PTS Pulse

2022 has been a terrific year for the organization despite its share of challenges. The pandemic brought
about some big changes in healthcare and specifically in PTS’ traditional
core markets.

Some customers who we expected to make a near full recovery in 2022 —like our traditional global screening customers— did see growth compared to 2021, but have continued to struggle. When we look at 2023, though, there are positive signs that the beginnings of the recovery we saw in 2022 will continue into 2023. Sales to Direct Screening customers and to Distributors who supply healthcare providers’ offices led a rally toward the end of the year.

Pharmacies, another core segment for PTS, have not re-embraced point-of-care testing at the rates we had hoped, as they continue to be distracted by the demands of providing vaccinations instead. The Home Health market, however, delivered strong results for A1CNow sales. Overall though, the net result is that the hard fought for successes combined with the Global Sales Teams’ concerted efforts to grow our U.S. distribution business and recapture lost tender business in Mexico have us poised to hit our overall profitability targets for 2022.

This puts us on much more solid ground for a building momentum in 2023 and beyond.

Facing New Challenges

There is no question that we will be facing increased competition in the marketplace as we head into 2023. Other medical device manufacturers are looking to grab some of our market share by positioning their products as better solutions in the pharmacy and healthcare provider markets. Dry blood spot cards and other devices continue to be a competitor in the home testing market.

However, we will continue to differentiate ourselves, along with our partners at Sinocare and Trividia, with our high-quality products, and our many years of experience as leaders in the management of diabetes and its comorbidities. We will also continue to lean on our culture of resourcefulness and creativity to think beyond our limits.

We must continue to diversify and expand our customer base in the US as well as our Distributor network around the world. Our products have far-reaching utility and in absence of new products we must add new vertical markets to achieve revenue targets. Areas like home health, physician office laboratories, pediatrics and community health represent significant growth opportunities in 2023 and beyond.

One of the ways we hope to prove our continued leadership in this space, is by launching a new point-of-care analyzer late in 2023 that measures a patient’s blood creatinine levels. That data is used to help healthcare providers identify patients who at risk of developing kidney disease.

At-home testing continues to be in demand in our post-pandemic world, as a way for people to complete their biometric screenings without the hassle of attending multiple appointments. To help meet the needs of these consumers, we plan to extend our home testing portfolio in 2023 to include CardioChek Plus Home with Lipid Panel + eGLU test strips. This will help us expand into a new market and mitigate some of the losses we have sustained due to changes in the Health & Wellness Screening industry.

The at-home testing market will also drive a greater need for our devices to offer seamless connectivity to healthcare provider’s patient record systems. Not only will this increase the ease and convenience of our test systems, it will also allow providers to have greater trust in receiving results from a patient’s self-test. If the results are being beamed directly from the device into the records system, there’s less likelihood of error in the reporting of the results.

Advancing Business Processes

In order to support new initiatives and our expansion into new markets, we will need to be creative with our resources and innovative in our approach. We will continue to look for ways to streamline our business processes and improve our reporting and analysis.

We anticipate that supply chain challenges are likely to continue to follow us into 2023. Our Finance and Sales teams will be working on providing real-time data analysis to allow for more precise forecasting that will give our Operations team information they need to continue to manage inventories and customer expectations.

We will also continue looking for ways to further align PTS Diagnostics and Trividia to expand our resources, strengthen our processes, reach new markets, and meet the growing needs of our customers.

We Are Counting on You

Our people are and will always be our biggest asset. We have a great culture made up of talented people and strong teams. In 2023, we will look for ways to invest in each of you by creating professional growth opportunities. Continuing our revenue growth trends and introducing new products and initiatives will better enable us to do that. I genuinely appreciate the important and significant role that each person at PTS plays in moving our business forward and in making this a rewarding place to work.

We have a unique product line, and in a post-pandemic world, management of high-risk persons with diabetes and other chronic disease states is seen as paramount to improving future outcomes. Our best days are clearly ahead of us. Thank you for being a part of the PTS Team.

On a typical day as a PTS employee, you might be a bit dismayed to see your email inbox filling up with dozens of rapid-fire messages from your bosses.
But it was no cause for email-induced anxiety on at least two days last month, as congratulatory messages poured in:

“Great job, team. This is a big deal.”

“Great job and your perseverance paid off!”

“Great news for all of us.”

“It sure is an exciting time to be part of PTS!!”

The causes for all this celebration were that, one, our IVDR team completed the process of self-certifying the CardioChek Plus analyzer allowing us to resume sales in the European Union, and two, we were awarded Mexico’s 2022 tender for lipid panel tests. Both are major accomplishments for us as an organization and are a testament to the grit and determination of PTS employees.

What It Takes to Get IVDR-Certified

In May of 2017, The European Union (EU) announced changes to its Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). The new regulations were designed, in part, to require more transparency from manufacturers and to unite EU member countries under a consistent regulatory framework.

In May of 2022, the EU began enforcement of the new regulations which requires manufacturers to have their products certified under IVDR before they can be sold in EU countries.

