| | MARCH 2022 19unit," 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. 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
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