Berkshire Biomedical

About the offering

Berkshire Biomedical is a medical technology company focused on developing secure personalized medication management systems. Our flagship product, COPA™ supported by a $2M NIH research grant, is designed to provide reliable, biometric-controlled dispensing of liquid oral medications, addressing a critical need in chronic disease such as Opioid Use Disorder (OUD) management. Currently in the pre-revenue phase, working with the FDA, we intend to file for marketing authorization and aim to initiate clinical studies in 2025 to generate data for commercialization of COPA™ targeted for 2026. Problem/Solution: COPA™ addresses a critical need in managing Opioid Use Disorder (OUD) by offering secure, dual biometric-controlled medication dispensing with remote monitoring designed to enable more patients to self administer their medication at-home . Leadership/Experience: Led by a team with decades of operational expertise in developing and commercializing healthcare innovation, Berkshire Biomedical is well-equipped to bring COPA™ to market. Breakthroughs/Progress: With multiple FDA pre-submission meetings and milestones and a clear path to filing for marketing authorization, supported by a $2M NIH grant award and the potential for another NIH grant to support the execution of studies to generate data for commercialization, COPA™ has the potential to disrupt traditional medication management solutions. Berkshire Biomedical is pioneering secure medication management with COPA™, a patented dual biometric-controlled device that addresses many chronic diseases beginning with those individuals impacted by the opioid crisis, by ensuring precise and secure dispensing of liquid oral prescriptions. Backed by strong support from NIH with one $2M grant already awarded, years of R&D and ongoing FDA pre-submission milestones, COPA™ has the potential to significantly increase the number of patients receiving treatment for Opioid Use Disorder by enabling patients to self administer their medication at home. *COPA™ is under development and has not been authorized for commercial sale by the FDA. The Problem: The opioid crisis in the United States remains a devastating public health issue, with over 5.7 million individuals battling Opioid Use Disorder (OUD) and only one in five receiving medication treatment. Traditional daily in-clinic dosing methods for medications like methadone impose logistical and financial burdens on patients, discourages sustained treatment, and increases the costs for Opioid Treatment Programs (OTP). OTP Providers lack the tools to feel comfortable in allowing many patients to self-administer methadone at-home. When patients are given take-home, Providers do not know who actually takes the medication, when they take the medication, or if the patient even takes the medication. This prevents many OUD patients from seeking treatment and leads to poor retention for many who initiate treatment, creating a gap in effective medical care. Our Solution: COPA™ by Berkshire Biomedical is designed to provide a secure, dual biometric-controlled solution to address many of these challenges. The handheld device verifies the user’s identity through fingerprint and dentition recognition prior to each dose, ensuring medication reaches only the intended patient. By enabling precise at-home dosing, COPA™ reduces logistical barriers, enhances adherence, and should increase patient treatment retention. Integrated cellular connectivity provides real-time data to healthcare providers, patients, patient loved ones, with the aim to improve proactive treatment oversight and better medical decisions. With a recurring revenue model from device sales and consumable components, COPA™ is designed for sustainability while addressing a critical healthcare need. The Market: Upon receiving regulatory authorization, the Company intends to initially seek opportunities to leverage COPA in the delivery and remote management of oral liquid methadone medication for Opioid Use Disorder 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. The global opioid use disorder (OUD) treatment market is projected to grow from $3.35 billion in 2024 to $7.48 billion by 2032, driven by increasing awareness and regulatory support for effective treatment solutions, though actual results may vary. COPA™ directly targets this growing demand, offering a secure, at-home medication management system for the over 5.7 million individuals in the U.S. who struggle with OUD. With its focus on secure dispensing and real-time monitoring, COPA™ provides a compelling solution for healthcare providers and patients seeking safer, more accessible treatment options. Our Traction: Berkshire Biomedical has completed five years of rigorous R&D work developing the COPA technology from concept to impending FDA submission, backed by a $2M NIH Small Business Innovation Research grant. The COPA™ system has strong intellectual property with 19 issued patents and has achieved critical milestones in FDA pre-submission discussions. The Company has validated the interest and acceptability of COPA with patients which has been corroborated by the acceptance of methadone user study by a peer-reviewed journal. With plans to develop clinical data in 2025 to support future commercialization and with another pending NIH grant, COPA™ is poised to make a meaningful impact in the OUD treatment landscape. Berkshire plans to leverage COPA's innovative design to capture a significant portion of the growing OUD market, with the potential to then be utilized in other chronic disease treatments including chronic pain. *The 1 million projection is based on internal estimates and market trends and is not guarantee of future outcomes. COPA™ is under development and has not been authorized for commercial sale by the FDA. Additional Traction Highlights: Leadership Team Expertise: The Berkshire Biomedical team boasts decades of operational experience in healthcare innovation, including product development, regulatory compliance, and commercialization. Their diverse backgrounds ensure a robust approach to tackling the opioid crisis with cutting-edge solutions. Intellectual Property: COPA™ is protected by 19 patents, solidifying its position as a unique solution in the dispensing of liquid oral medications for chronic diseases, including the OUD treatment space. Partnerships and Support: Backed by a $2M NIH Small Business Innovation Research grant, Berkshire Biomedical has collaborated with leading experts in healthcare and technology to ensure COPA™ will meet the highest standards of safety and effectiveness. Why Invest Investing in Berkshire Biomedical means joining the fight against the opioid crisis enabling those already affected to receive at-home treatment with COPA™, a groundbreaking, patented device designed for secure, patient self-administered medication management. Your investment will support final work in preparation for regulatory submission and FDA review, and begin to prepare for future commercialization. Be part of a mission to revolutionize patient care and help millions manage Opioid Use Disorder.

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