Shares digital

Diagnostics specialist BBI Holdings (BBI:AIM) is facing delays in getting FDA clearance to market the SensoCard Plus glucose meter in the US.

The talking blood glucose meter allows visually impaired and blind diabetes patients to monitor their blood glucose levels at home and is the only talking meter currently available in the UK. However, delays look certain after the FDA called for further investigation, and possibly the collation of further patient data.

BBI says that this is beyond its control and will involve investment by the manufacturer 77 Elektronika. BBI acquired SensoCard Plus in July 2006, giving the group exclusive distribution rights for the product in the UK where it is CE-marked, and shared distribution rights for the US, Canada and India.

The group had initially hoped to achieve FDA clearance in the first half of 2008. BBI now says that the timing of revenues from the meter in the US market ‘remains uncertain’ and it is unlikely to generate revenues in 2008/09. However, despite the setback, shares in BBI ticked up to 187.5p.

BBI recently agreed to a takeover by Massachusetts-based Inverness Medical Innovations (IMA:AMEX). IMI already had a 12% stake in BBI before the offer was made.

Shares says: Although a disappointing setback, the group has plenty of other solid developments/products up its sleeve.