Ophthalogix
Physician Clinical Reference

Aurora

Dehydrated Amniotic Membrane Allograft

Patent-Pending Central Aperture Design · FORMULA/5™ Processing · E-Beam Sterilized

Aurora delivers the full regenerative matrix of dehydrated amniotic membrane with a patent-pending 5 mm central aperture that preserves the visual axis throughout the dissolution cycle — enabling functional central vision from placement to resolution.

20+ICD-10 Covered Indications
5 mmPatent-Pending Central Aperture
$827Avg. Medicare Reimbursement / Eye
2 Sizes10 mm & 12 mm Configurations
The Aurora Difference

Three innovations that set Aurora apart.

Aurora was engineered from the ground up to address the clinical limitations of first-generation amniotic membrane products — not to replicate them.

01

Patent-Pending Central Aperture

The 5 mm central aperture is Aurora's defining innovation. Solid-disc designs block the visual axis entirely — Aurora preserves it. Patients retain functional central vision from placement through dissolution, improving compliance and enabling bilateral same-session treatment.

No central visual blackout. No compliance barrier.

02

FORMULA/5™ Processing

Conventional processing — freeze-drying, solvent extraction, chemical cross-linking — denatures the growth factors that drive healing. FORMULA/5™ minimal-manipulation air-drying preserves the full bioactive complement: EGF, bFGF, TGF-β, PDGF, HGF, and the complete anti-inflammatory cytokine profile.

Full bioactivity. No chemical compromise.

03

Room-Temperature Stability

E-beam sterilization eliminates pathogens without chemical cross-linking. Room-temperature storage means no cold chain management, no freezer logistics, and no risk of inadvertent thaw-refreeze cycles that compromise tissue quality — from your rep's bag to the exam chair.

No cold chain. No freezer. No excuses.

Product Overview

Regenerative Membrane Therapy — Reimagined for the Visual Axis.

Aurora is a dehydrated amniotic membrane (dAM) allograft processed under Ophthalogix's proprietary FORMULA/5™ protocol — a minimal-manipulation, air-drying method that preserves the full complement of growth factors, cytokines, and extracellular matrix proteins responsible for the regenerative cascade.

The patent-pending 5 mm central aperture distinguishes Aurora from conventional solid-disc designs. By leaving the visual axis unobstructed, Aurora eliminates the central visual blackout associated with full-coverage membranes — a clinically meaningful advantage for patient comfort, compliance, and bilateral treatment protocols.

Dehydrated amniotic membrane allograft — human tissue, FDA 21 CFR Part 1271
FORMULA/5™ minimal-manipulation processing — no solvents, no chemical cross-linkers
E-beam sterilization — preserves growth factor bioactivity
Patent-pending 5 mm central aperture — visual axis preserved throughout dissolution
Available in 10 mm and 12 mm diameters for broad indication coverage
Office-based and surgical suite compatible — no general anesthesia required for office use
Aurora amniotic membrane disc held with titanium forceps

Product Specifications

Tissue typeDehydrated amniotic membrane allograft
Aperture5 mm central (patent-pending)
Available diameters10 mm · 12 mm
ProcessingFORMULA/5™ minimal-manipulation air-drying
SterilizationE-beam irradiation
StorageRoom temperature — no refrigeration required
RegulatoryFDA 21 CFR Part 1271 · AATB accredited
Shelf lifePer current IFU
Clinical Indications

Broad ICD-10 Coverage Across the Ocular Surface Spectrum.

Aurora is indicated for a wide range of ocular surface conditions where regenerative membrane therapy is clinically appropriate.

