Berkshire Biomedical Awarded NIH Research Grant to Support Clinical Study Program to Evaluate Patient Retention and Other Benefits of the COPA™ System for Take-Home Methadone Medication Management

Funds from the Two-Phase Fast-Track SBIR Grant, Combined, Would Total Approximately $2.9 Million

DALLAS, June 2, 2025 /PRNewswire/ -- Berkshire Biomedical Corporation ("Berkshire" or "the Company"), focused on developing its proprietary 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 (1 R44DA061908-01A1) from the National Institutes of Health's (NIH) National Institute of Drug Abuse (NIDA).

Valued at approximately $2.9 million over 30 months, the two-phase grant will support execution of a clinical study to evaluate patient retention and other benefits of the Company's COPA™ System for Take-Home Methadone Medication Management as part of Medication for Opioid User Disorder (MOUD) treatment. Phase I funds of approximately $326,400 will support the execution of a single-site study. Receipt of the approximate $2.55 million Phase II award will support the execution of an open-label, randomized, parallel multi-site study, which will be contingent on an assessment of the Phase I report, as well as the review and approval of any other documentation necessary for continuation and availability of NIH funds.

COPA is a novel, oral liquid dispensing system specifically designed to deliver accurate and precise doses of controlled and non-controlled prescription medications to only an Authenticated Intended User (AIU™), upon confirmation of dual biometric identifications (fingerprint and dentition) prior to each dose, with the goal of enhancing patient wellness and providing remote monitoring.

"The Fast-Track SBIR grant process is highly competitive, with only 18% of applicants having been chosen under this program in 2023, alone," stated John Timberlake, Chief Executive Officer of Berkshire. This is Berkshire's second Fast-Track SBIR Grant from NIH. The Company received an initial two-phased award totaling $2.2 million (1R44DA057185) in 2022 which extended through 2024, to complete the development of the COPA system. Berkshire's receipt of this newest award reflects the NIH's continued 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."

Mr. Timberlake continued, "The requirement to travel to an Opioid Treatment Program (OTP) clinic, daily, has been shown to reduce treatment retention and deter some patients from even starting treatment. A mixed methods study found that take-home dose flexibility among stable patients was associated with receiving more take homes, higher rates of treatment retention, and lower rates of opioid-positive drug tests. Higher retention rates in opioid use disorder medication among patients with OUD were, therefore, associated with better outcomes. There have been a considerable number of retrospective studies evaluating opioid use disorder treatment retention; however, there are very few prospective comparison studies."

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 pioneering the use of biometric technologies, combined with encrypted HIPAA compliant cloud-based and healthcare provider-enabled remote management systems, to provide precise and 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 AIU upon confirmation of dual biometric identification (fingerprint and dentition).

Upon receiving regulatory authorization, the Company intends to initially seek opportunities to leverage COPA in the delivery and remote management of oral liquid medication methadone, for Medication Use for Opioid Use Disorder treatment and subsequently for the delivery of controlled medications for the treatment of pain, as those patients 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 Numbers R44DA057185 and R44DA061908-01A1. 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
[email protected]

Melody Carey
Founder, President, and CEO
Rx Communications Group, LLC
[email protected]

SOURCE Berkshire Biomedical Corporation