Pro-Dex Stock

Pro-Dex, Inc. (Pro-Dex) specializes in the design, development, and manufacture of autoclavable, battery-powered and electric, multi-function surgical drivers and shavers used primarily in the orthopedic, thoracic, and craniomaxillofacial (CMF) markets.

The company has patented adaptive torque-limiting technology and proprietary sealing solutions, which appeal to its customers, primarily medical device distributors. The company also manufactures and sells rotary air motors to a wide range of industries.

The company's patented adaptive torque-limiting software has been very well received in the CMF and thoracic markets and it has continued investment in this area with research and development focused on applying this technology to other surgical applications.

The company's medical device products utilize proprietary designs developed by it primarily under exclusive development and supply agreements and are manufactured in its Irvine, California facility, as are its rotary air motors. The company's medical device products are sold primarily to original equipment manufacturers and its air motors are sold primarily to a wide range of distributors and end users.

The company continues to focus a significant percentage of its time and resources on providing outstanding products and service to its valued principal customers. During 2021, the company's largest customer executed an amendment to its existing supply agreement such that it continues to supply their surgical handpieces to them through calendar 2025 and, during the fourth quarter of 2021, they executed a product development agreement and related statement of work for its assistance with the next generation of this handpiece.

Simultaneously, the company is working to build top-line sales through active proposals of new medical device products with new and existing customers. The company's patented adaptive torque-limiting software has been very well received in the CMF and thoracic markets.

The company holds the U.S. Food and Drug Administration (FDA) Establishment Registration and a State of California Device Manufacturing License (Department of Public Health Food and Drug Branch) with respect to its Irvine, California facility. In addition, both facilities produce products that are certified to ISO 13485:2016, Medical Device Directive 93/42/EEC - Annex II.

Research and Development

During the year ended June 30, 2023, the company incurred research and development expenses amounting to $2.8 million.

Patents, Trademarks, and Licensing Agreements

The company holds the U.S. and foreign patents relating to its handheld medical devices and torque-limiting screwdrivers. The company's patents have varying expiration dates. The company has certain federally registered trademarks relating to its products, including Pro-Dex, along with a number of other common law trademarks.

Regulation

The U.S. Food and Drug Administration (FDA) designates all medical devices into one of three classes (Class I, II, or III) based on the level of control necessary to assure the safety and effectiveness of the device (with Class I requiring the lowest level of control and Class III requiring the greatest level of control). The surgical instrumentation the company manufactures is generally classified into Class I.

The company's business is conducted in a manner consistent with the Environmental Protection Agency (EPA) and other agency regulations governing disposition of industrial waste materials.

The company's facilities have manufacturing systems and processes that are based on established Quality Management System standards. In addition, the company's Irvine, California and Tustin, California facilities are compliant with applicable Good Manufacturing Practices promulgated by the FDA and are compliant with applicable ISO standards set forth by the International Organization for Standardization.

History

Pro-Dex, Inc. was founded in 1978. The company was incorporated in 1994.