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."
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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.
Key Points
- 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.
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