IRadimed Stock

Iradimed Corporation develops, manufactures, markets and distributes magnetic resonance imaging (MRI) compatible medical devices and related accessories, disposables and services relating to them.

MRidium 3860+ MRI Compatible IV Infusion Pump System

The company is the only known provider of a non-magnetic intravenous (‘IV’) infusion pump system that is specifically designed to be safe for use during MRI procedures. The company was the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components, which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system.

The company’s patented MRidium MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. The company’s pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated to remain immobile during an MRI scan.

Each IV infusion pump system consists of an MRidium MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.

IRadimed 3880 MRI Compatible Patient Vital Signs Monitoring System

The company’s 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo algorithms; non-magnetic respiratory CO2; invasive and non-invasive blood pressure; patient temperature, and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.

The company sells its products primarily to hospitals and acute care facilities, both in the United States and internationally. The company employs a direct sales strategy in the United States and as of December 31, 2022, the company’s direct sales force consisted of 25 field sales representatives, supported by 3 regional sales directors, and supplemented by 5 clinical application specialists. Internationally, the company markets its products into approximately 80 countries through the use of independent distributors.

As of December 31, 2022, the company have sold approximately 6,582 MRI compatible IV infusion pump systems and approximately 1,596 of the company’s 3880 MRI compatible patient vital signs monitoring systems.

The company generate revenues from the sale of MRI compatible medical devices and related accessories, extended warranty agreements, services related to maintaining the company’s products and the sale of disposable products used with the company’s devices.

In 2022, the company introduced its ferromagnetic detection device, IRadimed FMD1 3600 with Remote Alarm Logging Unit (‘RALU’). This is the first ferromagnetic detection device with TruSense threat qualification technology. This technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status reducing false alarms, all while simultaneously circumventing background magnetic field noise.

Strategy

The company’s strategies include driving market awareness of the company’s MRI compatible IV infusion pump and the safety risks associated with using conventional IV pumps with long IV lines; driving market awareness of the company’s MRI compatible patient vital signs monitoring system; continuing to innovate with MRI compatible patient care products; and acquiring synergistic MRI patient care companies, products, or technology licenses to accelerate the company’s product development and leverage the company’s existing sales organization.

The company’s strategies also include continued development of its MRI-focused U.S. direct sales force and its international sales efforts; supporting commercial efforts with evidence-based information; and providing best in class customer service and user experience.

Products

Typical MRI Scanner Room

The company’s 3880 MRI compatible patient vital signs monitor is the only MRI monitor that can operate safely and reliably in very close proximity to the bore of the powerful magnet used to operate the MRI. Additionally, the company’s MRidium MRI compatible IV infusion pump is the only pump on the market approved to operate safely and reliably near the patient (area shown in blue). All other pumps must be placed at a distance from the MRI scanner, which may include being outside of the scanner room entirely.

The company offers three primary products for sale: the company’s MRidium 3860+ MRI compatible IV infusion pump system with associated disposable IV tubing sets; the company’s 3880 MRI compatible patient vital signs monitoring system with associated disposable products; and the company’s 3600 FMD1 with RALU ferromagnetic detection device.

MRidium MRI Compatible IV Infusion Pump System

The patented MRidium MRI compatible IV infusion pump system is based upon a non-magnetic, ultrasonic motor and other uniquely designed non-ferrous parts to provide accurate and dependable fluid delivery to patients undergoing an MRI procedure. The company’s MRidium MRI compatible IV infusion pump system has been designed to offer numerous advantages to hospitals, clinicians, and patients.

The company’s MRI compatible IV infusion pump system includes the 3860+ MRI compatible IV infusion pump, proprietary single-use IV tubing sets, a non-magnetic pole and a lithium battery. In addition, the company offers optional upgrade systems, including the 3861 Side Car, 3865 Remote Display/Control, DERS and an SpO2 monitor.

MRidium 3860+ MRI Compatible IV Infusion Pump

The MRidium 3860+ MRI compatible IV infusion pump was introduced in 2009 and improved upon the performance and features of the company’s first generation MRidium 3850 MRI compatible IV infusion pump. The MRidium 3860+ pump system can operate dependably in the presence of 0.2T to 3T magnets and is fully operational up to the 10,000 gauss-line. This means the company’s MRidium 3860+ is highly versatile and can operate virtually anywhere in the MRI scanner room, including close to the MRI scanner. The MRidium 3860+ MRI compatible IV infusion pump system has a 10-key numeric input keypad making the company’s system easy to accurately program and operate. The company’s pumping range of 0.1 mL per hour to 1,400 mL per hour provides a broad range of fluid flow control. The company’s broad range of infusion rates support differing patient needs, including low levels for pediatric sedation, mid-levels for continued IV infusion of medications to critically ill patients and high levels in the event of emergency situations. The company’s MRidium 3860+ MRI compatible IV infusion pump system offers a dose rate calculator, bolus dose programming, full alarm settings, and a rechargeable battery with a 12-hour life.