So, what has this meant for us and our products? Well, for starters, it has meant that our products were placed into new classes which require more rigorous documentation, and in some cases, additional certification by a “notified body” to become certified. (A notified body is a company that has been certified by the EU as a company that can legally certify manufacturers under IVDR.) It has also meant that before we could even begin the process of certifying a product, we had to certify our entire Quality Management System (QMS.)

Does all this sound a bit overwhelming? That’s because it is. Especially when you consider that no member of the IVDR team is solely focused on it as their only project. Each person on the team, which is led by Heidi Strunk, Carolyn Schmitt, Janice Keeney, and Steve Zucker, has been juggling multiple projects while wading through thousands—literally thousands!—of pages of new IVDR requests and clarifications.

Another important component of the project has been navigating the necessary changes to product labeling that are required with each IVDR submission. Latasha Little has led the IVDR labelling efforts for the better part of the last year, working in close collaboration with the Regulatory group to research labeling needs, create labeling drafts, and develop updated standards for creating artwork for vial labels, boxes, and package inserts.

This makes the fact that we were able to hit our deadlines for products in our space and achieve IVDR certification even more remarkable.

Being allowed to sell the CardioChek Plus analyzer in the EU has obvious benefits. But the current IVDR efforts may help us get additional products approved in the EU more quickly. Carolyn Schmitt, Regulatory Affairs Manager, explained:

“We took what learned from the QMS certification and applied it to the CardioChek Plus analyzer certification. Right now, we are working on getting Cholesterol and Lipid Panel through the certification process, and we are applying what we learned from the analyzer certification to those. Each one gets a little bit easier as we learn what EU commission and our notified body needs from us. There really wasn’t a roadmap, since all of this is new. We had to make our own.”

In the future, our IVDR efforts may also give us a future advantage in other markets. Other countries are beginning to request information in formats similar to the IVDR data submissions. The level of detail we have had to provide in our documentation of every aspect of our business—from production to post-market surveillance—and all the things we’ve learned along the way are preparing us to smoothly jump over any regulatory hurdle placed in front of us.

But what it takes to get certified under IVDR is more than an eye for detail and an abundance of patience. It takes people who care, and who work hard to support each other through big challenges like these!

¡Viva PTS! The 2022 Mexico Tender

Each year, our International Sales team submits a proposal for each of Mexico’s government tenders for A1C and Lipid Panel testing. Last year, we lost the A1C tender to a competitor. And, the Lipid Panel tender was abandoned, meaning that it was not awarded to anyone. It was a big disappointment, but it didn’t mean that David Brandt and his team were going to give up on it!

And, as we learned on September 7, that perseverance paid off. We were selected to supply Mexico’s government with Lipid Panel tests for 2022. According to David, this would not have been possible if we had not been in the right position to supply the tests.

“Before we can even bid, we have to complete all of our regulatory processes and make sure our Mexico registrations are current. We have the Quality & Regulatory team to thank for that. Also, the Mexican government had to feel confident enough in our operations to trust that we could deliver the products they needed on time. So, thank you to our production teams for running a world class operation. And, thanks in advance to our Customer Service and Technical Support teams who will be helping our customers in Mexico have the best possible experience with our products.”

To say that the PTS Diagnostics Domestic Marketing and Sales team have been here, there and a little bit everywhere is an understatement during most of Q2. However, this is a welcomed sign of the world transitioning back to a familiar sense of normalcy. One of the main business drivers our company focuses on is live, face-to-face meetings. These events span national medical professional association meetings and national distributor sales meetings throughout the year with the purpose to engage and interact with customers. To learn more about the roadshow the PTS team has been on, read below!

American Pharmacists Association March 18-21 || San Antonio, TX

Our “Why?”:

• Pharmacists utilize our products to bring business into their stores in addition to helping patients. They provide valuable health services, such as testing for cholesterol and A1C, outside of the traditional healthcare setting and closer to the patients.
• Traditionally, this business has been mostly done on a cash basis, but legislation is opening pharmacists’ services for reimbursement as well.
• Pharmacists have an excellent opportunity to further evolve their role via point-of-care testing (POCT), especially considering the pressure that COVID-19 has placed on the health care system. Proper training, certification, and advances in testing technology enable POCT to occur in any setting.
• Pharmacists using collaborative practice agreements based upon CLIA-POCT results have shown to provide efficacious and safe disease management. To get started, the pharmacy must enroll as a CLIA-waived testing site through the Centers for Medicare & Medicaid Services (CMS). The CMS 11612 form is an application that is mailed to the pharmacy’s state agency.
• The pharmacy continues to be an ideal place for health care advice, and pharmacists will continue to be sought out for recommendations of OTC treatments.
• The role of the pharmacist is evolving in patient care and using CLIA-waived tests in the community pharmacy setting is an opportunity to advance the profession and aid in disease management during COVID-19.

