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CEOCFO Magazine, PO Box 340
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Lynn Fosse, Senior Editor
Steve Alexander, Associate Editor
Bud Wayne, Editorial Executive
Christy Rivers -
Rudy A. Mazzocchi
Interview conducted by:
Lynn Fosse, Senior Editor
Published – September 14, 2020
CEOCFO: Mr. Mazzocchi, according to your site, “Berkshire Biomedical is providing The Last Mile in patient care.” What was the impetus for creating the COPA™ System?
Mr. Mazzocchi: We define the Last Mile in patient care as virtual care with drug therapy delivered in the most efficient and pragmatic way to provide patient care where and when patients most need it – the Last Mile. Back in 2016, our primary founder, Tommy Rouse, underwent three consecutive spine surgeries. Despite the fact that the procedures and his post-
In developing the COPA System, Berkshire Biomedical identified and partnered with world class engineers, manufacturers, FDA regulatory advisors, and trademark and patent attorneys to support the emerging business. You may have recently seen our press release announcing the issuance of additional U.S. patents surrounding this technology.
From that, the Computerized Oral Prescription Administration (COPA™) System was born! The COPA System is pioneering the use of Intended User biometric technology, in a hand-
As the product development processes evolved over four years, we learned and gained a deeper appreciation of the value the COPA System brings to the virtual care market. As our understanding and development advanced, it became clear to us that the value of the System’s features was even more important than the original device-
CEOCFO: How does the COPA System work?
Mr. Mazzocchi: Our COPA System is a handheld device—that is small enough to fit in the patient’s hand. It has an internal chamber where the vial of oral liquid medication is locked into position. The device will be procured from the pharmacist with your prescription and the dosage that is prescribed to the patient comes in standard amber vials. You may get a one month or three-
The differentiator between COPA and all other drug delivery vehicles is our unique ability to identify and dispense only to the Intended User. This is driven by our novel use of biometrics. There is a thumb print scanner on the surface which biometrically recognizes the registered patient, or the Intended User. Then, the second biometric element is the mouthpiece itself, which has a dental recognition element that identifies the patient’s dental structures and bite profile. Once the patient is confirmed, the device activates the pump mechanism and actually pushes the fluid prescription medication into the mouthpiece. Therefore, even if I were to activate the device myself and hand it to you for dispensing into your mouth, it would not work because it has to recognize the impression of my teeth, and only my teeth.
The system has a cloud-
CEOCFO: How easy or how difficult is it to set up and for the patient to become comfortable with a new method of taking pills?
Mr. Mazzocchi: That is a great question. By design, it’s actually very user-
CEOCFO: Has anything similar been tried?
Mr. Mazzocchi: No. There is a lot of smart technology now in healthcare but no one has the ability to identify and dispense medication to the Intended User in a virtual care platform. One example that we have identified is an Australian company called Adherium Limited, and they actually have a smart device for inhalers. However, it is not as sophisticated as the COPA System, and it is not really designed for a specific Intended User. It just provides data on the use of the device. We have taken it further by including biometrics and physician-
CEOCFO: How would someone get your COPA System? Would it be at the local pharmacy?
Mr. Mazzocchi: Under the currently proposed model, yes. The way it would work is that once the physician prescribes the medication with the use of a COPA System, the patient would go to their pharmacist, who will provide registration of the System in accordance with the specific patient. As you will recall, there is a connection between the Smart Cap that is placed on the standard vial and links directly to the COPA device and to its corresponding Intended User. It is actually pretty seamless. Again, we have tutorials that walk you through the processes. As I mentioned, we are collecting that data in the summative study or User Study, which we are filing as part of our 510K submission to the FDA later this month.
CEOCFO: How does the acceptance of telehealth help?
