Medisys, the Aberdeen-based medical devices group, has been hit by another delay to the launch of its revolutionary safety syringe and its marketing partner says it has "almost given up" on the product.
The Futura device has failed another set of last-minute safety tests conducted by Smiths Group, the FTSE 100 conglomerate that will distribute the product in the US. The revelation comes two months after Medisys said it had overcome design problems and that the product would be on the US market within a fortnight.
The string of delays has driven Smiths to despair, and its chief executive, Keith Butler-Wheelhouse, said he will not launch Futura until the problems have been comprehensively resolved. He said Smiths is no longer banking on the product making any sales at all. He said: "We cannot afford to put our reputation on the line for something that doesn't work correctly. We have almost given up on it, frankly".
The device, whose needle is pulled back inside the syringe with a rubber band to stop hospital staff pricking themselves, has been plagued by problems in development and manufacturing and last November even its launch was pulled at the last minute.
Tests by Smiths then had revealed defects which "in extreme circumstances, could affect its performance in certain clinical uses", but Medisys said it had successfully made the necessary improvements in July.
The latest tests to have thrown up problems are being conducted by staff at a number of US clinics.
Michael Barry, the finance director at Medisys, said that he did know of the data to which Mr Butler-Wheelhouse referred. The clinical process is still "incomplete", he said.
"In a clinical process there is a lot of data that has to be considered and collated and some comments have been positive, some negative. One of the comments we have had back is that the product needs in-service training," said Mr Barry.
A number of small UK companies have battled to design revolutionary syringes after the US - the world's biggest health market - introduced legislation to encourage the use of safer products so hospital workers are less likely to prick themselves. All have been plagued by delays. NMT abandoned the race entirely, saying it would try to sell its needleless syringe to drug companies, rather than direct to hospitals, while PowderJect Pharmaceuticals, recently sold to Chiron of the US, turned itself into a vaccines manufacturer.
Medisys shares were worth 166p in 2000, when the Futura syringe was supposedly just months away from launch. Yesterday, they were down 0.75p to 19.25p.Reuse content