Data published in Arthroplasty
Today demonstrate that patients treated with customized
knee implants had significantly lower adverse event rates and
transfusion rates, were significantly less likely to be discharged
to a rehabilitation or other high-cost post-acute care facilities,
had a lower average total cost of the episode of care and had a
significantly lower average cost of follow-up care.
ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that
offers joint replacement implants customized to fit each patient’s
unique anatomy, today announced the publication of a retrospective
study comparing adverse events rates and cost of care for total
knee arthroplasty (TKA) patients treated with either customized
individually made (CIM) implants or standard off-the-shelf (OTS)
implants. Results were published in the peer-reviewed journal
Arthroplasty Today on June 8, 2017.
According to the study results, a smaller percentage of TKA
patients treated with customized implants experienced adverse
events at both discharge (3.3% vs OTS 14.1%; P = .003) and 90
days after discharge (8.1% vs OTS 18.2%; P = .023). A
greater proportion of patients who received customized implants
were discharged in less than 3 days (42.1% vs OTS 30.3%; P =
.037). In addition, a smaller percentage of patients treated
with customized implants (4.8% vs OTS 16.4%; P = .003) were
discharged to a rehabilitation center or other post-acute care
facility. Further, fewer patients treated with customized
implants (2.4% vs OTS 11.6%; P = .005) required blood a
transfusion.
Furthermore, the total average real hospital costs between the
CIM and OTS groups were nearly identical (customized implant
$16,192 vs OTS $16,240; P = .913), suggesting that patients
with customized implants received improved hospital outcomes at no
additional cost to the hospital. However, risk-adjusted per
patient total cost of care showed a net savings of $913.87
(P = .240) per patient for the customized implant group for
bundle of care, including the preoperative computed tomography
scan, TKA hospitalization, and discharge disposition.
Follow-up care costs demonstrated a savings of $1,313 (customized
implant $5,048 vs OTS $6,361; P = .007).
“Our results in this single-site population of patients
illustrate that treatment with a customized implant led to
significantly lower transfusion rates, fewer adverse events and
reduced need for discharge to a rehabilitation facility or
post-acute care facility,” said Steven Culler, PhD, a healthcare
economist at Emory University. “We also found that improved
outcomes among patients treated with customized implants were
achieved without increasing overall costs and that post-discharge
costs were significantly lower among patients treated with
customized implants.”
In this study, which was financially supported by ConforMIS,
researchers completed a retrospective review of outcomes and costs
for 248 consecutive TKA patients treated at a single institution
and by the same surgeon. All surgeries occurred between April
1, 2010, and November 11, 2013 based on consistent intraoperative
protocols. Patients received either a customized knee implant
(designed and developed based on their unique anatomy (n=126)) or
an OTS implant selected from a range of pre-manufactured sizes
(n=122). Study data were collected from patients' medical record or
the hospital's administrative billing record.
When controlling for gender, age, body mass index (BMI) and
selected comorbid conditions, patients in the OTS arm were 5.5
times more likely to be discharged to a rehab or post-acute care
facility. Patients treated with OTS implants were also 4.6 times
more likely to require blood transfusion and 4.4 times more likely
to experience an adverse event.
“This study provides compelling data indicating that patients
treated with customized total knee implants achieve better outcomes
on several important measures without increasing real hospital
costs and while reducing the average total cost of the episode of
care and the average cost of follow-up care,” said Mark Augusti,
Chief Executive Officer and President of ConforMIS. “These findings
further demonstrate the benefits of customized total knee implants
technology to patients, surgeons, hospitals and payers.
Additionally, they are part of an important and changing
conversation about the role of total knee implants in the delivery
of better outcomes at lower costs – a conversation that we are
committed to pursuing.”
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’ clinical strategy, the potential clinical, economic or
other impacts and advantages of using customized implants, the
changing view of CIM v. OTS 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:
Media contacts:
Bill Berry
Berry & Company Public Relations
Bberry@berrypr.com
(212) 253-8881
Lynn Granito
Berry & Company Public Relations
Lgranito@berrypr.com
(212) 253-8881
Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598
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