Berkshire Biomedical Announces Acceptance of 510(k) Premarket Submission of Computerized Oral Prescription Administrationtm (COPA) System

DALLAS, Jan. 21, 2021 /PRNewswire/ -- Berkshire Biomedical, LLC ("Berkshire" or "the Company"), a privately-held digital health company developing a revolutionary virtual care and Intended User prescription drug management system, today announced that the Company's 510(k) application to the U.S. Food and Drug Administration (FDA) for pre-marketing clearance of the Computerized Oral Prescription Administration (COPAtm) System was accepted for review.    

"The 510(k) submission is the culmination of our vision to create a device and system to remotely support medication delivery with the ability to monitor Intended User adherence to prescribed therapy, and to communicate all of this information back to providers," said Thomas M. Rouse, Founder and Chairman of the Board of Berkshire Biomedical. "Developed over four years by world class hardware and software engineering teams along with leading medical technology industry experts, the COPA System, with its innovative approach to personalized, prescription drug delivery, is expected to be a disruptive technology that will support the transformation to virtual care."

"The acceptance of this submission is an important milestone for Berkshire as we advance the COPA System toward regulatory clearance with the goal of bringing this personalized prescription drug management system to patients and providers in need of a virtual care solution for remote drug therapy delivery.  Plans for commercialization are underway and we are working on scaling commercial manufacturing and assessing different strategic marketing plans to support the COPA System's launch.  In tandem, we are expanding discussions with potential strategic partners and are very encouraged by the high level of initial interest in and support for our virtual care drug delivery system," added Mr. Rouse.

"The COPA System was designed to enhance patient wellness by addressing the intersection of two unmet needs in today's healthcare delivery system: medication adherence and the increased demand for virtual care solutions to deliver medication and healthcare services at the point of care.  This is particularly important when you consider today's virtual environment and the ongoing need for surveillance of medications in a variety of indications such as addiction management, chronic pain management and mental health issues to name a few.  In addition, the system provides a record of adherence and the ability to provide real-time data delivery that is unrivaled?a potential game-changer for patients, physicians and caregivers," stated Colonel (ret) Geoffrey Ling, M.D., Ph.D., Professor of Neurology and Attending Neuro-Critical Care Physician at the Johns Hopkins Medical Institutions; a Professor of Neurology and the founder of the Center for Military Clinical Neurosciences at the Uniformed Services University of the Health Science (USUHS) and a member of the Advisory Board for Berkshire Biomedical. 

About the Computerized Oral Prescription Administration (COPAtm) System
The COPAtm System is currently under development as a virtual care and prescription drug delivery system that is pioneering the use of biometrics technology in a hand-held device that is cloud-based, HIPAA compliant and utilizes a mobile device-enabled database management system (DBMS). 

The COPA System is intended for use as an aid to medical providers in virtually managing therapeutic regimens for patients in the home or clinic. The system provides a means for the patient's prescribed medications to be stored in a delivery unit; for a medical provider to remotely schedule the patient's prescribed medications; to provide notification to the patient when the prescribed medications are due to be taken; to release the prescribed medications into the mouthpiece, on the patient's command; and to provide to the medical provider a history of the event.

The COPA System's patented technology provides precise, timely and consistent dosage of prescribed, liquid, oral drug regimens.  It features enabled, dual biometric controls including fingerprint and dentition recognition to confirm the Intended User before dispensing the prescription drug, which enhances safety, security, and drug adherence.  The COPA System integrates cellular technology for real-time usage data collection, which allows physicians to monitor patient behavior and make dosage adjustments.  It is also enabled with a cloud-based data storage and analytics system that can be disseminated to authorized physicians, pharmacists, and caregivers to further support medical decisions.

About Berkshire Biomedical, LLC
Berkshire Biomedical, LLC is a privately held healthcare solutions provider focused on impacting lives by leveraging technology to improve medical outcomes and enhance patient wellness.  The Company's lead product under development, the (COPAtm) System, is designed to address the intersection of two significant needs in the healthcare delivery system: virtual care delivery using technology combined with data and medication self-administration and adherence. 

Founded and funded by a team of experienced financial and medical technology executives, Berkshire Biomedical intends to seek broad opportunities in medical markets, drug applications, and businesses that manage the commercialization and data analytics of the device in order to maximize the COPA System's impact within the virtual care and medical technology sectors.

Additional information about Berkshire Biomedical and the COPA System can be found at www.berkbiomed.com.

CONTACT:

Barry R. Dunn
Vice President ? Corporate Development
Berkshire Biomedical, LLC
[email protected] 

Anne Marie Fields
Managing Director
Rx Communications Group, LLC
[email protected]

SOURCE Berkshire Biomedical, LLC