BIOSYNTECH REPORTS SUCCESSFUL SAFETY EVALUATION OF BST-GEL.BIOSYNTECH Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BSYI), Laval, Quebec, has successfully completed pre-clinical safety and evaluation studies of one of its lead products, BST-GEL(TM), an injectable, thermo-sensitive hydrogel hy·dro·gel n. A colloidal gel in which the particles are dispersed in water. hydrogel a gel that contains water. hydrogel Wound care A polymer absorptive wound dressing. See Dressing. for therapeutics delivery. The studies showed BST-GEL(TM) to have no systemic toxic effects at dose levels up to 100 times greater than would be used in clinical therapy. The pre-clinical acute and sub-chronic repeat-dose subcutaneous animal toxicology trials were performed at ITR See Internet Talk Radio. Laboratories Canada Inc., in full compliance with the Good Laboratory Practice (GLP See gateway location protocol. ) Regulations of the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . "The successful completion of these pre-clinical studies is very encouraging," said Dr. Ajay Gupta, vice president of Business and Product Development. "BST-GEL(TM) is at the core of the development of a wide array of innovative biomedical products in many different therapeutic areas." The BST-GEL(TM) was also found to localize as a deposit at the site of administration by injection, without causing any inflammatory response or other obvious indications of systemic effects, such as overt clinical signs, mortality, and loss of appetite loss of appetite Medtalk Anorexia, see there or of body weight. The terminal investigations in the sub-chronic studies showed no significant changes in the organ weights and gross pathology findings were limited to localized deposits of BST-GEL(TM) at injection sites without evidence of encapsulation or other adverse biological response. "We are very pleased with the safety profile emerging from these pre-clinical evaluations of BST-GEL(TM)," commented Marie-Claire Pilon, recently appointed 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 BIOSYNTECH. "With these results, we will be moving forward aggressively, as planned, to the next phase of clinical assessment." BIOSYNTECH is an advanced biomaterials company specializing in tissue engineering, the delivery of advanced injectable biomaterials and biotherapeutic agents. For more information, call 450/686-2437. |
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