KIPS - ($0.69) Checking FORM 424B2 (Filing Date: 1/24/2014) Quite long but I only underlined what I think we/I should expect some updates soon, perhaps something by Feb. 24-25 (safe to say end of this month). Any PRs/updates will move her. If I don't see her moving by Feb. 24-25 and still stalling @$0.70 then it's bouncing out for me. Seems like I've waited for ages LOL.
As of January 15, 2014, twelve sites, eight in Europe and four in the United States, have received ethics committee or institutional review board approval and have enrolled, or are actively recruiting, patients in the trial. We plan to add up to two additional international sites going forward. As of January 15, 2014, 47 patients had been enrolled in the eMESH I clinical feasibility trial. Additional enrollments of patients within the United States are contingent upon approval by the FDA after reviewing six-month follow-up angiogram data for the first 10 patients. In reviewing the early results of the eMESH I clinical feasibility study, we could be required to wait for additional angiogram data from a larger group of patients in order to support receiving an expanded approval from the FDA. Based upon consultations with our medical advisors and several of the cardiac surgeons participating in the eMESH I clinical feasibility study, we intend to propose to the FDA a combination of changes in the application of the eSVS Mesh to the saphenous vein grafts and to the surgical implant technique for the eSVS Mesh treated graft. We believe that these changes will reduce the variables in the study. These changes are intended to reduce the risk of early graft occlusion and may make it easier to implant the eSVS Mesh as well as reduce costs. We hope that based upon these changes, we will be allowed to enroll additional patients in the United States. We intend to formally submit these changes to the FDA within the next 30 days along with our request to expand enrollment in the United States. However, no assurance can be provided that the FDA will approve any additional enrollments in the United States. In addition, no assurance can be provided that our current feasibility trial or our anticipated larger pivotal study will be successful, or that once these studies are concluded, we will receive U.S. marketing approval for the eSVS Mesh.
