Clinical Studies Demonstrate Conformis iTotal CR Customized Knee Implants Provide Superior Outcomes and Potential for Economic Savings
New clinical study demonstrates potential for Conformis iTotal CR customized knee implants to contribute cost savings across episode of care
Bedford, Mass. – August 15, 2016 – Conformis, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, announced today the results from two clinical studies presented at the ICJR Pan Pacific Orthopaedic Congress, August 10 – 13, 2016.
In an independent, prospective, single-center investigator-initiated study of 62 total knee replacement patients in “fast track” surgeries, those who received an iTotal® CR had significantly better outcomes compared to patients who received a traditional “off-the-shelf” implant. Specifically, iTotal CR patients had a significantly shorter length of stay than off-the-shelf patients (1.6 days vs. 2.7 days, p=0.004). Additionally, a higher proportion of iTotal CR patients were discharged within 24 hours (66% vs. 30%, p=0.006) with a significantly higher proportion of iTotal patients discharged directly to home (97% vs. 80%, p=0.0496) as opposed to a skilled nursing facility. Further, a significantly higher proportion of iTotal patients were able to achieve range of motion greater than or equal to 120˚ (84% vs. 45%, p=0.003).
“I have been using Conformis’ iTotal CR for over 5 years and this data reinforces the superior outcomes and quicker recovery that I have observed in my patients,” said Richard Buch, MD, a fellowship-trained orthopedic surgeon with Dallas Limb Restoration Center in Plano, TX and clinical investigator for this study. “Knee replacement patients today are demanding more from their surgery. They want to get home faster and return to their daily activities. In my experience, the Conformis iTotal CR allows them to do that more frequently than any other implant I’ve used in my 30 years as an orthopedic surgeon.”
Based on the results of the study and other published economic data, Dr. Buch concluded that Conformis iTotal CR has the potential to save hospitals approximately $2,200 per patient. The recent rollout of the Comprehensive Care for Joint Replacement (CJR) model has incentivized hospitals to better manage costs and care coordination for knee replacement patients. Under the CJR model, which has been implemented in 67 Metropolitan Statistical Areas, the Centers for Medicare & Medicaid Services (CMS) has a stated goal of saving $150 million over 5 years. Two of the most costly components across the entire episode of care for total knee replacements are the initial inpatient hospital stay and the use of rehabilitation facilities after discharge. Based on a previously published cost analysis of length of stay1, by shortening the average length of hospital stay by 1.1 days compared with off-the-shelf implants, Dr. Buch concluded that there is potential for in-hospital cost savings of approximately $1,100 per patient. Similarly, based on another previously published cost analysis of discharge destination2, Dr. Buch concluded that a lower proportion of iTotal patients being discharged to skilled nursing facilities has the potential for an additional savings of approximately $1,100 per patient for a total potential savings of approximately $2,200 per patient.
Separately, in an update to an ongoing multi-center prospective study of 740 consecutively enrolled total knee replacement patients, those who received an iTotal CR implant were significantly faster than patients with an off-the-shelf implant at completing three functional tests of daily living: walking, getting in and out of a chair and walking up and down stairs. Study investigators used a validated functional test known as the Aggregated Locomotor Function (ALF) test, in which blinded operators assessed patients’ ability to perform these activities of daily living. Additionally, an analysis using the 2011 New Knee Society Score (KSS) found no statistically significant differences. Conformis provided financial support for this study.
“Our current healthcare environment is demanding that its treatments not only improve the lives of patients, but do so at a cost that does not overburden the payer system,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of Conformis. “Multiple studies have demonstrated that Conformis customized knee replacements offer superior patient outcomes compared to traditional off-the-shelf implants, and now we have additional evidence showing that our iTotal CR system can help reduce some of the biggest cost contributors for total knee replacement by shortening the average length of hospital stay and reducing the proportion of patients discharged to skilled nursing facilities. We believe our iTotal CR system offers cost savings to the hospital across the entire episode of care.”
1: S.J. Barad, et al., Is a shortened length of stay and increased rate of discharge to home associated with a low readmission rate and cost-effectiveness after primary total knee arthroplasty?, Arthroplasty Today (2015), http://dx.doi.org/10.1016/j.artd.2015.08.003
2: Ramos NL, et al, Correlation Between Physician Specific Discharge Costs, LOS, and 30-day Readmission Rates: An
Analysis of 1,831 cases, J Arthroplasty (2014), http://dx.doi.org/10.1016/j.arth.2014.04.005
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 recent 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 potential clinical, economic or other impacts and advantages of using customized implants, the potential impact of the CJR model and the potential impact and advantages of our products with respect to the CJR model, 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 the potential impact of the CJR model on the healthcare industry in general and us in particular, risks related to results seen in ongoing and future clinical and economic studies of our products, 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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