Amnio-Disc 10.00 mm (Dehydrated Amniotic Membrane)

Amnio‑Disc™ is a single‑use, devitalized, dehydrated human amniotic membrane allograft designed to provide temporary protection and structural support to compromised ocular surfaces. The controlled dehydration process preserves the native extracellular matrix , enabling a biologically supportive environment for epithelial repair.

Amnio‑Disc™ is indicated as a protective barrier and covering for the ocular surface in cases where the corneal epithelium is: Compromised Disrupted Delayed in healing Exposed following surgery or trauma Clinical scenarios include: Persistent epithelial defects Post‑surgical epithelial support Chemical/thermal injuries Temporary coverage during active healing phases

Amnio‑Disc™ performs the same protective and structural function as native amniotic membrane in vivo. Native function: protective, moisture‑retaining, structural tissue layer Clinical function: identical protective and supportive role at the ocular surface

Available Diameters 6 mm • 8 mm • 10 mm • 12 mm • 14 mm • 16 mm Designed to accommodate the full spectrum of ocular surface presentations. Sterility Gamma‑irradiated to SAL 10⁻⁶ Validated terminal sterilization Single‑use, aseptically processed Storage Ambient room temperature No cold chain required Supplied in sealed, sterile packaging

Amnio‑Disc™ is processed in compliance with 21 CFR 1271 minimal manipulation standards . Key features: Dehydration preserves basement membrane , stromal structure , and biologically active proteins No chemical cross‑linking No exogenous drugs, biologics, or non‑permitted additives Structural integrity superior to conventional dehydrated AM products (as per document) Quoted line: “The dehydration protocol maintains the native extracellular matrix architecture… without chemical alteration or cross‑linking.” A bandage contact lens may be applied separately by the clinician for retention.

Amnio‑Disc™ supports ocular surface healing through: a. Mechanical Protection Acts as a physical barrier shielding the epithelium from mechanical and environmental insult. b. Biological Repair Support Preserved ECM components (collagen, laminin, fibronectin) provide cues for: Epithelial migration Adhesion Proliferation c. Moist Microenvironment Maintains hydration essential for epithelial wound closure. d. Temporary Coverage Provides stable coverage during the active healing phase.

All tissue is recovered from healthy, consenting donors following live birth (C‑section) . Safety measures include: Medical & behavioral risk assessment Physical examination Medical record review Full infectious disease testing panel Medical Director–supervised eligibility determination All processes comply with 21 CFR 1271 Subpart C and CGTP/CGMP requirements.

Ready‑to‑use; no hydration or reconstitution required Apply directly to the ocular surface Conforms immediately upon contact Optional bandage contact lens for retention

Amnio‑Disc™ meets all six criteria for regulation solely as a 361 HCT/P under: Section 361 of the PHS Act 21 CFR Part 1271 Criteria satisfied: Minimally manipulated Homologous use Not combined with non‑permitted articles Does not rely on living cells Locally acting CGTP compliant This classification eliminates the need for FDA premarket approval or 510(k) .

For Surgeons Native architecture preserved Immediate application Six diameters for precise matching Reliable handling and placement For Procurement Ambient storage (no cold chain) Simplified regulatory pathway (361 HCT/P) Full donor‑to‑patient traceability CGTP/CGMP compliant manufacturing Safety Profile Terminal gamma sterilization (SAL 10⁻⁶) Multi‑modal donor screening Aseptic processing No exogenous additives

Akriti Ophthalmic Pvt. Ltd. M34–M36, Medical Devices Park, Sultanpur Village Patancheru Mandal, Hyderabad – 502319 Telangana, India www.akritiophthalmic.com