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Acera Surgical

acera-surgical.com ↗ · Midwest

FDA-cleared device company

Acera Surgical is a bioscience company developing and commercializing a portfolio of fully engineered materials for regenerative medicine. Acera’s electrospun fibers are sub-cellular in size and free of animal and human components. From company website Source · Oct 12, 2026

Keywords: Diabetic Foot Ulcer Surgical Wound Venous Leg Ulcer Wound Heal Synthetic Electrospun Fiber Matrix Restrata TM Wound Matrix Restrata

Profile checked Oct 10, 2026

5Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. FDA FDA 510(k) clearance: Restrata Soft Tissue Reinforcement (STR) — K251224, Jun 20, 2025. Applicant at approval: Acera Surgical, Inc. source ↗
  2. Trial start —: A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms source ↗
  3. Trial start Not phased (device or behavioral study): Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous source ↗
  4. Trial start Not phased (device or behavioral study): Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers source ↗
  5. Trial start Not phased (device or behavioral study): Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site source ↗
  6. Trial start Not phased (device or behavioral study): Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 5

RecordTitlePhaseStatusStartPrimary completion
NCT06578650A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous NeoplasmsNot listedRecruitingOct 31, 20242027-08 (estimated)
NCT04927702Assessment of Wound Closure Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers (DFU) and With Living Cellular Skin Substitute in Treating Venous Leg Ulcers (VLU)Not phased (device or behavioral study)TerminatedJul 19, 2021Jul 15, 2024 (actual)
NCT03312595Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)Not phased (device or behavioral study)CompletedSep 14, 2017Jul 15, 2018 (actual)
NCT04918784Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot UlcersNot phased (device or behavioral study)CompletedMay 5, 2021Jul 31, 2022 (actual)
NCT04829331Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor SiteNot phased (device or behavioral study)TerminatedApr 9, 2021Jan 1, 2022 (actual)

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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