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August 12, 2014
09:20 EDTKIPSKips Bay Medical provides feasibility study update
Enrollment in the eMESH I clinical feasibility trial has continued, although at a slower than expected pace during Q2. As of August 1, 56 patients had been enrolled in the eMESH I clinical feasibility trial. Kips Bay attributes part of this slowness to a delay in its receipt of the CE Mark approval incorporating the new implant technique approved by the FDA for use in the feasibility trial. In addition, organizational changes within two of the U.S. study sites delayed internal approvals required for those sites to resume the enrollment of study patients. In March, the FDA approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft, or SVG, and to the surgical implant technique for the eSVS Mesh treated graft. These changes were based upon the company's consultations with medical advisors and several of the cardiac surgeons participating in the eMESH I clinical feasibility trial and the company's initial review of early results from the eMESH I trial. The changes are intended to reduce the variables in the study and the risk of early graft occlusion. Kips Bay also believes these changes will simplify the process of applying and implanting the eSVS Mesh thereby reducing procedural costs. Also in March, the company requested an update of its CE Mark approval to incorporate the changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique that were approved by the FDA for use in the eMESH I clinical feasibility trial. Based upon recent communications with its notified body, the company believes that the review process is near completion and that Kips Bay will receive the updated approval during the third quarter. Kips Bay believes that the CE Mark review process has taken longer than the company had anticipated due to a backlog in the workload of the company's notified body. Currently, seven European study sites are now able to enroll study patients in the eMESH I clinical feasibility study, however, they may not use the new implant technique until the company receives an updated CE Mark approval. Three additional international sites have received ethics committee approval and are in the process of finalizing clinical trial agreements in order to begin enrollment, which is expected to commence during Q3.
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June 29, 2015
08:57 EDTKIPSKips Bay Medical announces orderly wind down of operations
The Board of Directors made its decision to approve a plan of dissolution and liquidation of the Company after completing an exhaustive evaluation of various strategic alternatives available to the Company for enhancing stockholder value, including but not limited to, continued execution of its business plan and further modification of the Company's eSVS Mesh device and implant technique; the sale of the Company or its assets, including its intellectual property portfolio; partnering or other collaboration agreements; a merger, reverse merger or other strategic transaction. The Company plans to seek stockholder approval of the dissolution and liquidation at an upcoming meeting of stockholders, which the Company intends to convene as early as September 2015. Despite the Company's plan to seek a dissolution and liquidation of the Company, the Company intends to continue to review and evaluate any available strategic alternatives. If, prior to its dissolution, the Company receives an offer for a transaction that, in the view of the Board of Directors, will provide superior value to the Company's stockholders than the value of the estimated distributions under the plan of dissolution and liquidation, taking into account all factors that could affect valuation, including timing and certainty of payment or closing, credit market risks, proposed terms and other factors, the Company could abandon the dissolution and liquidation in favor of such a transaction.The Company further announced that in light of the termination of its feasibility trial and intent to wind down its operations, the Company has implemented further cost-reduction measures, including additional staff reductions.
08:57 EDTKIPSKips Bay Medical announces termination of eMESH 1 clinical trial
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