What iRadimed Corp. told the SEC could break it.

Certain critical raw materials and components are proprietary to single third-party suppliers and are specifically cited in iRadimed's regulatory filings, so they cannot be re-sourced from another supplier without a regulatory application amendment — a hard sole-source dependency.

“Certain raw materials and components are proprietary products of those unaffiliated third-party suppliers and are specifically cited in our applications with regulatory agencies so that they must be obtained from that specific sole source or sources and could not be obtained from another supplier unless and until an appropriate application amendment is approved by the regulatory agency.”

Some critical raw materials and parts are single-sourced and certain components used by iRadimed or its suppliers come from Chinese or Taiwanese manufacturers, exposing production to China–Taiwan geopolitical tension, tariffs and trade disruption.

“Some of the raw materials and parts that are critical to the production and operation of our products are sourced from single suppliers. Some components we or our suppliers utilize are from Chinese or Taiwanese manufacturers.”

iRadimed's products and its suppliers' facilities are subject to extensive FDA and foreign medical-device regulation and periodic inspections; delays in 510(k) clearances or adverse inspection outcomes (including a potential request to cease distribution) could materially harm the business.

“All our products and facilities and those of our 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.”