Cardio Diagnostics Holdings, Inc. — Form 8-K
Filed August 20, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 28/100
What the filing says
This is an investor presentation (Exhibit 99.1 to an 8-K) outlining Cardio Diagnostics' two FDA-cleared diagnostic tests: Epi+Gen CHD (risk stratification, CPT 0439U, CMS rate $854) and PrecisionCHD (diagnostic aid, CPT 0440U, CMS rate $854). Key milestones: CPT codes assigned January 2024, CMS final payment rates set December 2025 at $854 per test, in-network coverage from Atlas Healthcare Physicians began June 2026, out-of-network billing capability established July 2026. Company claims $175B+ TAM, ~30% lab COGS reduction achieved via in-house CLIA lab, international partnerships underway with Aimil Ltd and Dr. Lal PathLabs in India. No specific revenue, patient volume, or current cash position disclosed.
Why this rating
Reimbursement milestones (CPT codes, CMS rates) remove key regulatory hurdles for a $5.8M-cap company; international partnerships signal revenue diversification. However, no revenue traction, patient numbers, or payer adoption metrics disclosed; early commercialization stage. Routine for pre-revenue diagnostic company.
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