FRAMINGHAM, MA -- (Marketwired) -- 09/08/15 -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), obtained favorable data from a preclinical toxicology test for AC5™ showing that the device did not cause sensitizing reactions in animals and is considered a "non-sensitizer." The test, called the Maximization Test, is a standardized test of contact sensitization and is performed in animals as 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 (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, mitigate fluid loss, and create an environment permissive to normal healing in order to provide more efficient 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 when using standardized success criteria based upon comparison with control materials. As a result, AC5 was classified as a non-sensitizer with no evidence of causing delayed contact sensitization. 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 sensitization to the overall biological system following application of standardized AC5 extract solutions in 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.
Read more: http://www.archtherapeutics.com/news/press-releases/detail/453/arch-therapeutics-obtains-additional-positive-safety-data