recruitment of half the number of patients is a significant milestone for us in the process of obtaining FDA clearance. Gardia is at an advanced stage towards FDA clearance to market the WIRION system in the United States for the clinical indication of embolic protection in carotid arteries catheterization procedures. The study safety data presented by Gardia is superior to historical results of other FDA approved protection devices of world leading companies. The successful achievement of all clinical trial objectives, including the primary endpoint, based on half the number of patients defined in the study protocol, while meeting very stringent criteria for statistical significance is remarkable and unprecedented. This will allow us to streamline the process towards obtaining FDA clearance at a significantly shorter timetable. In the next two months, the company plans to submit a full response to the FDA letter of request for additional information that includes some technical issues related to the company’s 510(k) submission for marketing the WIRION system in the US.
The Gardia WIRION system, which has been used successfully in over 250 procedures, in a variety of clinical indications, received a very favorable feedback from leading European physicians performing these procedures. The system includes significant competitive advantages over other FDA cleared products of world leading companies.
Mr. Alperovitz added: “According to Axis Research Mind, from April 2013, the catheterization market for the Gardia product is estimated at 550 million dollars per year and has been growing at an average annual rate of about 15% in the past five years. In light of the unique advantages of the WIRION system, we believe that Gardia can affect an increase in the total market size by further expanding the clinical indications, while creating value for our shareholders ".
The WIRION system is a unique, patent-protected embolic protection filter system that provides protection from blood clots and emboli produced during catheterization procedures for the opening of blocked blood vessels. The system has a unique locking mechanism that allows the physician to use any guide wire of choice and place the filter at a desired location. The flexibility to place the filter anywhere over any guide wire of choice makes the procedure more safe, convenient and simple for use, thus presenting significant advantages with respect to other protection solutions available in the market.
About Allium Medical
Allium is an Israeli company that specializes in minimally invasive medical solutions and presents a variety of technologies and product lines in this area. The Company’s strategy is to create value by expanding the basis of internal developments and by purchasing product lines and additional technologies. The Company is run by leading professionals with knowhow and experience in rapid promotion of products, from the development stage to the commercial stage, while ensuring long-term financing and economies of scale.
Contact:
Asaf Alperovitz, CEO
Allium Medical Solutions Ltd.
Tel.: +972-4-6277166, Ext. 101
Cell: +972-54-7777803
SOURCE Allium Medical Solutions Ltd.
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