In case it’s new to you, Kips Bay Medical, Inc., is a company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery (CABG). It’s device is CE marked and available in Europe, but now the boss has issued a letter to shareholders in which he outlines the company’s aspirations to gain FDA approval.
Kips Bay Medical’s eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts (SVG) to provide additional strength when used in CABG surgery. By strengthening the SVG, Kips Bay hopes to reduce or prevent undue expansion of the graft which can lead to failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. The company tells us eSVS Mesh is manufactured from nitinol wire which gives it considerable strength, while remaining highly flexible and kink-resistant.
Manny Villafaña, chairman and CEO of Kips Bay, noted in his letter to shareholders that the company now has 500+ commercial implants in Europe and the Middle East since the commercialization of its product began in June of 2010. Over this time, there have been no reportable device-related adverse events.
Additionally, with the U.S. FDA approval to begin feasibility trials in the United States, Kips Bay is in the process of, patient enrollment at numerous U.S. sites. They now have 30 patients enrolled in the feasibility trial.
The plan is to complete patient follow-up and data analysis from the feasibility trial in the next twelve months, following which they will seek approval to undertake a pivotal trial in the United States with a view to ultimate FDA approval.
In his letter, Villafaña states; “The key points that I want to get across to everyone are that we are doing well, we are confident that we can enroll our eMESH I clinical feasibility study, and we have adequate cash on hand to complete our feasibility study. Major clinical centers are on board, both in Europe and in the U.S., which are recruiting patients as we speak. We, of course, like you, have been disappointed by the trading price of our stock, but we’re hoping that this information will give you a better understanding of our activities and our potential for success.”
Read into all that what you will.
Source: Kips Bay Medical, Inc., Business Wire