Posted by Tim on January 01, 1999 at 20:55:22:
Originally posted by Tim on December 29, 1998 at 10:32:26:
N E W S R E L E A S E
For information contact: Joni Morford, Communicore 714/721-8081 firstname.lastname@example.org
ORQUEST ANNOUNCES FIRST CLINICAL TRIAL OF HEALOS, A BONE REGENERATION IMPLANT
Study Focuses On Spinal Fusion In Degenerative Disc Disease
For immediate release.....June 18, 1996......Mountain View, California......The first human feasibility study of Healos¨, a new bone grafting material, is underway in France. Patients in the study will be followed to determine how effectively Healos promotes bone formation resulting in fusion of the vertebrae and improved clinical outcome. The study compares Healos with autograft, the standard graft material for spinal fusion. Autograft requires a second surgical procedure on the patient's hip to harvest the bone graft material.
Healos, a new entry in the field of bone regeneration, is a patented, porous sponge-like material made from hydroxyapatite-coated collagen fibers. Animal studies have shown that, while initially providing the framework to support bone growth, the highly biocompatible material is fully resorbed, leaving behind only the newly formed bone. Degenerative disc disease (DDD) is the initial application for which Healos will be tested. Potential future applications include conditions involving spinal fractures, scoliosis, and high-risk fractures that do not heal without intervention.
Mitchell Seyedin, Ph.D., founder and chief executive officer of Orquest, Inc., said, "We are optimistic that this study will show good results in terms of speed of bone growth, bone density, and clinical outcomes. The first human implantation of Healos represents a significant milestone in establishing the effectiveness of this unique material in promoting the growth of bone in patients." The study is planned to ultimately include up to 300 patients in multiple sites throughout Europe following successful completion of the feasibility phase now underway.
Degenerative disc disease--only one of the applications for Orquest's new bone regeneration technology--is the most common identifiable cause of the chronic back pain suffered by more than five million Americans. Approximately 200,000 patients undergo spinal fusion requiring bone graft each year to relieve the discomfort and disability of spinal instability associated with DDD. The bone graft harvesting procedure adds significant cost and patient morbidity to spinal fusion procedures, creating a substantial need for technologies to make spinal fusion and other procedures requiring bone regeneration less invasive and more cost effective.
Orquest, Inc., a private company based in Mountain View, Calif., was founded in 1994 to develop cost-effective solutions to clinical situations requiring bone regeneration, such as spinal fusion and replacement of bone lost due to trauma or disease.
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