FT. LAUDERDALE, Fla., Dec. 2, 2008 (GLOBE NEWSWIRE) -- MAKO Surgical Corp. (NasdaqGM:MAKO - News), a medical device company focused on marketing its advanced robotic-arm solution and its implants for minimally invasive orthopedic knee procedures known as MAKOplasty(r), today announced that it received two 510(k) clearances from the US Food and Drug Administration (FDA) to market both the Company’s proprietary Version 2.0 Tactile Guidance System(tm) (TGS(tm)), branded as the MAKO RIO(tm), and its bicompartmental knee resurfacing implant system, branded as RESTORIS(r) MCK. MAKO currently expects to commercially launch both the RIO(tm) system and the RESTORIS(r) MCK system in the first half of 2009.
``We believe the advanced proprietary features of our Version 2.0 RIO(tm) robotic-arm system and the RESTORIS(r) MCK bicompartmental knee implant system provide the potential to address larger portions of MAKO’s target markets,’' said Dr. Maurice R. Ferre, President and CEO of MAKO. ``Obtaining the FDA 510(k) clearance for each of these products represents the achievement of a key milestone towards the continuing commercialization of innovative technology that restores patient quality of life.’'
About MAKO Surgical Corp.
MAKO Surgical Corp. is a medical device company that markets its advanced robotic-arm solution and implants for minimally invasive orthopedic knee procedures. The MAKO Tactile Guidance System (TGS) is a surgeon-interactive tactile platform that incorporates a robotic arm and patient-specific visualization technology and prepares the knee joint for the precise and consistently reproducible insertion and alignment of resurfacing implants through a minimal incision. This FDA-cleared TGS allows surgeons to provide a tissue-sparing, bone resurfacing procedure called MAKOplasty(r) to a large, yet underserved patient-specific population suffering from early- to mid-stage osteoarthritic knee disease. MAKO has an intellectual property portfolio of more than 200 licensed or owned patents and patent applications relating to the areas of computer assisted surgery, haptics, robotics and implants. Additional information can be found at http://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. We intend 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, you can identify forward-looking statements 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. Examples of such statements include, but are not limited to, statements about the timing of planned new product introductions, market acceptance of the MAKOplasty(r) solution and technologies, the future availability of implants and components of our Tactile Guidance System, or TGS, from third-party suppliers, our ability to sustain, and our goals for, sales and earnings growth and our success in achieving timely approval or clearance of our products with 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 these factors are beyond our ability to control or predict. Such factors, among others, may have a material adverse effect on our business, financial condition and results of operations and may include changes in competitive conditions and prices in our markets, decreases in sales of our principal product lines, increases in expenditures related to increased governmental regulation of our business, loss of key management and other personnel or inability to attract such management and other personnel and unanticipated intellectual property expenditures required to develop and market our products. These and other risks are described in greater detail under Item 1A ``Risk Factors,’' contained in our annual report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2008 and subsequent filings we have made with the US Securities and Exchange Commission. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We do not undertake any obligation to release any revisions to these forward-looking statements publicly to reflect events or circumstances in the future, even if new information becomes available.
``MAKOplasty(r),’' ``Tactile Guidance System,’' ``TGS,’' ``RESTORIS(r),’' and ``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:
MAKO Surgical Corp. Investors: Susan M. Verde 954-927-2044 x349 sverde@makosurgical.com
Westwicke Partners Mark Klausner 443-213-0500 mark.klausner@westwicke.com
Source: MAKO Surgical Corp
