Conformis, Inc. Announces 510(k) Clearance for Identity Imprint™ Knee Replacement System
May 10 2021 - 7:30AM
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
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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.
Source: Conformis, Inc.
Media Contact:
Investor Relations
ir@conformis.com
(781) 374-5598
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