MRidium 3860+ IV Tubing Sets

The MRidium 3860+ MRI compatible IV infusion pump system utilizes proprietary fluid delivery tubing sets, each known as an ‘IV tubing set.’ Each use of the company’s MRI compatible IV infusion pump requires a disposable IV tubing set. The company offers a variety of IV tubing sets for varying infusion scenarios and these include the company’s standard ‘spike’ infusion set, syringe adapter infusion set and extension infusion set. Each of the company’s IV tubing sets is latex-free and DEHP-free.

MRidium 1056 Standard Infusion Set: The company’s standard ‘spike’ infusion set features the ability to accurately deliver liquids from either a bottle or IV bag. The 1056 standard infusion set contains two needle-free injection ports and is typically used when starting a new infusion from a bottle or bag.

MRidium 1057 Syringe Adapter Infusion Set: The company’s syringe adapter IV set enables users to provide accurate delivery of IV fluids directly from standard syringes. The 1057 vented syringe adapter set benefits from a low priming volume of 4 ml, which minimizes inefficient waste of medication. This product is most commonly used for cardiac medications, anesthesia, and pediatric drug delivery.

MRidium 1058 Extension Infusion Set: The company’s extension infusion set allows users to transfer a patient on a standard infusion pump to the company’s MRI compatible IV infusion pump. The user simply disconnects the existing IV tubing at the patient site and primes and connects the MRidium extension set to the existing IV tubing. Once removed from the conventional infusion pump and connected to the company’s MRidium MRI compatible IV infusion pump, the user can program the pump and begin the infusion. The 1058 extension set includes one needle-free injection port and is typically used to provide uninterrupted critical medications to a severely ill patient during an MRI procedure.

MR IV Pole

The company offers a fully functional and weighted non-magnetic IV pole that is designed for mobility within the hospital and the MRI scanner room. The IV pole can support two MRidium 3860+ MRI compatible IV infusion pumps, each with a 3861 Side Car Pump Module. The IV pole is 66 inches (1.68 meters) high, stabilized with a wide pole radius and mobilized with five casters designed to roll easily during transport. The IV pole is equipped with four hooks for holding fluid bags.

Optional Features

The company’s 3860+ MRI compatible IV infusion pump system gives customers the ability to adapt their systems to meet their specific needs. In addition to the company’s standard product features, the company also offers system upgrades which include a modular add-on second IV channel through the company’s 3861 Side Car, a wireless remote control/display, DERS and an imbedded SpO2 monitor. The company also offers rechargeable lithium polymer battery packs which have 12-hour life when not connected to an electrical outlet.

3861 Side Car Pump Module

The company’s Side Car Pump Module can be attached to its 3860+ MRidium MRI compatible IV infusion pump to provide a second channel for infusion delivery. This flexible option allows hospitals to convert their single-channel infusion pump into a dual-channel system designed to deliver both large and small volume fluids in the MRI scanner room. The side car is fully functional with the company’s 3865 MRidium Wireless Remote, allowing clinicians the ability to control both channels with one remote control unit outside of the MRI scanner room. The additional delivery line has all of the same features and benefits as the 3860+ MRidium MRI compatible IV infusion pump.

3865 MRidium Wireless Remote Display/Control

The company’s wireless remote display/control unit allows for complete control and monitoring of the MRidium MRI compatible IV infusion pump system from the control room (outside of the MRI scanner room). The 3865 MRidium Wireless Remote relays all commands via a single channel and displays information bi-directionally between the MRI compatible IV infusion pump and the remote display/control unit. Utilizing the same user interface and large bright display as the MRidium pump, the company’s wireless remote display/control unit permits clinicians to adjust all pump parameters, including SpO2 monitoring parameters, rates, dose, volume, pump run/stop, alarms (adjust or reset), as well as real-time titration. The company’s remote display/control unit utilizes a proven MRI compatible 2.4 GHz frequency hopping spread spectrum radio technology for artifact-free operation that does not disturb the MRI imaging process. Clinicians may also use the remote display/control unit to adjust a second pump channel when used in combination with the company’s Side Car unit discussed above. The company’s 3865 MRidium Wireless Remote also functions as a battery charger for the company’s MRidium battery pack.

