Released:

Feb 10th, 2021

Update:

Berkshire Biomedical Publishes Letter to Shareholders

Berkshire Biomedical Publishes Letter to Shareholders


Dallas, February 10, 2021 – Berkshire Biomedical, LLC (“Berkshire” or “the Company”), a privately-held digital health company developing a revolutionary virtual care and prescription drug management system only for the Intended User, today announced that Thomas M. Rouse, Founder and Chairman of Berkshire Biomedical, has issued a Letter to Shareholders, the full text of which follows below.


To my fellow stakeholders:

As we enter the new year, we reflect on 2020 and the considerable advances we achieved in the face of the unprecedented global COVID-19 pandemic and look ahead to an exciting 2021 as we execute on our plans to bring the Computerized Oral Prescription Administration (COPA™) System to market. The journey was filled with twists and turns, but our team never lost sight of delivering on our goal to be a leader in the early adoption of Virtual Care by developing a revolutionary technology solution to address the unmet medical need for the safe, effective and patient-centric delivery and management of prescription drugs.

Throughout 2020, our Berkshire Biomedical team made significant inroads across a number of areas key to the Company's success -- engineering, intellectual property, regulatory, financial and corporate leadership. In addition to finalizing the engineering of the device and system, we expanded our patent portfolio and now have four families of intellectual property protection for the device, system and its usage. Importantly, we received U.S. Food and Drug Administration (FDA) acceptance of our 510(k) submission for review for pre-marketing clearance of the COPA System, and now expect a final clearance decision in the third quarter of 2021. We expanded our management team and board with clinical and corporate leaders who will guide us to our next stage of expansion. To help support our goals in 2021, we secured $3 million in funding through our first financing with third-party investors, which not only strengthens our balance sheet but provides outside validation of the potential for the COPA System in the multibillion-dollar virtual care marketplace.

We believe these accomplishments provide the infrastructure for Berkshire Biomedical to transition from a product development company to a product marketing company and positions us for a successful future. As we are building our foundation as a company, we are also pushing the boundaries of medical and cloud-based software technology to revolutionize personalized medication delivery.

Several years ago, following my own sub-optimal experience with post-operative pain management, I had a vision to create a device and system to remotely support personalized medication delivery to the Intended User with the ability to assess adherence and efficacy and to communicate all of this information back to providers. From that, the COPA System was born! We foresaw the growing need for virtual care and digital therapeutics, but also understood the need for a system that could ONLY be employed by the Intended User. So, while the pandemic has not changed our strategy, it has clearly put a spotlight on the need for a virtual care solution in medication delivery and management. The COPA System, with its pioneering use of Intended User biometrics technology in a hand-held device with a cloud-based, HIPPA compliant, mobile device-enabled DBMS system, is well positioned to serve patients effectively and efficiently in the growing virtual care setting.

In developing the COPA System, we identified and partnered with world class engineers, manufacturers, FDA regulatory advisors, and trademark and patent attorneys to support the emerging business. Importantly, we also built a team of talented, accomplished executives and a trusted advisory board of leaders, all with extensive experience in early-stage product development companies in the medical technology industry. Consequently, we proved unstoppable as we drove through the headwinds in 2020 to achieve our goal to file our 510(k) submission for marketing clearance of the COPA System with the FDA.

We know the COPA System can bring meaningful benefits to patients, particularly when you consider today’s virtual environment and the ongoing need for surveillance of medications as highlighted by the opioid crisis and the multibillion-dollar problem of wide-spread medical non-adherence.

The COPA System addresses a number of key unmet medical needs in our current healthcare ecosystem. First, it provides a critical level of safety that is activated via the patient’s own biometrics with medication dispensed only to the Intended User. This is the COPA System’s primary differentiator and one that no other system can claim. In addition, the system provides a record of adherence and the ability to provide real-time data delivery to patients, physicians and other approved stakeholders. This is expected to be a disrupter as this real-time data could drive critical physician decision making and improve overall patient wellness.

In preparation for FDA market clearance in 2021, we are currently working to identify and execute partnerships with one or more strategic partners within the coming year. Ideally, we will collaborate and establish cornerstone relationships with strategic partners and top-tier investors who want to fund co-development of additional clinical studies to support claims related to their drugs in combination with the COPA System. For now, we have submitted the COPA System with broad device claims, but may pursue small, confirmatory studies that demonstrate the device’s benefits in specific indications.

We have taken the crisis in modern medication delivery and management and turned it into an opportunity. We are doing so by delivering a virtual care solution that can enhance adherence, reduce drug misuse and abuse, provide important prescription dosing information to analyze the pharmacoeconomics of medication protocols, and can also enhance clinical trial conduct and tracking.

We personally funded the build-out of the COPA and hand-picked the experienced leadership team to bring it forward. It has been a challenging but transformative journey. My enthusiasm for and confidence in the opportunities ahead for the COPA System, Berkshire Biomedical and our shareholders has never been higher.

We look forward to an exciting year ahead as we accomplish a number of value-creating milestones and achieve our goal to bring the COPA System to patients in need of a virtual care solution to prescription drug management and delivery.

With my best wishes for a happy, healthy and prosperous 2021,

Thomas M. Rouse
Founder and Chairman
Berkshire Biomedical

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 (COPA™) 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
bdunn@berkbiomed.com

Anne Marie Fields
Managing Director
Rx Communications Group, LLC
afields@rxir.com

 

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