SAN ANTONIO, July 21, 2014 /PRNewswire/ -- ADB International Group Inc.: OTCQB: ADBI (ADBI or the Company) today announced a partnership with Austen BioInnovation Institute in Akron (ABIA or the Institute), for the purpose of bringing ADBI's E-QURE BST™, 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. As part of the Institute's fully integrated regulatory and device development service offerings, 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.
"E-QURE has the potential to provide significant relief to patients with chronic ulcers, particularly those who do not respond to conventional treatment," said Dr. Frank L. Douglas, ABIA President and CEO. "This is the type of patient-centered innovation we champion. The Institute is well positioned to assist ADBI, and other companies, in effectively getting their device to market and into the hands of practitioners in a timely and cost-effective manner, through ABIA's streamlined, proven process. We are tremendously pleased to be working on this project with the talented management team at ADBI."
Ron Weissberg, ADBI's Chairman, stated, "A successful U.S. market presence is an important part of our growth strategy. We strongly believe that our E-QURE's BST Device has the potential to become a well-established and proven product to improve care for those suffering from chronic wounds. We also believe that working with Austen BioInnovation Institute will facilitate our pursuit of the requisite regulatory approvals essential to executing a vigorous market entry and capturing sales and growth in America."
The clinical trial, required for federal regulatory application and approval, will take place during the next 15 months and involve patients in nursing homes and long-term care facilities throughout Ohio.
"With an in-house regulatory and medical device development team, ABIA is uniquely equipped to handle the comprehensive nature of a clinical project such as this," said Rob Ngungu, ABIA Director of Regulatory Affairs. "From site selection and training to enrolling participants, administering treatment, monitoring outcomes and submitting reports to the FDA, we can help companies get to market faster and more efficiently."
About ADB International Group Inc. ADB International Group Inc. (the "Company") was formerly engaged in the business of distributing water treatment products in the United States, Canada, Australia and New Zealand. The Company was not successful in generating revenues or profits from its endeavors in this industry. In December 2013, in connection with a change of control, appointment of a new management team and the infusion of capital, the Company determined to terminate its efforts in the water treatment distribution business and instead pursue efforts in the medical device industry. To that end, the Company announced that it had completed the purchase of the Bioelectrical Signal Therapy (BST)™ assets from LifeWave Ltd., which included the E-QURE BST Device (the "E-QURE BST Device"). Following this asset acquisition, the Company announced its entry into a clinical trial agreement with Austen BioInnovation Institute in Akron to conduct a trial to study and assess the safety and efficacy of E-QURE'S BST Device in subjects with stage II & III Pressure and Venus Stasis ulcers, as an adjunct to the "Standard of Care." The Company plans to pursue the right to market the E-QURE BST Device in the United States following the successful and timely completion of the clinical trial, of which there can be no assurance. Find out more at www.e-qure.com.
About Austen BioInnovation Institute in AkronThe Austen BioInnovation Institute in Akron (ABIA) – an exceptional collaboration of Akron Children's Hospital, FirstEnergy Foundation, John S. and James L. Knight Foundation, Summa Health System and The University of Akron – brings innovative minds together to create economic and personal vitality by inspiring patient-centered discovery and invention. The ABIA partnership shortens the time from idea to commercialization of new technologies and solutions by bringing together world-class scientists, physicians, engineers, researchers and entrepreneurs in the biomedical product and polymer science industries. ABIA works to secure Ohio's economic future through its patient-centered product innovation and cutting-edge healthcare workforce training. Find out more at www.abiakron.org.
Forward-looking Statements:
This press release may contain forward-looking statements, including information about management's view of the Company's future expectations, plans and prospects, within the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 (the "Act"). In particular, when used in the preceding discussion, the words "believes," "expects," "intends," "plans," "anticipates," or "may," and similar conditional expressions are intended to identify forward-looking statements within the meaning of the Act, and are subject to the safe harbor created by the Act. Any statements made in this news release other than those of historical fact, about an action, event or development, are forward-looking statements. Factors that could cause actual results to differ materially from those that we may anticipate in each of our segments reflected by our subsidiaries' operations include, among others: the results of ABIA's clinical trial; the ability to secure regulatory approvals within the parameters of the Company's financial and other resources; levels of competition in the medical device industry, generally, and in the wound healing segment, specifically, among other risk factors. These risk factors and others are included from time to time in documents the Company files with the Securities and Exchange Commission, including, but not limited to, its Form 10-Ks, Form 10-Qs and Form 8-Ks. Other unknown or unpredictable factors also could have material adverse effects on the Company's future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by the Company.
CONTACT: Scott Rainone, +1-330-572-7581, news@abiakron.org
