Company Overview of Austen BioInnovation Institute in Akron
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Austen BioInnovation Institute in Akron Key Developments
ADB International Group, Inc. Announces Partnership with Austen Bioinnovation Institute in Akron to Bring E-QURE BST Wound Healing Device to U.S. Market
Jul 21 14
ADB International Group Inc. announced a partnership with Austen BioInnovation Institute in Akron for the purpose of bringing ADBI's E-QURE BST(TM), a bioelectrical signal therapy device (the E-QURE BST Device), to the U.S. market. The Institute, which has significant expertise in wound healing, clinical trial development and regulatory operations, will conduct a clinical trial that will include 70 patients in a double-arm, controlled, randomized, multi-center study to assess the safety and efficacy of the E-QURE BST Device in subjects with stage II & III Pressure and Venus Stasis ulcers, as an adjunct to the 'Standard of Care'. The company's E-QURE BST Device currently is marketed in Europe for similar indications. It aims to accelerate healing of hard-to-heal chronic wounds by delivering electrical stimulation to an injury site and thus effectively mimicking the electrical currents of chronic wounds in order to enhance the body's natural healing mechanisms. The company's management selected ABIA's Product Innovation and Commercialization Division to spearhead its pre-market clinical trial program, which is necessary to apply for regulatory approval from the FDA to distribute in the United States. ABIA will prepare on behalf of the company an investigative device exemption application to obtain FDA approval to conduct the clinical trials. The initial trial includes 70 patients in a double-arm, randomized, multi-center study to assess the safety and efficacy of E-QURE's BST Device of which data will be submitted to the U.S. Food and Drug Administration to obtain marketing clearance.
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