Key Developments: Kips Bay Medical Inc (KIPS.W)
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22 May 2013
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Latest Key Developments (Source: Significant Developments)
Kips Bay Medical Inc Announces FDA Approval For Additional US Study Patients-DJ
Dow Jones reported that Kips Bay Medical Inc announced that the United States Food & Drug Administration (FDA) has granted approval for additional US patients to be enrolled in Kips Bay Medical's eMESH I clinical feasibility trial of its eSVS Mesh. In its initial approval, the FDA indicated that it would allow a staged enrollment within the United States, starting with five patients at up to four sites in the United States. The FDA has now increased the approved number of patients from five to 15. The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medical's eSVS Mesh in CABG Surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (SVG) support device during coronary artery bypass (CABG) surgery. The Company expects to enroll up to 120 patients at eight European and four U.S. sites and further expects to use the data from this study as the basis for a pivotal trial in the U.S. Full Article
Kips Bay Medical Inc Announces Closing Of $6.5 Million Public Offering Of Common Stock
Kips Bay Medical Inc announced that it has closed its previously announced offering of 10,000,000 shares of its common stock for total gross proceeds of $6.5 million. After the closing of the offering, Kips Bay has 26,346,079 shares of common stock outstanding. Sunrise Securities Corp. acted as the sole book-running manager. Aegis Capital Corp. acted as co-manager. Full Article
Kips Bay Medical Inc Announces Pricing Of Public Offering Of Common Stock
Kips Bay Medical Inc announced the pricing of an underwritten public offering of 10,000,000 shares of its common stock for total estimated gross proceeds of $6.5 million. Kips Bay Medical has also granted the underwriters a 45-day option to purchase up to 1,500,000 additional shares of common stock. The offering is subject to customary closing conditions and is expected to close on December 27, 2012. Kips Bay Medical intends to use the net proceeds of this offering to seek regulatory approval to market its eSVS Mesh in the United States and abroad, including continuing its human clinical trials for the United States Food & Drug Administration, to develop and test additional applications of its eSVS Mesh, and for working capital and general corporate purposes. Sunrise Securities Corp. is acting as the sole book-running manager. Aegis Capital Corp. is acting as co-manager. Full Article
Kips Bay Medical Inc Announces Filing IDE For U.S. FDA Study
Kips Bay Medical Inc announced that Kips Bay Medical has filed an application for an Investigational Device Exemption with the U.S. Food & Drug Administration to include four U.S. sites in its 'eMESH I' clinical feasibility study of its eSVS Mesh device being pursued in EuropeKips Bay Medical submitted this IDE application based upon the FDA’s response to its April 2012 Pre-IDE submission in which Kips Bay provided additional information to the FDA on the performance of its eSVS Mesh. The FDA advised Kips Bay Medical that it was allowed to proceed with this filing for an IDE. The objective of this study is to demonstrate the initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study. Kips Bay Medical is working through the ethics committee review and approval process at a select group of European study sites. Full Article
Kips Bay Medical Inc Announces Zurich Heart Center Reports Excellent Early Clinical Experience With eSVS Mesh At International Society of Minimally Invasive Cardiothoracic Surgeons Annual Meeting
Kips Bay Medical Inc announced that Prof. Michele Genoni, MD, Chief of Cardiovascular Surgery of the Triemli Hospital, Zurich, Switzerland, presented his center’s early clinical experience with the eSVS Mesh device at the 14th Annual meeting of the ISMICS in Los Angeles, CA. Since 2011, Prof. Genoni and his surgical team have implanted the eSVS Mesh in 20 patients undergoing off-pump coronary artery bypass procedures (OPCAB). All patients received two arterial bypass grafts, using the left and right internal mammary arteries, and one saphenous vein graft (SVG), treated with the eSVS Mesh device, to the right coronary artery. The Kips Bay Medical eSVS Mesh is a knitted, nitinol prosthesis that is designed to fit around the outside of the saphenous vein so as to minimize the undesirable over-expansion which can cause graft failure. All bypass grafts were evaluated with computed tomography (CT) angiograms performed prior to the patient’s discharge from the hospital. The data from these patients demonstrated excellent flow in the SVG grafts treated with the eSVS Mesh device. The results from these twenty patients showed that 95% of the saphenous vein grafts treated with the eSVS Mesh were open, or patent, and 100% of the arterial grafts were open. Full Article
Kips Bay Medical Inc Announces $20 Million Common Stock Purchase Agreement with Aspire Capital Fund
Kips Bay Medical, Inc. announced that it has entered into a common stock purchase agreement with Aspire Capital Fund, LLC, an Illinois limited liability company, whereby Aspire Capital has committed over the next 3 years to purchase up to $20 million of Kips Bay common stock based on prevailing market prices over a period preceding each sale. Cohen & Company Capital Markets, LLC, a wholly owned subsidiary of PrinceRidge Holdings LP, acted as financial advisor to Kips Bay in connection with the transaction. Key aspects of the purchase agreement include: Kips Bay will control the timing and amount of any sales of common stock to Aspire Capital and will know the sales price before giving notice directing Aspire Capital to purchase shares. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases as the Company directs, in accordance with the purchase agreement. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the purchase agreement. Kips Bay has issued 378,788 shares of its common stock to Aspire as a commitment fee in connection with entering into the purchase agreement. The purchase agreement may be terminated by Kips Bay at any time, at its discretion, without any cost or penalty to the Company. Full Article
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