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Conformis Highlights New Clinical Study Findings that Knee Shapes are Highly Individualized and are Not Determined by Identifiers, Including Gender, Body Type, or Ethnicity

CFMS

As published in The Knee, new study supports Conformis’ longtime assertion that knee joint replacements that are fully personalized to each patient’s unique anatomy may be best to limit post-surgical pain and optimize patient satisfaction

BILLERICA, Mass., May 24, 2022 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS), a leading medical device company that features personalized knee and hip replacement products, today announced results of a published study that investigated the characteristic shapes of knees to see if typical patient identifiers such as gender, body type, or ethnicity influence the shape of the knee joint. The study, published in The Knee1, found that knee shape occurs independently from characteristics typically used to identify patients.

The study also found that identifiers, such as gender, body type, and ethnicity do not help surgeons determine which off-the-shelf replacement system or implant size will best fit each individual. This recent clinical study further underscores the value of precisely matching a replacement joint with the specific anatomy of each patient.

The absence of predictable shapes or morphotypes “makes it difficult to further reduce the bone to implant mismatch with off-the-shelf implants,” note the authors. Trying to do so, they say, might require an excessive number of sizes of standardized implants that provides significant logistical challenges for facilities. An alternative, they conclude, is the use of customized implants using “patient-specific implant design.”

Led by Benjamin Hohlmann and Malte Asseln of the Helmholtz Institute for Biomedical Engineering at Aachen University in Germany, the authors conducted their analysis using a data set of computed tomography images from more than 1,000 pathological knees provided by Conformis. Conformis also shared in the funding for this study.

“This new research reinforces the importance of precisely matching the implant to the individual patient,” said Mark Augusti, Chief Executive Officer and President of Conformis. “This is only possible with a patient-specific implant system available through our Platinum Services Program, such as our fully personalized Identity knee system. This study further supports our long-held business case that fully personalized implants provide the best fit for patients, eliminate clinically-significant overhang, minimize post-operative pain, speed recovery time, and enhance flexibility and performance.”

The authors used two different methodologies to analyze the knee images in an effort to find “clusters” of knees that could provide a way to standardize knee design based on patients’ gender, body type, ethnicity, or other characteristics like age. As expected, the data did not generate any clusters that could be used as predictors to better fit of off-the-shelf implants to the specific anatomies of patients undergoing total knee arthroplasty (TKA).

The article in The Knee follows a retrospective study published in The Journal of Bone & Joint Surgery Reviews (JBJS Reviews2), announced by Conformis on February 28, 2022, which found that patients who had undergone TKA surgery preferred their Conformis fully personalized knee compared to their bilateral off-the-shelf knee at a rate of more than 10 to 1.

That earlier study compared patients who had a fully personalized Conformis implant in one knee after receiving a competitive off-the-shelf implant in the other knee, and found that 72.3 percent of the patients studied preferred their fully personalized Conformis knee replacement, compared to only 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 authors of the new study concluded, “The data exhibited no morphotypes. This showed that there are no relevant identifiers, e.g., gender, body type, or ethnicity which influence the shape of the knee joint. Instead, knee shape is determined by the unique characteristics of each individual.”

Conformis has been a leader in patient specific technology since its founding in 2004. The company continues to innovate and make significant advances for surgeons and patients alike. Most recently, Conformis launched the Image-to-Implant® Platinum Services℠ Program, the first deluxe personalization upgrade services program in the orthopedic market.

1 Hohlmann, Benjamin, Asseln, Malte, Xu, Jiacheng, Radermacher, Klaus, Investigation of morphotypes of the knee using cluster analysis, The Knee 35 (2002) 157-163 https://www.thekneejournal.com/action/showPdf?pii=S0968-0160%2822%2900034-5

2 Schroeder, 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.

For more information, visit www.conformis.com. To receive future press releases via e-mail alerts, sign up at ir.conformis.com.

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.

CONTACT
Investor contact
ir@conformis.com
781.374.5598

Source: Conformis, Inc.


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