AcellFX®

THE ACELLULAR AMNIOTIC TISSUE

Blythe Medical has worked with biologics processors and innovative eye care providers since 2007 to find, based on science, the safest and best performing amniotic membrane product. AcellFX® is the acellular allograft amniotic membrane – designed to be both easy on your patient and easy on your practice.  Patients will benefit from AcellFX’s high transparency and BioRinse processing. This process reduces potential sources that can cause pain, discomfort, and ultimately costly patient returns to your office. Your practice will benefit from AcellFX’s performance, ease of application, long shelf life and low cost.

Why is AcellFX so comfortable?

  • AcellFX is an acellular amniotic membrane containing bioactive components for healing
  • AcellFX processing removes the potentially inflammation-causing cells of the chorion and fetus epithelium
  • AcellFX processing uses no cryo-preservants, cross-linkers, germicides, antibiotics or ethanol that may cause reaction in the eye
  • AcellFX placement is achieved without a ring or up/down orientation

AcellFX amniotic membrane tissue is processed using a proprietary decellularization and stabilization process, providing the ultimate patient comfort and healing in the treatment of eye injury and disease. The dCELL and BioRinse processes remove cells and cellular contents from the biomaterial without altering the extracellular matrix and its bioactive components. This process results in the removal of donor DNA. The removal of donor DNA is considered essential to providing a safe biologic tissue.

AcellFX is available in several disc sizes. Blythe Medical was the first company to offer 8mm and 5mm discs. Large sizes can slow repair time due to longer resorbtion times.

Sizes include the following:

  • 5 mm Disc (round)
  • 8 mm Disc (round)
  • 10 mm Disc (round)
  • 14 mm Disc (round)

AcellFX is derived from human placental tissue collected from consenting donors having planned C-sections at 36+ weeks of gestation. The Extracellular Matrix (ECM) components available in the allograft allow for a regulated and regenerative healing process. Amnion is known to have components of long chain high molecular weight HA, collagens, fibronectin, proteoglycans, laminin, and growth factors. Prior to being packaged in a double-pouch packaging system and subjected to low dose gamma irradiation.

Easy on your patient

AcellFX is a unique high-purity acellular amniotic tissue, designed to reduce irritants that may cause inflammatory response and discomfort in the patient’s eye. Major patient benefits include:

  • Comfortable
  • No painful ring required for placement
  • Translucent upon application
  • Bioactive peptides promote healing
  • Reduces need to callback or revisit physician office
  • Round shape designed for the eye

AcellFX’s patented process eliminates potentially inflammation-causing cells of the chorion and epithelium. Furthermore, AcellFX processing uses no cryo-preservants, cross-linkers, germicides, antibiotics or ethanol that may cause reaction in the eye. This results in an amniotic tissue that is far more comfortable for the patient, reducing the need for call backs or additional visits.

Easy on YOUR Practice

AcellFX is the acellular amniotic tissue, featuring ease of patient application, long shelf life and reduced patient visits due to eye discomfort. These benefits make AcellFX the amniotic tissue of choice for your practice:

  • Five size-configurations starting as low as $165
  • No up/down orientation for simplified application
  • No uncomfortable ring to apply
  • Tissue transparency helps in monitoring the healing process
  • Room temperature stable with 5-year shelf life
  • Advanced comfort reduces patient callbacks
  • Satisfaction Guaranteed!
AcellFX-Box-Shot

What makes AcellFX different

Blythe Medical has worked with biologics processors and innovative eye care providers since 2007 to find, based on science, the safest and best performing amniotic membrane product. AcellFX is manufactured using a the dCELL and BioRinse decellularization and stabilization process. Highly variable biologic materials are prepared through a process that removes cellular membranes and cellular material from the amnion. This process does not alter the bioactive components of the extracellular matrix, such as long chain high molecular weight HA, collagens, fibronectin, proteoglycans, laminin, and growth factors.  Bioactive components allow for a regulated and regenerative healing process.

Residual DNA Impacts Performance

Biomaterials

Volume 33, Issue 6, February 2012, Pages 1771–1781

Consequences of ineffective decellularization of biologic scaffolds on the host response

The results show that more aggressive decellularization is associated with a shift in macrophage phenotype predominance from M1 (pro-inflammatory) to M2 (anti-inflammatory and promotes new cellular migration). A clear association between macrophage phenotype and remodeling outcome exists and effective decellularization remains an important component in the processing of ECM-based scaffolds.

Acellular and smaller graft size allows for quicker shift to M-2 macrophages.

Amnion Study

The concept of ECM scaffold degradation as a critical determinant of constructive tissue remodeling becomes even more clinically relevant when considering the widespread use of commercially available ECM materials that have been subjected to chemical and physical methods designed specifically to prevent scaffold degradation and increase the mechanical strength of the materials.

