Conformis Announces Achievement of Third Milestone Under Development and License Agreements
April 22 2021 - 4:30PM
Conformis, Inc. (NASDAQ:CFMS) announced today that it received
510(k) clearance by the U.S. Food and Drug Administration for
patient-specific instrumentation (“PSI”) developed by the Company
under its License Agreement and Development Agreement with
Howmedica Osteonics Corp., a wholly owned subsidiary of Stryker
Corporation also known as Stryker Orthopaedics. With the clearance
of this PSI system, which is designed for use with Stryker’s
Triathlon® Total Knee System, the Company has achieved the third of
three milestones under the agreements and will receive $11.0
million from Stryker.
“With the recent FDA clearance, we are pleased to have attained
the last milestone of our project and to report the successful
conclusion of our joint development agreement with Stryker,” said
Mark Augusti, President and Chief Executive Officer. “Despite the
global challenges of the last 12 months, the dedication of our
project and support teams has enabled us to achieve this major
milestone on schedule. We now will turn our efforts to focusing on
our long-term distribution agreement, under which Conformis will
manufacture and supply PSI to Stryker. We continue to believe this
initiative will create shareholder value as we satisfy the
increasing demand for efficient outpatient ambulatory surgery
center joint replacement.”
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
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
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at ir.conformis.com.
Cautionary Statement Regarding Forward-Looking
Statements
Statements in this press release about our future expectations,
plans and prospects, including statements about the anticipated
timing of our product launches, and our financial position and
results, total revenue, product revenue, gross margin, operations
and growth, 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. We may not actually achieve the
forecasts disclosed in our forward-looking statements, and you
should not place undue reliance on our forward-looking statements.
Actual financial 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
related to our estimates and expectations regarding our revenue,
gross margin, expenses, revenue growth and other results of
operations, and the other 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.
CONTACT:
Investor Contact
ir@conformis.com
+1 (781) 374-5598
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