BILLERICA, Mass., June 20, 2017 (GLOBE NEWSWIRE) -- 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