American College of Cardiology April 2-4 || Washington, DC

Our “Why?”:

• PTS Products are perfectly suited for in-office testing during visits for a wide range of medical specialties that include but are not limited to Family Practitioners, General Practitioners, Pediatricians, and Cardiologists.
• Cardiologists have shown strong interest in the CardioChek products as they can quickly get a baseline for patients that may not have been to their regular physician in a while for annual exams. Other patients simply forget to bring their numbers to their appointments or don’t know how to access their results via online hospital portals, etc.
• About 1 in 5 adolescents have an unhealthy cholesterol reading, and nearly 93 million U.S. adults aged 20 or older have high cholesterol. But since high cholesterol doesn’t have symptoms, many people don’t know their levels are high.
• When cholesterol testing should be done:
  • Every 5 years for people aged 20 or older who are at low risk for cardiovascular disease.
  • More frequently than every 5 years for people with cardiovascular disease risk factors.
• Point of care testing for cholesterol, related lipids, and blood glucose can serve as a diagnostic tool that provides information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
• Healthcare providers use lipid panels for both children and adults to evaluate the risk of cardiovascular diseases like heart disease, heart attack (myocardial infarction), and stroke.

• Who Benefits?
  • Patients requiring primary prevention of cardiovascular disease.
  • Management of patients with pre-existing cardiovascular disease.
  • Patients with a history of familial hypercholesterolemia.
  • Children can also have high cholesterol, which may require a lipid panel blood test.

• Reasons a provider may order a lipid panel include:
  • As a routine test to determine if the cholesterol level is normal or falls into a borderline-, intermediate- or high-risk category.
  • To monitor the cholesterol level if you had abnormal results on a previous test or other risk factors for heart disease.
  • To monitor the body’s response to treatment, such as cholesterol medications or lifestyle changes.
  • To help diagnose other medical conditions, such as liver disease.

Henry Schein National Sales Meeting March 22 || Virtual Meeting

Our “Why?”:

• Henry Schein is one of our main national distribution partners
• PTS provides Henry Schein branded CardioChek Plus analyzers and private labeled Lipid+eGLU Smart Bundle test strips.
• This year was a virtual meeting format due to covid concerns.
• The virtual format consisted of 12, 10-minute sessions with different Henry Schein teams rotating through, mostly grouped by geography.
• The virtual meeting was beneficial, but all will be looking to get back to in-person meetings.
• As our national distributors carry thousands of products, it is important to have dedicated time to connect with their sales teams and keep our products top of mind.
• This includes product details and benefits, key features to promote, how to handle any objections, and how we compare to the competition.
• As Covid has started to diminish in many parts of the country, our national distribution partners are looking to revitalize revenue streams beyond covid testing and vaccinations.
• Henry Schein recognizes the value of our products as they promote the Henry Schein branded PTS Diagnostics product line; it is important to continue to work with their sales teams as there are many products fighting for their attention to present to end-users.

NDC (National Distribution & Contracting) April 11-13 || Nashville, TN (Corporate Office Location)

Our “Why?”:

• Even though NDC is a national distribution partner of PTS Diagnostics, it consists of hundreds of small, independent health care distributors that utilize NDC’s membership to help provide efficiencies and support.This includes group buying power, distribution and logistics, contracts & rebates, and promotions & incentives.
• From a manufacturing perspective, NDC partners with over 700+ manufacturers including PTS Diagnostics to save both time and money through their custom supply chain solutions that maximize efficiencies for distribution members.
• This year’s event was held at the Gaylord Opryland Hotel in Nashville, TN.
• The annual conference is always held in Nashville where the corporate offices are located.
• Not all NDC distributors specialize and call on the same customer base. Some may specialize in lab equipment while others may focus on consumables for example.
• This year’s conference was in a roundtable format as opposed to a traditional trade-show concept.
• Attendees were able to pre-schedule personal, dedicated one-to-one meetings with us at the show.
• PTS met with several distributors that were looking for new opportunities to carry our products, further expanding our presence in the market.

McKesson National Sales Meeting May 17-19 || Las Vegas, Nevada

Our “Why?”:

• As of 2021, McKesson is the 7th largest US corporation in the Fortune 500.
• McKesson works with biopharma companies, care providers, pharmacies, manufacturers, governments, and others to deliver insights, products, and services.
• McKesson is another national distribution partner of PTS Diagnostics that we have worked with for years.
• Due to Covid, this was the first time to reconnect in person with their sales team and management in a few years on a large scale.
• The PTS booth had hundreds of interested sales and marketing team members visit the booth and had just under 100 individuals looking for more information and interested in a follow-up conversation with a PTS sales team member.
• Like Henry Schein, McKesson sales members and management are eager to find additional revenue paths post-Covid and see PTS Diagnostics’ products as a potential solution.

IMCO (Independent Medical Distributors) June 12-15 || Lake Buena Vista, FL

Our “Why?”:

• IMCO is like NDC in that it is made up of independent distribution members.
• PTS exhibited to the nearly 200 member distributors representing veterinary, dental, home health, acute care, etc.
• PTS visited with familiar faces and continued to promote our CardioChek and A1C product lines.