Amnio Patch‑C™ — Product Information 

Cryogenic Human Amniotic Membrane Allograft
Regulated as a 361 HCT/P under 21 CFR 1271.10

1. Product Overview

Amnio Patch‑C™ is a single‑use, cryogenically preserved human amniotic membrane allograft designed to provide biologically active, structurally intact coverage for compromised ocular and epithelial surfaces. The cryopreservation process maintains the native extracellular matrix (ECM) and biologically relevant growth factor profile, offering a closer analogue to fresh amniotic membrane.

Key attributes

• Cryogenically preserved AM (retains native hydration and ECM structure)
• Devitalized (no living cells)
• Preserves natural biological components
• Stored at –80°C or equivalent cryogenic conditions
• Fully compliant with 21 CFR 1271 and Section 361 PHS Act
• Not combined with drugs, biologics, or non‑permitted additives

2. Intended Use & Homologous Function

Intended Use

Amnio Patch‑C™ is intended to serve as a temporary biological covering and structural scaffold for ocular surface and epithelial defects requiring enhanced biological support.
Typical indications include:

• Persistent epithelial defects
• Post‑surgical ocular surface reconstruction
• Chemical/thermal injuries
• Conjunctival and limbal epithelial compromise
• Stromal thinning requiring biologically active coverage

Homologous Use Rationale

In its native environment, the amniotic membrane provides:

• Protection
• Structural support
• Moisture retention
• Biological cues for epithelial repair

Amnio Patch‑C™ performs the same basic protective and structural function at the ocular surface, satisfying the FDA’s homologous use requirement under 21 CFR 1271.3(c).

3. Product Description & Specifications

Composition

Amnio Patch‑C™ is derived from full‑term, live‑birth placental tissue from consenting donors.
Cryopreservation maintains:

• Native hydration
• Basement membrane integrity
• Stromal ECM
• Growth factors and cytokines naturally present in AM

Sterility

• Aseptically processed
• Terminal sterilization (if applicable) or validated aseptic workflow
• Single‑use sterile packaging

Storage

• Cryogenic storage at –80°C
• Requires cold‑chain maintenance
• Thaw immediately before use
• Use within recommended post‑thaw window

4. Minimal Manipulation — 21 CFR 1271.10(a)(1)

Amnio Patch‑C™ meets the FDA definition of minimal manipulation for structural tissue because:

• Cryopreservation does not alter the original relevant characteristics of the amniotic membrane
• ECM architecture, mechanical properties, and biological matrix remain intact
• No chemical cross‑linking or exogenous additives
• No drugs, biologics, or device components are combined

Cryopreservation is recognized as a permitted preservation method that maintains tissue integrity without altering its structural utility.

5. Mechanism of Action

A. Physical Barrier

Provides immediate protection to compromised epithelium.

B. Structural Scaffold

Supports epithelial migration, adhesion, and proliferation.

C. Moisture Retention

Cryogenic AM retains natural hydration, supporting optimal wound healing.

D. Biological Activity

Preserves native growth factors and ECM proteins that support epithelial repair.

E. Temporary Coverage

Acts as a biological dressing during the active healing phase.

6. Donor Eligibility & Safety Standards

All tissue is recovered from healthy, consenting donors following full‑term live births.
Eligibility determination includes:

• Medical & behavioral risk assessment
• Physical examination
• Infectious disease testing per 21 CFR 1271 Subpart C
• Medical Director–supervised review
• Full donor‑to‑recipient traceability

Manufacturing complies with:

• CGTP (Current Good Tissue Practice)
• CGMP (Good Manufacturing Practice)

7. Clinical Handling & Application

Thawing

• Remove from cryogenic storage
• Thaw per IFU (typically sterile saline bath)
• Use immediately after thawing

Placement

• Apply directly to ocular surface
• Orientation markers (if provided) ensure correct placement
• May be secured with a bandage contact lens or sutures depending on procedure

Stability

• Conforms naturally to ocular surface
• Maintains hydration and biological activity during healing

8. Regulatory Classification — Section 361 HCT/P

Amnio Patch‑C™ satisfies all criteria under 21 CFR 1271.10(a):

1. Minimally manipulated
2. Homologous use
3. Not combined with non‑permitted articles
4. No living cells
5. Local action only
6. Donor eligibility & CGTP compliance

Therefore, Amnio Patch‑C™ is regulated solely under Section 361 of the PHS Act, with no requirement for FDA premarket approval or 510(k).

9. Procurement Summary

Operational Advantages

• Biologically active cryogenic AM
• High clinical value for complex ocular surface disease
• Strong surgeon preference in severe epithelial defects

Procurement Considerations

• Requires cold‑chain storage (–80°C)
• Must be used immediately after thaw
• Ideal for tertiary eye care centers and cornea units

Institutional Benefits

• Supports advanced ocular surface reconstruction
• Complements dehydrated AM products (Amnio‑Disc™, Amnio‑Ring™)
• Ensures availability for severe or non‑healing epithelial defects

10. Manufacturer

Akriti Ophthalmic Pvt. Ltd.
Medical Devices Park, Sultanpur Village
Patancheru Mandal, Hyderabad – 502319
Telangana, India
www.akritiophthalmic.com