Dynatronics Profile
Dynatronics Corporation (Dynatronics), a medical device company, designs, manufactures, and sells a broad range of products for clinical use in physical therapy, rehabilitation, pain management, and athletic training.
The company, through its distribution channels, markets and sells to orthopedists, physical therapists, chiropractors, athletic trainers, sports medicine practitioners, clinics, and hospitals. The company's products are marketed under a portfolio of high-quality, well-known industry brands including Bird & Cronin, Solaris, Hausmann, PROTEAM, and Mammoth, among others.
Business Strategy
Dynatronics is a leading manufacturer of restorative products known for trusted high-quality brands, on-time delivery, and superior customer care. The company is a executing a strategy to grow its organization organically and through a value-driven acquisition program in order to realize its vision to become the recognized standard in restorative solutions. The company intends to provide value to clinicians, investors, and all stakeholders by executing on its core strategy of sustained revenue growth, strong financial performance, and focused business development.
Products
The company sells products that it manufactures or which are manufactured by its Dynatronics affiliated entities or contract manufacturers.
The company offers a broad range of restorative products for clinical use in physical therapy, rehabilitation, orthopedics, pain management, and athletic training. The company's offerings include orthopedic soft bracing and supports, patient care products, treatment tables, rehabilitation equipment, therapeutic modalities, and related supplies. The company's products are used primarily by orthopedists, physical therapists, chiropractors, athletic trainers, sports medicine practitioners, clinics, and hospitals.
Orthopedic Soft Bracing Products
The company's orthopedic soft bracing products are designed to accelerate health for patients both pre- and post-surgical intervention, and during fracture recovery, joint stabilization, and ligament injury.
The company's Bird & Cronin products include, among others, cervical collars, shoulder immobilizers, arm slings, wrist and elbow supports, abdominal and lumbosacral supports, maternity supports, knee immobilizers and supports, ankle walkers and supports, plantar fasciitis splints, and cold therapy. The company continually seeks to update its line of soft bracing products.
Physical Therapy and Rehabilitation Products
The company's physical therapy and rehabilitation products are designed to accelerate health in a wide range of clinical settings, including physical therapy, rehabilitation, pain management, and athletic training.
The company's Solaris, Hausmann, PROTEAM, and Mammoth brands include products for physical therapy, rehabilitation, and athletic training. These products include treatment tables, rehabilitation equipment, therapeutic modalities, and related supplies.
Therapeutic Modalities: The company manufactures and distributes a premium line of therapeutic modality devices that include electrotherapy, ultrasound, phototherapy, traction, hot and cold therapy, and electrodes. These modalities can be effective in treating pain, increasing local blood circulation, promoting relaxation of muscle spasms, preventing retardation of disuse atrophy, and accelerating muscle re-education. The company's branded line of modalities are well known to clinicians across all of its end-markets.
Treatment Tables, Exercise and Rehabilitation Equipment: The company manufactures a premium line of power and manually operated treatment tables, mat platforms, work tables, parallel bars, training stairs, weight racks, and other related equipment. These products are essential to treating patients in a variety of clinical settings.
Supplies: The company manufactures and distributes various clinical supplies that include exercise bands and tubing, lotions and gels, orthopedic bracing, paper products, and other related supplies.
Sales Mix among Key Products
Sales of product the company manufactures or is manufactured by its contract manufacturers represented approximately 98% of total product sales, excluding freight and other revenue, in fiscal year 2023 (year ended June 30, 2023).
Patents and Trademarks
Patents: The company owns a United States patent on its thermoelectric technology that will remain in effect until February 2033. The company also holds a United States patent on its combination traction/phototherapy technology that will remain in effect until December 2026, and a United States patent on its phototherapy technology that will remain in effect until August 2025.
Trademarks and Copyrights: The company owns trademarks used in its business, particularly marks relating to its corporate and product names. United States trademark registrations that are significant to its business include Dynatron, Dynatron Solaris, Dynaheat, BodyIce, Powermatic, Bird & Cronin, Physician's Choice, Hausmann, PROTEAM, and Mammoth.
