MAKO Surgical Corp., developer of human-interactive surgical
robotic arm technology used to achieve accuracy in treating
osteoarthritic disease, today announced the first results from a
ten-year, prospective, randomized controlled trial evaluating the
accuracy of unicompartmental knee arthroplasty (UKA) implant
positioning, with and without robotic arm surgical assistance.
Early results from this pivotal study are compelling, showing that
robotic arm assisted UKA enhanced the accuracy of implant placement
and decreased the levels of pain.
Performed under the guidance of orthopaedic surgeons Mark Blyth,
M.D., Bryn Jones, M.D., Angus Maclean, M.D, and Iain Anthony,
Ph.D., and Phil Rowe, Ph.D., at the Glasgow Royal Infirmary and the
University of Strathclyde, in Glasgow, Scotland, the trial compared
implant placement accuracy in patients receiving MAKO's RESTORIS®
MCK implants using MAKO's RIO® Robotic Arm Interactive Orthopedic
System to patients receiving manual placement of the Oxford®
Partial Knee implant from Biomet Orthopedics. One hundred patients
have been enrolled in the study and randomly assigned (50 MAKO vs.
50 Oxford) to receive UKA with or without the aid of robotic arm
assistance. The three-month results from 50 patients in each group
also assessed early clinical outcomes such as patient reported
post-operative pain levels and satisfaction. It is anticipated the
trial will ultimately have 75 patients in each group. The patients
will be tracked for ten years post-operatively.
"The early results are encouraging, as the data show more
accurate component placement, as well as considerably lower
self-reported post-operative pain levels out to six weeks," said
Dr. Blyth. "The early results suggest that robotic arm assisted UKA
with the RIO system greatly enhances the accuracy of implant
placement, which can be achieved with only minimal deviation from
the pre-operative plan."
Poor implant positioning in UKA is associated with suboptimal
functional outcome following surgery1; however, robotic arm
technology for UKA provides pre-operative surgical planning for
more accurate and minimal bone resection (excision of part of the
bone), and intra-operative joint balancing for improved
post-operative function and kinematics.
The primary endpoint of the clinical study is to validate the
intra-operative implant alignment values recorded by the RIO system
and to compare the accuracy of this implant positioning using
robotic arm assistance with that achieved using conventional
instrumentation in a randomized cohort. Among the secondary
endpoints, the trial also examines early post-operative pain, and
initial results show a reduction in patient reported post-op pain,
which persists for almost 90 days following surgery. This ongoing
trial will assess patient clinical, psychological and functional
outcomes pre-operatively and at three months, one year, two years,
five years and ten-years post-operatively.
"We are very happy with the early results for this randomized
clinical trial, as it demonstrates the effectiveness of our RIO
system and MAKOplasty® Partial Knee Resurfacing as a minimally
invasive surgical option for patients with early to mid-stage
osteoarthritis," said Maurice R. Ferré, M.D., president and chief
executive officer of MAKO. "Results also suggest that robotic arm
assisted surgery for UKA may improve recovery with regard to less
pain immediately following the procedure. We believe these early
results underscore the importance of accuracy and precision in UKA
surgeries, and the benefits that MAKOplasty can provide surgeons
and their patients."
About MAKOplasty
MAKO's RIO Robotic Arm Interactive Orthopedic System coupled
with its proprietary RESTORIS family of implants, enable surgeons
to perform MAKOplasty for knee resurfacing and total hip
arthroplasty. The RIO system overcomes limitations of conventional
arthroplasty by providing auditory, visual and tactile guidance
that, when integrated with the touch and feel of the surgeon's
skilled hand, provide consistently reproducible precision in
partial knee resurfacing and total hip replacements. This advanced
treatment option is designed to relieve pain and restore range of
motion for adults living with osteoarthritis and other degenerative
hip diseases.
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that markets its
RIO Robotic-Arm Interactive Orthopedic system, with specific
applications for partial knee resurfacing and total hip
replacement, and proprietary RESTORIS Family of Implants for
orthopedic procedures called MAKOplasty. The RIO is a
surgeon-interactive tactile surgical platform that incorporates a
robotic arm and patient-specific visualization technology, which
enables accurate, consistently reproducible bone resection for
accurate insertion and alignment of RESTORIS knee and hip implants.
The MAKOplasty solution incorporates technologies enabled by an
intellectual property portfolio including more than 300 U.S. and
foreign, owned and licensed, patents and patent applications.
