Kips Bay Medical to Dissolve Following Stockholder Vote

Stockholders voted to shut down Minneapolis, Minn.-based Kips Bay Medical in the wake of a failed device clinical trial.

Led by St. Jude Medical founder Manny Villafana, Kips Bay had placed its hopes on its saphenous vein support technology, designed for use in coronary artery bypass grafting surgery.

The company said earlier this year that it hoped to obtain positive data from a clinical trial to serve as the basis for a request to perform a larger pivotal study in the U.S. The news followed earlier issues expanding a feasibility study, with the FDA asking for more information related to a July 19, 2012, IDE application to add four U.S. sites.

In January, Kips Bay announced a series of staff reductions to bring monthly operating expenses to under $200,000, excluding costs related to the trial.

Top officials also agreed to temporary salary reductions to keep the company afloat through the end of the year (IDDM, Jan. 6).

However, poor six-month angiographic results in the first 26 patients who had an eSVS Mesh implanted brought more bad news, and the trial was subsequently terminated.

Kips Bay announced plans to dissolve in June, unless a strategic alternative presented itself.

Ahead of the shareholder vote, Villafana stepped down, and the board appointed Chief Operating Officer Scott Kellen as CEO, before tendering their own resignations. He remains the sole board member and company executive. — Elizabeth Hollis