“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.
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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 representingConforMIS' views as of any date subsequent to the date hereof.
CONTACT:Investor contact Oksana Bradley(781) 374-5598Media contacts: Bill BerryBerry & Company Public Relations(212) 253-8881 Lynn GranitoBerry & Company Public Relations(212) 253-8881
Published at Conformis Press Release
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