Additional information can be found at www.makosurgical.com.
Forward-Looking Statements
This press release contains forward-looking statements
regarding, among other things, statements related to expectations,
goals, plans, objectives and future events. MAKO intends such
forward-looking statements to be covered by the safe harbor
provisions for forward-looking statements contained in Section 21E
of the Securities Exchange Act of 1934 and the Private Securities
Reform Act of 1995. In some cases, forward-looking statements can
be identified by the following words: "may," "will," "could,"
"would," "should," "expect," "intend," "plan," "anticipate,"
"believe," "estimate," "predict," "project," "potential,"
"continue," "ongoing," or the negative of these terms or other
comparable terminology, although not all forward-looking statements
contain these words. These statements are based on the current
estimates and assumptions of our management as of the date of this
press release and are subject to risks, uncertainties, changes in
circumstances, assumptions and other factors that may cause actual
results to differ materially from those indicated by
forward-looking statements, many of which are beyond MAKO's ability
to control or predict. Such factors, among others, may have a
material adverse effect on MAKO's business, financial condition and
results of operations and may include the potentially significant
impact of a continued economic downturn or delayed economic
recovery on the ability of MAKO's customers to secure adequate
funding, including access to credit, for the purchase of MAKO's
products or cause MAKO's customers to delay a purchasing decision,
changes in general economic conditions and credit conditions,
changes in the availability of capital and financing sources for
our company and our customers, unanticipated changes in the timing
of the sales cycle for MAKO's products or the vetting process
undertaken by prospective customers, changes in competitive
conditions and prices in MAKO's markets, changes in the
relationship between supply of and demand for our products,
fluctuations in costs and availability of raw materials and labor,
changes in other significant operating expenses, slowdowns, delays,
or inefficiencies in MAKO's product research and development
cycles, unanticipated issues relating to intended product launches,
decreases in sales of MAKO's principal product lines, decreases in
utilization of MAKO's principal product lines or in procedure
volume, increases in expenditures related to increased or changing
governmental regulation or taxation of MAKO's business, both
nationally and internationally, unanticipated issues in complying
with domestic or foreign regulatory requirements related to MAKO's
current products, including initiating and communicating product
actions or product recalls and meeting Medical Device Reporting
requirements and other required reporting to the United States Food
and Drug Administration, or securing regulatory clearance or
approvals for new products or upgrades or changes to MAKO's current
products, developments adversely affecting our potential sales
activities outside the United States, increases in cost containment
efforts by group purchasing organizations, the impact of the United
States healthcare reform legislation enacted in March 2010 on
hospital spending, reimbursement, unanticipated changes in
reimbursement to our customers for our products, and the taxing of
medical device companies, any unanticipated impact arising out of
the securities class action or any other litigation, inquiry, or
investigation brought against MAKO, loss of key management and
other personnel or inability to attract such management and other
personnel, increases in costs of retaining a direct sales force and
building a distributor network, unanticipated issues related to, or
unanticipated changes in or difficulties associated with, the
recruitment of agents and distributors of our products, and
unanticipated intellectual property expenditures required to
develop, market, and defend MAKO's products. These and other risks
are described in greater detail under Item 1A, "Risk Factors," in
MAKO's periodic filings with the Securities and Exchange
Commission, including MAKO's annual report on Form 10-K for the
year ended December 31, 2012 filed on February 28, 2013. Given
these uncertainties, undue reliance should not be placed on these
forward-looking statements. MAKO does not undertake any obligation
to release any revisions to these forward-looking statements
publicly to reflect events or circumstances after the date of this
press release or to reflect the occurrence of unanticipated
events.
"MAKOplasty®," "RESTORIS®," "RIO®," as well as the "MAKO" logo,
whether standing alone or in connection with the words "MAKO
Surgical Corp." are trademarks of MAKO Surgical Corp.
Oxford® is a registered trademark of Biomet Orthopedics
1 Collier WB, Engh CA, McAuley JP, et al. Factors
associated with the loss of thickness of polyethylene tibial
bearings after knee arthroplasty. J Bone Joint Surg Am
2007;89:1306.
CONTACT: Media Contacts:
Amy Cook
925.552.7893
amycook@amcpublicrelations.com
Sue Siebert
954.628.0804
ssiebert@makosurgical.com
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