Amniotic membrane products

 
 

iPatch™

single layer amnion, intended for ocular applications

xPatch™

single layer amnion, intended for a range of clinical applications

 
 
 

iPatch™ | xPatch™:

  • Packaged in an easy-peel, double-pouch, small form factor

  • Terminally sterilized to a Sterility Assurance Level of 10⁻⁶ using a validated dose of electron beam radiation

  • Stored at room temperature until used

  • Minimally manipulated during processing

  • Confirmed to meet all specifications prior to distribution

  • No preparation required

 

Common and custom sizes available.

 
Amnion / amniotic ocular disc. Standard sizes include 5, 8, 10, and 12 millimeters (mm). Custom sizes available.

iPatch™ is designed specifically for a range of ocular indications.
Standard sizes include 5, 8, 10, and 12 millimeters (mm). Custom sizes available.

The single layer xPatch™ and double layer xxPatch™ grafts are available in a wide range of standard shapes and sizes.

The single and double layer xPatch™ (“ex patch”) grafts are available in a wide range of standard shapes and sizes—and nearly unlimited custom sizes—to address a broad range of clinical indications. xPatch™ sizes shown in centimeters (cm).

Services

 

We provide branded and private label options to fit your brand and product strategy.

 

Our great name.
Our great products.

C5 Branded

Standard and custom sizes

Single and double layer options

Short lead time

Small form factor, user-focused C5 packaging

Let's talk about C5 branded products

Your great name.
Our great products.

Private Label

Standard and custom sizes

Single and double layer options

Short lead time

Your branded packaging

Let’s talk about private label options

Quality | Safety

 

Quality

C5 Biomedical’s quality management system is designed to meet FDA’s 21 CFR 1271 regulations and the American Association of Tissue Banks’ Standards for Tissue Banking. Robust manufacturing process controls ensure that all bioimplants are of the highest quality and confirmed to meet specifications prior to distribution.

Safety

All tissue donors are screened and tested in accordance with FDA’s regulations and guidance documents as well as the American Association of Tissue Banks’ Standards for Tissue Banking. Screening of donors for the following infectious diseases occurs at an FDA-registered, CLIA certified laboratory:

  • Hepatitis B Core Total Antibody

  • Hepatitis B Surface Antigen

  • Hepatitis C Antibody

  • HIV-1 & HIV-2 Antibody

    HTLV I/II Antibody

  • Syphilis (Nontreponemal)

 

  • HIV-1/2 (NAT)

  • Hepatitis B (NAT)

  • Hepatitis C (NAT)

  • West Nile Virus (NAT)

 

Licenses | Registrations

State licenses: DE, IL, MD, OR

FDA registered