Conformis, Inc. Announces Clearance in Australia for iTotal® PS, the Only Personalized, Posterior-Stabilized Total Knee Replacement System

Rhea-AI Summary

Conformis announces the clearance of its iTotal® PS total knee replacement system by Australia's Therapeutic Goods Administration. This system, designed for patient-specific implants, aims to enhance knee replacement procedures by addressing common issues such as overhang and instability. With over 50,000 knee replacements performed annually in Australia, the clearance expands the potential market for Conformis' technology, which leverages its proprietary iFit® Image-to-Implant® technology. This advancement reinforces the company's position in the growing global knee joint reconstruction market, projected to exceed $9 billion.

Positive

• Clearance of iTotal® PS knee replacement system by Therapeutic Goods Administration in Australia, expanding market access.
• iTotal® PS provides patient-specific implants, improving surgical outcomes and mitigating pain associated with traditional implants.
• Potentially increases the addressable market with over 50,000 knee replacements performed annually in Australia.

Negative

• None.

The iTotal® PS total knee replacement system is designed so that its patient-specific implants fit the unique size and shape of each patient’s knee, and provide optimal stability throughout the full range of motion

BILLERICA, Mass., March 01, 2021 (GLOBE NEWSWIRE) -- Conformis, Inc. (NASDAQ: CFMS) today announced the clearance of its patient-specific iTotal® PS total knee replacement system by the Therapeutic Goods Administration, which is part of the Australian Department of Health, and which authorizes the marketing of medical devices and other healthcare products in Australia.

The iTotal® PS system, which launched in the United States in 2016, is designed to address the shortcomings of traditional, off-the-shelf knee replacements that are manufactured in limited sizes and shapes. iTotal® PS implants are specifically designed to restore the natural shape of each patient’s knee, and to avoid overhang, rotation, and sizing compromises associated with pain after surgery. Primary total knee implants are designed to either retain the patient’s own posterior cruciate ligament (cruciate-retaining, or CR), or substitute for it (posterior-stabilized, or PS). iTotal® PS implants use a customized cam and spine feature to serve the function of the posterior cruciate ligament and to provide optimal stability throughout the full range of motion.

“Receiving clearance for our iTotal® PS product in Australia will allow us to offer a best-in-class, patient-specific solution to relieve patients’ chronic knee joint pain,” said Mark Augusti, President and CEO. “With this clearance, we have greatly expanded the number of potential patients who will be candidates for our personalized knee replacement implants, and we are thrilled to offer the benefits of our unique technology to surgeons in Australia who prefer a posterior-stabilized design to a cruciate-retaining one.”

iTotal® PS is designed with the following features and benefits:

• patient-specific femoral and tibial fit to avoid overhang, under-coverage, and sizing compromises;
• patient-specific shape designed to provide stability throughout the range of motion and to restore kinematics;
• patient-specific cam and spine to provide optimal stability and to reduce the potential for a “mechanical” feel;
• pre-operative surgical plan to enable a predictable, reproducible knee replacement procedure; and
• a safe and simple delivery model that includes a single pre-sterilized kit, a single reusable instrument tray, and no implant inventory.
  

The global knee joint reconstruction market is projected at more than $9 billion. HCF, Australia’s largest nonprofit health insurer, reports that more than 50,000 knee replacement procedures are performed in Australia each 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 it refers 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 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 significance of the clearance for Conformis' iTotal® PS system in Australia?

The clearance allows Conformis to market its patient-specific knee replacement system in Australia, expanding its market access.

How does the iTotal® PS system improve total knee replacement surgeries?

The iTotal® PS system is designed to fit the unique anatomy of each patient, reducing issues like overhang and instability often seen with traditional implants.

What is the estimated size of the knee joint reconstruction market?

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

How many knee replacement procedures are performed in Australia each year?

More than 50,000 knee replacement procedures are performed annually in Australia.