--The Company received CE Mark approval for its self-expanding Nitinol carotid EPS, further validating the MGuard MicroNet technology and strengthening its distributor and partnership strategy in the near term.
Recent Events--On April 16, the Company completed an underwritten public offering of 12.5 million common shares, raising net proceeds of approximately $22.6 million. A portion of the proceeds were used in connection with the retirement of the Company's outstanding debentures and the Company intends to use the balance of the proceeds to support the worldwide commercialization of the MGuard EPS, to pursue FDA approval in the U.S. of the MGuard EPS and for general corporate purposes. Concurrent with this funding, the Company's shares commenced trading on the NYSE MKT.
--On April 19, Gwen K. Bame joined the Company as Vice President of Corporate Development, a new position created to strengthen the Company's focus on executing strategic programs and partnerships designed to meet the Company's ambitious global growth objectives. Ms. Bame, who previously held executive positions with Boston Scientific and Covidien, is expected to identify and negotiate in/out licensing agreements, analyze strategic partnerships and structure joint ventures worldwide.
--On April 23, the Company announced it received approval with conditions from the FDA to commence a pivotal trial in support of its IDE application. An approval with conditions indicates the FDA concurs with the overall trial design and, while minor details are being finalized, it allows the Company to initiate enrollment in the randomized MASTER II IDE trial of patients suffering from ST Elevation Myocardial Infraction (STEMI). The principal investigators f
|SOURCE InspireMD, Inc.|
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