On Thursday, Endologix, Inc. (NASDAQ:ELGX)’s shares declined -0.54% to $14.75.
Endologix, Inc. (ELGX), developer and marketer of innovative treatments for aortic disorders, declared recently the presentation of 30-day outcomes for the pivotal cohort from the Company-sponsored investigational device exemption (IDE) clinical investigation, the EVAS FORWARD-IDE Study (www.clinicaltrials.gov, NCT01726257). This multicenter, prospective, single arm clinical study is designed to evaluate the safety and effectiveness of the Nellix(R) EndoVascular Aneurysm Sealing System (“Nellix EVAS System”) for the endovascular repair of infrarenal abdominal aortic aneurysms (“AAA”). The study primary endpoints are major adverse events at 30 days (safety), and Treatment Success at one year (effectiveness). Jeffrey P. Carpenter, MD, Professor and Chairman of Surgery for Cooper Medical School and Chief of Surgery for Cooper Health System in New Jersey, and National Principal Investigator of the EVAS FORWARD-IDE clinical study, presented on behalf of the study investigators at the Society for Vascular Surgery 2015 annual meeting in Chicago. The Nellix EVAS System is approved only for investigational use in the U.S. and is commercially accessible in Europe and select other international markets.
The EVAS FORWARD-IDE clinical study enrolled eligible patients with AAA at 29 centers in the U.S. and Europe. After enrolling the first patient, each site enrolled patients to comprise the 150-patient pivotal cohort between February and November 2014. Protocol-defined follow-up at one month, six months, one year, and annually thereafter to five years comprises a clinical assessment and high resolution computed tomography angiographic (CTA) scan with core laboratory assessment for the presence of endoleaks, occlusion, migration, aneurysm stability and device integrity.
Key highlights from the presentation comprise:
- 100% procedural technical success with few device-related serious adverse events
- Median fluoroscopy and procedure times of 10 minutes and 87 minutes, respectively.
- Low 30-day mortality (0.7%) and overall major adverse events (2.7%) as adjudicated by an independent Clinical Events Committee, with no aneurysm rupture or conversion to open repair.
- Low incidence of any endoleak on the 1-month CTA scan (6%).
- No lumen thrombosis or occlusions or other device integrity issues
Based on current assumptions and timelines, the Company anticipates submission of the premarket approval (PMA) application to the U.S. FDA in early 2016, and is anticipating FDA approval of the Nellix System by the end of 2016.
Endologix, Inc. develops, manufactures, markets, and sells medical devices for the treatment of abdominal aortic aneurysms in the United States and internationally. The company offers minimally-invasive endovascular repair (EVAR) products, including EVAR stent graft and catheter delivery system under the brand names Powerlink, IntuiTrak, AFX, and VELA Proximal Endograft.
Ciena Corporation (NYSE:CIEN)’s shares dropped -1.27% to $24.08.
Ciena Corporation (CIEN) and Cyan, Inc. (CYNI), declared that early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (the “HSR Act”) has been granted, effective June 15, 2015, for Ciena’s planned acquisition of Cyan.
Expiration of the waiting period under the HSR Act satisfies one of the conditions necessary for the consummation of the merger. The transaction remains subject to other closing conditions, counting certain approvals of Cyan stockholders at its annual meeting presently predictable to be held on Friday, July 31, 2015. The parties continue to expect that this transaction will close during the third quarter of calendar year 2015.
Ciena Corporation provides equipment, software, and services that support the transport, switching, aggregation, service delivery, and administration of voice, video, and data traffic on communications networks worldwide. The company’s Converged Packet Optical segment offers networking solutions optimized for the convergence of coherent optical transport, OTN switching, and packet switching. Its products comprise the 6500 Packet-Optical Platform, 5430 Reconfigurable Switching System, CoreDirector Multiservice Optical Switches, and OTN configuration for the 5410 Reconfigurable Switching System.
At the end of Thursday’s trade, Boeing Co (NYSE:BA)‘s shares dipped -0.37% to $140.21.
Boeing [ BA] and Embraer S.A. (ERJ) declared that they intend to collaborate to test environment-focused technologies through the ecoDemonstrator Program in a joint effort to improve aviation’s environmental performance. This expands ongoing cooperation between two of the world’s largest airplane manufacturers.
Frederico Curado, president and CEO of Embraer, and Marc Allen, president of Boeing International, signed a Memorandum of Understanding at the Brazil-U.S. Business Summit organized by the Brazil-U.S. Business Council. The business summit, hosted by the U.S. Chamber of Commerce, occurred during an official visit by Brazil’s President Dilma Rousseff with U.S. President Barack Obama.
Boeing launched its ecoDemonstrator Program in 2011 to accelerate testing and use of new technologies that can reduce fuel use, carbon emissions and noise. The company has so far tested more than 50 technologies with a Next-Generation 737-800, 787 Dreamliner and, presently, a 757. Through their collaboration, Boeing and Embraer are planning to conduct ecoDemonstrator tests with an Embraer airplane in 2016.
The Boeing Company, together with its auxiliaries, designs, develops, manufactures, sells, services, and supports commercial jetliners, military aircraft, satellites, missile defense, human space flight, and launch systems and services worldwide. The company operates in five segments: Commercial Airplanes, Boeing Military Aircraft, Network & Space Systems, Global Services & Support, and Boeing Capital.
Hudson City Bancorp, Inc. (NASDAQ:HCBK), ended its Thursday’s trading session with -1.09% loss, and closed at $10.00.
Hudson City Bancorp, Inc. (HCBK), the holding company for Hudson City Savings Bank (the “Bank”), declared recently that it has released the 2015 capital stress test results for the Bank as required by the Dodd-Frank Wall Street Reform and Consumer Protection Act (“DFA”). The results can be obtained on the Company’s web site http://www.hcsbonline.com. The results, per regulatory guidance, are for the Bank only.
The DFA requires national banks and federal savings associations with total merged assets of more than $10 billion, such as the Bank, to conduct annual stress tests. Accordingly, the Bank conducted a DFA company-run stress test (“DFAST”) under three hypothetical supervisory scenarios (baseline, adverse and severely adverse) and guidance offered by the Office of the Comptroller of the Currency (“OCC”) and the Board of Governors of the Federal Reserve System (“Federal Reserve”). The DFA and regulatory guidance require the Bank to publicly disclose the results of the DFAST under the supervisory severely adverse scenario.
Hudson City Bancorp, Inc. operates as the holding company of Hudson City Savings Bank that provides various banking products and services in the United States. Its deposit products comprise passbook and statement savings accounts, interest-bearing transaction accounts, checking accounts, money market accounts, and time deposits, in addition to IRA accounts and qualified retirement plans.
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