Elron Electronic Industries : CartiHeal’s Agili-C Implant was Granted Breakthrough Device Designation by the FDA
October 13, 2020 at 04:10 am EDT
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Translation of Immediate Report Filed by Elron on October 11, 2020 with the Israeli Securities Authority
Tel-Aviv, October 11, 2020 - Elron Electronic Industries Ltd. ("Elron") (TASE: ELRN) hereby announces with respect to CartiHeal (2009) Ltd. ("CartiHeal"), that CartiHeal's Agili-C implant was granted designation as a Breakthrough Device by the U.S. Food and drug Administration (FDA).
The FDA's Breakthrough Devices Program is a voluntary program designed to allow faster access to devices that provide effective treatment or diagnosis for life-threatening illnesses or illnesses that cause severe and irreversible disability, in the absence of alternative effective treatment. In the event that a device qualifies as a "Breakthrough Designation", it is possible, among other things, to speed up the examination process of the marketing approval application by the FDA.
As stated in Section 26 of Part I (Description of Corporation's Business) of Elron's annual report for 2019 published on March 19, 2020, which is included by reference herein (including the forward looking statement in Section 26.13), CartiHeal expects to complete the follow-up period for the pivotal clinical trial of the Agili-C device in October 2021, and to announce final trial results at the end of 2021. Shortly thereafter and insofar as the results will demonstrate success in the pivotal trial, CartiHeal is expected to submit a U.S. marketing approval application to the FDA. FDA approval, if received, may take approximately one year from submission to approval. The review process of the marketing approval application may be expedited following the Breakthrough Device Designation of CartiHeal's Agili-C implant by the FDA.
CartiHeal is approximately 27% held by Elron (25% on a fully diluted basis).
Regarding the investment and option to sell CartiHeal, see the immediate report filed by Elron on July 16, 2020.
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Elron Electronic Industries Ltd. published this content on 11 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 October 2020 08:09:04 UTC
Elron Electronic Industries Ltd. is an operational holding company that focuses on building and enhancing technology companies, mainly in the field of medical devices. Its group companies include companies at different stages of development and business maturation, operating in various technology fields, such as medical device and other fields. It is involved in the management of its group companies by means of membership and providing assistance to management. It operates in the Holdings and Corporate Operations segment. It is engaged in matters of policy guidance, strategic planning, marketing, selecting and manning senior management positions, determining the business plan, approving investments and budgets, development and operational guidance, assistance in creating strategic partnerships, and the overall ongoing monitoring of its group companies' performance. Its main group companies include BrainsGate Ltd, Pocared Diagnostics Ltd. and RDC Rafael Development Corporation Ltd.