Allograft products & contract manufacturing

FDA-Compliant Tissue Products. Built for Global Distribution.

Every VitaLync product is ethically sourced from US-based partner processors, meets AATB standards, ships internationally with full regulatory documentation, and is available for private-label contract manufacturing.

Regulatory standing
VitaLync is registered with the US Food and Drug Administration (FDA) as a tissue establishment and operates in accordance with 21 CFR Part 1271 governing Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Aligned with AATB Standards. Aligned with ISO 13485 (certification in progress).
Contract Manufacturing
4
Core product categories available for distribution
8+
Standard and custom sizes available per product
SAL
10⁻⁶ sterility assurance — sterilized by gamma / E-beam irradiation
OEM
Private-label contract manufacturing for distributors & health systems
NovaLync amniotic membrane patch
NovaLync NovaLync™ — Flagship product

Human amniotic membrane allograft — wound covering and protective barrier

NovaLync is a dehydrated human amniotic membrane allograft — a conformable, pliable covering and protective barrier. Minimally manipulated and sterilized to SAL 10⁻⁶ sterility using a validated dose of e-beam radiation. Sourced from ethically consented donors during healthy, full-term deliveries and processed in AATB-certified facilities. Available in single-layer and dual-layer configurations. Room temperature storage. No preparation required. Bi-directional application — either side may be applied to the wound. Sourced from ethically consented donors during planned, healthy, full-term deliveries and processed in AATB-certified facilities to SAL 10⁻⁶ sterility.

Available in single-layer and dual-layer configurations. Room temperature storage. No preparation required. Bi-directional application — either side may be applied to the wound.

FDA-compliant SAL 10⁻⁶ sterile Room temp storage Custom sizes available
Intended use

Indicated for homologous wound coverage

NovaLync is indicated for homologous use as a wound covering. For use as a covering for acute and chronic wounds, ocular surfaces, and surgical sites.

Every donor is tested and confirmed negative or non-reactive for HIV-1 & 2, Hepatitis B Core Total Antibody, Hepatitis B Surface Antigen, Hepatitis C Antibody, HTLV I/II Antibody, HBsAg, HCV, Syphilis, NAT for HIV/Hepatitis C/Hepatitis B, and West Nile Virus — by an FDA-registered, CLIA-certified laboratory.

  • Chronic wound covering — conformable protective barrier for acute and chronic wound surfaces
  • Burn and thermal injury site covering — sterile protective barrier
  • Acute wound covering — protective barrier at the application site
  • Surgical site covering — protective barrier for surgical wounds and soft tissue sites
  • Surgical covering — barrier between tissue surfaces at surgical sites
  • Ocular surface covering — for use as a covering on corneal and ocular surfaces
NovaLync Why clinicians choose NovaLync

Five clinical advantages

Biocompatibility
Recovered from screened, eligible donors and processed under Current Good Tissue Practice (CGTP) in accordance with 21 CFR Part 1271 and established tissue banking standards, with donor infectious disease testing performed at an FDA-registered, CLIA-certified laboratory.
Advanced protective covering
Serves as a conformable covering and protective barrier at the application site.
Bi-directional application
Either side of the patch may be applied to the wound without affecting performance.
Ready to use
No preparation required. Room temperature storage makes it ideal for markets with cold-chain limitations. Stable at room temperature, enabling reliable use even in the most resource-limited and logistically challenging environments.
Structural matrix integrity
Maintains the inherent structural composition of native amniotic tissue.
Product variants

Single-layer and dual-layer configurations

Choose the right NovaLync configuration for your clinical application. Both variants are available in 8 standard sizes with custom sizing on request.

NovaLync — Standard

Single-Layer Amniotic Membrane

  • Lightweight and flexible — ideal for delicate applications where minimal bulk is required
  • Optimal transparency — excellent visibility for monitoring underlying tissues
  • For use as a covering — wound surfaces, surgical sites, and ocular surfaces
  • Conforms to the application site
Available sizes
2×2 cm 2×4 cm 4×4 cm 4×8 cm 6×8 cm 10×10 cm 10×15 cm Custom sizes
NovaLync Pro

Dual-Layer Amniotic Membrane

  • Added strength and durability — two layers for enhanced structural integrity
  • Superior protection — increased resistance to external contaminants and mechanical stress
  • Extended coverage — for use as a covering at larger or more complex wound and surgical sites
  • Improved barrier function — protective interface between tissue surfaces
Available sizes
2×2 cm 2×4 cm 4×4 cm 4×8 cm 6×8 cm 10×10 cm 10×15 cm Custom sizes
Storage
Room temperature · 10°C to 30°C. No cold chain required.
Sterilization
Gamma or E-beam irradiation. SAL 10⁻⁶. AAMI TIR37:2007 compliant.
Use window
Transplant or discard within 24 hours of opening. Single use only.

Ready to build tissue access in your market?

Email
connect@vitalyncthebank.com
Phone
(202) 888-6897
Location
Falls Church, Virginia