Berkshire Biomedical Awarded Phase II Funding for 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, Total Just Over $2.0 Million

DALLAS, Dec. 7, 2022 /PRNewswire/ -- 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 second 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).

The total grant, including this second phase, valued at just over $2.0 million, will support the continued non-clinical development of the Company's Computerized Oral Prescription Administration System (COPA™) for at home methadone administration as part of Opioid User Disorder (OUD) 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 (AIU^TM).

"With the completion and review of the Company's Phase I progress, receipt of this second phase funding reflects the NIH's continued belief in the strength of the technology behind COPA and its potential to significantly increase the number of persons, suffering from OUD, who would be allowed to utilize take home therapy," stated John Timberlake, Chief Executive Officer of Berkshire. "Award of this research grant, for which Phase I proceeds were received in July 2022, is a significant achievement for the Company, given that only 15% of all applicants were chosen under this program in 2021."

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), it is estimated that 2.7 million people had OUD in the U.S. in 2020. Data shared at the 2022 American Association for the Treatment of Opioid Dependence Conference noted that nearly 600,000 people currently receive treatment for their OUD at Opioid Treatment Programs (OTPs), utilizing medication assisted therapy, primarily with methadone. Patients using medication for OUD saw a 76% lower overdose rate and a 32% reduction in opioid-related ER visits. Additionally, patients' retention of OUD treatment plans into their daily lifestyle is highest when structural advantages such as proximity to treatment clinics or approval for take home use are supportive of the plan.

Mr. Timberlake continued, "It is clear that there is a critical need for a system capable of accurately and securely dispensing methadone for at home use that incorporates real-time remote monitoring. This could allow existing OTPs to treat significantly more patients with the same resources and allow more patients to take or extend the number of days they are permitted to take their medication at home and avoid the disruptive nature of daily clinic visits. With assistance from this NIH SBIR grant, we aim to complete all necessary testing, followed by the subsequent submission of a De Novo medical device application for review by the U.S. Food and Drug Administration (FDA). If cleared, our goal is to bring COPA to market to help more patients take control of their OUD and return to productive and rewarding lives."

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 (AIU™). 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.

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SOURCE Berkshire Biomedical Corporation