MD Biologix · Ophthalmic Allografts

Amniotic membrane allografts, made for the ocular surface.

We’re extending our FDA-registered tissue platform to ophthalmology — minimally manipulated human amniotic membrane allografts for homologous use in ocular surface management, backed by the compliance and reimbursement support our partners rely on.

FDA-Registered Tissue Bank Intermediary

cGTP / cGMP Processing        Section 361 HCT/P

The tissue

A biologic membrane for ocular surface support

Human amniotic membrane is the innermost layer of the placenta — a basement membrane over an avascular stromal matrix. As an allograft, it serves as a natural biologic covering for the ocular surface, providing a scaffold that supports the surface environment during healing.

MD Biologix sources amniotic allografts processed and tested to the highest tissue-banking standards and intended for homologous use — the same quality-first, compliance-led approach behind our advanced wound-care portfolio, now applied to ophthalmology.

FDA-registered tissue platform

A licensed FDA tissue bank intermediary supplying placental-based allografts manufactured under cGTP and cGMP with rigorous third-party quality testing.

Distribution reach

Physician office, ambulatory surgery center, and hospital outpatient channels supported across our distribution verticals.

The line

Three ocular allografts. One trusted
supply chain.

Our ophthalmic portfolio is built around amniotic membrane allografts for ocular surface
management. OptiCover is available now, with two additional allografts in development.

Available

Amnion Membrane Disc

OptiCover

Ringless, room-temperature-stable lyophilized amnion membrane disc allograft, designed to support homologous use in ocular surface management.

View product
In Development

Amniotic Membrane Allograft

Product Two

A second ocular surface allograft is joining the portfolio. Product details will be published here as they become available.

Details coming soon
In Development

Amniotic Membrane Allograft

Product Three

A third ocular surface allograft is in development. Contact our team to learn more about the expanding MD Biologix ocular line.

Details coming soon

Amniotic Membrane Allograft

OptiCover

Lyophilized amnion membrane disc allograft · ringless · room-temperature stable

OptiCover is a ringless, lyophilized human amnion membrane disc allograft — minimally manipulated and terminally sterilized — designed to support homologous use in ocular surface applications. Its natural adhesive characteristics allow it to be retained on the ocular surface beneath a bandage contact lens (BCL) or collagen shield, and it is stored at room temperature for handling convenience.

 
12 mm
12 mm

Ringless design

A ringless disc format intended for patient comfort and straightforward placement on the ocular surface.



Room-temperature stable

Lyophilized for shelf-stable storage — no freezer or cold-chain logistics required.



Native architecture preserved

AGNES™ processing retains the spongy and amnion layers, including Type IV collagen and the HC-HA/PTX3 complex present in native placental tissue.

Enhanced structural integrity

Designed for greater structural integrity than conventional dehydrated amniotic membranes.



Terminally sterilized

Gamma-irradiated to a sterility assurance level (SAL) of 10⁻⁶. Single-use, for qualified professionals.



BCL & collagen-shield compatible

Natural adhesive characteristics allow retention beneath a bandage contact lens or collagen shield.



Tissue Type
Human amnion membrane allograft
Form
Ringless disc
Size
12 mm
Storage
Room temperature
Processing
AGNES™ lyophilization · aseptically processed, devitalized
Sterilization
Gamma irradiation · SAL 10−6
Intended Use
Homologous use · ocular surface management
Regulatory
Human tissue (HCT/P), Section 361 · 21 CFR Part 1271
Packaging
Double sterile pouch · single-use
Distributed By
MD Biologix · mfd. by Cellution Biologics, Inc.

Donor screening

Every donor is evaluated by the Medical Director — including infectious-disease test review, informed-consent verification, detailed medical and behavioral history, physical examination, and review of medical records — with tissue recovered from consented donors under cGTP and cGMP.

Infectious-disease testing (negative / non-reactive)
HIV-1/2 Ab HIV NAT HBsAg HBV Core Ab HBV NAT HCV Ab HCV NAT HTLV-I/II Ab Syphilis WNV NAT Malaria
Accreditations & Standards
AATB Accredited CAP Accredited SGS GMP DNV·GL ISO 13485

Inspect

Inspect the label and outer pouch. Do not use if the pouch is damaged or the seal is compromised.

Open outer pouch

Open the outer foil pouch and present the inner pouch to the sterile field using aseptic technique.

Retrieve

Open the inner pouch to retrieve OptiCover. The stromal side is packaged face-up; the epithelial side faces the metallic pouch.

Hydrate

Hydrate with sterile saline, sterile water, or balanced salt solution prior to application.

Apply & retain

Place the epithelial side onto the BCL/collagen shield, stromal side toward the cornea; use a BCL or collagen shield to retain on the ocular surface.

OptiCover is intended for homologous use as a biologic covering that supports the ocular surface. Selection of patients, clinical application, and use are determined by the treating qualified healthcare professional based on independent clinical judgment.

Indications and any efficacy statements are subject to regulatory/legal review prior to publication.