Synthetic Bone Takes the Pain Out of Back Surgery; Sulzer Medica to Launch Orquest's Bone Graft Substitute in Europe.Business Editors & Health/Medical Writers MOUNTAIN VIEW, Calif.--(BW HealthWire)--Oct. 10, 2000 Sulzer Spine-Tech, a subsidiary of Sulzer Medica medica (māˑ·dē·k , and Orquest, Inc., announced today at the EuroSpine 2000 meeting in Antwerp, Belgium, the market launch of a new biological product that acts as a template for bone formation. Healos(R) Bone Graft bone graft Orthopedic surgery Sterilized bony tissue, often of cadaveric origin, used to fill and/or 'sculpt' bone defects Indications Spinal fusion, revision of failed articular prostheses, filling traumatic or malignant bone defects, or periodontal defects. Substitute, bioengineered from the same collagen and mineral that are found naturally in bone, is designed to eliminate a painful, costly and time consuming surgical procedure. Healos has received CE Mark clearance in Europe for use as a replacement for bone material which is normally harvested from the patient's hip. This bone material, (autograft autograft: see transplantation, medical. ) is used in spinal surgery to support the fusion of two vertebrae Vertebrae Bones in the cervical, thoracic, and lumbar regions of the body that make up the vertebral column. Vertebrae have a central foramen (hole), and their superposition makes up the vertebral canal that encloses the spinal cord. . Autograft represents the clinical gold standard in spinal fusion spinal fusion n. A surgical procedure in which vertebrae are joined. Also called spondylosyndesis. Spinal fusion operations and other bone grafting Bone Grafting Definition Bone grafting is a surgical procedure by which new bone or a replacement material is placed into spaces between or around broken bone (fractures) or holes in bone (defects) to aid in healing. applications. Healos is the first synthetic product that has performed as well as autograft in a controlled spinal fusion clinical study. Each year more than 600,000 spinal fusion procedures are performed worldwide to treat patients suffering from debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction back pain or injury. A synthetic substitute for autograft in spinal fusion is a major unmet medical need because the autograft harvesting procedure increases surgery time, can cause chronic hip pain and deformity, a longer hospital stay and post-operative disability. In new two-year data to be presented at a seminar preceding EuroSpine 2000, patients treated with Healos continue to demonstrate excellent clinical results and to experience relief from their back pain. In addition, over 200 patients have been treated with Healos since the beginning of 2000 in 30 hospitals across Europe. In the U.S., Healos is currently under clinical investigation in combination with Sulzer Spine-Tech's BAK Bak Bak A member of the bcl-2 family expressed in a wide range of cells which, when overexpressed in NGF-deprived sympathetic neurons accelerates apoptosis, and counteracts Bcl-2's apoptosis-protecting effects. See Bcl-2. (TM) Interbody Fusion system of cage implants and has been implanted in over 100 patients. Healos (R) Bone Graft Substitute is available for sale in Europe through Sulzer Medica. "We are excited to introduce Healos to spine surgeons throughout the European Community," said Rich Lunsford, General Manager of Sulzer Spine-Tech, a subsidiary of Sulzer Medica. "Healos represents a true advance in less invasive treatments for spine care." Gregory D. Casciaro, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Orquest, Inc., the developer of Healos, said "Healos is the first real off-the-shelf alternative to the very painful procedure of cutting away the patient's own bone for use in spinal fusion surgery. We believe Healos will have a huge impact on the billion dollar bone grafting market because it improves patient well being, reduces provider costs, and is easy to use." Sulzer Medica, the parent company of Sulzer Spine-Tech, is headquartered in Winterthur, Switzerland. It develops, manufactures and markets implantable medical devices and biomaterials for the cardiovascular and orthopaedic markets worldwide. (Swiss Stock Exchange:SMEN) (NYSE NYSE See: New York Stock Exchange :SM). Sulzer Spine-Tech, based in Minneapolis, Minn., is a worldwide leader in minimally invasive spine surgery technology. As the pioneer in interbody fusion cages, Sulzer Spine-Tech first introduced the BAK system of implants to the US marketplace in September 1996. Over 40,000 procedures have been performed using BAK interbody fusion cages. Orquest is a privately held medical technology company dedicated to setting new biological standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given in orthopaedics. With two platform technologies and several novel products in the clinic, Orquest is the clear leader in orthobiologics. The Company's products encompass the growth market segments in orthopaedics: spine surgery, fracture management, and cartilage repair. Healos Bone Graft Substitute joins HealosMP52, a next generation bone grafting matrix, and Ossigel(R) -- an injectable product for fracture healing -- in Orquest's expanding line of materials for bone and cartilage regeneration. THE SAFE HARBOR STATEMENT UNDER THE US PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 1995 This news release contains forward-looking statements, such as projecting future financial results and possible acquisitions, which include some risk and uncertainty. These statements are subject to change based on known risks detailed from time to time in the company`s Securities and Exchange Commission filings and other known and unknown risks and various other factors which could cause the actual results or performance to differ materially from the statement made herein. This press release is available on Sulzer's web site: www.sulzermedica.com/media/mainpage.htm. This press release is also available on Orquest's web site: www.orquest.com. |
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