SonoSite Announces FDA Clearance for Its New NanoMaxx Ultrasound Tool

* Reuters is not responsible for the content in this press release.

Mon Oct 5, 2009 1:12pm EDT

Company now shipping the breakthrough NanoMaxx system to US customers
BOTHELL, Wash.--(Business Wire)--
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 new NanoMaxx ultrasound system and is commencing US
customer deliveries. International deliveries began at the end of June. 

Based on SonoSite`s 4th generation Turbo technology, the six pound NanoMaxx
system is the latest addition to SonoSite`s suite of specialized products for
point-of-care visualization in medicine. Complete with streamlined one button
optimization technology, a touch screen user interface and SonoSite`s
industry-leading 5-year warranty, the NanoMaxx system is ideal for both hospital
and office markets and designed to provide healthcare professionals with
improved patient safety practices, expanded workflow capabilities and exam room
flexibility. 

Among the first to take delivery of a system, the Queensland Ambulance Service
in Australia, is integrating ultrasound into their rapid response vehicle.
"Ultrasound is an essential tool for providing immediate diagnostics, improving
patient safety and ultimately raising the standard of patient care," said
Stephen Rashford, MD, the department`s medical director. "With a hand-carried
system, our department will be able to assess and diagnose patients at the scene
of an accident, such as aggressively managing chest injuries, and for higher
level trauma cases, pre-notify the hospital of a patient`s arrival to guarantee
the availability of an operating room." 

One Button Control for Increased Efficiency

The new ultra portable and one button design of the NanoMaxx system makes high
quality ultrasound available to a much broader range of clinicians. The system
incorporates SonoSite`s advanced proprietary imaging algorithms, including
SonoMB and SonoAdapt to deliver superior image quality in a lightweight, rugged
form factor. 

With a touch screen that responds easily to the tap of a finger, and one button
optimization, clinicians can readily acquire high resolution images to increase
clinical productivity at the point-of-care. A system boot-up time of less than
20 seconds and long battery life further enhance workflow when using the
NanoMaxx system. 

Reduce Length of Stay. Improve Patient Safety.

Designed to help hospitals meet the new standards of patient care, the NanoMaxx
is the perfect diagnostic ultrasound for clinical assessment and procedural
guidance at the hospital bedside and in the physician`s office. The ultimate
tool for reducing patient safety risks and healthcare delivery costs, the use of
bedside ultrasound is proven to increase the accuracy of interventional
procedures and the use of ultrasound guidance is now recommended by two
government-based agencies1 and three US medical societies2. 

At introduction, the NanoMaxx tool is available with a complement of five
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. The clinical capabilities of the NanoMaxx will help
eliminate the risk and cost of transporting patients to the imaging lab for many
examinations and procedures. 

Mount it. Carry it. Or Use it on a Stand.

The small footprint of the system, along with its space-saving solutions,
enables seamless integration with a multitude of exam-room configurations. For
convenience and flexibility, the system can be wall mounted, placed on an exam
table with kickstand attached, or used from a highly maneuverable stand.
Physicians can easily carry the NanoMaxx tool from room-to-room, to a satellite
office, to the operating room or to a field site for immediate use. 

Drop Tested at 3 Feet

The NanoMaxx system`s highly integrated architecture and ruggedized design,
including the industry`s first elastomeric bumper for extra durability, plus
magnesium outer shell, allows it to be used in the most demanding and austere
environments. Proving its reliability, the NanoMaxx system and its transducers
successfully passed SonoSite`s standard three foot durability drop test. 

In addition, to further reduce the risk of infection, the NanoMaxx system`s
fluid-resistant user interface makes the system easy to clean and disinfect,
helping to address the growing concern over infection control in the medical
community. 

Affordable and Easily Accessible with Web-Based Purchasing Program

Affordably priced, the NanoMaxx system and its transducers include SonoSite`s
industry-leading 5-year warranty, to provide the lowest cost of ownership in
ultrasound. 

Also, SonoSite`s One-to-One Purchase Program further extends the cost saving
advantages of the NanoMaxx ultrasound tool by replacing or complementing the
traditional on-site, pre-sale demonstration with a personal phone consultation
and webcast demonstration provided by a professional clinical sales consultant.
Visit the NanoMaxx ultrasound tool website to learn more about SonoSite`s newest
system and to experience a personal, interactive product demo. In addition,
Apple iPhone and iPod mobile device users can view a video of the NanoMaxx
system on SonoSite`s new SonoAccess application.

About SonoSite

SonoSite, Inc. (www.sonosite.com) is the innovator and world leader in
hand-carried ultrasound. 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. The company employs approximately 750 people
worldwide. 

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. 

1 Agency for Health Care Research and Quality (AHRQ) report: Making Healthcare
Safer: A Critical Analysis of Patient Safety Practices 2001. 

National Institute for Clinical Excellence (NICE) report: Guidance on the Use of
Ultrasound Locating Devices for Placing Central Venous Catheters. 2002. 

2 The American Board of Internal Medicine. "Training and Procedural
Requirements; Critical Care Medicine." Critical Care MedicinePolicies. 2009. The
American Board of Internal Medicine. .


The American College of Chest Physicians. "Consensus Statement; La Societe de
Reanimation de Langue Francaise Statement on Competence in Critical Care
Ultrasonography." 135 (2009): 1050-1060. 

The American College of Emergency Physicians."Policy Statement; Emergency
Ultrasound Guidelines." 53 (2009): 550-70. 

Photos/Multimedia Gallery Available:
http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6065612&lang=en

SonoSite, Inc.
Lisa Fritzky, 425-951-1375 



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.