About Milestone Scientific

Milestone Scientific Inc. (Milestone Scientific) operates as a biomedical technology research and development company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical, dental, and cosmetic use. The company engages in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. The company has focused its resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections from the healthcare provider. The company's proprietary DPS platform that advances the development of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical injections. The company's computer-controlled injection devices make injections precise, efficient, and virtually painless. The company has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, its DPS (Dynamic Pressure Sensing Technology System), to meet the needs of various subcutaneous drug delivery injections and fluid aspiration - enabling healthcare practitioners to achieve multiple unique benefits. The device, using The Wand, a single use disposable handpiece, is marketed in dentistry under the trademark CompuDent, and STA (Single Tooth Anesthesia System) and is suitable for all dental procedures that require local anesthetic. The dental devices are sold in the United States, Canada, and in 38 other countries. Milestone Scientific also has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo Epidural Computer Controlled Anesthesia System (the CompuFlo Epidural System) in the lumbar spine region. In 2020, the company received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) related to its new CompuPulse System, which combines the benefits of its CompuWave technology with a manual syringe. The new CompuPulse System allows one to identify a pulsatile pressure waveform in a variety of applications, thereby improving the reliability and safety of a drug delivery procedure. Establishing Milestone's DPS Dynamic Pressure Sensing technology platform as the standard-of-care in painless and precise drug delivery, providing for the first time, objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications. Following obtaining successful FDA clearance of the company's first medical device, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company. Expanding the company's global footprint of its CompuFlo Epidural and CathCheck System by utilizing a direct field sales force and partnering with distribution companies worldwide. The company's dental devices have been used to administer tens of millions of injections worldwide. Each of the company's devices has a related single use disposable handpiece, leading to a continuing revenue stream following sale of the device. The company sells disposable handpieces unique to its legacy product (the Wand and CompuDent) to users In 2017, the company received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for certain medical applications. The company intends to continue to expand the uses and applications of its DPS Dynamic Pressure Sensing technology. Given the company's experience and established brand awareness within the dental industry beginning with its first commercial product, the first computer-controlled local anesthesia delivery (C-CLAD) system marketed as the Wand and re-branded as the CompuDent System, the company elected to focus its product development efforts on improving the patient experience and making the device more versatile and precise for the practitioner. The company's next significant intellectual property advancement was a quantum improvement over ots CompuDent System - the development of its proprietary CompuFlo Computer-Controlled Drug Delivery System with DPS Dynamic Pressure Sensing Technology, an advanced and FDA-approved technology for the painless and accurate delivery of drugs, anesthetics, and other medicaments into all tissue types, as well as for the aspiration of bodily fluids or previously injected substances. Its regulation and control of the flow rate continues to provide painless delivery benefits, while its innovative dynamic pressure sensing capability provides visual and audible in-tissue pressure feedback, identifying tissue types to the healthcare provider. The company's CompuFlo Epidural System provides an objective tool that it consistently and accurately identifies the epidural space by detecting the difference in pressure between the ligamentum flavum and the intrafilamentary tissue. During 2016, Milestone Scientific filed for 510(k) marketing clearance with the U.S. Food and Drug Administration (FDA) for both intra-articular and epidural injections with the CompuFlo Epidural System. In November 2017, the company announced plans for the commercial launch of its proprietary cosmetic injection device using its DPS Dynamic Pressure Sensing technology platform and its CompuFlo Cosmetic System for delivery of botulinum toxin. The company's proprietary cosmetic injection device features improved needle placement with a comfortable stylus grip, precise dosing, the same technology platform that has made dental and epidural injections painless, and a new, intuitive touch-screen interface. The company is reviewing using CompuFlo's DPS Dynamic Pressure Sensing Technology for less painful injections for use in rhinoplasty, colorectal surgery, podiatry, and other disciplines. Patents and Intellectual Property Milestone Scientific and its subsidiaries holds approximately 216 U.S. and foreign patents, and many patent applications. Milestone Scientific and its subsidiaries also holds approximately 36 registered U.S. and foreign trademarks, including CompuDent, CompuFlo, DPS Dynamic Pressure Sensing technology, Safety Wand, STA Single Tooth Anesthesia System, and The Wand. Manufacturing Milestone Scientific has informal arrangements with an U.S. manufacturer of the Wand/STA System, and epidural devices. Distribution and Marketing The company has used a combination of exclusive and non-exclusive distributors to sell its dental products. On the global front, the company has granted exclusive marketing and distribution rights for the Wand STA System to select dental suppliers in various international regions in Asia, Africa, South America, and Europe. Additionally, the company is in the process of evaluating international distributors and adding new distributors globally as required based on the economics of the region. The company markets and sells its medical products in the international markets, such as Italy, Switzerland, Greece, Canada, and the Middle East through exclusive distributors. In the United States the medical products are sold by a direct sales team and a medical distributor covering 22 states. Research and Development The company's research and development expenses for the year ended December 31, 2022, were approximately $1.2 million. Trademarks The company's registered U.S. trademarks include CompuDent; CompuMed; CompuFlo; DPS Dynamic Pressure Sensing technology; Milestone Scientific; CathCheck, the Milestone logo; Safety Wand; STA Single Tooth Anesthesia System; and The Wand. Government Regulation The FDA cleared the Wand, the company's CompuDent System, and its disposable handpieces, for marketing in the United States for dental applications in July 1996; the CompuMed System for marketing in the United States for medical applications in May 2001; the Safety Wand for marketing in the United States for dental applications in September 2003; the Wand/STA System for dental applications in August 2006; and the company's CompuFlo Epidural System in June 2017. The company is subject to pervasive and continuing regulation by the FDA, whose regulations require manufacturers of medical devices to adhere to certain Quality System Regulation requirements as defined by the U.S. Food, Drug and Cosmetic Act. The Medical Device Reporting (MDR) regulation obligates the company to provide information to the FDA on product malfunctions or injuries alleged to have been associated with the use of the product or in connection with certain product failures that could cause serious injury. History Milestone Scientific Inc. was founded in 1989. The company was incorporated in the state of Delaware in 1989.