Spinal Restoration And Baxter Announce Agreement For Developing Spinal Disc Application
Austin, TX - Spinal Restoration and Baxter Healthcare Corporation have entered into an exclusive, long-term partnership to develop and commercialize Biostat BIOLOGX Fibrin Sealant, a key element of Spinal Restoration's new biologic therapy for chronic low back pain. Baxter's fibrin sealant will be combined with the Company's proprietary technologies to create the Biostat Disc Augmentation System, a minimally invasive product that will be developed and tested for the treatment of painful degeneration of intervertebral discs.
Biostat BIOLOGX Fibrin Sealant will be developed to augment the healing and repair of painful defects within the intervertebral disc area of the spine. The product is intended to exploit the biologic benefits of fibrin, the human-based, protein polymer used by nature to guide and stimulate all human tissue wound repair.
Baxter is the manufacturer of fibrin sealants and one of only two companies with FDA approval to market products in the U.S.
"The therapeutic benefits of our fibrin sealants have been proven in a wide variety of clinical applications," said Ronald Lloyd, vice president and general manager of Regenerative Medicine at Baxter. "Baxter is excited to partner with Spinal Restoration to expand the application of our technologies with the potential to help the millions of people who suffer from chronic back pain."
Baxter joins an already impressive list of Spinal Restoration business partners, including its device development partner Accellent, the world's largest OEM manufacturer of medical devices, and Regulatory & Clinical Research Institute, the largest medical device CRO in the U.S. Spinal Restoration will use this partnership with Baxter to further enhance their preparation for an investigational device exemption (IDE) clinical study scheduled for the first quarter of 2008.
"We are honored to have Baxter as our partner for the development of Biostat BIOLOGX Fibrin Sealant," said Gary Sabins, President and CEO of Spinal Restoration. "Baxter's fibrin sealants have a long history of safety and clinical success and we are excited about applying the technology to create an effective non-surgical therapy for this large patient population."
SOURCE: Spinal Restoration and Baxter Healthcare Corporation