|May 14, 2003
IGI Receives US FDA Clearance
|DenX announced today that it has received United States Food and Drug Administration (FDA) approval for its Image Guided Implantology (IGI) system allowing the Company to enter the lucrative US dental implant market.
FDA approval represents a significant milestone in DenX's ten-year history, clearing the path for the launch of the company's first clinical product in the United States on the back of its first product, DentSim, an advanced dental training simulator used in the training laboratories of some of the world's leading dental universities.
Having established its technology and brand name through DentSim (which, to date, has generated sales of approximately $15 million), FDA clearance for IGI will enable DenX to unlock the potentially immense value of its proprietary real time surgery navigational technology in the dental implant market.
Dental implant surgery is one of the most lucrative procedures in dentistry and is attracting increasing numbers of practitioners, despite the inherent risks in today's relatively primitive methods. Driven by ageing populations and the superiority of dental implants over bridges and dentures, the demand for dental implants has been growing steadily for the past 6 years with industry estimates projecting this rate of growth will continue at around 15% per annum1. Of the approximately 1 million dentists worldwide, it is estimated that 7% (70,000) currently perform about 3 million implant procedures per year.
IGI is DenX's breakthrough dental implant navigation system and has the potential to significantly accelerate the growth of the dental implants market by reducing the risk and increasing the precision of dental implant surgery. Using image-viewing software and DenX's proprietary Motion Tracking Technology, IGI is a state-of-the-art planning and real time navigational tool. As a planning tool, IGI evaluates CT data and provides the medium for assisting in the choice of the optimal placement of the dental implant. During the implantation procedure, IGI compares the plan in real time to the actual performance of the implant practitioner using visual and audio signals for continuous guidance to assure maximum correlation between pre operative planning and actual drilling.
DenX's IGI system also has European regulatory approval and initial sales have been made in Germany, Spain and Italy. Initial sales have also been recorded in Japan, Taiwan, Korea and Hong Kong with further sales in Japan pending local regulatory approval.( The global dental implants market is currently valued at approximately $US3 billion per annum.)
The US is, however, DenX's major target market and for several months the Company has been working on the establishment of a US Center of Excellence for dental implants. We are presently in negotiations with a leading practice specialising in dental implants with clinics in Florida and are hopeful of performing our first implants in the US in coming months. Subject to the successful completion of negotiations these clinics will act as a base from which DenX can develop its optimal revenue model for the US.
Established in Israel in 1994, DenX (ASX:DNX) is a developer of some of the world's most advanced and cost-effective surgery navigation technology. DenX listed on the ASX in November 2002 following Helm Corporation's acquisition of the company and a capital raising, conducted principally to increase shareholder spread. Helm subsequently changed its name to DenX Limited and now derives all earnings from the operations of DenX. Based on image guided methods, DenX's proprietary surgery technology has been used as the basis for the development of the company's two key products for the dental market - DentSim and the Image Guided Implantology dental navigation system (IGI). DenX's technology additionally has possible applications in other surgery markets including the potential to revolutionise a variety of high-risk orthopaedic procedures.
Angus Holt - Executive Director
Ph: 03 9642 0722
Mob: 0412 353 395