Company Received FDA 510(k) Clearance and is Now Shipping the EDGE System to US Customers
BOTHELL, WA - November 17, 2011 - Sonosite, Inc. (Nasdaq:SONO), the world leader and specialist in hand-carried ultrasound for the point-of-care, announced today that the company has received FDA 510(k) clearance for its fifth generation, high performance EDGE™ ultrasound system. Designed with physician feedback in mind, the EDGE system reaches a new level of clinical performance and product design, arming physicians with a tool to deliver better, safer and improved patient care. The company is now commencing US customer deliveries. International deliveries are pending CE marking.
“The EDGE system is a tremendous product and we are excited to bring it to point-of-care medicine, said Kevin M. Goodwin, Sonosite’s President and CEO. “We are encouraged by the timely regulatory review process, which represents a collaborative effort by many. We look forward to adding this new tool to our core markets and providing physicians with the impact they have been asking for in healthcare delivery.”
“The Sonosite EDGE ultrasound system provides brighter, crisper images with improved detail,” said Robert Blankenship, MD, FACEP, Medical Director, St Vincent Medical Center Northeast, Ultrasound Director, St Vincent Emergency Physicians, Indianapolis. “Anytime image quality is enhanced, my ability to make clinical decisions is also improved. It can be hard dealing with the bright lights and volatile environment of the Emergency Department; the redesigned black, backlit keyboard, brighter high-resolution display, and aluminum frame in the EDGE system are great enhancements. Overall, the EDGE system maintains the durability that I depend on from Sonosite, while improving the design and appeal of ultrasound.”
Helping Physicians Improve Patient Care
Designed to help meet the new standards of patient care, the EDGE system is a perfect diagnostic ultrasound tool for clinical assessment and procedural guidance at the hospital bedside and in the physician’s office. The system features new imaging algorithms, enabling clinicians to clearly visualize images, while reaching deeper levels of penetration. The EDGE system also boasts a high luminance LED, high resolution 12 inch display, which is the company’s largest monitor to date– making it easier for clinicians to see the image from across the bed during procedures. The EDGE introduces a new level of clean-ability with its sealed silicone keypad – reinforcing Sonosite’s ongoing commitment to assist medical facilities in the reduction of hospital spread infections.
The Sonosite Performance and Durability Standard
Dedicated to providing the most robust products, the EDGE ultrasound system and transducers are the latest products to pass Sonosite’s rigorous durability standard– the three foot drop test. With a highly integrated architecture, new magnesium shell and aluminum core, the EDGE system can withstand the harshest and most demanding clinical environments. Also, the EDGE system weighs less than 10 pounds and includes our industry leading 5-year warranty.
At introduction, the EDGE system is available with a complement of fourteen transducers to support a wide range of examinations and procedures including thoracic assessment for pathology, vascular access, needle aspirations and injections, as well as abdominal, cardiac, nerve, OB/Gyn, musculoskeletal, small parts and vascular scanning.
Sonosite, Inc. (www.sonosite.com) is the innovator and world leader in bedside and point-of-care ultrasound and an industry leader in ultra high-frequency micro-ultrasound technology and impedance cardiography equipment. Headquartered near Seattle, the company is represented by ten subsidiaries and a global distribution network in over 100 countries. Sonosite’s small, lightweight systems are expanding the use of ultrasound across the clinical spectrum by cost-effectively bringing high-performance ultrasound to the point of patient care.
Forward-looking Information and the Private Litigation Reform Act of 1995
Certain statements in this press release relating to the market acceptance of our products, possible future sales relating to expected orders, and our future financial position and operating results are “forward-looking statements” for the purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the opinions and estimates of our management at the time the statements are made and are subject to risks and uncertainties that could cause actual results to differ materially from those expected or implied by the forward-looking statements. These statements are not guaranties of future performance and are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions. Factors that could affect the rate and extent of market acceptance of our products, the receipt of expected orders, and our financial performance include our ability to successfully manufacture, market and sell our ultrasound systems, our ability to accurately forecast customer demand for our products, our ability to manufacture and ship our systems in a timely manner to meet customer demand, variability in quarterly results caused by the timing of large project orders from governmental or international entities and the seasonality of hospital purchasing patterns, timely receipts of regulatory approvals to market and sell our products, regulatory and reimbursement changes in various national health care markets, constraints in government and public health spending, the ability of our distribution partners and other sales channels such as the physician office sales force to market and sell our products, the impact of patent litigation, our ability to execute our acquisition strategy, the effect of transactions and activities associated with our issuance of senior convertible debt in July 2007 on the market price of our common stock, and as well as other factors contained in the Item 1A. “Risk Factors” section of our most recent Annual Report on Form 10-K, as updated by our most recent quarterly reports filed on Form 10-Q filed with the Securities and Exchange Commission. We caution readers not to place undue reliance upon these forward-looking statements that speak only as to the date of this release. We undertake no obligation to publicly revise any forward-looking statements to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
iPhone and iPod are trademarks of Apple, Inc., registered in the US and other countries.