FzioMed

Timeline

1. May 1, 2026 FDA FDA 510(k) clearance: Oxiplex — K253326, May 1, 2026. Applicant at approval: Fziomed, Inc. source ↗
2. Mar 26, 2026 Trial start Not phased (device or behavioral study): Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome source ↗
3. Jun 17, 2025 FDA FDA De Novo grant: Oxiplex® — DEN240038, Jun 17, 2025. Applicant at approval: Fziomed, Inc. source ↗
4. Apr 23, 2018 Trial start Not phased (device or behavioral study): Confirmatory Clinical Study of Oxiplex source ↗

Upcoming milestones

• 2029-08 (ESTIMATED) · Not phased · Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome · NCT06593977

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 2

FDA records (last 2 years)

• May 1, 2026 FDA 510(k) clearance: Oxiplex — K253326, May 1, 2026. Applicant at approval: Fziomed, Inc. source ↗
• Jun 17, 2025 FDA De Novo grant: Oxiplex® — DEN240038, Jun 17, 2025. Applicant at approval: Fziomed, Inc. source ↗

NIH awards 2

Annual award amounts. Total $200K.

• Sep 22, 2005 NIH award 1R41AR052189-01A1 FY2005: $100,000 awarded for that fiscal year; activity R41 (STTR); PI BERG, RICHARD A; recipient as written: FZIOMED, INC., SAN LUIS OBISPO, CA. Injectable Delivery of Bone Growth Factor, source ↗
• Sep 30, 1997 NIH award 1R43AR045350-01 FY1997: $100,000 awarded for that fiscal year; activity R43 (SBIR); PI SCHWARTZ, HERBERT; recipient as written: FZIOMED, INC., SAN LUIS OBISPO, CA. BIOADHESIVE BARRIER FOR THE PREVENTION OF source ↗