…compares several commercially available ECM scaffold materials has shown that the methods used to process these scaffolds, especially chemical methods to create molecular crosslinks, have marked effects upon host macrophage phenotype surrounding the ECM scaffold and downstream remodeling events.

Ease of Application

AcellFX is very easy to apply, facilitating a simple uniform implementation across your practice. No up/down orientation means you’ll get it right the first time, without having to lift and reposition the tissue. And no need for an outer ring device that complicates the application process and is uncomfortable for the patient.

Available Sizes and Configurations

  • 5 mm Disc
  • 8 mm Disc
  • 10 mm Disc
  • 14 mm Disc

Intended Use

AcellFXᅠis an allograft tissue intended for homologous use and can be used in a variety of ophthalmology applications. It is regulated by 21 CFR Part 1271 and Section 361 of the PHS Act.

For specific instructions on the use and risks of AcellFXᅠproducts please refer to the instructions for use package insert

ACELLFX applications

Amniotic Tissue in Ophthalmology & Optometry

The use of amniotic tissue has been successful in treating a variety of ophthalmic conditions and diseases, including:1

  • Corneal ulcers including neurotrophic keratitis
  • Keratitis
  • Pterygium post-keratoplasty, glaucoma or cataract
  • Chemical trauma
  • Bullous keratopathy
  • Neoplasm of the ocular surface
  • Reconstruction of the conjunctiva and fornix
  • Corneal degeneration
  • Recurrent epithelial erosion
  • Primary and secondary limbal stem cell deficiency
  • Mucous membrane pemphigoid
  • Dystrophy
  • Mechanical trauma
  • Chronic Stevens-Johnson syndrome or Lyell’s syndrome
  • Reconstruction of the anophthalmic cavity
  • Physical trauma
  • Eyelid reconstruction
  • Dysfunctional tear syndrome

1. Stephenson, Michelle. “Newsletters.” Review of Ophthalmology® Treatment Options with Amniotic Membrane. Review of Ophthalmology, 5 Nov. 2015. Web. 12 May 2016.

IMPORTANT: The above applications are for reference purposes only. This information does not guarantee payment, and is not legal advice. It is the provider’s responsibility to check their Medicare LCD for proper coding and billing.

Treatment

Ocular surface disease in many instances is a chronic condition that is multifactorial in its causes, symptoms and signs. In chronic ocular surface disease (dry eye disease) there can be epithelial cell damage, hyperosmotic tear film (aqueous layer) and elevated MMP-9s indicating inflammation.

The goal of the physician is to optimize the corneal surface environment to create the opportunity for the body to return to homeostasis. This will require systemic and topical therapies based on the individual patient’s needs. Providing a healthy epithelial surface allows for more moisture on the eye, allowing the inflammatory-causing hypertonic tear film to return to an isotonic state. Healthy epithelial cells are required for anchoring points of the patient’s mucin molecules and holding water on the ocular surface.

How to return to a healthy corneal surface

To provide a patient’s best vision and comfort, a healthy ocular surface requires healthy epithelial cells. Healthy epithelial cells provide anchor points for mucin or OTC hyaluronan drops to hold water on the ocular surface.

AcellFX® acts as a substrate for cellular migration for epithelial cells. The AcellFX® peptides and GAGs stimulate the body’s own wound healing cascade, inhibit scarring, are anti-inflammatory (after the initial wound healing inflammation) and are anti-angiogenic. AcellFX’s anti-inflammatory properties and epithelial cell regeneration properties allow for more mucin to develop and adhere to the epithelial layer.

If the patient is not producing enough mucin, an OTC drop containing hyaluronan (HA) can supplement this deficiency. HA drops are known to hold up to 1000 times their weight in water. HA is a molecule very similar to mucin and binds to CD-44 receptors on healthy epithelium.

After creating a healthy epithelial surface and more water is retained on the eye, it will be important to institute therapies that improve goblet cell secretion of mucins. Meibomian gland secretions of lipids will further enhance the health of the tear film and cornea. This would include a lid cleaning protocol, nutraceuticals, moist heat therapy, moisture retention glasses.

AcellFX Safety

AcellFX is a room temperature stable allograft derived from human placental tissue collected from consenting donors. Post-decellularization and stabilization, this acellular amniotic membrane is packaged in a double pouch packaging system and subjected to low dose gamma irradiation. AcellFX is an allograft tissue intended for homologous use regulated by 21 CFR Part 1271 and Section 361 of the PHS Act.

If you have questions about AcellFX, please check out frequently asked questions.