Dose Error Reduction System (‘DERS’)

The company’s DERS software for use with its MRidium 3860+ MRI compatible IV infusion pump system incorporates the latest dosing safety features for patients. The DERS system enables users to create a unique drug library and establish nominal values and limits for dose and concentration for specified infusion protocols. With DERS, patient safety and user convenience are supported by user-programmed infusion hard limits (maximum and minimum) and soft limits (high and low limits that require user confirmation to exceed). The dose applied via DERS is displayed and can be adjusted directly on the running screen at any time during the infusion. The memory card port allows for easy archiving and updating of the drug library.

SpO2 Monitoring with Sensor and Accessories

The company’s MRidium 3860+ MRI compatible IV infusion pump system also offers state-of-the-art Masimo SET SpO2 capability providing a unique ability to have SpO2 monitoring and IV delivery combined in one unit. This feature offers users the ability to start sedations outside of the MRI scanner room, transport to the scanner, and then back to recovery without having to discontinue SpO2 monitoring of the patient. In addition, the company’s fiber optic MRI SpO2 sensor and accessories provide a safe connection between the patient and the company’s MRI compatible IV infusion pumps. This fiber optic based SpO2 sensor delivers outstanding performance while avoiding potentially hazardous heating or image artifact during MRI scans. The method of patient attachment uses a medical-grade silicone rubber sensor grip that allows easy and convenient attachment to the patient’s hand or foot, and accommodates pediatric, adult, and infant patients with various size grips.

The company’s MRidium 3860+ MRI compatible IV infusion pump system and its customizable features comprehensively and uniquely address the needs of MRI departments within hospitals and other medical facilities.

MRI Compatible Patient Vital Signs Monitoring System

The company’s 3880 Monitor has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The 3880 Monitor system is fully operational in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room.

The company’s 3880 Monitor has a compact, lightweight design allowing it to travel with the patient from the critical care unit, to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units.

The basic configuration of the 3880 Monitor includes wireless ECG with dynamic gradient filtering, wireless SpO2 using Masimo algorithms, and non-invasive blood pressure. Optional features include all or a combination of non-magnetic respiratory CO2; invasive blood pressure; patient temperature, and/or optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements.

The MRI compatible patient vital signs monitoring system also includes an extended range remote tablet that allows for remote monitoring from outside the MRI scanner room; a base station control center that facilitates printing, wireless communications between the remote tablet and the monitor, and acts as a battery charger for the remote tablet; and wireless ECG, SpO2 and invasive blood pressure pods that facilitate the respective monitoring modalities.

IRadimed FMD1 with Remote Alarm Logging Unit (RALU)

The company’s 3600 ferromagnetic detection device, IRadimed FMD1 with Remote Alarm Logging Unit (RALU) is the first ferromagnetic detection device with TruSense threat qualification technology. The company’s patent pending TruSense technology predicts an approaching ferrous hazard by uniquely sensing a threat’s speed, trajectory, and Zone IV door status. with IRadimed’s expertise in Dynamic Signal Processing. This technology reduces false alarms, all while simultaneously circumventing background magnetic field noise. The 3600 can be self-installed and does not require drilling, special tools, permits or contractors like traditional FMD systems.

The wireless touchscreen, RALU is unique in the industry and provides a full color visual representation of the MRI door and FMD status. When an incident occurs, this wireless touchscreen uniquely allows users to quickly and easily log all ferrous items as they enter the MRI Zone IV improving the reporting accuracy hospitals require for accreditation.

Intellectual Property

The company has 16 issued U.S. patents and 4 issued foreign patents with remaining lives that range from 1 to 18 years. The company also has a number of U.S. patent applications pending. These patents and patent applications relate to several of the company’s products, including the company’s MRI compatible IV infusion pump system and its components and the company’s MRI compatible patient vital signs monitoring system.

Sales and Marketing

The company sells its MRI compatible products through its direct sales force in the U.S. and independent distributors internationally. In the U.S., the company sells its products through its 25 direct field sales representatives, 3 regional sales directors and 5 clinical application specialists. The company has distribution agreements for its products with independent distributors selling the company’s products internationally. The company has developed an experienced team of international distributors that have a strong MRI/radiology product portfolio and focus. The company’s international distributors are managed by the company’s international sales team.

The principal customers for the company’s MRI compatible products include hospitals and acute care facilities. The key decision maker in a purchase varies on the hospital department making the purchase. The company serves these customers through its sales and service specialists and the company’s specialists are well-positioned to build upon these customer relationships. The company communicates with its customers on a regular basis to understand potential issues or concerns, as well as to improve the company’s products and services in response to their needs. Product orders and inquiries are handled by trained service representatives who communicate with customers after equipment shipments, installations, and service repair calls. The company has implemented various other programs, which enable the company to assess its customers’ needs. These programs include surveys and visits to customer sites.

