COMPANY
Cytovale
Timeline
- FDA FDA 510(k) clearance: IntelliSep Test — K250912, Nov 19, 2025. Applicant at approval: Cytovale, Inc. source ↗
- FDA FDA 510(k) clearance: IntelliSep Test (CV-ICG-048) — K250513, Mar 21, 2025. Applicant at approval: Cytovale, Inc. source ↗
- Trial start —: CV-SQuISH-ED: Clinical Validation Study source ↗
- Trial start —: SQuISH-COVID: A Pilot Study source ↗
Clinical trials (lead sponsor) 2
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04933760 | CV-SQuISH-ED: Clinical Validation Study | Not listed | Unknown status (ClinicalTrials.gov) | May 18, 2021 | Jan 13, 2022 (actual) |
| NCT04372472 | SQuISH-COVID: A Pilot Study | Not listed | Unknown status (ClinicalTrials.gov) | Apr 7, 2020 | Aug 14, 2020 (actual) |
FDA records (last 2 years)
NIH awards 7
- NIH award 5R44HL123878-03 FY2017: $734,141 awarded for that fiscal year; activity R44 (SBIR); PI SHAH, AJAY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Enabling Point of Care Screening for Sepsis source ↗
- NIH award 2R44HL123878-02 FY2016: $750,000 awarded for that fiscal year; activity R44 (SBIR); PI SHAH, AJAY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Enabling Point of Care Screening for Sepsis source ↗
- NIH award 5R43EB018749-02 FY2015: $349,993 awarded for that fiscal year; activity R43 (SBIR); PI TSE, HENRY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Biomechanical enrichment of malignant cells source ↗
- NIH award 5R43TR000351-02 FY2014: $199,720 awarded for that fiscal year; activity R43 (SBIR); PI TSE, HENRY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Robust High-throughput Mechanical Phenotypin source ↗
- NIH award 1R43HL123878-01 FY2014: $225,000 awarded for that fiscal year; activity R43 (SBIR); PI SHAH, AJAY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Automated Sample Preparation for Onsite Bloo source ↗
- NIH award 1R43EB018749-01A1 FY2014: $349,993 awarded for that fiscal year; activity R43 (SBIR); PI TSE, HENRY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Biomechanical enrichment of malignant cell source ↗
- NIH award 1R43TR000351-01A1 FY2013: $199,999 awarded for that fiscal year; activity R43 (SBIR); PI TSE, HENRY; recipient as written: CYTOVALE, INC., SOUTH SAN FRANCISCO, CA. Robust High-throughput Mechanical Phenotyp source ↗
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