Fourth Quarter 2011 and Full Year
Highlights
Eighteen RIO® systems sold in the quarter, of which sixteen were
sold to domestic customers
Total of 48 RIO systems sold worldwide in 2011, increasing
worldwide commercial installed base to 113 RIO systems and domestic
commercial installed base to 111 RIO systems
2,258 MAKOplasty® procedures performed in the quarter, a 97%
increase over the same period in 2010
Total of 6,932 MAKOplasty procedures performed in 2011, a 99%
increase over in 2010
37 MAKOplasty Total Hip Arthroplasty (THA) applications sold in
the quarter
Total of 49 MAKOplasty THA applications sold in 2011, resulting
in 44% of domestic commercial installed base having MAKOplasty THA
application
2012 Annual Guidance
2012 RIO system sales anticipated to be 56 to 62 systems
11,000 to 13,000 MAKOplasty procedures anticipated to be
performed in 2012
MAKO Surgical Corp. (Nasdaq:MAKO), a medical device company that
markets its RIO® Robotic Arm Interactive Orthopedic surgical
platform, MAKOplasty® joint specific applications, and proprietary
RESTORIS® implants that together enable orthopedic surgeons to
consistently, reproducibly and precisely treat patient specific
osteoarthritic disease, today announced its selected operating
results for its fourth quarter and for the year ended December 31,
2011 and provided 2012 annual guidance in anticipation of its
business update presentation at the 30th Annual J.P. Morgan
Healthcare Conference at the Westin St. Francis Hotel in San
Francisco on Wednesday, January 11, 2012 at 7:30 am PST.
MAKO will provide a live webcast of the business update
presentation. Interested parties may access the live webcast by
visiting the investor relations section of MAKO's web site at
www.makosurgical.com. A replay of the webcast will be available on
the MAKO website after the live presentation.
2011 Fourth Quarter and Full Year Review
RIO Systems – Eighteen RIO systems were sold during the fourth
quarter, of which sixteen were sold to domestic customers and two
were sold to two new international distributors, which will be used
by the distributors to demonstrate MAKOplasty to build interest in
their respective markets. A total of 48 new RIO systems were sold
worldwide in 2011, bringing MAKO's worldwide commercial installed
base of RIO systems to 113 systems and domestic commercial
installed base to 111 RIO systems as of December 31, 2011.
MAKOplasty Procedure Volume – During the fourth quarter, 2,258
MAKOplasty procedures were performed, of which 2,167 were performed
at domestic sites and 117 were Total Hip Arthroplasty (THA)
procedures. The 2,258 MAKOplasty procedures performed represent a
25% increase over the procedures performed in the third quarter of
2011 and a 97% increase over the procedures performed in the fourth
quarter of 2010. The average monthly utilization per system was 7.2
procedures during the fourth quarter of 2011, an increase from 6.5
procedures per system per month in the third quarter of 2011 and
6.7 procedures per system per month in the fourth quarter of 2010.
A total of 6,932 MAKOplasty procedures were performed in 2011,
representing a 99% increase over the total procedures performed in
2010. Through December 31, 2011, a total of 12,801 procedures have
been performed since the first procedure in June 2006.
MAKOplasty Total Hip Arthroplasty – In the fourth quarter, 37
MAKOplasty THA applications were sold, of which nine were sold and
installed with RIO systems sold during the fourth quarter. A total
of 49 MAKOplasty THA applications were sold in 2011 and as of
December 31, 2011, 44% of MAKO's domestic commercial installed base
has purchased and received the MAKOplasty THA
application.
"We are pleased with our strong RIO system sales and the
interest in our hip application during the fourth quarter. In
addition, we believe the increased MAKOplasty procedure volume and
utilization trends continue to demonstrate the clinical value of
our technology," said Maurice R. Ferre, M.D., President and Chief
Executive Officer of MAKO. "2011 was a positive year for MAKO and
we look forward to continuing to drive the adoption of MAKOplasty
in 2012."
2012 Annual Guidance
MAKO anticipates that it will sell 56 to 62 RIO systems and that
its customers will perform 11,000 to 13,000 MAKOplasty procedures
in 2012.
Conference Call
MAKO will host a conference call on March 6, 2012 at 4:30 pm ET
to discuss its fourth quarter and full year 2011 results. To
listen to the conference call, please dial 877-843-0414 for
domestic callers and 914-495-8580 for international callers
approximately ten minutes prior to the start time. The participant
code is 41384079. To access the live audio broadcast or the
subsequent archived recording, visit the Investor Relations section
of MAKO's website at www.makosurgical.com.
About MAKO Surgical Corp. MAKO Surgical Corp.
is a medical device company that markets its RIO® Robotic-Arm
Interactive Orthopedic system, joint specific applications for the
knee and hip, and proprietary RESTORIS® 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 precise,
consistently reproducible bone resection for the accurate insertion
and alignment of MAKO's RESTORIS 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," "guidance" or the negative of these terms or
other comparable terminology, although not all forward-looking
statements contain these words. Examples of such statements
include, but are not limited to, statements about the nature,
timing and number of planned new product introductions; market
acceptance of MAKOplasty, including the RIO system, and MAKO
RESTORIS® family of implant systems; the future availability from
third-party suppliers, including single source suppliers, of
implants for and components of the RIO system; the anticipated
adequacy of our capital resources to meet the needs of MAKO's
business; MAKO's ability to sustain, and MAKO's goals for, sales
and earnings growth including projections regarding systems
installations; and MAKO's success in achieving timely approval or
clearance of products with domestic and foreign regulatory
entities. 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
competitive conditions and prices in MAKO's markets, unanticipated
issues relating to intended product launches, decreases in sales of
MAKO's principal product lines, decreases in utilization of MAKO's
principal product line 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
or securing regulatory clearance or approvals for new products or
upgrades or changes to MAKO's current products, the impact of the
recently enacted United States healthcare reform legislation on
hospital spending, reimbursement, and the taxing of medical device
companies, the potential impact of the informal Securities and
Exchange Commission inquiry and the findings of that inquiry, loss
of key management and other personnel or inability to attract such
management and other personnel 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, 2010
filed on March 10, 2011 and quarterly report on Form 10-Q for the
quarter ended September 30, 2011 filed on November 9, 2011. 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.
CONTACT: Investors:
MAKO Surgical Corp.
954-628-1706
investorrelations@makosurgical.com
or
Westwicke Partners
Mark Klausner
443-213-0500
makosurgical@westwicke.com
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