Berkshire Biomedical Announces the Publication of Study Results in the Peer-Reviewed Journal, Innovations in Clinical Neuroscience 

New Study Findings Strongly Validate the Need for Take-Home Methadone Treatment and Patients’ Willingness to Adopt Berkshire’s COPA™ Technology

Dallas, TX, January 16, 2025 – Berkshire Biomedical Corporation (“Berkshire” or the “Company”), focused on developing its proprietary drug dispensing technology to enhance patient wellness, today announced that data from a study of patients being treated for Opioid Use Disorder (OUD) with methadone has been published in the peer-reviewed journal, Innovations in Clinical Neuroscience. Lead authored by Eric Morse, M.D., an addiction and sports psychiatrist with Carolina Performance and Founder, President and Chief Medical Officer of Morse Clinics in Raleigh, North Carolina, the paper is entitled, “Patient Challenges in Utilization of Methadone to Treat Opioid Use Disorder and Perspectives on a Solution for Improved Security and Convenience in Take-home Dosing,”  and demonstrates the strong need for methadone take-home access, and patient acceptance and willingness to adopt Berkshire’s Computerized Oral Prescription Administration (COPA™) technology.

Adult patients, treated with methadone at a single-site Opioid Treatment Program (OTP) clinic, were recruited to participate in one-on-one qualitative interviews regarding their experience with methadone and the impact that expansion of take-home doses would have on their lives. Participants were then provided with printed resources describing COPA and were able to handle a COPA device before being asked for their perspectives.

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), with the goal of enhancing patient wellness and providing remote monitoring.

Methadone is commonly used to treat opioid use disorder (OUD). By law, methadone is only accessible from federally certified OTPs, which limits access to treatment, impacts quality of life, and reduces OUD treatment program retention. Methadone for OUD treatment has been shown to lower overdose rates by 76% and opioid-related emergency room visits by 32%. Berkshire’s COPA system is designed as a dual-biometric dispensing device for take-home dosing that could meaningfully reduce the impacts of methadone administration on patients and clinic staff.

Key Study Findings:

• Average time spent for methadone dosing and travel when administered by an OTP was 75 minutes (range 30 to 180) at a mean cost to the patient of $36.58 per trip (range $15 to $80)
• 92% of participants expressed an interest in having a larger number of take-home doses to reduce the frequency of clinic visits.
• 88% of participants confirmed take-home methadone made it easier to maintain employment.
• 67% of participants said they would use COPA if recommended by their healthcare provider.
• 80% of the participants who currently did not have any take-home privileges stated they would pay a mean of $126.88 per month out of their own pocket to use COPA, if it enabled them to receive take-home doses. 100% of the participants who already had take-home privileges stated they would pay a mean of $117.50 per month if the use of COPA enabled them to expand their number of take-home doses and reduce frequency of trips to the clinic.

Study Conclusions:

Participants endured a monetary and time burden to access their current methadone treatment and wished to have more take-home doses to reduce the frequency of their visits to the OTP clinic. Participants viewed take-home doses as having a positive impact on their ability to care for family members, hold a job, and travel, and they appreciated the key attributes of COPA and were willing to invest their own funds to gain access to the device. COPA is a potential solution to expand take-home methadone access to patients while ensuring safety, adherence, retention, and appropriate use.

Read the full results including study methodology, participant selection and study limitations here.

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.

As previously announced, the Company is developing COPA with the support of a $2.0 million Fast-Track Small Business Innovation Research grant from the National Institute of Drug Abuse of the National Institutes of Health under award number R44DA057185.

In the future, the Company will look to expand COPA usage into a broader set of drug therapeutics, possible clinical applications, as well as with companies that utilize and commercialize 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 communication 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

mcarey@rxir.com