Conformis iTotal CR Knee Replacement System Awarded “3A” Rating from the Orthopaedic Data Evaluation Panel in the United Kingdom
Rating highlights positive three-year survivorship following total knee arthroplasty
BILLERICA, Mass., March 01, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants designed and manufactured to fit and conform to each patient’s unique anatomy, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) awarded the Conformis iTotal CR knee replacement system a “3A” rating. The 3A rating is based on strong evidence of implant performance over three years, including low revision rates as indicated in the United Kingdom’s National Joint Registry.
ODEP is an independent panel of leading orthopedic surgeons and experts in the UK that evaluates data related to use of hip and knee implant technologies and provides a rating to indicate performance in key areas including survivorship. ODEP provides the National Health Service (NHS) with an approved list of products that meet the revision rate standard set by the National Institute for Health and Care Excellence (NICE) in the United Kingdom. The 3A rating (as explained in more detail at http://www.odep.org.uk/ODEPExplained.aspx#2) is based on three-year performance data. ODEP ratings provide a simple, independently verified assessment as to the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to ensure that the implants that they use comply with these national guidelines. Only products that demonstrate compliance with NICE guidance are awarded a rating.
“The positive ODEP 3A rating reaffirms my experience treating patients with the Conformis iTotal CR knee replacement system, which I believe offers my patients a more natural feeling knee with improved performance and mobility,” said Mr. Ian McDermott FRCS, Senior Consultant Knee Surgeon at London Sports Orthopaedics, based at the London Bridge Hospital in London, UK. “The clinical evidence and three-year survivorship data together are consistent with the improvement I am seeing with my patients’ outcomes after knee replacement surgery using Conformis knee prostheses.”
“ODEP ratings provide a reliable, simple and independent assessment of the performance of an implant” said, Mr. Fahad G. Attar, MBChB, FRCS, Consultant Trauma & Orthopaedic Surgeon at BMI Alexandra and Whiston Hospital, St. Helens & Knowsley Teaching Hospitals, United Kingdom. “I expect that this 3A rating will now provide additional reassurance and peace of mind to my patients and reinforce the performance reputation of Conformis iTotal CR knee replacement implants that contribute to the improved clinical outcomes I am seeing in my practice.”
“The ODEP awarded the Conformis iTotal CR system a 3A rating based in part on positive implant survivorship and performance data from the UK National Joint Registry at three years’ post-surgery,” said Mark Augusti, Chief Executive Officer and President of Conformis. “This rating provides another independent verification that our design philosophy, predicated on patient conforming implants, results in performance where it counts the most, in patients. “We hope that this 3A rating also provides an opportunity for Conformis to expand our product offering to more patients receiving their healthcare in NHS facilities.”
More information on the ODEP can be found on their website at http://www.odep.org.uk/ODEPExplained.aspx
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 designed and manufactured to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of patient conforming total and partial knee systems that include sterilized single-use instruments delivered in a single package to the hospital. Conformis owns or exclusively in-licenses approximately 420 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 ability to offer implants to patients in the United Kingdom, that potential clinical benefits 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 clinical studies, 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’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’ views as of any date subsequent to the date hereof.
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