DYSIS gains FDA Clearance to Market
DYSIS MEDICAL ANNOUNCES USA MARKET ENTRY
EDINBURGH, SCOTLAND, March 2011
DYSIS Medical, headquartered near Edinburgh, has today confirmed its intention to market its unique DYSIS device in the United States of America. The announcement was made following a Clearance to Market notification from the US Food and Drugs Administration under the 510(k) programme. DYSIS is a breakthrough device that provides clinicians with a non-invasive method to assist in the detection of cervical cancer at the earliest possible stages of the disease.
Cervical cancer is the second most common cancer, affecting around 500,000 women and resulting in 250,000 deaths a year in the developed world. DYSIS Medical estimates that widespread adoption of its device would not only dramatically reduce the number of deaths but would also reduce cervical cancer healthcare related costs.
Alastair Atkinson, Chief Executive Officer, said, “Last year our focus was entirely on Europe where we achieved excellent growth in the installed base, and developed a strong network of 14 partner relationships across Europe and the Middle East. Our clearance to market DYSIS in the USA opens the next chapter in the company’s growth plan.” DYSIS will be exhibited first at the American College of Obstetricians and Gynaecologists (ACOG) conference at Washington DC, in May.
The company, formerly known as Forth Photonics, has its global headquarters in Livingston near Edinburgh, Scotland with a Sales and Customer Service Centre in Athens, Greece. It designs, manufactures and markets imaging systems that are based on a patented method of analysing bio-chemical interactions to highlight pre-cancerous lesions.
For further information contactAlastair Atkinson, CEO, DYSIS Medical Ltd.
Notes for editors
ABOUT DYSIS Medical
DYSIS Medical has developed a proprietary technology platform that has the potential to address a number of diseases affecting millions of people worldwide and costing billions of dollars to healthcare systems. The first product introduced to the market is DYSIS, which focuses on assisting the non-invasive, in vivo detection and diagnosis of cancerous and pre-cancerous lesions of the cervix. DYSIS provides advanced tools to aid medical practitioners in the detection, grading, and documentation of cervical neoplasia. Clinical trials have demonstrated and proven the substantial advantage created by DYSIS and argue strongly for its adoption as a new standard of care.