Posted by Mike on December 28, 1998 at 17:43:32:
I found this at the following site.
N E W S R E L E A S E
For information contact:
Joni Morford, Communicore
ORQUEST ANNOUNCES FIRST CLINICAL TRIAL OF HEALOS¨,A BONE
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
S. 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
End of document.
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