Conformis Announces U.S. Commercial Launch of Cordera™ Match Hip System
Cordera™ Match Hip System combines the proven Cordera™ hip stem with Conformis’ state-of-the-art, personalized pre-operative plans and patient-specific instruments.
BILLERICA, Mass., December 17, 2020 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ: CFMS) announced today the U.S. commercial launch of the Company’s new Cordera™ Match Hip System. The Company previously announced 510(k) clearance by the U.S. Food and Drug Administration for the Cordera™ Hip System on September 29, 2020, and Cordera™ Match represents one of multiple planned product extensions featuring the proven Cordera™ Hip System.
The Cordera™ Match Hip System is an uncemented, primary total hip replacement system composed of femoral (thigh) and acetabular (socket of the hip bone) components. It is implanted utilizing a surgeon-approved, personalized surgical plan (iView®) and patient-specific instrumentation (PSI or, specifically, iJigs®). A Cordera™ Match hip replacement procedure can be performed with just one reusable instrument tray. All implants and patient-specific instruments are delivered sterile to hospitals and ambulatory surgery centers (ASCs).
“Our new Cordera™ Match Hip System begins the expansion of our growing total hip portfolio. The system, which is inserted using either an anterior or posterior surgical approach, is designed to allow more surgeons to treat a wider range of hip patients effectively,” said Mark Augusti, President and CEO. “Over the next year, we plan to launch multiple product extensions featuring the Cordera™ stem. With this first offering, surgeons who like to operate with the Cordera™ stem will benefit from the significant value provided by Conformis’ personalized surgical plan and best-in-class PSI guides, all delivered through a safe, sterile, and efficient model for hospitals and ASC sites of care.”
Conformis engineers design the Cordera™ Match iView® surgical plan and iJigs® based on each patient’s unique anatomy. Surgeons have the option to then adjust the surgical plan before approving the order.
The iView® also provides a Digitally Reconstructed Radiograph (DRR). The DRR is a simulated full pelvis image created from the CT scan. The image is aligned parallel to the anterior superior iliac spine (ASIS), reducing the possibility of a tilted pelvis and thus providing more precise measurements. Leg length measurements are then taken referencing the patient’s anatomical landmarks to provide the surgeon with data needed to help make intraoperative decisions.
According to OrthoWorld, the global hip joint reconstruction market is projected to exceed $8 billion, with nearly 500,000 hip replacements to be performed in the United States next year.
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 and instruments that are individually sized and shaped, which we refer to as personalized, individualized, or sometimes as customized, to fit and conform to each patient’s unique anatomy. Conformis offers a broad line of sterile, personalized knee and hip implants and single-use instruments delivered to hospitals. In clinical studies, the Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. 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, 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. You should not place undue reliance on our forward-looking statements. Actual 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 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.
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