Imaging Therapeutics, Inc. Receives FDA Marketing Clearance for Hip Bone Mineral Density
REDWOOD CITY, Calif. -- Imaging Therapeutics, Inc has received marketing clearance from the United States Food and Drug Administration to market its OsDx[TM] Hip Bone Mineral Density (BMD) system. OsDx Hip BMD is a stand-alone x-ray image-processing software system intended to provide an estimate of BMD of the proximal femur using standard antero-posterior hip or pelvis radiographic images. This information may be used by physicians in the assessment of osteoporosis.
According to the 2004 Surgeon General Report on Bone Health and Osteoporosis, an estimated 10 million Americans suffer osteoporosis while another 34 million Americans are at risk of disease. There are more osteoporosis-related bone fractures in the United States than heart attacks, symptomatic strokes, or new diagnosis of all forms of cancers. Osteoporosis-related fractures often lead to deterioration in physical and mental health. For hip fractures, the impact is especially problematic as the mortality rate approaches 25% within the first year of fracture.
At the present time, bone mineral density testing is most commonly estimated using dual energy x-ray absorptiometry. However, limited instrument availability, decreasing reimbursement, and other factors all act to limit testing for many patients. This results in a majority of people at risk and in need of treatment not being identified.
Imaging Therapeutics' technology permits BMD testing to be performed using any conventional x-ray system. Because there are far more conventional systems than dual energy x-ray absorptiometers. OsDx software will help make BMD testing more convenient and readily available. Increased early detection will allow for early drug intervention and lifestyle modifications reducing fractures and their associated morbidity and mortality.
Dr. Patrick Hess, Imaging Therapeutics' President and CEO comments "I am very pleased with achieving this important milestone. It represents the first of several important products that will collectively act to increase capacity for screening osteoporosis as well as significantly improve the ability to assess an individual's risk for osteoporosis-related bone fracture. It is our vision to reduce the enormous societal burden that osteoporosis has become by helping to reduce individual pain, suffering, and cost."
About Imaging Therapeutics, Inc.
Imaging Therapeutics, Inc. is a privately held advanced medical technology company that develops novel, proprietary image processing technology for advancing the treatment and management of osteoporosis and osteoarthritis. A pipeline of software products is being developed to advance the ability of clinicians to screen for, diagnose, monitor, and predict disease.