Corneal Conditions

H16.0xCorneal ulcer (bacterial, viral, fungal, Acanthamoeba)
H16.1xSuperficial keratitis without conjunctivitis
H16.2xKeratoconjunctivitis
H16.3xInterstitial & deep keratitis
H16.4xCorneal neovascularization
H18.0xCorneal pigmentations & deposits
H18.3xCorneal edema
H18.5xHereditary corneal dystrophies
H18.6xKeratoconus
H18.7xCorneal degeneration (Salzmann, band keratopathy)

Ocular Surface & Conjunctival

H04.1xChronic dacryocystitis / lacrimal gland disorders
H10.1xAcute atopic conjunctivitis
H10.4xChronic conjunctivitis
H11.0xPterygium
H11.1xConjunctival degenerations & deposits
H11.3xConjunctival hemorrhage
H11.4xOther conjunctival vascular disorders
H19.xDisorders of sclera & cornea in diseases classified elsewhere
T26.xxBurns & corrosions confined to eye & adnexa
H02.8xOther specified disorders of eyelid (exposure keratopathy)

ICD-10 codes are provided for educational reference. Coding must reflect the actual diagnosis and clinical documentation. Consult current payer guidelines and your compliance team before submission.

Mechanism of Action

Three Biological Pillars. One Regenerative Cascade.

Aurora's regenerative activity is driven by the preserved biological matrix of human amniotic membrane — a tissue uniquely suited to ocular surface restoration.

01

Growth Factor Delivery

FORMULA/5™ processing preserves the full bioactive complement: EGF, bFGF, TGF-β, PDGF, HGF, and VEGF. These mediators drive epithelial proliferation, stromal remodeling, and neovascular regulation at the wound site.

EGF — epithelial migration & proliferation
bFGF — stromal fibroblast activation
TGF-β — anti-fibrotic modulation
PDGF — wound contraction regulation
02

Extracellular Matrix Scaffold

The intact basement membrane complex — collagen IV, laminin, fibronectin, and proteoglycans — provides a structural scaffold that guides epithelial cell migration and supports organized tissue regeneration rather than fibrotic scar formation.

Collagen IV & VII — basement membrane integrity
Laminin — epithelial cell adhesion substrate
Fibronectin — cell migration guidance
Hyaluronic acid — anti-inflammatory hydration
03

Anti-Inflammatory Modulation

Amniotic membrane is inherently immunoprivileged. Aurora delivers IL-1RA, IL-10, and TSG-6 — cytokines that suppress the pro-inflammatory cascade, reduce MMP activity, and create a permissive environment for regeneration rather than chronic inflammation.

IL-1RA — interleukin-1 receptor antagonism
IL-10 — Th2 anti-inflammatory signaling
TSG-6 — MMP suppression & matrix protection
Pentraxin-3 — complement pathway modulation
Key Clinical Benefits

Designed Around the Clinician. Optimized for the Patient.

Every design decision in Aurora addresses a real clinical friction point — from patient compliance to procedural efficiency to billing confidence.

Visual Axis Preservation

The 5 mm central aperture eliminates the central visual blackout inherent to solid-disc designs. Patients retain functional central vision from placement through dissolution — improving compliance and enabling bilateral same-session treatment.

Full Bioactive Matrix

FORMULA/5™ processing preserves the complete growth factor and cytokine profile. No solvents, no chemical cross-linkers, no freeze-drying cycles that denature the proteins responsible for the regenerative cascade.

Office-Based Efficiency

Aurora is designed for in-office application with a bandage contact lens — no surgical suite, no general anesthesia, no OR scheduling friction. Integrate into existing anterior segment workflows with minimal disruption.

Anti-Fibrotic Remodeling

The preserved anti-inflammatory cytokine profile — IL-1RA, IL-10, TSG-6 — suppresses MMP activity and modulates the fibrotic cascade, supporting clear, organized epithelial regeneration rather than scar tissue formation.

Broad Indication Coverage

Twenty-plus ICD-10 covered indications spanning corneal ulcers, keratitis, pterygium, dry eye disease, chemical burns, and post-surgical ocular surface compromise — one product across the full spectrum of anterior segment practice.

Regulatory & Quality Assurance

Processed under FDA 21 CFR Part 1271 HCT/P regulations at an AATB-accredited tissue bank. E-beam sterilization without chemical cross-linking. Room-temperature storage — no cold chain management required.

FORMULA/5™ Processing

Not all amniotic membrane is the same.

