Kips Bay to Again Seek Approval for U.S. Clinical Trial

The Plymouth-based company said it has gathered additional information on its eSVS Mesh device in order to address questions that regulators had raised.

Plymouth-based medical device maker Kips Bay Medical, Inc., said Friday that it will once again seek approval from the Food and Drug Administration (FDA) to carry out clinical trials of its device in the United States.

Kips Bay said in September that regulators wanted additional information about its eSVS Mesh device before they would allow it to pursue a clinical trial in the United States. The device is a mesh sleeve that is placed over a saphenous vein graft during coronary artery bypass surgery and is designed to improve the structural characteristics and long-term performance of the vein graft.

The company said Friday that it has gathered additional information in order to address questions raised by the FDA. The data includes clinical results from a study through which patients were implanted with eSVS Mesh devices at the American Hospital in Dubai, United Arab Emirates.

Kips Bay has a feasibility study planned in Europe for later this year, but said it wants to include two to four U.S. hospitals in the study and will apply for permission to do so.

“While there can be no assurance that the FDA will approve the application, the company remains optimistic,” Kips Bay said in its news release.

Meanwhile, the company's 2011 fourth quarter sales were down about 19 percent to $94,000 from the same period the prior year. Its net loss for the quarter increased to $1.1 million, compared to a loss of $803,000 during the fourth quarter of 2010. For the full 2011, net sales totaled $252,000, up about 13 percent from $223,000 in 2010. The company's net loss for the year was $4.3 million, down from a $10.9 million net loss in 2010.

Kips Bay was founded in 2007 by Manny Villafa–a, a serial entrepreneur behind medical companies like Cardiac Pacemakers and St. Jude Medical. He was named one of Twin Cities Business' “200 Minnesotans You Should Know” in 2010 and inducted into the Minnesota Business Hall of Fame in 2003.

Kips Bay's product has already gone through clinical studies in Europe and the United Arab Emirates, and the eSVS Mesh is currently being sold in six countries and has been implanted in roughly 250 patients. The company completed an initial public offering in February 2011.

“We continue to be inspired by the positive response from the physicians we meet” Villafa–a said in a statement. “Their enthusiasm for the eSVS Mesh is infectious. . . . In the upcoming year, we will focus on developing the clinical data to support physicians and our distributors in driving adoption of the eSVS Mesh at the hospital level.”