FRAMINGHAM, MA--(Marketwired - Jun 9, 2015) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), obtained data from a preclinical toxicity test for AC5™ that show the device was well-tolerated and classified as "not toxic" in a standardized test of systemic toxicity. The systemic toxicity animal test is a major component of the biocompatibility test panel that a medical device must typically complete successfully prior to use in humans. Testing was conducted under the guidelines provided by the International Organization for Standardization's (ISO) and the study also complied with Good Laboratory Practice (GLP), a Federal regulation (21 CFR part 58) governing the conduct of nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration (FDA). AC5 is a development-stage hemostasis product being evaluated to control bleeding and fluid loss in order to provide faster and better surgical and interventional care.
In this standard in vivo study, designed to provide general information on the health hazards likely to arise from acute exposure to clinically relevant quantities of AC5, AC5 was well tolerated and classified as not-toxic using standardized success criteria based upon comparison with control materials, monitoring animal body weight and any changes in animal behavior. Results from this biocompatibility safety study indicate that AC5's peptide structure and mechanism of action, which is based on the formation of a local physical-mechanical barrier at the wound site, does not promote toxicity to the overall biological system following injection of standardized AC5 solutions into animals. The results of this study provide further evidence of the absence of toxicity for AC5, and represent a critical step toward demonstrating biocompatibility of this medical device.
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