secwatch.observer — SEC 8-K summary
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Issuer:     HeartSciences Inc. (HSCS)
CIK:        0001468492
Form:       8-K
Filed at:   2025-12-15T23:59:59+00:00
Accession:  0001193125-25-319234
Event type: earnings
Sentiment:  neutral
Materiality: 0.50
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

HeartSciences reports no Q2 revenue, $2M cash; submits wavECG to FDA
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- No meaningful revenue for FQ2 2026; cash and equivalents $2.0M, shareholders' equity $4.2M as of Oct 31, 2025.
- MyoVista wavECG device submitted to FDA for 510(k) clearance, a key regulatory milestone.
- MyoVista Insights software platform (MDDS, exempt from 510(k)) launched May 2025; V1.1 released; commercial discussions underway.
- Company plans investor call early 2026 to demonstrate MyoVista Insights software and provide commercialization strategy.
- Algorithms for LVDD assessment separated from device submission due to updated ASE guidelines.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1468492/000119312525319234/0001193125-25-319234-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1468492/000119312525319234/hscs-20251215.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-319234

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