Kips Bay said in June that it would pull the plug after terminating the Emesh I clinical feasibility trial of its eSVS mesh based on poor 6-month results.
Today the company said founder, chairman & CEO Manny Villafaña, the medtech legend behind STJ, has resigned from Kips Bay, which he named after a boyhood club he credits with setting him on his life’s path.
Kips Bay named COO/CFO Scott Kellen to replace Villafaña until the shutdown is complete, expected Sept. 24. Directors Robert Munzenrider, Robert Sheehy and Arch Smith also stepped down effective immediately, the company said.
“As a result of the resignations, Mr. Kellen will be the sole officer and employee of the company and member of the board,” according to a regulatory filing.
Back in June Kips Bay said it had $2 million in cash and equivalents, sufficient to “pay off all of its current and anticipated liabilities and to conduct an orderly wind down of its operations.”
The 106-patient Emesh 1 study looked at external saphenous vein graft supports, using the company’s device, and returned poor 6-month angiographic results for the first 26 patients implanted using a new surgical technique, the company said.
The eSVS mesh was designed to keep vein grafts open during in coronary artery bypass graft surgeries, and is composed of a flexible sleeve that fits around the outside of the vein to reduce vessel wall stress and mitigate the potential for vessel injury.
“We are, needless to say, extremely disappointed with the poor 6-month angiographic results from the new technique patients. We had hoped the new technique would reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery. I would like to thank the patients who participated in this study as well as our clinical trial investigators and their teams. I am also very appreciative of our employees, to many of whom we must now sadly say goodbye and for the continued support and loyalty of our stockholders,” Villafaña said last June.
In May Kips Bay said it was considering closing shop after initial results failed to meet a last-ditch bar set in March, when it turned to Villafaña and other backers for a private placement worth up to $3.25 million. The deal called for the investors to put the cash up in 4 equal tranches, but not before the Emesh I trial generates 10 angiograms from eSVS-treated patients demonstrating that it’s “advisable for the company to continue with the Emesh I clinical feasibility trial and to continue to pursue marketing approval by the FDA for the eSVS mesh,” Kips Bay said in March.
In September 2011 the FDA issued a non-approvable letter for the device, asking for more information on the eSVS mesh before granting permission for a feasibility study. That approval came in November 2012 and was later expanded. In March, Kips Bay, which let its listing on the NASDAQ exchange expire last September, said it reached the enrollment goal for the Emesh I feasibility study.
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