Endologix (NSDQ:ELGX) is warning customers that material weakness during the manufacturing process is causing polymer leaks during implantation of its Ovation iX abdominal stent graft system. The FDA today gave the recall a Class I designation — its most serious level. Out of 12,763 Ovation iX systems sold between August 2015 and May 2020, there were […]
Endologix
Endologix shares fall on missed Q1 projections
Endologix (NSDQ:ELGX) posted first-quarter results that missed the consensus forecast on Wall Street and cut its outlook for the rest of the year. The company — maker of endovascular stent-grafts for the treatment of abdominal aortic aneurysms (AAA) — reported losses of -$18.1 million, or -90¢ per share, on sales of $28.5 million for the three […]
COVID-19 upends medtech’s financial outlook
The uncertain times brought on by the COVID-19 pandemic have affected businesses worldwide, and several sectors of medtech industry are projecting hits to their bottom lines. A number of companies have announced decisions to withdraw financial guidance, cut hours and/or staff, among other major business decisions. Initial impacts of the global pandemic on Wall Street […]
Endologix wins FDA approval for abdominal stent graft system
Endologix today said it received FDA approval for its Alto abdominal stent graft system. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]
Endologix rises after posting improved Q3 earnings
Endologix (NSDQ:ELGX) shares are up today on third-quarter results that improved from the same quarter last year and topped the consensus forecast. The Irvine, Calif.-based AFX stent graft developer posted losses of -$7.8 million, or -40¢ per share, on sales of 35.8 million for the three months ended Sept. 30, for a 23.2% bottom-line gain on […]
Endologix defends AFX stent grafts after FDA warning
Endologix (NSDQ:ELGX) moved to defend its AFX stent grafts after the FDA this week warned of the risk of endoleaks with the devices, which are used to treat abdominal aortic aneurysms. The FDA added the Irvine, Calif.-based company’s The AFX with Duraply and AFX2 to last year’s warning about the AFX with Strata device, citing data […]
FDA warns on two more Endologix stent grafts
Updated on Oct. 29 with comments from Endologix. Endologix (NSDQ:ELGX) shares plummeted today after the FDA issued a warning for patients using the company’s AFX endovascular stent grafts for the treatment of abdominal aortic aneurysms. The AFX with Duraply and AFX2 were all mentioned by the FDA as stent grafts with a risk of endoleaks, along […]
Endologix spikes plan for $25m offering
Endologix (NSDQ:ELGX) yesterday spiked its plan to sell as much as $25 million worth of its own stock, saying it has no intention of selling stock over the short term. The Irvine, Calif.-based company had tapped Piper Jaffray to offer more than 22.2 million shares at $6.45 apiece, with the proceeds earmarked for manufacturing, clinical trials, […]
Endologix looks to raise $25m in stock offering
Endologix (NSDQ:ELGX) has registered a stock offering of up to $25 million, according to a regulatory filing. The Irvine, Calif.-based company has engaged Piper Jaffray to offer more than 22.2 million shares of common stock at $6.45 per share. Proceeds will be used for manufacturing, clinical trials, R&D, sales and marketing expenses, general and administrative […]
Endologix shares dip on Q2 loss of $27.1 million
Shares in Endologix (NSDQ:ELGX) slipped by 8% to $6.06 apiece in midday trading today following yesterday’s second-quarter results that beat The Street on earnings expectations and sales. The Irvine, Calif.-based company reported a net loss of $27.1 million or -$1.50 per share on sales of $36.24 million for the three months ended June 30, 2019, […]
Endologix closes $52m offering, debt refinancing deal
Endologix (NSDQ:ELGX) has closed a $52.2 million offering and debt exchange agreements with certain holders of its senior convertible notes for approximately $73.4 million, according to an SEC filing. In its offering deal, announced earlier this week, the Irvine, Calif.-based company said it floated approximately 7.9 million new shares of its common stock at a price of […]