Customers and Markets
The company sells products to licensed practitioners, such as orthopedists, physical therapists, chiropractors, and athletic trainers. The company's customers also include professional sports teams and universities, sports medicine specialists, post-acute care facilities, hospitals, clinics, retail distributors and equipment manufacturer (OEM) partners. The company utilizes a network of over 300 independent dealers throughout the United States. Most dealers purchase and take title to the products, which they then sell to end users. In addition, the company utilizes a network of independent sales representatives combined with a small number of targeted direct sales representatives.
The company has entered into agreements with independent clinics and hospitals, regional and national chains of physical therapy clinics and hospitals, integrated delivery networks, group purchasing organizations (GPOs), and government agencies. The company sells products directly to these clinics, hospitals, and groups pursuant to preferred pricing arrangements. In fiscal year 2023, two major customers were responsible for 11.6% and 10.4% of its total net sales.
Manufacturing and Quality Assurance
The development and manufacture of a portion of the company's products manufactured to its specifications by Ascentron is subject to rigorous and extensive regulation by the U.S. Food and Drug Administration, or FDA, and international regulatory agencies, as applicable. In compliance with the FDA's Current Good Manufacturing Practices, or cGMP, and standards established by the International Organization for Standardization, or ISO, the company has developed a comprehensive quality system that processes customer feedback and analyzes product performance trends. The company's Utah facility holds certification to ISO 13485:2016. Applicable quality systems enhance the company's ability to provide products and services that meet the expectations of its customers.
Seasonality
Sales are typically higher in the company's first and fourth fiscal quarters (the summer and spring months), while sales in its second and third fiscal quarters are generally lower (the fall and winter months). Therefore, the company's quarterly operating results are not necessarily indicative of operating results for the entire year (year ended June 30, 2023), and historical operating results in a quarterly or annual period are not necessarily indicative of future operating results.
Regulatory Matters
The manufacture, packaging, labeling, advertising, promotion, distribution and sale of the company's products are subject to regulation by numerous national and local governmental agencies in the United States and other countries. In the United States, the FDA regulates some of the company's products pursuant to the Medical Device Amendment of the Food, Drug, and Cosmetic Act, or FD&C Act, and regulations promulgated under the FD&C Act. Advertising and other forms of promotion (including claims) and methods of marketing of the products are subject to regulation by the FDA and by the Federal Trade Commission, or FTC, under the Federal Trade Commission Act, as applicable.
As a medical device manufacturer, the company is required to register with the FDA and once registered it is subject to inspection for compliance with the FDA's Quality Systems Regulations, as applicable. These regulations require the company to manufacture its products and maintain related documents in a prescribed manner with respect to manufacturing, testing, and control activities. Further, the company is required to comply with various FDA requirements for reportable events involving its devices. The FD&C Act and its medical device reporting regulations require the company to provide information to the FDA if allegations are made that one of its products has caused or contributed to a death or serious injury, or if a malfunction of a product would likely cause or contribute to death or serious injury. All of the company's therapeutic treatment devices, as currently designed, are cleared for marketing under section 510(k) of the Medical Device Amendment to the FD&C Act, or are considered 510(k) exempt. The company is in compliance with the Affordable Care Act and it has systems in place designed to achieve continued compliance.
The company's Utah, Minnesota, and New Jersey facilities are subject to periodic inspection by the FDA for compliance with the FDA's cGMP and other requirements, including appropriate reporting regulations and various requirements for labeling and promotion.
Advertising of the company's products is subject to regulation by the FTC under the FTC Act, as applicable. Section 5 of the FTC Act prohibits unfair methods of competition and unfair or deceptive acts or practices in or affecting commerce. Section 12 of the FTC Act provides that the dissemination or the causing to be disseminated of any false advertisement pertaining to, among other things, drugs, cosmetics, devices or foods, is an unfair or deceptive act or practice. Pursuant to this FTC requirement, the company is required to have adequate substantiation for all advertising claims made about its products.
History
Dynatronics Corporation was founded in 1979. The company, a Utah corporation, was incorporated in 1983.
