Tue, Jul. 15, 10:28 AM
- InspireMD (NSPR) appoints James Barry, Ph.D., as Chief Operating Officer. He will focus on three main areas: advancing the product pipeline including finalizing the drug eluting stent MGuard platform, managing all global clinical trial activities and driving operations to systematically enhance quality and reduce costs, including consummating the outsourcing of manufacturing activities of the firm.
- Previously, Dr. Barry held various senior roles at Boston Scientific.
Wed, Apr. 30, 1:08 PM
- Based on reports of MGuard Prime EPS stent dislodgements InspireMD (NSPR -12.7%) initiates a Voluntary Field Action (VFA). The problems have allegedly occurred during the preparation of the device, upon the removal of the protective sleeve or during the withdrawal of the device into the guide catheter.
- The company believes it has identified the cause of the problems and will modify all existing units of the CE Mark-designated device after the approval of European regulators. Products already shipped will be modified in the field. Shipments to European customers should restart in Q2.
- Enrollment in the MASTER II U.S. clinical trial is suspended pending the FDA's review of manufacturing improvements to the MGuard Prime EPS. The delay will likely be three to six months.
- Management says the costs to upgrade the products and delay the clinical trial are modest and will have minimal effect on the company's cash position.
Wed, Apr. 30, 12:46 PM
Mon, Apr. 14, 5:53 PM
Thu, Feb. 27, 12:48 PM
Wed, Feb. 26, 5:23 PM| Comment!
Nov. 26, 2013, 4:00 PM
- Oppenheimer starts InspireMD (NSPR +3.9%) at Outperform.
- Analyst Steven Lichtman calls the company's MGuard Embolic Protection Stent "a novel and potentially disruptive technology for the treatment of ST Elevation Myocardial Infarction."
- Lichtman sees approval in "late 2016."
- Price target is $6, representing ~126% upside from current levels.
Nov. 11, 2013, 5:15 PM
Oct. 29, 2013, 5:42 PM
Oct. 29, 2013, 9:12 AM
Sep. 17, 2013, 4:33 PM
May. 23, 2013, 5:33 PM
May. 23, 2013, 4:00 PMInspire MD (NSPR -14%) gets smacked down today, flying in the face of largely posititve results from six-month trials of its MGuard Embolic Protection Stent that showed a lower mortality rate. The MGuard EPS uses a micro-net mesh sleeve to prevent unstable arterial plaque and clots that cause heart attack blockage from breaking off and exacerbating damage. | Comment!
May. 23, 2013, 12:45 PM
May. 21, 2013, 6:00 PM
May. 6, 2013, 5:49 PM
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