BEDFORD, Mass., July 06, 2016 (GLOBE NEWSWIRE) -- ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient's unique anatomy, announced today interim results from an ongoing, multi-center, prospective study of iTotal CR in the United States, in which more than 300 patients have been enrolled. The results of the study, which is financially supported by ConforMIS, were presented at the 2016 SICOT International Orthopaedic “Specialized Knee Surgery” Conference in Würzburg, Germany, June 30 – July 2, 2016.
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As a part of this interim data analysis, researchers examined patient satisfaction after total knee replacement with the iTotal CR and found that 92% of patients were satisfied on average at the 1-year post-operative time point. In comparison, a previously published study indicates that approximately 20% of patients who receive an off-the-shelf total knee replacement are not satisfied with the results.1
“A satisfied patient is the ultimate goal of knee replacement,” said Gregory Martin, MD, a fellowship-trained orthopedic surgeon in Boynton Beach, FL and clinical investigator in the study. “A growing body of clinical evidence continues to support my belief that customized implants improve important patient outcome measures like patient satisfaction. With the ConforMIS iTotal CR, I’ve seen a meaningful shift towards happier, more satisfied patients.”
This new analysis corroborates a previously published matched-pair study in Germany that showed statistically significantly higher satisfaction rates with the ConforMIS iTotal CR as compared to off-the-shelf implants. This matched-pair study, presented at the 2015 ICJR World Arthroplasty Congress, compared 35 iTotal CR patients with 35 off-the-shelf patients. At one-year follow-up, 94% of iTotal patients reported that they were satisfied with their procedure, while only 74% of off-the-shelf patients reported that they were satisfied (p<0.05). This study also reported iTotal CR patients had a statistically significantly higher patient reported outcome score (Knee injury and Osteoarthritis Outcome Score, or KOOS) and were able to return to activities of daily living statistically significantly faster when compared to off-the-shelf patients.
“We are seeing a growing body of evidence in multiple clinical studies that patients receiving ConforMIS iTotal CR implants demonstrate better functional outcomes and objective outcomes than patients receiving off-the-shelf implants,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS. “Improved patient satisfaction and better quality care are the essence of what we strive for as we continue to innovate and bring new products to the joint replacement market.”
Additional data from the multi-center prospective study was also presented at SICOT, which found that iTotal CR patients experienced statistically significant improvements from baseline pre-operative scores across all 5 domains of the KOOS (pain, symptoms, activities of daily living, recreation and quality of life).
1: According to a study of 1,703 patients published by Robert Bourne in 2009 in the peer-reviewed journal Clinical Orthopaedics and Related Research (In this study entitled Patient Satisfaction after Total Knee Arthroplasty: Who is Satisfied and Who is Not?, “the overall satisfaction question was used to determine a two category satisfaction outcome by combining patients who answered very dissatisfied, dissatisfied, or neutral into one group, and patients who answered satisfied or very satisfied into the second group.”)
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 the increased satisfaction and 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. We 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 we make 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 and other results of operations, 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's views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS's 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's views as of any date subsequent to the date hereof.
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