Conformis Announces 510(k) Clearance for iTotal® Identity PS

Rhea-AI Summary

Conformis, Inc. (NASDAQ: CFMS) has received 510(k) clearance from the U.S. FDA for its iTotal® Identity PS Knee System. This innovative system utilizes advanced imaging and custom surgical planning, offering features like titanium tibial baseplates and refined iJigs for improved surgical outcomes. CEO Mark Augusti emphasized that the new PS option enhances treatment capabilities for a broader patient range. The global knee joint reconstruction market is valued over $9 billion, with the U.S. set to conduct about 1 million knee replacements this year.

Positive

• 510(k) FDA clearance for iTotal® Identity PS Knee System enhances product portfolio.
• Innovative features such as titanium baseplates and refined instruments improve surgical outcomes.
• Expands treatment options for a wider range of patients.

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• None.

BILLERICA, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ:CFMS) today announced 510(k) clearance by the U.S. Food and Drug Administration of the Company’s next generation iTotal^® Identity PS Knee System.

The iTotal^® Identity PS Knee System uses proprietary advanced imaging and design software, to deliver a patient-specific, pre-operative surgical plan with a comprehensive set of iJig instruments and patient-matched implants.  Updates to this system include stem extensions available for patients with high Body Mass Index (BMI), titanium tibial baseplates with patient-specific cement rails, and metal cut guides and refined iJigs for a more traditional bone cutting experience.

“Our new iTotal^® Identity PS knee is an important addition to our total knee portfolios. Having a Posterior Stabilized (PS) option for our Identity system will allow surgeons to treat a wider range of patients more effectively and with greater confidence than ever before,” said Mark Augusti, President and CEO of Conformis, Inc. “We remain the leader in bringing best-in-class PSI guides in a market-leading, efficient 'knee-in-a-box' model to the orthopedic surgeons.”

The global knee joint reconstruction market is projected at over $9 billion, with approximately 1 million knee replacements projected to be performed in the United States this 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.

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.

FAQ

What is the iTotal® Identity PS Knee System from Conformis?

The iTotal® Identity PS Knee System is a new knee replacement solution that features advanced imaging technologies and patient-specific surgical planning.

When did Conformis receive FDA clearance for the iTotal® Identity PS Knee System?

Conformis received the 510(k) clearance for the iTotal® Identity PS Knee System on June 22, 2020.

What are the benefits of the iTotal® Identity PS Knee System?

The system provides patient-specific implants and instruments, which enhance surgical precision and potentially improve patient outcomes.

What market opportunity does Conformis target with its knee system?

The global knee joint reconstruction market is projected to exceed $9 billion, with a significant number of knee replacements performed annually in the U.S.