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COMPANY

Tulavi Therapeutics

HQ: Los Gatos, CA source · tulavi.com ↗ · West Coast

FDA-cleared device company

Keywords: hydrogel Peripheral Nerve Injuries Nerve Cap

Location: Los Gatos, CA · source · Oct 15, 2026

Profile checked Oct 10, 2026

1Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. Trial start —: Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study source ↗
  2. FDA FDA 510(k) clearance: allay Nerve Cap (TL5515-1); allay Nerve Cap (TL5515-2); Delivery Tips (TL-7627) — K252051, Sep 29, 2025. Applicant at approval: Tulavi Therapeutics, Inc. source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 1

RecordTitlePhaseStatusStartPrimary completion
NCT07246980Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success StudyNot listedRecruitingMay 6, 2026Jan 1, 2029 (estimated)

FDA records (last 2 years)

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LinkedIn page linked from the company's own site: source · seen 2026-10-12

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