secwatch.observer — SEC 8-K summary
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Issuer:     HeartSciences Inc. (HSCS)
CIK:        0001468492
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0000950170-24-136647
Event type: earnings
Sentiment:  neutral
Materiality: 0.50
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

HeartSciences reports Q2 FY2025 zero revenue; cash $4.1M; MyoVista device on track for FDA submission Q1 2025
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- No revenue in Q2 FY2025; cash and equivalents $4.1M, shareholders' equity ~$4.0M at Oct 31, 2024.
- MyoVista wav ECG device on track for FDA submission around Q1 2025; final pre-submission meeting with FDA requested.
- MyoVista Insights Phase 1 (no regulatory clearance) completion by end of 2024; test sites targeted H1 2025. Phase 2 AI-ECG clearance target H2 2025.
- Pre-validation of Mount Sinai-licensed low ejection fraction AI-ECG algorithm progressing; CMS 2025 OPPS final rule includes reimbursement path.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1468492/000095017024136647/0000950170-24-136647-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1468492/000095017024136647/hscs-20241216.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-136647

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer