UK distributor takes on controversial glucose device
This article was originally published in Clinica
Biocontrol Technologies, the company which has been waging a 12-year unsuccessful battle to develop and gain FDA approval for its non-invasive glucose monitoring device, has signed a contract for the product with a UK distributor.
Euro Surgical, a £2.7 million ($4.4 million) turnover company, which handles products from major companies such as Utah Medical and Cooper Surgical, has agreed to distribute the Diasensor 1000 device for a one-year period. Sales will only begin when the company can attach a CE mark to the Diasensor.
The chairman and managing director of the Guildford, Surrey-based company, George Cranstone, said that he was aware of the problems that Biocontrol has faced. He said company representatives told him that stories in a local newspaper had been the source of the recent controversy surrounding Biocontrol.
Mr Cranstone, who went to Pittsburgh and saw the company's R&D laboratories and visited a patient on Biocontrol's clinical trial, said that he was cautious over the possibilities for the device. He said: "I have been aware of the fact that they have had some sort of difficulties in the US. I think a lot more work needs to be done - even in the UK. The device needs specialised and careful treatment and we will be working with both the patient and the clinician."
Last month Biocontrol confirmed that it has received subpoenas to defend charges in court that the share price of the company may have been illegally inflated.
Biocontrol is at present concentrating its efforts on selling the product abroad and says it is distributing the product in the Philippines. The Pittsburgh, Pennsylvania-based company is attempting to attach a CE Mark, using the services of a German notified body. It also announced last year that it was to make its third attempt to apply for FDA approval in the US.