BrainZ Instruments Limited (ASX:BZI) has lodged a submission with the United States Food and Drug Administration ("FDA") for its computer-assisted seizure detection algorithm1. The BrainZ computer-assisted seizure detection algorithm will assist clinical staff to detect seizure activity in "at risk" infants in the Neonatal Intensive Care Unit. It will be sold as an upgrade to new and existing BrainZ BRM2 bedside brain monitor customers.

BrainZ CEO Dr Justin Vaughan says, "This additional sophistication to the BRM2 capability further differentiates the BrainZ technology and adds a much needed and highly valued additional resource for those clinicians and support staff involved in managing at-risk infants."

BRM2 monitors are currently in use in 16 countries around the world, mainly within Neonatal Intensive Care Units. In Australia, units retail for $25,000. BrainZ reported half yearly sales growth of 29% in its most recent investor update.
"Over the past quarter we have experienced strong sales growth and the seizure detection capability feature will further increase the BRM2's desirability catalysing further growth for BrainZ. In terms of worldwide sales, the past three months have seen 31 BRM2 monitor sales compared to 25 in the previous six months and 5 in the same period last year. The sales delivered in the last quarter include our first into South Africa, which is a market of considerable potential," Dr Vaughan added.

The BRM2 offers valuable insights into the neurological status of at-risk infants and affords clinical staff better information upon which to base patient management and treatment decisions. There is limited but active competition to the BrainZ BRM2 in neonatal intensive care units but none of the available competition is able to provide any form of automated seizure detection capability. The addition of the computer-assisted seizure detection algorithm to the BRM2 would provide an immediate additional point of difference over the current competition.

Dr Vaughan stated, "The addition of a seizure alarm system adds significant clinical utility to the BRM2 monitor and considerably enhances the value proposition to our customers. It is a quantum leap in terms of technology advancement. Also, the seizure detection method provides BrainZ with a core technology platform to springboard into wider markets, including adult areas."

510(k) PreMarket Notification is being sought 1
The data supporting the seizure detection algorithm has been presented at multiple international medical conferences over the past 18 months. The data presented indicated that the BrainZ seizure detection algorithm had higher sensitivity, higher positive predictive value, higher correlation, and a lower level of false positive detection than two other recognized seizure detection algorithms. The latest presentation was made to the Pediatric Academic Societies' meeting in San Francisco in May 2006.

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