Conformis, Inc. Announces 510(k) Clearance for Identity Imprint™ Knee Replacement System

Rhea-AI Summary

Conformis, Inc. (CFMS) announced FDA 510(k) clearance for its Identity Imprint Knee Replacement System on May 10, 2021. This system, available in cruciate retaining and posterior stabilized versions, offers a cost-effective solution with faster delivery times. Using a proprietary algorithm, it optimizes implant selection based on CT scans, enhancing surgical efficiency. The knee joint reconstruction market is projected to exceed $9 billion, with 1 million knee replacements expected in the U.S. this year, indicating a growing demand for efficient, personalized orthopedic solutions.

Positive

• FDA clearance for Identity Imprint Knee Replacement System enhances product portfolio.
• Integration of 3D algorithm improves surgical efficiency and patient matching.
• Faster delivery times (3 weeks vs. 6 weeks) for personalized systems cater to surgeon needs.

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• None.

Leveraging Conformis’ extensive library of personalized knee design data and patient images, Identity Imprint is designed to match patients’ anatomy with an optimal arthroplasty solution while at the same time offering greater efficiency, cost savings, increased intraoperative flexibility, and faster delivery times

BILLERICA, Mass., May 10, 2021 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug Administration for the Company’s Identity Imprint Knee Replacement System.

Identity Imprint is a new total knee replacement system, available in both cruciate retaining (CR) and posterior stabilized (PS) versions, that expands the range of options open to Conformis’ orthopedic surgeon customers and their patients. Whereas the Conformis iTotal® Identity knee replacement system is designed and manufactured individually to fit the unique size, shape, and curvature of each patient’s anatomy, Identity Imprint combines pre-determined implant sizes with standard and patient-specific surgical instrumentation. Identity Imprint will provide surgeons with faster delivery times and intraoperative options that are more similar to standard knee systems.

Identity Imprint utilizes a proprietary 3-dimensional (3D) “best-fit” algorithm to select the implant that most closely meets the geometric and anatomic requirements of the patient based on the patient’s computed tomography (CT) scans. The Identity Imprint will be delivered using Conformis’ sterile “surgery-in-box” system, which is expected to provide ambulatory surgical centers (ASCs) greater procedural efficiency and improved sterilization cost savings than standard systems.

“Our Identity Imprint knee system is a tremendous new addition to our product portfolio that leverages our technical innovations and data from tens of thousands of personalized implant designs. It is a terrific option for those surgeons who want more traditional intraoperative flexibility and faster product availability. We will be able to provide a patient-matched Identity Imprint system in 3 weeks versus the six weeks lead time for the iTotal Identity fully personalized system,” said Mark Augusti, President and CEO. “This offering is extremely well-positioned to meet the needs of the ASC care setting, but will provide value to in-patient hospital care as well, especially in the post-COVID environment. Importantly, it also provides surgeons and their patients a new choice among Conformis’ world-class treatment options.”

The global knee joint reconstruction market is projected at over $9 billion, with approximately 1 million knee replacements expected to be performed in the United States this year, with a growing number of knee procedures to be performed in the ASC and outpatient settings.

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 standard implants, along with single-use instruments delivered to hospitals and ambulatory surgical centers.  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.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com.

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.

Source: Conformis, Inc.

FAQ

What is the Identity Imprint Knee Replacement System by Conformis?

The Identity Imprint Knee Replacement System is a newly FDA-cleared product that offers optimized knee replacement solutions using a proprietary fitting algorithm.

When did Conformis receive FDA clearance for the Identity Imprint system?

Conformis received FDA 510(k) clearance for the Identity Imprint Knee Replacement System on May 10, 2021.

What advantages does the Identity Imprint system provide for surgeries?

The system provides greater efficiency, cost savings, intraoperative flexibility, and faster delivery times for knee replacements.

How does the Identity Imprint system match patients' anatomy?

It uses a proprietary 3D algorithm to select the implant that best fits the patient's anatomy based on CT scans.

What is the projected market size for knee joint reconstruction?

The global knee joint reconstruction market is projected to exceed $9 billion.