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Optasia Medical Limited Receives U.S. FDA 510(k) Clearance for SpineAnalyzer(TM)


2/9/2011 7:33:04 AM

MANCHESTER, UK, and SUDBURY, MA--(Marketwire - 02/09/11) - Optasia Medical, a leading image analysis software applications provider, today announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for SpineAnalyzer™, an innovative workflow tool for the quantitative assessment of vertebral deformities in patients at risk of osteoporosis. The output of the device may be used by physicians to assist in the diagnosis of vertebral fractures, a key factor to determine if therapeutic intervention is indicated.

"The aging population and resulting increase in the number of patients suffering from osteoporosis is placing an ever increasing burden on healthcare systems, yet the existing tools to assist with the diagnosis of vertebral fractures are inadequate," said Peter Steiger, Optasia Medical's Chief Executive Officer. "In 2005, over 2 million osteoporosis-related fractures occurred in the US, a number expected to reach 3 million by 2025. The costs related to these fractures were $16.9 billion in 2005 and are predicted to rise to $25 billion by 2025. Despite the availability of bone densitometry and pharmacological therapies, the incidence and costs related to osteoporosis have not decreased."

Alan Brett, Optasia Medical's Founder and Chief Technology Officer, added: "Only 25% of vertebral fractures are clinically apparent, and 20% of women who are not considered osteoporotic by bone densitometry have vertebral fractures. The National Osteoporosis Foundation's Clinician's Guide to Prevention and Treatment of Osteoporosis states that patients with a clinical or morphometric vertebral fracture should be considered for treatment. In addition, the Guide recommends using the World Health Organization's Fracture Risk Assessment Tool (FRAX) to estimate a patient's 10-year fracture risk, where previous fractures, including vertebral fractures, have a significant impact on a patient's risk."

Harry K. Genant, Professor Emeritus of Radiology, Orthopedic Surgery, Medicine, and Epidemiology at the University of California San Francisco, commented: "I believe that, in the hands of physicians, the SpineAnalyzer Program represents a major step forward in facilitating and standardizing their assessment of vertebral fractures across a broad spectrum of osteoporosis clinical and research practice."

"A vertebral fracture, found on a radiograph, is the most important risk factor for future fracture" said Dr. Steven R. Cummings, Professor of Medicine and Epidemiology, at the University of California in San Francisco. "Patients who have evidence of a fracture on x-ray should receive effective drug therapy to prevent additional fractures. However, most vertebral fractures are missed by current clinical assessments and reports. We have used SpineAnalyzer to assess hundreds of spine films and I am impressed that it would change practice by making accurate assessment of vertebral deformities an easy, routine part of radiologic practice; this would substantially improve patient care."

Optasia Medical has recently established distribution capability in the U.S. and plans a formal launch of SpineAnalyzer.

For more information on Optasia Medical and SpineAnalyzer, please visit www.optasiamedical.com.

About Optasia Medical Optasia makes software that facilitates the reading of x-rays for the management of musculoskeletal diseases. Our products are used in clinical trials and by physicians to identify and monitor patients who will benefit from treatment. With Optasia Medical's automated workflow tools, x-rays can be evaluated more rapidly, more accurately and more reproducibly. Optasia Medical's current offerings include SpineAnalyzer™, a PACS/DICOM workstation software solution for the assessment and documentation of vertebral deformities in osteoporosis, KneeTool™, for the quantification of joint space narrowing in Osteoarthritis, and RapidScore™, for the rapid documentation of disease progression in hand and foot x-rays of patients suffering from rheumatoid arthritis. For more information about the software applications that Optasia can provide visit: www.optasiamedical.com.

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=1506262 Contact:

Contacts: Peter Steiger CEO Tel: +1 508 405 4392 Email: Email Contact Alan Brett CTO Tel: +44 (0)161 491 7860 Email: Email Contact


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