Source: Arch Therapeutics & reported by http://www.marketwired.com/
FRAMINGHAM, MA--(Marketwired - Mar 14, 2016) - Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of the AC5 Surgical Hemostatic Device™ ("AC5™"), has obtained favorable results from a broad panel of preclinical biocompatibility tests that were performed on AC5, which is required prior to the planned filing of a CE Mark application and commercialization of AC5 in Europe. Results from these biocompatibility safety studies 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 exposure to AC5.
Arch Therapeutics President and CEO Terrence Norchi, MD, stated, "This testing of AC5, performed under International Organization for Standardization (ISO) and Good Laboratory Practice (GLP) protocols, represents another step in our progress toward commercialization. Outcomes of the biocompatibility tests can be meaningful predictors of human safety, which enhances our confidence as we continue with our first human trial. Further, they are an important component of a CE Mark application, which we expect to file this summer -- and obtaining a CE Mark is a required critical step for commercialization."
The standardized studies included tests to assess cytotoxicity, implantation, irritation, pyrogenicity, sensitization and systemic toxicity. The testing was conducted on AC5 samples that were produced and sterilized under the same Good Manufacturing Practice (GMP) protocols as used for the product being tested in the Company's human trial that is underway in Western Europe. Testing was conducted under the guidelines provided by the ISO. The studies also complied with 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 United States Food and Drug Administration (FDA).
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