COMPANY
Acera Surgical
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
Timeline
- FDA FDA 510(k) clearance: Restrata Soft Tissue Reinforcement (STR) — K251224, Jun 20, 2025. Applicant at approval: Acera Surgical, Inc. source ↗
- 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 ↗
- 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 ↗
- Trial start Not phased (device or behavioral study): Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers source ↗
- Trial start Not phased (device or behavioral study): Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site source ↗
- Trial start Not phased (device or behavioral study): Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) source ↗
Upcoming milestones
- 2027-08 (ESTIMATED) · · A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms · NCT06578650
Clinical trials (lead sponsor) 5
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06578650 | A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms | Not listed | Recruiting | Oct 31, 2024 | 2027-08 (estimated) |
| NCT04927702 | 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 Leg Ulcers (VLU) | Not phased (device or behavioral study) | Terminated | Jul 19, 2021 | Jul 15, 2024 (actual) |
| NCT03312595 | Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) | Not phased (device or behavioral study) | Completed | Sep 14, 2017 | Jul 15, 2018 (actual) |
| NCT04918784 | Comparing Synthetic Hybrid-Scale Fiber Matrix With Standard of Care in Treating Diabetic Foot Ulcers | Not phased (device or behavioral study) | Completed | May 5, 2021 | Jul 31, 2022 (actual) |
| NCT04829331 | Utility of Restrata With Split Thickness Skin Graft to Reconstruct the Forearm Donor Site | Not phased (device or behavioral study) | Terminated | Apr 9, 2021 | Jan 1, 2022 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Restrata Soft Tissue Reinforcement (STR) — K251224, Jun 20, 2025. Applicant at approval: Acera Surgical, Inc. source ↗
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