Seeing Machines Regulatory News (SEE)

15 Aug 2007 09:27

Seeing Machines Limited15 August 2007 15 August 2007 Seeing Machines Limited ("Seeing Machines" or the "Company") SEEING MACHINES RECEIVES FDA CLEARANCE FOR TRUEFIELD ANALYZER Seeing Machines (AIM: SEE), a leading developer of advanced computer basedimaging software systems, announces today that it has received marketingclearance from the United States Food and Drug Administration (FDA) for itsrevolutionary new medical device, the TrueField(R) Analyzer (TFA). The TFA helps doctors measure defects in a patient's visual field, a crucialstep in the detection and management of diseases of the vision system, includingfor example, glaucoma. The TFA offers many outstanding new benefits to both thepatient and the doctor. Most importantly the device is both objective and it isquick and easy for the patient and operator. Unlike traditional standard automated perimetry (SAP) devices, the TFA measuresboth eyes concurrently, and does the entire test of both eyes in approximately 5minutes (including rest breaks within the test). The objectivity of the TFA testoffers doctors the possibility of significant improvements over the test-retestvariability issues that impact SAP. For patients it means an end to the buttonpressing associated with SAP - the only task required of the patient in the TFAtest is simply to look at the display. The clearance of the device by the FDA satisfies this regulatory hurdle andallows the TFA to be commercially introduced into the United States market - thelargest healthcare market in the world. Receipt of this FDA clearance allows usto remain on track to meet our original objective of launching the TFA in late2007, and as such the device will be exhibited at the upcoming Annual Meeting ofthe American Academy of Ophthalmology in New Orleans in November 2007. Dr Nick Cerneaz, CEO of Seeing Machines commented: "Clearance by the FDA is atremendously important milestone in the development of both the TrueFieldAnalyzer and indeed our Company. Achieving FDA clearance has been an importanthurdle along the path to the commercialization of our vision testing technologyand it paves the way for the introduction of the TFA to the highly significantUS market." "The TFA was first exhibited at the ARVO 2007 trade show in Ft. Lauderdale,Florida in May this year (see: http://www.truefield-analyzer.com/arvo2007.html)and the outstanding response from the clinical and academic community at thatmeeting was very encouraging. With the FDA clearance received today we are wellon the way to realizing a highly significant element of our company's strategicvision." Further information about the TrueField Analyzer(R) can be obtained from the website: www.truefield-analyzer.com. Further information about Seeing Machines canbe obtained from the company website www.seeingmachines.com. --- ENDS --- Enquiries:Seeing Machines Limited Insinger de Beaufort Parkgreen CommunicationsNick Cerneaz, CEO Peter Ward Justine Howarth+61 (0) 2 6125 6501 +44 (0) 20 7190 7015 +44 (0) 20 7851 7480www.seeingmachines.com Notes to editors: About Seeing Machines Seeing Machines is an award winning Technology Company which focuses on visionbased human machine interfaces. Formed in 2000 in Canberra, Australia, SeeingMachines' purpose is to commercialise its computer-vision across a range ofindustries and applications. Seeing Machines deliver advanced computer vision solutions for researches anddevelopers in human factors, transportation safety, computer human interaction,robotics, medical research and psychology. The flagship product faceLAB(R)provides an automated and contact-free gaze and head tracking technology, itsolves the problem of observing human behaviour naturally, non-intrusively andwith a high degree of accuracy and usability. Building on these unique facetracking and pupil measurement and monitoring capabilities, the TrueFieldAnalyzer(R) is a development undertaken by Seeing Machines in partnership withcolleagues from the Research School of Biological Sciences (RSBS) at theAustralian National University (ANU). The TrueField Analyzer(R) offers a new objective method to help doctors diagnoseand manage a range of eye diseases including glaucoma, age related maculardegeneration and diabetic retinopathy. Glaucoma affects about 2-3% of thepopulation over 40 years of age and is a leading source of blindness. Unlikemost other devices available to the clinician the TrueField Analyzer is acompletely objective test and it is quick and easy for patients and techniciansalike. The device measures both eyes concurrently and due to the reliabilitythat arises from the objective nature of the test, it has the potential tobecome a new standard in the measurement of visual field defects and thus in thediagnosis and management of disease such as glaucoma. More generally Seeing Machines' computer vision systems are able to measure theorientation and position of a human head, estimate eye-gaze direction, detecteye blinks and track other facial features. This functionality is achievedentirely though visual means, using video cameras connected to advanced imageprocessing software, with no attachments required on the subject. Products suchas faceLAB(R) are designed to allow human factors researchers and designers toassess the interaction of an operator in an environment and this findsapplication in designing operator environments, such as cockpits for cars,trucks, trains, and aeroplanes for instance, and other industrial designapplications, as well as medical and psychological research situations. Thetechnology also has application in monitoring automobile drivers and if itdetects drowsiness or that the driver is distracted and their attention has beendiverted from the road, an alarm can be raised to alert the driver to eitherpull over and rest in the case of drowsiness or to pay more attention to theroad. The systems work in real-time, enabling the behaviour of subjects to be trackedin real-time. This technology is paving the way in promoting safer drivingconditions and works to enhance the driving experience and to eliminateaccidents caused through driver drowsiness or distraction. There are many different sectors that can benefit from this revolutionarysoftware, for which it has been developed, including: automotive; academicresearch; medicine/healthcare; defence; autostereoscopy (next generationdisplays); sport; and games. This information is provided by RNS The company news service from the London Stock Exchange