The company enters into agreements with integrated delivery health systems and healthcare supply contracting companies, which are commonly referred to as Group Purchasing Organizations (‘GPOs’) in the U.S., which enable the company to sell and distribute its products to their member hospitals.

Seasonality

The company’s business is seasonal. The company’s third quarter sales have typically been lower, compared to other fiscal quarters, principally because the fiscal quarter (year ended December 2022) coincides with the summer vacation season, in the U.S., Europe and Japan.

Research and Development

The company’s research and development expenses were $2.3 million in 2022.

Regulatory Matters

Governmental Regulation and Other Matters

The company’s medical device products are subject to extensive, complex and increasing oversight and regulation by the FDA, and other domestic and foreign governmental authorities.

All the company’s products and facilities and those of its suppliers are subject to drug and medical device laws and regulations promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including for example, Health Canada’s Health Products and Foods Branch, the U.K.’s Medicines and Healthcare Products Regulatory Agency, and Australia’s Therapeutic Goods Agency. These authorities regulate a range of activities, including among other matters, manufacturing, post-marketing studies in humans, advertising and promotion, product labeling, post-marketing surveillance and adverse event reporting.

Regulation of Medical Devices in the United States

The development, manufacture, sale, and distribution of the company’s medical device products are subject to comprehensive governmental regulation. Most notably, all the company’s medical devices sold in the United States are subject to the Food, Drug, and Cosmetic Act of 1938, as amended (‘FDC Act’), as implemented and enforced by the FDA. The FDA, and in some cases other government agencies, such as the U.S. Federal Communications Commission (‘FCC’), administer requirements covering the design, testing, safety, effectiveness, manufacturing, labeling, promotion and advertising, distribution, and post-market surveillance of the company’s products.

Unless an exemption applies, each medical device that the company markets must first receive either premarket notification clearance (by making what is commonly called ‘a 510(k) submission’) or premarket approval (by filing a premarket approval application (‘PMA’) from the FDA pursuant to the FDC Act.

All aspects of the company’s manufacturing and distribution of regulated products and those of the company’s suppliers are subject to substantial governmental oversight. Facilities used for the production, packaging, labeling, storage, and distribution of medical devices must be registered with the FDA and other regulatory authorities. All manufacturing activities for these products must be conducted in compliance with current good manufacturing practices (‘cGMPs’). The company’s manufacturing facilities and those of its suppliers are subject to periodic, routine and for-cause inspections to verify compliance with cGMPs.

Healthcare Fraud and Abuse Laws

As a manufacturer and distributor of medical devices to hospitals and other healthcare providers, the company and its customers are subject to laws which apply to Medicare, Medicaid, and other federal and state healthcare programs in the U.S. One such law, the Anti-kickback Statute, prohibits the solicitation, offer, payment or receipt of remuneration in return for referral or purchase, or in return for the recommending or arranging for the referral or purchase, of products covered by the programs.

Regulation of Medical Devices Outside of the United States

The EU has enacted legislation restricting the use of hazardous substances in electronic equipment (Directive 2011/65/EU, referred to as ‘RoHS 2’), such as the company’s devices. The company’s products are compliant with RoHS 2.

Anti-Bribery Laws

The company’s global activities are subject to the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act, and other countries’ anti-bribery laws that have been enacted in the support of the Organization for Economic Cooperation and Development’s Anti-bribery Convention.

Other Laws

The company is also subject to a variety of other laws, directives, and regulations in and outside of the U.S., including those related to the following: environmental laws and regulations; the safety and health laws of the U.S. Occupational Safety and Health Act, which sets forth requirements for workplace conditions; California’s Proposition 65, which sets forth a list of substances that are deemed by the state of California to pose a risk of carcinogenicity or birth defects; and various customs, export control, anti-boycott and trade embargo laws and regulations administered by U.S. and foreign government agencies, including the U.S. Customs and Border Protection, the Bureau of Industry and Security, the Department of Commerce and the Office of Foreign Assets Control Treasury Department, as well as others.

Competition

The company competes with manufacturers of ‘shielded box’ solutions that are intended to permit use of conventional IV pumps inside the MRI scanner room. The providers of shielded boxes include B. Braun, Fresenius Kabi and MIPM Mammendorfer Institut für Physik und Medizin.

History

IRadimed Corporation was incorporated in Oklahoma in 1992 and reincorporated in Delaware in 2014.