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Ultrasound is so named because it is beyond the limits of normal human hearing and so is inaudible. Medical scanning and diagnosis with ultrasound — ultrasonography — has been employed for many years, particularly to produce a scan of a womb and foetus to check the baby is developing normally.
A scan makes it simple to determine that the body shape is correct and that all organs are in place and properly shaped. In addition, the size of head, abdomen and limbs can be determined and measured against norms using software. This is called quantification.
The current limitation of the technology is that that the transducer or sensor produces a segment-shaped image rather like a slice of pizza. To examine an area or areas outside the segment demands further scans from different points, then piecing together the multiple images.
Intelligent Ultrasound, based at the Oxford Centre for Innovation, has developed software that combines the scanned segments to produce an integrated, 3D moving image.
The company, founded by Professor Alison Noble, Dr Aris Papageorghiou and chief executive Andy Hill, is in the final stages of spinning out from Oxford University’s Institute of Biomedical Engineering.
Ultrasound’s great advantage is that it is safe, making it ideal for obstetrics. It is also simple and relatively cheap. Scanners range in size from a laptop to a trolley: contrast that with an MRI scanner, which demands a huge magnet, special facilities and costs millions.
Clinical applications for ultrasound go far beyond foetal scans. Cardiologists find it invaluable, as do surgeons, who can determine the patient’s condition without an exploratory operation. A scan will even identify the size, shape and location of a tumour, making it ideal for cancer treatment.
With advances in non-invasive treatments for tumours, ultrasound offers a very accurate tumour location. This allows the therapy to be aimed precisely and avoid damage to surrounding tissues. “Ultrasound works very well in soft tissue,” explained Prof Noble. “It can’t really penetrate bone and obesity can both weaken and distort the signal.”
To image organs obscured by bone, an ultrasonologist has to find a gap, an acoustic window, through which to point the transducer. So in an area like the knee, scans have to be taken from several points to get both a clear and a complete picture.
But pre-operation scans to ‘get the picture’ can be conducted by a non-expert, and quickly, a distinct advantage for any surgeon. The 3D images from Intelligent Ultrasound’s software are built up in layers, each of which can be stripped away to allow a view deeper into the tissue.
Prof Noble and her team have been researching the technology for seven years. The arrival of 3D transducers onto the market in 2003 was a major breakthrough. Since then, the research has focused on improving the quality of the image analysis and speed of operations.
The company will produce its software as a medical device to be sold to manufacturers of ultrasound hardware. The plan is to have a cardiology application ready six months after start-up and then partner with hardware manufacturers to design other specific applications.
“We took the strategic decision to write the software as a medical device to create confidence with the manufacturers,” said Mr Hill. “It means recording the data to make it compliant with both UK and US regulations. And it will meet ISO 13485, the standard for medical devices. That means inspection by both the British Standards Institute and the US Food and Drug Administration, but that is all to our advantage.”
Manufacturing will be to the stringent US Good Manufacturing Practice standard, with the program running either as an application or embedded as part of an existing software.
Mr Hill’s background has been in medical devices and fundraising with UK, European and US companies.
His new company needs £750,000 of start-up capital, which is scheduled to bring it to profitability. So far, he has raised £500,000, mainly from UK business angels, but is finding the last tranche a touch more difficult. Intelligent Ultrasound qualifies under the Enterprise Investment Scheme, which affords tax advantages to investors.
“We need to push the boundaries of ultrasound,” Mr Hill said. “Right now, only about 70 per cent of patients who could benefit from such a scan can access one. With our technology, that rises to near 100 per cent. The great thing too is that our software fits existing hardware without demanding expensive upgrades to the machinery, so it’s an attractive proposition.”