Kips Bay Medical, Inc. (NASDAQ: KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS ® Mesh, for use in coronary artery bypass grafting surgery, today provided a business update and announced financial results for its second quarter ended June 29, 2013.
Enrollments and site activations are continuing in the Kips Bay eMESH I clinical feasibility trial. This includes the activation of two additional U.S. sites, the Texas Heart Institute in Houston, Texas and the Emory University Hospital Heart and Vascular Center in Atlanta, Georgia. Both sites have completed their internal review and approval processes, have received study approval from the Center for Medicare and Medicaid Services and have begun to actively recruit patients. This brings the number of actively recruiting sites to nine as of August 1, 2013, with five in Europe and four in the United States. Kips Bay also plans to add some additional international sites going forward. As of August 8, 2013, 29 patients have been enrolled in the eMESH I clinical feasibility trial, up from 16 patients at the end of the first quarter of this year.
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using the Company’s eSVS Mesh in coronary artery bypass grafting (CABG) surgery for the U.S. Food and Drug Administration (FDA). Currently, to be eligible to participate in the eMESH I study, the patient must meet a number of specific criteria as identified in the study protocol, including having two vein graft segments which qualify for use of the eSVS ® Mesh - one vein graft that receives the eSVS Mesh and one vein graft that serves as a control.After discussions with several cardiac surgeons participating in the trial, the Company has requested a modification to the study protocol allowing the enrollment of patients with only one qualifying graft. Based upon initial discussions with the FDA, the Company is currently implementing this modification with its European study sites and expects to modify the US protocol upon the receipt of approval from the FDA. The first European sites are expected to be in a position to begin enrolling patients with one qualifying graft in early September. The Company hopes to obtain FDA approval of this modification for the U.S. sites shortly thereafter.