Mr. Mazzocchi: Earlier, we talked about the Last Mile in patient care. During this pandemic we have learned so much about the importance of telehealth in the today’s marketplace and, with our quarantine and isolation, we began questioning how we can properly manage patient’s medications during that Last Mile in a new remote world. Looking at the patient’s journey – whether they are on a chronic medication or a medication following a surgery a procedure – procuring, dispensing and reporting progress to the physician is challenging. Today, more than ever, we do not have the ability to freely run to our doctors, the clinic or the pharmacist. It is more about self-
CEOCFO: What has changed in your strategy for bringing the COPA System to market? What are you finding and how are you adapting with the pandemic and COVID-
Mr. Mazzocchi: Another interesting question. Actually, our strategy hasn’t changed. Four years ago, when our founders were developing the COPA System, they knew there was a growing need for a virtual care medication delivery system and we had defined and fixed our strategy prior to the onset of this pandemic. That said, there is no way they could have predicted the COVID-
Another area that the COVID-
CEOCFO: With your long history in the industry I am guessing you have a great many opportunities. Why Berkshire Biomedical and what surprised you when you actually came on board?
Mr. Mazzocchi: You are right. Throughout my career I have been involved in the build out of many medical technologies and biotech companies. However, at the heart of it, I am really a medical device guy. It is a specialty I developed early on in my career, ranging from active implantable devices to, what I call, procedural-
What we do for patients is so critical, particularly when you consider today’s virtual environment and the ongoing need for surveillance of medications as highlighted by the opioid crisis. The COPA System fulfills a number of key unmet medical needs in our current medication delivery system. First, we provide a critical level of safety that is activated via the patient’s own biometrics with medication dispensed only to the Intended User. This the 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-
I have been in this industry for a long time and have seen the evolution of healthcare markets and how they adopt to new technologies. Given the current need for safer medication delivery and the call for real-
CEOCFO: Is COPA strictly liquid at the moment? Might pills be in the future?
Mr. Mazzocchi: That is a great question. It is currently designed for liquid oral medications, even though we know that the majority of prescriptions are pill based. As we speak to pharmaceutical companies, they are confirming what we knew-
We believe there could be enormous opportunity in taking this foundational technology and adapting it for other applications. I previously mentioned smart inhalers. This would be ideal. There are many other ways we can expand the reach of this technology in a variety of markets. For example, we have talked to ophthalmology companies that are looking at how to deliver controlled liquid medication, in the form of eye drops, to the surface of the eye to treat macular degeneration. In addition, we are already exploring expansion into other formulations that meet direct to mouth dispensing and which would require modest modifications but not complete retooling. In terms of transitioning the COPA System to use pill or capsule formulations, I am not sure we would want to focus on this now as it would take time and additional investment to conduct the reengineering needed to make that conversion. What we could see happening in the nearer term is the transition of therapeutic developments moving from pill or capsule formulations to liquid oral medications. As mentioned earlier, we see this trend is already happening today.
CEOCFO: What are some of the key events or milestones we should look for at Berkshire Biomedical in the next six to twelve months?
Mr. Mazzocchi: We have an exciting year ahead as we expect to file our submission to the FDA this Fall and anticipate receipt of FDA market clearance for the COPA System sometime around the end of the year. In the meantime, we are working to identify and execute an appropriate partnership with one or more strategic partners within 6-
In tandem, we are making plans for full commercialization in Q3 of next year and continue to work on scaling commercial manufacturing and assessing different strategic marketing plans to support the COPA System launch. Ideally, it would be with strategic partners who want to fund co-
We are pleased with the response from our early outreach, and we have generated considerable initial interest in the COPA System among these potential partners. It is particularly encouraging when you consider that we have only recently come out of our ‘stealth mode’ with the announcement of our additional U.S. patents last week. So far, it has been a great process and we are making traction toward our goals to identify and establish multiple strategic alliances. While there had been some challenges with connecting to the right people during quarantine, we are now finding that the increased interest in virtual care highlighted by the pandemic has helped spur interest in the COPA System.
This is going to be a very exciting year ahead and we are looking so forward to seeing this technology in the hands of patients and their providers, so the time is now!
CEOCFO: What, if anything, might people miss or misunderstand about Berkshire Biomedical and the COPA System when they first look?
Mr. Mazzocchi: One of the biggest misconceptions about the COPA System on first introduction is that people think this is just a medication dispenser. It isn’t until you actually sit down with someone and describe the complete multi-
Berkshire Biomedical, Rudy Mazzocchi, COPA, Improve Medication Adherence, Prescription Drug Monitoring System, Berkshire Biomedical with their Cloud-
“We believe that the COPA System, with its innovative approach to personalized prescription and drug delivery to the Intended User can be a leading product in this transformation to virtual care.” Rudy Mazzocchi