Conformis iTotal® CR Knee Replacement System Awarded “7A” Performance Rating from the U.K.’s Orthopaedic Data Evaluation Panel
Independently verified assessment of the performance of the fully personalized iTotal CR system over a 7-year period confirms that it meets the panel’s demanding standards
BILLERICA, Mass., Feb. 24, 2022 (GLOBE NEWSWIRE) – Conformis, Inc. (NASDAQ:CFMS), an orthopedic medical device company that features personalized knee and hip replacement products, today announced that the Orthopaedic Data Evaluation Panel in the United Kingdom (ODEP) awarded the Conformis iTotal® CR knee replacement system a “7A” rating. The latest ODEP ratings can be found at www.odep.org.uk.
The 7A rating (denoting the assessment of 7 years of performance data) supersedes Conformis’ previous 5A (5-year period) rating and demonstrates continued strong evidence of successful implant performance. In particular, the iTotal CR knee replacement system has shown low rates of revision (removal and replacement of at least part of the original implant), as indicated in the U.K.’s National Joint Registry (NJR). In addition, the company’s iTotal® CR knee with iPoly XE insert has received a 5A rating from the respected quality benchmarking agency.
ODEP is an independent panel of leading orthopedic surgeons and experts in the United Kingdom that evaluates data from hip, knee, and other joint implants generating a rating that measures performance in key areas including survivorship. ODEP provides the U.K.’s 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 U.K.
“The latest ratings from ODEP provide continued independent validation of the Conformis design philosophy and our unique, customized manufacturing capabilities,” said Mark Augusti, Chief Executive Officer and President of Conformis. “Our goal is to provide a better experience where it matters most – in patients’ lives – and the ODEP rating reflects the high performance of our products at NHS facilities throughout the United Kingdom”
The 7A rating awarded to the iTotal CR Knee Replacement System is based on seven years of performance data provided by Conformis to the panel. ODEP ratings provide a simple, independently verified assessment of the performance of an implant, assessed against national clinical best practice guidelines. This enables clinicians to choose only those implants that comply with these national guidelines and provides peace of mind to patients as they evaluate implant choices with their doctors.
“The updated performance ratings complement what I have already learned from my years of using Conformis knee implants – namely, Conformis provides superior fit and extremely high-quality outcomes,” said Mr. Stuart Roy, Consultant Trauma and Orthopaedic surgeon at Spire Hospital Cardiff and Royal Glamorgan Hospital in Cardiff (South Wales), United Kingdom. “I continue to recommend the Conformis iTotal CR knee for many of my patients.”
Only products that demonstrate compliance with NICE guidance are eligible for ODEP ratings. To date, more than 70 surgeons in the UK have implanted more than 1,300 iTotal® CR implants with a seven-year cumulative revision rate of 2.2 percent versus 2.5 percent for all other total knee replacements in the National Joint Registry at the same 7-year post-operative time-point. For Conformis’ iTotal CR with the iPoly XE insert, more than 40 surgeons have treated more than 700 patients, and the five-year revision rate has been 1.2% versus 2.1% for the rest of the NJR.
About Conformis, Inc.
Conformis is a medical technology company focused on advancing orthopedic patient care and creating a world without joint pain. Its product portfolio is designed to maximize surgeon and patient choice by offering fully personalized solutions through its Image-to-Implant® Platinum Services℠ Program as well as data-informed, standardized solutions that combine many benefits of personalization with the convenience and flexibility of an off-the-shelf system. Conformis’ sterile, just-in-time, Surgery-in-a-Box™ delivery system is available with all of its implants and personalized, single-use instruments. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover personalized implants and patient-specific instrumentation for all major joints.
Cautionary Statement Regarding Forward-Looking Statements
Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations and growth, 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 forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth 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 our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.
New Clinical Study Finds Bilateral Knee Patients Prefer Conformis’ Fully Personalized Solution Over Competitive Off-the-Shelf Implants by a Factor of Over 10 to 1
Study included only patients with a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant
Conformis, Inc. Announces Strong Clinical Study Results for Its Personalized Knee Implants
A retrospective review of 540 procedures performed demonstrated 98.5% Implant Survivorship and 89.0% Patient Satisfaction for the Conformis patient-specific iTotal®