The regenerative activity of amniotic membrane is directly dependent on processing methodology. Conventional approaches — aggressive freeze-drying, solvent extraction, chemical cross-linking — denature the growth factors and cytokines that drive the healing cascade. FORMULA/5™ was developed specifically to avoid these compromises.

Minimal-manipulation air-drying preserves the full biological matrix from donor to patient. E-beam sterilization eliminates pathogens without the chemical cross-linking that compromises bioactivity. The result is a membrane that retains the regenerative potential of fresh amniotic tissue in a room-temperature, shelf-stable format.

No solvents — no chemical extraction that strips growth factors
No chemical cross-linkers — no aldehyde or epoxide treatment
Minimal-manipulation air-drying — preserves native matrix architecture
E-beam sterilization — pathogen elimination without bioactivity compromise
Room-temperature storage — no cold chain, no freezer management
Processing FactorFORMULA/5™Conventional
Growth factor preservation✓ Full↓ Reduced
Cytokine bioactivity✓ Intact↓ Denatured
ECM architecture✓ Native↓ Disrupted
Chemical treatment✓ None✗ Solvents / cross-linkers
Sterilization methodE-beamVariable
Storage requirementRoom tempFrozen / refrigerated
Anti-inflammatory profile✓ Preserved↓ Compromised
Reimbursement & Practice Support

A Reimbursable Procedure with Established Coding Pathways.

Amniotic membrane transplantation is a well-established, reimbursable procedure under Medicare and most commercial payers. Ophthalogix provides dedicated practice support to help your team navigate coding, documentation, and billing workflows.

CPT Coding Reference

65778

Placement of amniotic membrane on the ocular surface; without sutures

Primary code for office-based Aurora application

~$827 / eye
65779

Placement of amniotic membrane on the ocular surface; single layer, sutured

Surgical suite application with suture fixation

Variable
65780

Ocular surface reconstruction; amniotic membrane transplantation, multiple layers

Multi-layer reconstruction for complex surface disease

Variable
Q4206

Amniotic membrane per square centimeter (HCPCS tissue code)

Facility/ASC billing — confirm with payer

Per cm²

CPT code selection must reflect the actual procedure performed. Reimbursement rates are approximate Medicare averages and vary by MAC jurisdiction, facility type, and payer.

Reimbursement Support

MAC-specific reimbursement rate lookup
CPT & ICD-10 coding guidance
Prior authorization support
Documentation templates
Billing staff training resources
Interactive Medicare reimbursement map
View Medicare Map

Practice Integration

Clinical onboarding & staff training
Patient selection guidance
Workflow integration support
Patient communication templates
Clinical case consultation with Dr. Kabiri
Dedicated regional representative support
Build Your Practice
Product Availability & Ordering

Available Now. Direct and Through Authorized Distributors.

Aurora is available for direct order through Ophthalogix and through authorized ophthalmic distributors. Contact your regional representative or our clinical support team to establish an account.

ProductConfigurationStorage
Aurora 10 mm10 mm disc · 5 mm aperture · Single unitRoom temperature
Aurora 12 mm12 mm disc · 5 mm aperture · Single unitRoom temperature
Aurora Starter KitMixed 10 mm & 12 mm · Introductory packRoom temperature

Contact your Ophthalogix representative for current pricing, volume discounts, and consignment program availability.

Clinical Partnership

More Than a Graft. A Clinical Partnership.

Ophthalogix provides the clinical education, reimbursement support, and direct physician access that transforms a product relationship into a practice-building partnership.

Ophthalogix

Aurora is a human tissue product regulated under FDA 21 CFR Part 1271. This document is intended for licensed healthcare professionals and is provided for educational and informational purposes only. Product information is subject to applicable labeling, regulation, and clinical judgment. Refer to the current Instructions for Use for complete product-specific information, contraindications, warnings, and precautions. CPT codes and reimbursement rates are provided for reference only and do not constitute coding or billing advice. Consult current payer guidelines and your compliance team before submission.

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