Pomerantz LLP announces that a class action lawsuit has been filed against Endologix, Inc. (“Endologix” or the “Company”) and certain of its officers. The class action, filed in United States District Court, Central District of California, and docketed under 17-cv-00061, is on behalf of a class consisting of all persons or entities who purchased or otherwise acquired Endologix securities between August 2, 2016 and November 16, 2016, both dates inclusive (the “Class Period”), seeking to recover compensable damages caused by defendants’ violations of the Securities Exchange Act of 1934.
Endologix develops, manufactures, markets, and sells medical devices for the treatment of abdominal aortic aneurysms in the United States and internationally.
Endologix’s products are intended for the minimally invasive endovascular treatment of abdominal aortic aneurysms. One of the Company’s products is built on the platform of endovascular sealing (“EVAS”). Endologix’s current EVAS product is the Nellix® EndoVascular Aneurysm Sealing System (“Nellix EVAS System”).
The Nellix EVAS System is currently engaged in the U.S. Food and Drug Administration (“FDA”) premarket approval process (the “PMA process”), which requires Endologix to collect and submit nonclinical and human clinical data on Nellix EVAS System for its intended use to demonstrate that it is safe and effective. In the PMA process, the FDA will approve the medical device and thereby authorize its commercial distribution in the U.S. if it determines that the probable benefits outweigh the risks for the intended patient population, and, therefore, makes a determination of reasonable assurances of safety and effectiveness.
In December 2013, Endologix received Investigational Device Exemption (“IDE”) approval in the United States to begin a clinical trial for the Nellix EVAS System, which commenced in January 2014 (the “IDE Study”). Enrollment in the IDE study was completed in November 2014. In the third quarter of 2015, Endologix obtained IDE continued access approval for additional patients.
On May 26, 2016, Endologix reported purportedly positive clinical data from the IDE Study and submitted the results to the FDA as part of the PMA process for the Nellix EVAS System.
The complaint alleges that throughout the Class Period, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (1) Endologix did not have the requisite clinical data for FDA premarket approval of its NellixAr EndoVascular Aneurysm Sealing System; and (2) as a result, Endologix's public statements were materially false and misleading at all relevant times.
On November 16, 2016, before market hours, Endologix issued a press release entitled “Endologix Provides Update on Nellix PMA Process,” revealing “that the U.S Food and Drug Administration (FDA) has requested the Company provide 2-year patient follow-up data from the EVAS-FORWARD IDE Study of the Nellix® EndoVascular Aneurysm Sealing System (Nellix EVAS System).”
On this news, Endologix’s share price fell $2.02, or over 20.5%, from its previous closing price, to close at $7.82 on November 16, 2016, damaging investors.