Leading Experts in Ophthalmology Come Together to Establish New Standard of Care Consensus Guidelines for Using Cryopreserved Amniotic Membrane to Treat Corneal Diseases

Published reference guide shares acquired knowledge about utilizing cryopreserved amniotic membrane (CAM) at earlier stages of treatment for cornea-involved ocular surface diseases

Miami, FL – April, 10,2020 — Bio-Tissue, Inc. (Bio-Tissue), a TissueTech, Inc. company and pioneer and market leader in the ocular surface clinical application of human birth tissue-based products, announced today the availability of a collaborative publication designed to help clinicians optimize outcomes by improving the management of cornea-involved ocular surface diseases and the preparation of the ocular surface for refractive cataract surgery, all of which present continued unmet needs.

Redefining the Standard of Care: A Consensus Guideline was collectively authored by key opinion leaders Neel Desai, MD, Director of Cornea, Refractive and Cataract Surgery, The Eye Institute of West Florida; Marguerite McDonald, MD, Clinical Professor of Ophthalmology at NYU School of Medicine and Tulane University Health Sciences Center; Mark Milner, MD, Associate Clinical Professor at the Yale University School of Medicine’s Department of Ophthalmology; Clifford Salinger, MD, Director of the V.I.P. Laser Eye Center; and John Sheppard, MD, Professor of Ophthalmology at Eastern Virginia Medical School. It features the most common cornea-involved ocular surface diseases such as persistent epithelial defect (PED), corneal ulcer/infectious keratitis, recurrent corneal erosion (RCE), severe dry eye disease (DED), epithelial basement membrane dystrophy (EBMD), neurotrophic keratitis (NK), and in preparation for refractive cataract surgery. Each indication is discussed with regards to the background of the disease state, the limitations of the current standard of care, how CAM treats the indication, and CAM’s agreed upon place within the indication’s treatment protocol. Each indication section also includes a real-world case study example from the authors.

Physicians can access the published reference guide through the TissueTech Physician Portal. Reprints are also available by request through Bio-Tissue Account Managers or for non-medical professionals through the TissueTech Online Newsroom.

“Based on our collective experience with cryopreserved amniotic membrane for treating corneal-involved ocular surface diseases and pre-surgical optimization of the ocular surface, we have revised current treatment protocols to recommend its use at earlier stages of disease,” said Dr. John Sheppard. “Cryopreserved amniotic membrane should be considered a disease-modifying therapy and utilized over palliative treatments where it makes sense. I was more than happy to share my experiences in the hopes that more eye care professionals will take advantage of and incorporate CAM into their daily practice. We are hopeful that this will empower healthcare professionals to deliver optimal patient healing outcomes.”

Dr. Marguerite McDonald agreed and said, “The existing standards of care for many of these conditions are outdated. I recommend the use of cryopreserved amniotic membrane early on, at the point of initial injury. Once the inflammatory cascade is initiated, macrophages are activated, and fibroblasts start producing scar tissue. However, early intervention with cryopreserved amniotic membrane may prevent potentially irreversible damage as it has shown to have anti-scarring, anti-inflammatory, and anti-angiogenic properties. CAM has even been shown to help corneal nerves regenerate.”1,2

Bio-Tissue utilizes a proprietary cryopreservation technology called CryoTek® to preserve the natural properties of amniotic membrane. This cryopreservation process allows CAM to retain heavy chain peptide (HC) covalently conjugated with high molecular weight hyaluronic acid (HA), which is noncovalently complexed with pentraxin-3 (PTX3)—HC-HA/PTX3. referred to throughout the consensus guideline as cryopreserved amniotic membrane complex (CAM-C)—a biologic matrix that has been linked to CAM’s anti-inflammatory and anti-scarring properties. Scientific research has shown that CAM-C facilitates faster recovery and regenerative healing.3

Bio-Tissue’s CAM products come in two forms. The first are PROKERA®, PROKERA® Slim, PROKERA® Plus, and PROKERA® Clear, which are sutureless, and delivered via a patented self-containing conformer ring. PROKERA products have been cleared by the FDA as class II medical devices. The second Bio-Tissue CAM product is AmnioGraft®. It is a transplantation graft of cryopreserved amniotic membrane that does not feature a conformer ring and is applied surgically.

To request for a copy of the Consensus Guide, click here.

 

About Bio-Tissue, Inc.

Bio-Tissue, Inc., a TissueTech, Inc. company, is the pioneer and market leader in the clinical application of cryopreserved amniotic membrane-based products for the treatment of diseases and disorders of the ocular surface. Established in 1997, Bio-Tissue serves a previously unmet need for better surgical and therapeutic alternatives for helping eye care professionals manage ocular surface conditions, such as keratitis, recurrent corneal erosions, conjunctivochalasis, pterygium, and dry eye. Connect with Bio-Tissue on our Physician’s Portal (for healthcare professionals only), Website, Facebook, LinkedIn, Instagram and Twitter.

About TissueTech, Inc.

TissueTech, Inc., the parent company of Bio-Tissue, Inc. and Amniox Medical, Inc., pioneered the development and clinical application of human birth tissue-based products. Founded in 1997, Bio-Tissue markets products for the ophthalmology and optometry markets; and Amniox markets products for use in the musculoskeletal and wound care markets. Clinicians have performed more than 500,000 human implants with the company’s products and published more than 360 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA to act as an anti-scarring, anti-inflammatory and anti-angiogenic agent and support epithelial adhesion and differentiation. Learn more at www.tissuetech.com.

 

  • John, T., et al., Corneal Nerve Regeneration after Self-Retained Cryopreserved Amniotic Membrane in Dry Eye Disease. Journal of Ophthalmology, 2017. 2017: p. 10.
  • Morkin, M.I. and P. Hamrah, Efficacy of self-retained cryopreserved amniotic membrane for treatment of neuropathic corneal pain. Ocul Surf, 2018. 16(1): p. 132-138.
  • Cooke M, Tan EK, Mandrycky C, He H, O’Connell J, Tseng SC, Comparison of cryopreserved amniotic membrane and umbilical cord tissue with dehydrated amniotic membrane/chorion tissue. J Wound Care 2014; 23: 465—76.