FDA Clearance Delay
January 03 2008 - 11:16AM
UK Regulatory
RNS Number:0518L
BBI Holdings PLC
03 January 2008
BBI Holdings Plc
Delay in FDA clearance for SensoCard Plus
BBI Holdings Plc ("BBI"), the AIM listed developer and manufacturer of rapid
result diagnostic tests and reagents for the diagnostic industry, announces a
delay to the process in gaining FDA clearance to market the SensoCard Plus
glucose meter in the USA.
This delay has been prompted by issues raised by the FDA which will require
further investigation, and possible additional collation of patient data. These
requirements are beyond BBI's control and will involve investment by the
manufacturer, 77 Elektronika ("E77"). The product is CE marked and is
distributed by BBI in the UK. BBI also holds the distribution rights for the US
market.
The SensoCard Plus talking blood glucose meter enables visually impaired and
blind diabetes patients to monitor their blood glucose levels at home, and is
currently the only talking meter available in the UK.
The timing of revenues from this product in the US market remains uncertain and
the Board of BBI does not expect it to generate revenues in 2008/09.
For further information:
BBI Holdings plc 029 2074 7232
Julian Baines, Chief Executive
Cenkos Securities plc 020 7397 8900
Ian Soanes / Adrian Hargrave
Parkgreen Communications Ltd 07980 541 893
Paul McManus paul.mcmanus@parkgreenmedia.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCQXLFBVFBFBBZ
Bbi Holdings (LSE:BBI)
Historical Stock Chart
From Jun 2024 to Jul 2024
Bbi Holdings (LSE:BBI)
Historical Stock Chart
From Jul 2023 to Jul 2024