Seizure Detection Algorithm: FDA Clearance sought
9 June 2006
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 computerassisted seizure detection algorithm1. The BrainZ computerassisted 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 muchneeded 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 halfyearly 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 computerassisted 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.
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.
- 510(k) submission lodged with FDA for BRM2 automated seizure detection capability.
- Provides additional and substantial competitive advantage over current competition and will add an additional revenue stream to the business.
- Data suggests a number of significant advantages over two other recognized seizure detection algorithms
- Most important milestone for the company since the initial regulatory approvals for the BRM2
- Provides BrainZ with a core technology platform to springboard into wider markets, including adult areas.
- Sales growth of existing BRM2 product has been robust
- Introduction of the seizure detection system will provide an additional catalyst to rapid growth in sales
- Full commercial release targeted Q4 2006.