Released:

Jul 25th, 2022

Update:

Berkshire Biomedical Awarded NIH Research Grant to Support Continued Development of the COPA System for Automated at Home Methadone Administration

Berkshire Biomedical Awarded NIH Research Grant to Support Continued Development of the COPA™ System for Automated at Home Methadone Administration

Funds from the Two-Phase Fast-Track SBIR Grant, Combined, Would Total Approximately $2.0 Million

DALLAS, July 25, 2022 - Berkshire Biomedical Corporation ("Berkshire" or "the Company"), focused on developing its proprietary, hand-held, automated personalized drug dispensing technology to enhance patient wellness, today announced that it has been awarded the first phase of a two-phase Fast-Track Small Business Innovation Research (SBIR) grant (1R44DA057185-01) from the National Institutes of Health's (NIH) National Institute of Drug Abuse (NIDA).

Valued at approximately $2.0 million over two years, the two-phase grant will support continued non-clinical development of the Company's Computerized Oral Prescription Administration System (COPA™) for at home methadone administration as part of Medication for Opioid User Disorder (MOUD) treatment. COPA is a novel oral liquid dispensing system with remote monitoring and advanced analytics specifically designed to deliver accurate and precise doses of controlled and non-controlled prescription medications to only a biometrically authenticated Intended User. Berkshire has been awarded Phase I funds of approximately $266,000. Receipt of the approximate $1.7 million Phase II award will be contingent on an assessment of the Phase I report, the review and approval of any other documentation necessary for continuation, and availability of funds.

"The Fast-Track SBIR grant process is highly competitive, with only 15% of applicants having been chosen under this program in 2021. Berkshire's receipt of this award reflects the NIH's belief in the strength of the technology behind COPA and its potential to significantly increase access to Opioid Treatment Programs for persons suffering from Opioid Use Disorder (OUD) by dramatically increasing the number of persons being allowed to utilize take home therapy," stated John Timberlake, Chief Executive Officer of Berkshire.

Mr. Timberlake continued, "Prior to the COVID-19 epidemic, there was a serious unmet need to support OUD patients.  Now there is an even greater critical need for a system capable of accurately and securely dispensing methadone for at home use that incorporates real-time remote monitoring, as the pandemic has limited access to methadone maintenance treatment (MMT) programs in both urban and rural sections of the U.S. That said, with assistance from this initial Phase I SBIR grant and the subsequent Phase II award, our goal is to complete the development of our enhancements to COPA, complete all necessary device, system, and human factors testing, followed by the subsequent submission of our De Novo request for review by the U.S. Food and Drug Administration (FDA)."

About the National Institute on Drug Abuse (NIDA)
NIDA is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world's research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. For more information about NIDA and its programs, visit www.nida.nih.gov.

About the National Institutes of Health (NIH)
NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About Berkshire Biomedical Corporation
Berkshire Biomedical Corporation is a privately held medical device company. Berkshire is developing drug dispensing technologies designed to deliver oral liquid drugs accurately and precisely. This is accomplished by pioneering the use of biometric technologies, combined with cloud-based and physician-enabled remote management systems, to provide accurate personalized medication delivery to only the authenticated Intended User. The Company's lead product under development, the Computerized Oral Prescription Administration System (COPA™), is a hand-held, automated, personalized oral liquid dispensing system designed and intended to deliver controlled and non-controlled liquid oral medications to only the authenticated Intended User upon confirmation of dual biometric identifications (fingerprint and dentition). Three overarching features under development combine to make COPA unique: security, compliance support (advanced data analytics) with remote monitoring, and precise oral liquid dispensing. Upon receiving regulatory authorization, the Company intends to initially seek opportunities to leverage COPA in the delivery and remote management of controlled oral liquid medications for Medication for Opioid Use Disorder (MOUD) and the treatment of pain, as they have the greatest need for the benefits of COPA's features.

In addition, the Company will look to expand COPA use in broader drug therapeutic categories, clinical applications, and businesses that manage the commercialization and data analytics provided by electronic devices to improve outcomes and reduce risk.

Additional information about Berkshire Biomedical and the COPA System can be found at www.berkbiomed.com.  The COPA™ System is currently under development, has NOT been reviewed by the U.S. Food and Drug Administration and is not available for commercial sale.

Disclaimer: Research reported in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number R44DA057185. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

CONTACT:

Berkshire Biomedical Corporation
info@berkbiomed.com

Melody Carey
Founder, President, and CEO
Rx Communications Group, LLC
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