Amnio-Patch 3cm X 3cm 50 Micron

AMNIO‑PATCH™ WOUND‑HEALING PRODUCTS

(Ophthalmic, Dental, and General Wound‑Care Applications)

Regulatory Basis: 21 CFR 1271.10(a) – HCT/P, Section 361 PHS Act

1. Product Overview

Amnio‑Patch™ is a dehydrated human amniotic membrane allograft intended to provide temporary coverage and protection to compromised epithelial surfaces.
It is processed under aseptic conditions and terminally sterilised to SAL 10⁻⁶, preserving the native membrane architecture.

“Amnio‑Patch™ is a single‑use, devitalised, dehydrated amniotic membrane allograft processed entirely under aseptic conditions… terminal sterilisation to SAL 10⁻⁶.”
(Attached Document)

The product qualifies as an HCT/P regulated solely under Section 361 because it meets all criteria under 21 CFR 1271.10(a):

• Minimally manipulated
• Intended for homologous use
• No reliance on living cells
• Not combined with non‑permitted articles
• Local action only
• CGTP compliant

2. Regulatory Classification (HCT/P – 21 CFR 1271.10(a))

Amnio‑Patch™ satisfies all six criteria for regulation as a 361 HCT/P:

2.1 Minimally Manipulated

Dehydration and sterilisation preserve original relevant characteristics.

2.2 Homologous Use

The membrane functions as a protective, structural covering, mirroring its natural biological role.

“Its function is primarily mechanical and structural — providing a physical barrier, retaining moisture, and supporting the underlying epithelium.”
(Attached Document)

2.3 No Living Cells

The tissue is devitalised.

2.4 Not Combined with Non‑Permitted Articles

No drugs, biologics, or devices are added.

2.5 Local Action Only

No systemic effect is intended.

2.6 CGTP Compliant

Manufactured under 21 CFR 1271 Subpart C.

3. Catalogue Structure for Wound‑Healing Applications

Below is a ready‑to‑publish catalogue section for your product portfolio.

A. OPHTHALMIC APPLICATIONS

A1. Clinical Indications

Amnio‑Patch™ provides temporary coverage and structural support for ocular surface disorders, including:

• Persistent epithelial defects (PEDs)
• Neurotrophic keratitis
• Corneal ulcers
• Stevens‑Johnson Syndrome
• Chemical/thermal injuries
• Post‑operative ocular surface reconstruction
• Recurrent corneal erosion
• Band keratopathy (post‑debridement)
• Severe dry eye disease
• Superficial punctate keratitis (SPK)

These indications align with homologous use, as the membrane naturally provides protection, moisture retention, and a basement membrane scaffold.

A2. Ophthalmic Product Catalogue

Amnion‑Only (30–50 microns)

Designed for delicate corneal applications, epithelial defects, and surface protection.

Amnion + Chorion (70–100 microns)

For structural reinforcement, deeper defects, and conjunctival/scleral coverage.

B. DENTAL APPLICATIONS

B1. Homologous Use Justification (Dental)

The amniotic membrane naturally functions as a protective, structural barrier.
In dental applications, it provides temporary coverage to oral mucosal surfaces — a homologous extension of its native protective role.

B2. Dental Indications

• Periodontal soft‑tissue coverage
• Gingival recession management
• Oral mucosal defects
• Post‑extraction socket protection
• Implant‑site soft‑tissue healing
• Oral ulcer coverage
• Frenectomy wound protection

B3. Recommended Catalogue Sizes for Dental Use

• 2 × 2 cm (AOPL/AMD/A2.D or A11.D)
• 3 × 3 cm (AOPL/AMD/A3.D or A12.D)
• 4 × 4 cm (AOPL/AMD/A4.D or A13.D)
• Round 6 cm (AOPL/AMD/A19.D or A21.D)

These sizes provide optimal coverage for intraoral defects.

C. GENERAL WOUND‑CARE APPLICATIONS

C1. Homologous Use Justification (Wound Care)

The membrane’s natural role is protective coverage and moisture retention.
In wound care, it provides temporary coverage to dermal and mucosal surfaces — consistent with homologous use.

C2. Indications

• Chronic non‑healing wounds
• Diabetic ulcers
• Pressure ulcers
• Venous stasis ulcers
• Traumatic skin loss
• Burn wounds (superficial/partial thickness)
• Surgical wound coverage

C3. Recommended Catalogue Sizes

• 4 × 4 cm (AOPL/AMD/A4.D or A13.D)
• 5 × 5 cm (AOPL/AMD/A5.D or A14.D)
• 6 × 6 cm (AOPL/AMD/A6.D or A15.D)
• Large format 10 × 6 cm / 10 × 4 cm
• 20 × 24 cm (AOPL/AMD/A23.D) for extensive wounds

4. Key Product Features (All Applications)

• Terminally sterilised (SAL 10⁻⁶)
• Room‑temperature storage
• Single‑use only
• Preserved basement membrane & stromal matrix
• Moisture retention
• Biocompatible, devitalised tissue
• No refrigeration required
• CGTP‑compliant manufacturing
• FDA‑registered HCT/P establishment (FEI: 3042228518)

The FDA listing confirms: “Amniotic Membrane – Recover, Screen, Donor Testing, Package, Process, Store, Label, Distribute.”
(Attached Document)

5. Ordering Information

All products are:

• Individually packaged
• Terminally sterilised
• Labeled with catalogue code, size, configuration, and single‑use designation
• Available for institutional supply agreements