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 in their other knee.
BILLERICA, Mass., Feb. 28, 2022 (GLOBE NEWSWIRE) – Conformis, Inc. (NASDAQ:CFMS), the pioneer and leader of fully personalized orthopedic medical devices, today announced results of a published retrospective study of patients showing the superiority of Conformis’ implants in several key measures of clinical success and patient satisfaction. According to the study published in The Journal of Bone & Joint Surgery Reviews (JBJS Reviews)1, patients who had undergone bilateral total knee arthroplasty (TKA) preferred their Conformis fully personalized knee compared to their bilateral off-the-shelf knee at a rate of more than 10 to 1.
The study surveyed 47 TKA patients who had a fully personalized Conformis implant in one knee after previously receiving a competitive off-the-shelf implant in their other knee. The study found that 72.3 percent of the patients studied preferred their fully personalized Conformis knee replacement, compared to 6.4 percent of patients who preferred their traditional off-the-shelf (OTS) implant. The remaining 21.3 percent reported no perceived difference between the two knee implants.
The study, believed to be the first ever to directly examine patient-reported outcomes comparing fully personalized and traditional off-the-shelf implants in the same patient as a control, underscores the higher levels of satisfaction and lower levels of pain and joint awareness associated with fully personalized implants. The patients reported less pain, better perceived mobility and a more “normal” feeling in the fully personalized Conformis implant.
“This study confirms what the surgeons and engineers working at Conformis have known from the beginning: a fully personalized knee replacement that is designed specifically for each patient’s unique anatomy and original motion clearly contributes to better clinical outcomes and happier patients,” said Mark Augusti, Chief Executive Officer and President of Conformis. “Our fully personalized knee system has demonstrated its clinical benefits in dozens of peer-reviewed studies over the years, and this patient self-controlled research further validates that the patients who are living with two different knee implants can feel the difference. Simply put, our fully personalized implants fit better and feel more natural.”
The patients in the study were evaluated using the well-established Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR), the Forgotten Joint Score (FJS) and preference questionnaire methodologies. “New technological advances in the past decades have fueled the race for the ‘happiest patient’ following total knee arthroplasty,” wrote the authors. “Patients in this study with bilateral knee joint replacement showed an overall preference for customized total knee arthroplasty.”
“Participants in the present study overall favored the custom total knee arthroplasty (C-TKA) over the standard prostheses in all surveyed categories: pain, motion, stability, ‘normal’ feel, and overall preference,” noted the authors. “On the basis of these findings, the combination of more precise implant fit and component rotation of C-TKA compared with OTS TKA may have been a contributing factor for lower pain levels and functional superiority, thus contributing to patients’ preference for customized over OTS TKA.”
Conformis has been a leader in patient specific technology since its founding in 2004. The company continues to innovate. Most recently, Conformis launched the Image-to-Implant® Platinum Services℠ Program (PSP), the first deluxe personalization upgrade services program in the orthopedic market.
1Schroeder, Lennart MD1,a; Dunaway, Andrew DO2; Dunaway, Daniel MD3 A Comparison of Clinical Outcomes and Implant Preference of Patients with Bilateral TKA, JBJS Reviews: February 2022 – Volume 10 – Issue 2 – e20.00182 doi: 10.2106/JBJS.RVW.20.00182
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.
Conformis Launches Patient Awareness Campaign to Highlight the Benefits of Personalized Knee Replacement Procedures
The campaign underscores that patients have a choice of implant when undergoing total knee arthroscopy, and that they should advocate
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