Disc Dynamics Inc. Receives Approval to Begin U.S. Clinical Trial of Its DASCOR(TM) Disc Arthroplasty System
Posted on: Wednesday, 2 August 2006, 09:00 CDT
Disc Dynamics Inc. announced it has received U.S. Food and Drug Administration (FDA) approval to commence a clinical study of its DASCOR Disc Arthroplasty System. DASCOR is a catheter-based, minimally invasive nucleus replacement technology designed to treat lower back pain associated with degenerative disc disease.
"This is a major achievement for our company, and is a direct result of the significant efforts of our employees and clinical advisors," said Steven J. Healy, chief executive officer. "We are excited about beginning the process of bringing Disc Dynamics' novel DASCOR technology to U.S. patients."
Back pain is a significant health complaint in the United States. Annually, there are approximately 10 million patient visits due to lower back pain. While 90 percent of lower back pain sufferers recover without surgical intervention, Disc Dynamics intends to target the remaining 10 percent who seek surgical options for relief.
The DASCOR Disc Arthroplasty System has been in clinical use outside of the U.S. since 2003. In July 2005, Disc Dynamics received CE Mark approval for the commercial sale of the technology in the European Union.
About Disc Dynamics
Based in Eden Prairie, Disc Dynamics Inc. is an orthopedic spine company founded in 2000 to provide patients and physicians with a minimally invasive surgical alternative for treating degenerative disc disease. The company has developed the DASCOR Disc Arthroplasty System, a catheter-based, minimally invasive nucleus replacement technology for the treatment of degenerated lumbar discs. The goal of the DASCOR technology is to relieve pain, restore function and preserve anatomy. For more information, visit the company's Web site at www.discdyn.com.
Disc Dynamics is funded by strategic and venture investors. The lead venture investors include Split Rock Partners, Pequot Ventures, Affinity Capital and Brightstone Capital.
Source: Business Wire
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