Healthcare Industry News: Biostat
News Release - June 20, 2007
Baxter Signs Agreements to Evaluate TISSEEL Use With New, Innovative TherapiesFibrin sealant to be used in combination with investigational treatments for chronic back pain and wound repair
DEERFIELD, Ill., June 20 (HSMN NewsFeed) -- Baxter International Inc. (NYSE: BAX ), today announced that it has signed individual licensing agreements with Intercytex (LSE: ICX.L ) and Spinal Restoration to evaluate the use of Baxter's fibrin sealant TISSEEL ® in novel regenerative medicine therapies.
"Baxter's new partnerships will broaden the application of TISSEEL in new and investigational applications that are intended to address unmet needs," said Ronald Lloyd, vice president and general manager of Regenerative Medicine at Baxter. "These agreements reflect our ongoing commitment to improving clinical procedures through the therapeutic use of our fibrin sealants."
Under terms of the agreements, Baxter will supply Intercytex and Spinal Restoration Inc. with TISSEEL at agreed upon pricing for use in their investigational treatments. Baxter will also obtain shares as part of the Spinal Restoration agreement.
Intercytex, Cambridge, England, will use TISSEEL in combination with allogeneic dermal fibroblasts (cells that are critical to the wound healing process) in the continuing development of two of its products; ICX-PRO, an investigational topical wound care product designed to actively stimulate healing in chronic wounds and ICX-SKN, an investigational skin replacement designed to replace autologous skin grafts.
Currently in Phase II and III trials, ICX-PRO is being evaluated in a variety of chronic wound settings including venous leg ulcers and diabetic foot ulcers. ICX-SKN recently completed a Phase I trial.
Spinal Restoration Inc., Austin, Texas, is working with Baxter to use TISSEEL in the development of its Biostat BIOLOGX(TM) Fibrin Sealant to augment healing and repair of painful defects in the intervertebral disc area of the spine. The sealant will be combined with the company's proprietary technology to create the Biostat(TM) Disc Augmentation System, a minimally invasive product that will be studied to determine safety and efficacy for the treatment of painful degeneration of intervertebral discs.
Fibrin is a protein polymer involved in the clotting of blood that is used by the body to stimulate the repair of human tissue wounds. TISSEEL is part of Baxter's Regenerative Medicine business unit within the BioScience division. The Regenerative Medicine business unit also sells products used in hemostasis, tissue sealing and tissue regeneration and adult stem-cell therapies for cancer patients.
About TISSEEL® [Fibrin Sealant]
TISSEEL is indicated for use as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature and cautery, is ineffective or impractical. TISSEEL is not indicated for the treatment of massive and brisk arterial or venous bleeding. TISSEEL has also been shown to be an effective sealant as an adjunct in the closure of colostomies and is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass.
TISSEEL is contraindicated in individuals who are known to be hypersensitive to bovine protein. Do not inject TISSEEL directly into blood vessels. Intravascular application or injection of TISSEEL directly into tissues may result in life-threatening, thromboembolic events and/or allergic/anaphylactoid reactions. Especially in coronary bypass surgery, TISSEEL should be applied with caution to minimize any risk of inadvertent intravascular application. The safety and effectiveness of TISSEEL used alone or in combination with biocompatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated. As with all human plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated. For more information, see http://www.baxter.com/products/biopharmaceuticals/downloads/Tisseel_PI.pdf.
Baxter International Inc (NYSE: BAX ), through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
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