CDIOW — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• Cardio expects that sales and partnership cycles will continue to be long. A recurring question from investors is why revenue growth does not immediately follow the development and validation of a clinically promising test. While product development may appear straightforward — develop the test, dem…

• The commercialization lifecycle for diagnostic tests generally involves multiple stages:

• The Company must conduct rigorous analytical and clinical validation studies to demonstrate the safety, accuracy and clinical utility of its tests. Publication of supporting data and peer-reviewed evidence is often an important component of this process.

• Depending on the regulatory pathway, the Company must comply with applicable federal and state regulatory standards. Regulatory processes may involve submissions, inspections, or other oversight requirements that can extend development timelines.

• Revenue generation depends significantly on securing third-party reimbursement. Following launch, the Company must obtain coverage determinations from government programs, including the Centers for Medicare & Medicaid Services (“CMS”), and subsequently from commercial payors. Coverage decisions ofte…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• Cardio expects that sales and partnership cycles will continue to be long, especially with the current economic uncertainty. Our ongoing strategy for expanding our business operations and increasing revenue generation include the following:

• Develop additional products, including clinical tests for stroke, congestive heart failure and diabetes;

• · Offer laboratory services once our laboratory setup is complete;

• · Explore additional market opportunities in the US and internationally;

• As of November 12, 2025, the Company sold 1,117,763 shares of its Common Stock on a Reverse Stock Split-adjusted basis under the Sales Agreement resulting in proceeds to the Company of $15,061,270, net of offering costs. The Company has paid Craig-Hallum $386,186 in sales commissions.