ASX Announcements

Compumedics’ world-class premium GRAEL (TM) HD-PSG Sleep System receives FDA Market Clearance

22 Jan 2010

Melbourne Australia, Friday, 22 January 2010

Leading medical devices company, Compumedics Limited (ASX:CMP) is pleased to announce that it has received market clearance from the United States Food and Drug Administration (FDA) for its GRAEL^TM HD-PSG Sleep Diagnostic Amplifier System.  The GRAEL^TM HD PSG/EEG (polysomnography/electroencephalography) is the world's first HD (high definition) PSG/EEG amplifier.  The FDA clearance allows introduction and sale in the USA of Compumedics’ newest and most technologically advanced amplifier system into the world’s largest medical devices market.

Incorporating 22 years of innovation in designing PSG and EEG amplifiers, including Compumedics’ renowned E-Series, the new GRAEL^TM showcases Compumedics’ ongoing commitment to design leadership in the sleep diagnostics and clinical EEG marketplace.  The GRAEL^TM is a specifications benchmark that simply outclasses every other combination sleep and clinical EEG amplifier currently on the market, with features including: 24-bit A/D converter (including sampling and storage); 77 channels; true DC-coupling; integrated light, snore, body position and RIP (respiratory inductive plethysmography) sensors; and a single IP cable connection; all integrated into a sleek, compact case with a unique and convenient mounting cradle.
 
Describing this milestone, David Burton, CEO of Compumedics, said:  “With GRAEL^TM, Compumedics further enhances the sleep-diagnostics industry’s broadest product range, covering all regulatory types I-IV of sleep product classifications in both wireless and wired configurations. As a premier product, GRAEL^TM offers the features and flexibility to meet even the most demanding research applications while providing unmatched and exceptional signal quality in any clinical lab environment.”

Phillip Moses, Compumedics’ new VP of USA Sales, also commented:
“We are excited to have the much anticipated GRAEL^TM HD-PSG Sleep Diagnostic Amplifier System available for our customers. It further demonstrates the technological innovation that defines Compumedics and distances our company well in front of all competitors.”  We expect GRAEL^TM to significantly contribute to USA revenue growth for the balance of the year and beyond.  Our customers are queued up to purchase GRAEL^TM, and our sales team is excited to add the GRAEL^TM to Compumedics’ suite of exceptional software and lab management products.  GRAEL^TM allows us to truly address the most demanding clinical and research requirements.”

The USA sleep-diagnostics market is estimated to be in excess of AUD125 million per annum with the global market at approximately AUD250 million per annum. Currently, Compumedics has an installed base of over 4,000 beds world-wide for sleep diagnostics.

The Company is carrying a near record number of orders-on-hand for shipment into the second half of the financial year at 31 December 2009 ($3m approximately) which is reflective of improving economic conditions and market demand particularly in its key Us market, despite a slightly softer first half (six-months to 31 December 2010) finish than the Company had anticipated.

The Company will release its December 31 results the third week of February 2010.

For Further information:

Mr David Burton                       Mr David Lawson
Executive Chairman, CEO          Chief Financial Officer
Phone: + 61 3 8420 7300         Phone: + 61 3 8420 7300 
Fax: +61 3 8420 7399              Fax: +61 3 8420 7399

Investor Relations & Media Enquires:

Mr Rod North
Managing Director
Bourse Communications Pty Ltd
Phone: +61 3 9510 8309
Mobile: +61 (0) 408 670 706

About Compumedics

Compumedics Limited, founded in 1987, is a global leader in the design and manufacture of diagnostic technologies for sleep disorders, neurophysiology and cardiology.
In 1987, Compumedics established Asia Pacific’s first fully computerised sleep laboratory.  Compumedics holds 80% share of the Australian sleep-diagnostic market, and has a major and rapidly growing presence in the US, European and Asian marketplaces for its sleep, neurological, and Doppler blood-flow diagnostic monitoring devices.
In 1995, the company was selected to supply equipment to the US Sleep Heart Health Study, the world’s largest sleep study of its kind, currently exceeding 14,000 studies with 20,000 patients scheduled by 2008. With headquarters in Melbourne, Australia and offices in the United States, and Europe the products are distributed in over 50 countries.
In 1998, Compumedics was awarded the overall Australian Exporter of the Year.
In 2000, Compumedics was listed on the Australian Stock Exchange.
In 2002, Compumedics acquired US-based Neuroscan - the world's leading supplier of instruments for brain-research.  In the US - the world's largest medical device market - Neuroscan holds around 90% of the market for brain-research products.
In 2003, Compumedics was awarded the Frost & Sullivan Award for Market Expansion Strategy.
In 2004, Compumedics acquired German-based DWL Elektronishe GmbH, enabling Compumedics to expand its global operations into the neurovascular and cardio-vascular diagnostic fields.
In 2006, Compumedics was awarded the Frost and Sullivan Technology Leadership award for the innovative Somté recorder product.
In 2007, Compumedics and Chairman were inducted into the Victorian Manufacturing Hall of Fame.
In 2008, the DWL division received the top 100 German Innovation award.  With 20,000 systems installed globally across the finest hospital, universities and clinics the Compumedics sales have grown more than 4 fold from $9 million (1999) to $39 million (2008).
In 2009, Compumedics was awarded a design award for its Grael™ PSG/EEG premium laboratory based product.

Visit : www.compumedics.com for more information

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