Core Focus Areas
Our Solutions
Regenerative Tissue Products
Amniotic, placental, and dermal allografts for wound healing.
Distribution
Network
National and international master distribution partnerships.
Clinical
Support
Physician training, education, and billing support.
Research &
Innovation
Advancing tissue science with biotech partners.
Wound Care & Regeneration
Global Tissue Network supports advanced biotechnology products for chronic wounds such as diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers. We prioritize evidence-based products that promote faster closure, reduce infection, and enhance quality of life.
Research & Innovation:
- Collagen-based Cellular & Tissue Products (CTPs) demonstrating faster epithelialization.
- Smart dressings with antimicrobial, oxygen-permeable, and exosome-releasing layers.
- Electrospun nanofiber scaffolds for moisture balance and infection prevention.
Regulation & Compliance:
- FDA Class II–III Wound Devices (21 CFR 878).
- CMS Local Coverage Determination (LCD) allows ≤10 CTP applications per 12 weeks for DFU/VLU.
- ISO 10993 Biocompatibility and Sterilization Standards.
Product Portfolio:
- Collagen Matrix – PriMatrix® – Supports ECM integration and cell migration
- CTP Allograft – Apligraf® – Dual-layer skin equivalent for chronic wounds
- Advanced Dressing – Theraskin™ – Preserved human skin for re-epithelialization
Clinical Impact:
- Peer-reviewed trials show up to 45% reduction in healing time for chronic ulcers with advanced biologics versus conventional dressings.
Limb Salvage & Vascular Reconstruction
Focused on critical limb ischemia and diabetic wound preservation, our platform includes vascularized scaffolds, angiogenic biologics, and ECM-based regenerative grafts that enhance perfusion and tissue regeneration.
Scientific Insights:
- Fetal bovine collagen membranes have demonstrated improved limb salvage outcomes.
- Bioengineered ECM scaffolds promote angiogenesis and endothelial migration.
- Combined use of biologics with NPWT systems reduces amputation risk.
Compliance Reference:
- HCT/P Regulation 21 CFR 1271 (minimal manipulation & homologous use).
- FDA Biologics License Application (BLA) for advanced cellular constructs.
- ISO 13485 & 11137 Sterilization Validation.
Outcome:
- Up to 35% reduction in major amputation rates in integrated limb salvage programs using advanced biologic matrices.
Dermatology & Aesthetic Regeneration
Dermatology applications include burns, scar revision, and post-surgical skin regeneration using bioengineered dermal substitutes and growth-factor-based therapies.
Key Technologies:
- Dermal equivalents combining keratinocytes and fibroblasts for aesthetic recovery.
- Collagen-elastin composites supporting tensile strength and elasticity.
- Hydrogel formulations enabling scar modulation and hydration balance.
Regulatory Framework:
- FDA 510(k) clearance for skin substitutes.
- EU MDR Annex IX conformity for biocompatibility.
- GMP-compliant manufacture ensuring consistent purity and structure.
Results:
- Documented 60% improvement in scar flexibility and cosmetic outcome scores in multi-center trials.
Oncology & Reconstructive Therapies
Biotechnology-based reconstruction after oncologic resection and radiation injury focuses on restoring both form and function using safe and clinically proven matrices.
Emerging Research:
- Stem-cell-based bioimplants to repair radiation-damaged tissue.
- Hybrid collagen scaffolds supporting angiogenesis in irradiated fields.
- Bioprinted soft-tissue scaffolds for complex defect reconstruction.
Compliance & Safety:
- FDA PMA/BLA requirements for biologic implants.
- Long-term oncologic safety testing and tumor-recurrence surveillance.
Integrated Care:
- Interdisciplinary collaboration among oncology, reconstructive surgery, and wound care teams ensures optimal patient recovery.
Partner With Us
We welcome collaborations with
Quality & Compliance Framework
Concise verification steps, ethical sourcing requirements, and post-market monitoring guidance.
| Criterion | Regulatory Reference | Verification Method |
|---|---|---|
|
FDA Clearance
Medical device market entry
|
21 CFR 807 / 814 | Verify device 510(k) / PMA approval |
|
HCT/P Classification
Human Cells, Tissues, and Cellular Products
|
21 CFR 1271 | Confirm minimal manipulation & homologous use |
|
ISO 13485 Certification
Quality management system
|
Quality System | Validate certificate & audit frequency |
|
CMS Coverage
Billing & reimbursement
|
LCD / LCA | Check indication eligibility for DFU / VLU |
|
Clinical Evidence
Efficacy & safety data
|
Peer-reviewed studies | Minimum 2 RCTs or registry data required |
Ethical Sourcing
All donor tissues are procured from FDA-registered facilities and follow strict consent, traceability, and preservation protocols.
Post-Market Monitoring
Routine performance surveillance, adverse event reporting, and supplier audits ensure ongoing safety and compliance.
Centralized Accuracy
Ensuring precise, reliable, and consistent data management through a unified, centralized accuracy system.
🌏 Global Expansion Ongoing
United States | Asia | Europe
☎️ Contact Info
ISO 13485 | FDA Registered | GMP Compliant | Ethical Tissue Sourcing


