New Tool From UK’s Zilico Goes After Cancer Diagnosis Market

The pace of new device development is one of things that makes the medical device industry so fascinating. During last week’s Medica trade fair (held Nov. 14-17) in Dusseldorf, Germany, it was almost impossible to keep up with all the new technology being unveiled—much of it for the first time and some of it in the initial phases of rollout.

For the past year or so, Zilico Ltd. is a firm that has been providing glimpses of its innovative system, which is designed to detect cervical dysplasia (the abnormal growth of precancerous cells on the surface of the cervix) more quickly, accurately and easily. The goal is real-time diagnosis, versus waiting several weeks, which often is the current norm.

The device is called the ZedScan I, and it’s due to be launched next year. Sameer Kothari, the company’s chief executive, was on hand at Medica to discuss the technology. Kothari was eager to explore potential commercial partnerships with sales and marketing companies that have experience with selling into the gynecology market.

The company’s system consists of a portable hand-held device, a single-use disposable sleeve and docking station and, according to Zilico officials, is safe and painless. According to Kothari, the device will reduce the number of biopsies taken and has the potential to facilitate the wider use of “see and treat” modality. Using electrical impedance spectroscopy technology, it can measure the resistivity of cells and so detect changes as cells progress from normal to precancerous and then to cancerous.

Brian Brown, professor of Medical Physics and Clinical Engineering at the University of Sheffield, has spent the past 20 years pioneering the use of electrical impedance tomography and electrical impedance spectroscopy (EIS) as clinical tools. He is also the academic founder of Zilico.

According to Brown, the human body conducts electricity “pretty well” and a key research area for him has been examining the electrical properties of tissue.

“Around 20 years ago, I began to develop a technique called electrical impedance tomography, where you place electrodes onto a part of the body and produce an image of the impedance distribution in that area,” he explained. “Different organs have characteristic electrical impedances. For example, lung and muscle tissues have high impedance, whereas blood, that has a lot of extracellular fluid, has a relatively low impedance. Further research showed it was possible to predict the impedance of different tissues once you knew enough about their structure. Tissue impedances change with frequency and it is the impedance spectrum that is characteristic of a particular tissue. EIS is the technique for making these measurements.”

The second application, which is under development, will be positioned as a screening device and will help to reduce the subjectivity and time taken with current tests.

The referral application completed a pivotal European trial of 400 women in 2011 across three hospitals in the United Kingdon and Ireland. The company has since been disseminating these results at key scientific meetings across the world, and was recently awarded the Best Scientific Presentation at the 2012 annual meeting of the American Society for Colposcopy and Cervical Pathology in March. The company also recently participated in the AdvaMed 2012 meeting in October in Boston, Mass.

“The diagnostic tool, including the recent pivotal trial data, has the potential to make a significant impact on how women are managed within the cervical cancer pathway,” Kothari said. “This makes the Zilico proposition very attractive to those considering potential partnerships.”

Just prior to the Medica meeting, Zilico secured approximately $1.2 million in additional investment from The North West Fund for BioMedical. This follows another round of funding of approximately $1.6 million in June.

Zilico originally was spun out from the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust in the United Kingdom.

Cervical cancer affects around 500,000 women worldwide each year and is responsible for 300,000 deaths. Under current UK screening practices, a woman will have a Pap smear or liquid based cytology test every three or five years. If the test is positive, she will be referred to a colposcopy clinic for a detailed cervical examination. The investment will be used to manufacture commercial devices and to establish its route to market for European Union and other areas.

After its launch in Europe, the company hopes to follow with the U.S. market.

Going forward, the company’s technology has potential for use in the diagnosis of other forms of cancer, Brown said, particularly anal or oral cancer, where “incidences are on the rise.”

“Both these types of cancer are accessible for this type of testing and the particular kinds of cell arrangements involved are likely to give good results for EIS,” he said.