BILLERICA, Mass., Jan. 04, 2018 (GLOBE NEWSWIRE) -- ConforMIS, Inc. (NASDAQ:CFMS), a medical technology
company that offers joint replacement implants designed and manufactured to fit each patient’s unique anatomy, today announced the
publication of a prospective study in The Journal of Knee Surgery, a peer-reviewed orthopedic
journal, on December 14, 2017. The study investigated the ability of the iTotal CR Knee Replacement System
restoring coronal plane mechanical axis alignment in a patient’s leg.
The study, which was independently performed by Dr. Gary Levengood at Sports Medicine South in Lawrenceville, Georgia, examined
63 consecutive patients he operated on using the ConforMIS iTotal CR implant system and ConforMIS iJig patient-specific
instrumentation. Results in each of the cases were verified using computer-assisted surgery (CAS). According to the
study results, perfect neutral coronal mechanical alignment of 0° was achieved in 84% of patients, with the remaining 16% of
patients within +/-2° of neutral. The patients had an average pre-operative deformity of 5.57° (range 12° valgus to
15°varus), and a post-operative average of 0.18° (range 0-2°) (p<0.0001). Additionally, while 40 of the 63 patients had
pre-operative extension deficits (the inability to fully extend the leg), no patients had postoperative extension deficits.
According to the study, neutral mechanical limb alignment, or alignment within +/- 3°, has previously been linked to better
survivorship in TKA, while poor alignment has been linked to higher rates of implant failure. This study’s findings are consistent
with those of a previous published study by Ivie et.al. from the Journal of Arthroplasty in 2014, which concluded that the
ConforMIS iTotal was 1.8 times more likely to achieve a neutral mechanical alignment as compared to standard off-the-shelf
knees.
Based on a review of the published literature, the authors reported that the results observed with the ConforMIS iTotal CR
patient-specific, custom-made total knee implant with patient-specific instrumentation were found to be more consistently accurate
than previous reports on patient-specific cutting guides used with standard off-the-shelf implants. The authors noted that,
according to the literature, patient-specific cutting guides used with standard off-the-shelf implants resulted in a high
percentage of cases with an overall error in mechanical axis alignment greater than a threshold of 3 degrees. The authors of
the study suggest several key differences that may have contributed to the greater accuracy of the iTotal system with its iJig
instrumentation compared with the published literature, including the use of a full set of ConforMIS patient-specific jigs with the
ConforMIS custom-made implant, and the ability to maintain native medial and lateral offsets of the femur.
“As a surgeon, one of the most important goals to me with any knee replacement, is to achieve a neutral mechanical limb
alignment. The inherent variability noted in the literature when using patient-specific jigs with an off-the-shelf implant, where
the mechanical alignment too often fell outside of the +/- 3° acceptable range, was the impetus in studying this metric as I began
to use this iTotal technology,” said Dr Levengood. “As our data shows, we were able to achieve precise alignment, with absolutely
no outliers. Prior to using the ConforMIS iTotal CR, I utilized computer navigation to achieve a reproducible alignment; however,
this added substantial time to my procedures and required surgical placement of tracking pins in each patient's femur and tibia
during the operation. With the iTotal, I am provided a complete operative plan, from the CT scan each patient gets prior to
surgery. Based on these results, I have full confidence in the system to deliver consistent and improved surgical
outcomes.”
“This independent study provides compelling new data demonstrating the accuracy of utilizing ConforMIS iJig instrumentation,
with its built-in mechanical axis alignment and image guidance, in combination with our individually designed, patient-specific
implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “Importantly, it is consistent
with earlier published results. One of the drawbacks of patient-specific cutting guides when used with standard off-the-shelf
implants that are not patient-specific has been the inability to consistently achieve neutral mechanical alignment. Dr. Levengood’s
data demonstrate that the ConforMIS iTotal CR system does not share this problem. This study adds enlightening data and
analysis to the growing body of evidence that ConforMIS iJig Instrumentation, when used in conjunction with ConforMIS individually
designed, patient-specific iTotal implants, provides superior results compared to other patient-specific instrumentation used with
off-the-shelf implants.”
ConforMIS did not provide any economic support for this study. Dr. Levengood previously has served as an advisor to
ConforMIS.
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 recent 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 420 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.
Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about
the potential clinical benefits 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 clinical studies, 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:
Kelly Wakelee
kwakelee@berrypr.com
(212)-253-8241
Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598
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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0a97a95b-0207-4472-8c47-59d8a3b3b3ba
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cb3cb524-e1b7-4e82-a02a-4d4dadbc0177
