hear is the latest announcement.
BrainZ Business Update
US FDA Clearance sought for Seizure Detection Algorithm
BrainZ Instruments Limited (ASX:BZI) today announced it 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 that “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 has 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.”
1 510(k) Pre-Market Notification is being sought
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.
Dr Vaughan states that “The data behind the seizure detection system is extremely robust,
particularly its low rates of false positive detection which is critical for effective use within the
intensive care environment.
The fact that many of the world’s leading neonatal units are lining up to trial the algorithm is
testament to the attractiveness of the technology and the buzz associated with it throughout the
international community. The process from here is that we shall select leading centres for beta
testing of the seizure detection system and aim for full commercial release in the fourth quarter of
2006.”
Dr Vaughan advised that BrainZ had recently completed an extensive survey of all Australasian
neonatal customers. 100% of respondents indicated that the BRM2 monitor was benefiting the
management, treatment and care of their neonatal patients.
About BrainZ Instruments Limited: BrainZ is a New Zealand based medical device company
specialising in bedside brain monitoring technology. BrainZ listed on the ASX in December 2005.
BrainZ has filed for patent protection of the novel methodology behind the seizure detection system
in multiple international territories.
About FDA 510k: Section 510(k) of the US Food, Drug and Cosmetic Act requires device
manufacturers to notify FDA, at least 90 days in advance, of their intent to market a medical
device. This is known as Premarket Notification - also called PMN or 510(k). It allows FDA to
determine whether the device is equivalent in terms of safety and effectiveness to a legally
marketed device.