Conformis Announces 510(k) Clearance for iTotal® Identity PS
June 22 2020 - 7:38AM
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,
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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.
Media Contact:
Investor Relations
ir@conformis.com
(781) 374-5598
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