SAN JOSE, Calif.–(BUSINESS WIRE)–DFine, Inc., a developer of minimally invasive solutions for treating vertebral compression fractures, announced today that distribution agreements have been signed for the Netherlands and Saudi Arabia by DFine GmbH, a subsidiary of DFine Inc. DFine is now commercially available in seven countries within Europe and the Middle East. In 2009, distribution agreements in Austria, UK, Greece and Turkey were completed to supplement the company’s direct organization in Germany and expand commercialization efforts throughout Europe.
“Adding distribution agreements in key markets where we can leverage our infrastructure, and where there is potential to treat patients suffering from vertebral compression fractures, remains a top priority for DFine,” said Kevin Mosher, Chief Executive Officer of DFine, Inc. “Continued focus on global commercialization efforts is essential to creating a robust international business focused on achieving DFine’s mission statement to develop and market therapeutic devices that treat vertebral compression fractures and other spinal disorders in a minimally invasive manner to improve patient quality of life.”
Regulatory approvals slated for the second half of 2010 in key countries within Latin America will provide additional market expansion opportunities for DFine and allow patients suffering from vertebral compression fractures access to advanced medical treatment. Expanding global commercialization efforts coupled with several key product launches scheduled throughout 2010 further reinforce DFine’s position as the technology leader in the treatment of vertebral compression fractures.
About Vertebral Compression Fractures:
There are approximately 750,000 vertebral compression fractures (VCFs) due to osteoporosis that occur in the US each year with only 1/3 being diagnosed by physicians. [1][2] Several studies have documented a decrease in mobility, patient quality of life and life expectancy due to osteoporotic vertebral compression fractures indicating it is a significant problem for elderly patients. [3][4][5] Economic studies have shown there are over 100,000 admissions due to VCFs in the US each year costing in excess of $500 Million/year in the United States alone. [6][7] As pain medication and bed rest can exacerbate the degree of bone loss and decrease patient mobility leading to other medical problems, the use of minimally invasive treatments like vertebroplasty and kyphoplasty have become increasingly common in the US and Europe to relieve pain and regain patient mobility and improve quality of life. [1],[6]
About DFine
DFine, Inc., a privately held medical device company based in San Jose, Calif., is dedicated to advancing minimally invasive solutions for treating vertebral compression fractures and other spinal disorders to improve patient quality of life. DFine’s RF Kyphoplasty procedure with the StabiliT® Vertebral Augmentation System provides physicians greater control in the treatment of vertebral compression fractures through site and size specific cavity creation and an ultra high viscosity bone cement over an extended working time using a remote controlled delivery system to stabilize the fracture, relieve pain and improve patient quality of life. For more information, visit www.dfineinc.com.
References
1. Melton L, Thamer M, Ray N et al. Fractures attributable to osteoporosis: report from the National Osteoporosis Foundation. J Bone Miner Res 12:16-23 1997
2. Papaioannou A, Watts N et al. Diagnosis and Management of Vertebral Fractures in Elderly Adults. Am J Med 113:220-228 2002
3. Gold D. The Clinical Impact of Vertebral Fractures: Quality of Life in Women with Osteoporosis. Bone 18:1855-1895 1996
4. Kado D, Browner W et al. Vertebral Fractures and Mortality in Older Women. Arch Inter Med 159:1215-1220 1999
5. Cauley, J Thompson D et al. Risk of Mortality Following Clinical Fractures. Osteoporosis International 11:556-561 2000
6. Gehlbach S, Burge T, et al. Hospital care of osteoporosis-related vertebral body fractures. Osteoporosis International 14:53-60; 2003
7. Riggs B, Melton L. The Worldwide Problem of Osteoporosis: Insights Afforded by Epidemiology. Bone 17:505S-511S 1995
