ConforMIS yanks FDA clearance bid for iTotal hip, shares slide

ConforMIS (NSDQ:CFMS) shares slid today after the medical device company said it’s withdrawing its bid for FDA clearance for the iTotal personalized hip replacement after the federal safety watchdog raised questions about the bid.

Bedford, Mass.-based ConforMIS said the FDA raised “a number” of questions about its 510(k) clearance application – too many for the company to answer in the allotted review time. The company said it plans to answer those questions, “including conducting any associated testing,” in time for a new submission during the 2nd half of the year.

“Submissions to the FDA have a fixed timeline,” founder, president & CEO Dr. Philipp Lang said in prepared remarks. “To address the questions raised by the FDA, we have elected to withdraw our application for clearance, but we are planning for a resubmission in the 2nd half of 2016. We cannot predict if or when we will be able to submit a new application, receive clearance or initiate the limited launch of iTotal hip, which, as we stated previously, will be delayed past 2016. However, we will continue to actively seek FDA clearance and to develop and optimize manufacturing for iTotal hip in preparation for a limited launch. We remain enthusiastic about iTotal hip and believe that, like our existing line of knee replacement products, it will offer significant benefits to patients, doctors and hospitals.”

Lang said the company is focused on the full commercial launch of its iTotal PS total knee replacement it announced last month.

“We are excited about the opportunity in front of us, as iTotal PS nearly triples our addressable market. The ConforMIS iTotal PS was designed to address the shortcomings of traditional knee replacements, which come in a fixed set of sizes and shapes. Over 1,000 patients were treated with iTotal PS during the limited launch and feedback has been extremely positive. Surgeon interest since the start of the full commercial launch has exceeded our expectations as evidenced by participation in our training events, and we are very excited about the response to iTotal PS by the surgeon community,” Lang said.

CFMS shares were down -5.8% to $11.30 apiece in early-afternoon activity.

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