Berkshire Biomedical Corporation
COPATM The Medication Adherence Novelty

It’s a no-brainer that medication adherence is an important part of treatment and disease management. Non-adherence is linked to hospital admissions, worse health outcomes, increased morbidity/ mortality, and higher healthcarerelated costs. Reports show that lack of adherence causes nearly 125,000 deaths, 10 percent of hospitalizations and costs healthcare system up to $289 billion a year. Yet, even while the monumental impacts of non-adherence are known, approximately half of all medications that are filled continue to result in inappropriate administration of the wrong dose, frequency, or duration. Applied to specific medications, opioids for instance, this high-rate of non-adherence led to the ‘U.S. Opioid Epidemic’, a serious national crisis. And thus, there exists a conundrum; a dire need to treat patients, like those who suffer from chronic pain and are treated with opioids, and a dire need to reduce improper and non-medical use of the medications prescribed.

Enter Berkshire Biomedical Corporation!

A privately-held medical device company, Berkshire focuses on developing drug delivery devices designed to accurately and precisely deliver oral liquid drugs to enhance patient wellness. “Our mission is to bring secure, accurate and precise personalized medication delivery to the authenticated intended user by pioneering the use of biometric technologies, and combining with cloudbased platforms, remote monitoring and a physician-enabled management system,” says John Timberlake, the CEO of Berkshire Biomedical Corporation. The company’s lead product under development, the Computerized Oral Prescription Administration System (COPATM) device is an authenticated Intended User automated oral liquid dispensing system. It delivers controlled and non-controlled liquid oral medications to an intended user upon confirmation of dual biometric identifications (fingerprint and dentition).

Three overarching features combine to make the COPA offering unique: security, compliance support (metrics) and remote monitoring, with accurate and precise liquid dispensing. The COPA device includes the novel technological feature of continuous dentition biometric confirmation during liquid oral medication delivery, along with other technological features previously reviewed and cleared by FDA for other devices but which have not previously been combined into a single device.
“Our device is software-controlled, and is designed to store and efficiently deliver precise doses of a liquid oral prescribed medication at fixed or variable times (as per the prescription) directly into the mouth of the patient through the mouthpiece of the medication delivery unit,” mentions Timberlake. As a portable, battery-powered system with wireless communication capability, it is designed to remotely synchronize new prescriptions and dose scheduling (originated from a medical provider and/ or dispenser) directly onto the device.

The COPA device consists of the software-controlled hand-held dispensing unit (COPA), an encoded, unique disposable SmartCap attached to each pharmacy filled amber medication bottle, and the COPA Management System (COPA MS) that drives the system, and a USB charging cable. The COPA communicates with the COPA MS through cellular technology. A SIM card is installed within the unit during manufacturing and provides the path for receiving and sending secure data between the COPA and the COPA MS.

Cellular connectivity is only required for initial patient identification capture and loading of prescription information onto the COPA, which are functions managed within the professional dispenser/pharmacy setting. Cellular connectivity is not required for daily biometric identification (fingerprint and dentition confirmation) and patient dosing, once the initial setup has been completed.

Short and long-term memory on the COPA hold all active identification and prescription information, as well as dose records and event logs since last sync. Patients may continue using COPA even if the device is physically located in out-of-coverage areas. Once the patients are back within cellular coverage, the COPA device auto-detects cell network and records will synchronize between the device and COPA MS.

The COPA is a intended to be a prescription-only device a for recurring use by a single authenticated patient with only one liquid oral medication at any given time. It is not intended to be used by any other patient. Each SmartCap assembly is single use. The COPA Management System and device supports multiple SmartCaps per prescription and after any bottle is empty the device will support the insertion of additional bottles, as prepared and registered by authorized dispensers per prescription details. After the medication in a SmartCap secured bottle has been depleted, both the cap and the bottle can simply be disposed according to local guidelines.

With a revolutionary product at its helm, Berkshire is preparing to seek regulatory clearance from the FDA through a De Novo filing and intends to initially seek opportunities to leverage COPA in the delivery and remote management of controlled liquid oral medications. “More specifically, we intend to initially focus on the treatment of acute and chronic pain (by delivering medications such as oxycodone, and morphine) as well the treatment for opioid use disorder through the delivery of methadone in Medication Assisted Therapy (MAT),” concludes Timberlake.