Milestone Scientific Inc.

Greetings. Welcome to the Milestone Scientific 2022 Year-End Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, David Waldman, Investor Relations. You may begin.

Thank you, Holly. Good morning, and thank you for joining Milestone Scientific's 2022 year-end financial results conference call. On the call with us today are Ariane Haberhals, Chief Executive Officer, and Peter Milligan, Chief Financial Officer of Milestone Scientific. The company issued a press release today, March 31st, containing 2022 year-end financial results, which is also posted on the company's website. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at 212-671-1020. The company's management will now provide prepared remarks reviewing the financial and operational results for the year ended December 31st, 2022. Before we get started, we would like to remind everyone that during this conference call, we may make forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive, and market conditions and future business decisions, all of which are difficult or impossible to predict accurately, and many of which are beyond milestones control. Some of the important factors that could cause the actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, Changes in customer market requirements and standards and the risk factors detail from time to time in milestones, periodic filings with the securities and exchange commission, including without limitation milestones report on form ten K for the year end December thirty first two thousand twenty two. The forward looking statements made during this call are based upon management's reasonable belief as of today's date. March thirty first two thousand twenty three milestone undertakes no obligation to revise or publicly update any forward looking statements for any reason. With that, we'll now turn the call over to Arjen Haverhals, Chief Executive Officer. Please go ahead, Arjen.

Thank you, David, and thanks to everyone for joining us today. 2022 was an eventful year for the company as we achieved a number of milestones related to the rollout of the CompuFlow epidural system. Most importantly, we were successful in seeding the market across a number of key hospitals, healthcare systems, and pain management clinics. as well as key opinion leaders in the field of anesthesiology and pain management. The fact that our technology was adopted by these leading physicians and hospital systems reinforces our confidence in the market potential for our instrument, particularly within the labor and delivery and pain management markets, where we focused our initial efforts in 2022. More recently, we received 510K FDA clearance for use of the CompuFlow epidural system in the thoracic region of the spine, including the cervical thoracic junction, where the incident rates of morbidity are believed to be much higher than in the lumbar spine region at 17 and 30% respectively, due to the difficulties accessing the epidural space. These widely acknowledged risk factors have helped drive adoption of our CompuFlow epidural system within a number of prominent pain management clinics. The importance of the pain management market cannot be understated. The pain management market is believed to be at least twice the size of the labor and delivery market segment, and not only includes numerous hospitals, but also specialty centers, outpatient centers, and sports medicine centers. Furthermore, we have experienced that the decision-making time or sales cycle is much shorter in these private pain clinics compared to the labor and delivery department at hospitals. In other words, the recent FDA 510 approval increased our accessibility to the total addressable market for epidural analgesia. Within just two weeks of receiving the thoracic clearance, we announced that we commend sales of CompuFlow epidural disposables across three pain management clinics in Colorado. Adoption of the technology by these clinics follows a successful evaluation process by Dr. Brad Sisson, MD, a recognized pain management doctor. Dr. Sisson initially conducted several cases using the CompuFlow epidural instrument in which he reported 100% success. The evaluation included procedures within the thoracic region of the spine. Similarly, Dr. Demesman, an interventional pain medicine physician, has begun using our technology within his practice at University Pain and Spine Center following a similar successful evaluation. As a result, we commenced the sales of our CompuFlow epidural disposables across the University Pain and Spine Center in Somerset, New Jersey, which operates in another seven offices across New Jersey and New York. We remain encouraged by the interest in our epidural instruments by anesthesiologists and pain management providers, especially for patients with complex anatomy and difficult cases that involve the thoracic and cervical thoracic junction. The further evaluation of our technology by these physicians illustrates their commitment to incorporating the latest technologies to improve patient outcomes and safety. Another important milestone in 2022 was the issuance of a category three CPT code, which became effective on January 1st of this year. We believe this would potentially allow billing and payment pathways for healthcare personnel who choose to use our technology for coverage and discretionary payment by payers such as Medicare and Medicaid, as well as commercial health plans. This code will be a focus of ours in 2023 and is expected to play an important role, especially in private pain clinics where administration or financial decision-making will be made easier, thereby potentially helping accelerate our commercial rollout. In addition, we were recently granted registration with the U.S. Government System for Award Management, also known as SAM, which is a key step in the overall governmental decision making and payment process. A SAM registration is required for entities to bid on contracts and conduct business with Department of Defense and the Department of Veterans Affairs, Indian Health Service, and other government agencies. We are actively pursuing U.S. federal supply service approval for the CompuFlow epidural instrument, which, if granted, would provide uniform pricing and reimbursement across government agencies. In addition to our direct sales channel, we are also expanding our network of distribution partners to assist in further adoption of CompuFlow epidural systems. We recently added a new international distributor in Greece and re-engaged with our domestic partner, Clinical Technology Incorporated, a leading specialty distributor of medical products in the Midwest and East Coast regions of the US. Each of these distributors brings relationships within key global markets and proven track records, introducing medical devices within their territories. We look forward to announcing additional international distributors as we advance our commercial rollout. So to summarize, we are continuing our efforts to seed the market with our technology among key physicians, which we believe will ultimately translate into widespread adoption. We remain committed to our goal of establishing the CompiFlow Epidural Instrument as the new standard of care in epidural anesthesia by providing patients with effective pain relief while reducing the risk of complications. Turning now to our dental segment, we made a number of key changes to our sales and marketing strategy this past year that we believe will enhance our long-term growth. In the United States, we launched a new online portal for U.S. dentists to order the STA single-tooth anesthesia system instruments and handpieces. This new site went live on January 3, 2023. We ended the agreement with our prior distributor at the end of 2022. This change in U.S. distribution strategy resulted in lower fourth quarter 2022 sales as the prior distributor wound down its operations and did not preorder handpieces for the first quarter of 2023 as they did in the fourth quarter of 2021. Despite this short-term impact, we expect our new direct online channel will provide us with a closer and direct relationship with our customers, which we believe will result in better follow-up and improved margins. In turn, we believe this strategy could result in an increase in dental sales at higher margins in the US market in the coming quarters. Meanwhile, we continue to work closely with other channel partners for our STA instruments, especially in specialized areas of dentistry, such as implant dentistry and aesthetics, as well as large dental groups, also known as dental service organizations, or DSO. Offsetting the temporary weakness in domestic sales due to our transition to a direct sales model we witnessed continuous growth in international sales, excluding China. As part of our strategy to grow our dental business, we have placed a major emphasis on entering new markets and expanding our penetration within existing international markets. Specifically, we have added new global distribution partners. For instance, we recently granted Technica Health Technologies exclusive distribution rights to market milestones FDA single-tooth anesthesia system in Brazil, one of the three largest world markets in dentistry. In fact, Brazil has a population more than 200 million people with over 240,000 dentists. We also recently appointed Sweden and Martina as our exclusive distributor in Italy, France, Spain and Portugal. We believe that Sweden and Martina is an ideal partner given that deep penetration within these key European markets, which represent a combined population in excess of 180 million people. We look forward to announcing additional international distribution agreements as we continue to build our network across Asia, Africa, South America, and Europe. At the same time, we continue to carefully manage our expenses while investing in sales marketing and new product development along with analyzing new areas for our technology. So to summarize, we believe that through our new sales strategy in combination with our increased marketing efforts, we aim to further grow the dental business in the coming years. Our dental business continues to generate positive cash flow on a standalone basis. As we continue to grow our revenues, we expect to benefit from economies of scale due to the recurring nature and high margins on our disposables. At this point, I'd like to turn the call over to our Peter Milligan, Chief Financial Officer, to go over the financials in detail. Please go ahead, Peter.