BEDFORD, Mass., April 04, 2016 (GLOBE NEWSWIRE) -- ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient's unique anatomy, today announced an update on its iTotal Hip submission to the United States Food and Drug Administration, or FDA. As previously reported, ConforMIS submitted an application for 510(k) clearance of iTotal Hip with the FDA in 2015. In the course of its review of that application, the FDA raised a number of questions, and ConforMIS was not able to address all of those questions within the allowed review timeline. Therefore, after consultation with the FDA, ConforMIS elected to withdraw the application. ConforMIS plans to address the questions raised by the FDA, including conducting any associated testing, and submit a new application for 510(k) clearance of iTotal Hip in the second half of 2016.
“Submissions to the FDA have a fixed timeline,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “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 second 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.”
Dr. Lang continued, “In the meantime, our focus will be on the full commercial launch of our iTotal PS customized total knee replacement, which we announced on March 2, 2016. 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.”
About ConforMIS, Inc.
ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient's unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.
Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS' strategy, future and operations, the results of additional testing of iTotal Hip, the 510(k) clearance process for iTotal Hip or other products, the limited or commercial launch of iTotal Hip, the commercial launch of iTotal PS, and the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. ConforMIS may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements ConforMIS makes as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales, FDA clearance, and the other risks and uncertainties described in the "Risk Factors" sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS' views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS' views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS' views as of any date subsequent to the date hereof.
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