ConforMIS Announces FDA 510(k) Clearance for iTotal Hip System
June 20 2017 - 8:00AM
ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that
offers knee replacement implants customized to fit each patient's
unique anatomy, today announced it has received FDA 510(k)
clearance of the Company’s primary iTotal Hip replacement system.
A photo accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/a2f06ce1-6e8f-4f5e-b521-0a2f9b95aef4
“Having treated over 50,000 patients with customized knee
replacement implants, ConforMIS brings over a decade of experience
in patient-specific technology to the hip replacement market,” said
Mark Augusti, Chief Executive Officer and President of
ConforMIS. “FDA clearance of iTotal Hip demonstrates the
ability to apply our proprietary iFit® image-to-implant technology
to other joints. There has been a trend towards personalized
healthcare and we believe patients expect and deserve personalized
treatment.”
The ConforMIS iTotal Hip system features proprietary iFit
technology similar to that used to design, manufacture and deliver
customized knee implants. The system utilizes ConforMIS’s
patient-specific technology, single-use 3D printed instruments and
just-in-time delivery model to create a system that requires
limited reusable instruments.
“Standard hip replacement surgery can be challenging, presenting
risks of dislocation, discrepancies in leg length and limited
reproducibility,” said Scott Ball, MD, Department of Orthopaedic
Surgery, University of California, San Diego and a member of
the iTotal Hip design team. “With the ability to achieve a
better match to a patient’s own anatomy, the iTotal Hip system aims
to address these shortcomings and improve patient outcomes.”
“We expect to leverage synergies with sales representatives,
surgeons and hospitals upon limited launch, which is anticipated
for 2019,” added Augusti. “We are excited about the
opportunity iTotal Hip represents in expanding our product
portfolio to address a broader orthopedic market with our
proprietary technology.”
In the United States, approximately 400,000 hip replacements
were performed in 2016. The global hip joint reconstruction
market is projected at over $6B.
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 that are
individually sized and shaped, or customized, to fit each patient’s
unique anatomy. ConforMIS offers a broad line of customized knee
implants and pre-sterilized, single-use instruments delivered in a
single package to the hospital. In clinical studies, ConforMIS
iTotal CR demonstrated superior clinical outcomes, including better
function and greater patient satisfaction, compared to traditional,
off-the-shelf implants. ConforMIS owns or exclusively in-licenses
approximately 450 issued patents and pending patent applications
that cover customized 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
Any statements in this press release about future expectations,
plans and prospects for ConforMIS, including statements about
ConforMIS’s development of the iTotal Hip implant system, potential
clinical, economic or other impacts and advantages of using
customized implants, 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
plans, intentions or expectations disclosed in our forward-looking
statements, and you should not place undue reliance on our
forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in
the forward-looking statements we make as a result of a variety of
risks and uncertainties, including risks related to our product
development and commercialization efforts, 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 ConforMIS’s views as of the date hereof.
ConforMIS anticipates that subsequent events and developments may
cause ConforMIS’s views to change. However, while ConforMIS may
elect to update these forward-looking statements at some point in
the future, ConforMIS specifically disclaims any obligation to do
so. These forward-looking statements should not be relied upon as
representing ConforMIS’s views as of any date subsequent to the
date hereof.
CONTACT:
Media contacts:
Jenna Iacurci
Berry & Company Public Relations
jiacurci@berrypr.com
(212) 253-8881
Sara Zelkovic
Berry & Company Public Relations
szelkovic@berrypr.com
(212) 253-8881
Investor contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598
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