Redman Biosciences provides amniotic tissue derived allografts, Catalyst-AC™ graft which are minimally manipulated to satisfy HCT/P regulatory requirements and for superior clinical impact including:

  • stem cell recruitment,

  • immune privilege,

  • anti-inflammatory effect,

  • and introduction of growth factors that contribute to healing.

Amnion-Chorion grafts are also available as well as chorion-only grafts to *increase the proportion of therapeutic benefits inherent to placental tissue (*chorion is three times as thick as amnion).

Amniotic tissue has demonstrated inherent capabilities as an effective biological (or surgical) barrier, analgesic, and resource for regenerative cytokines, growth factors, and extra cellular molecules. Amnion also works as an anti-inflammatory and scar reducing agent.

Clinical Applications

  • Chronic/Non-Healing Wounds:

  • Surgical Site Applications: to reduce or inhibit scarring and add an anti-inflammatory effect to aid in healing at external surgical sites

  • Adhesion Barrier: for internal surgical regions to reduce or prevent post-surgical adhesions and other fibrotic conditions resulting from surgery

  • Ocular grafts: application of amnion has been shown to assist in the resolution of inflammation, relief of symptoms, restoration of regular and stable corneal epithelium, and restoration of the structural integrity of the eye 2, 9

Formats & Graft Sizes

Catalyst AC™ grafts are available in multiple graft formats to satisfy a range of clinical needs:

  • Cryopreserved

  • Dehydrated

  • Micronized

  • Fluid

​Multiple graft sizes are available.

 

Graft Sizing Options

  • Wound Healing: Grafts are available in multiple sizes to cover non-healing or chronic wounds. A 2x4 cm graft, for example, is frequently applied to address chronic wounds when standard treatment options have been ineffective and to speed healing at external surgical sites.

  • Ocular trauma: Catalyst AC™ grafts are produced in varying diameters to be used for epithelial effect or corneal repair.  Fully suturable, surgeons can select the appropriate graft size to introduce an anti-inflammatory effect in cases of chemical burn or inflammatory eye diseases such as Stevens-Johnson syndrome.

  • Internal & External Surgical Wound Healing: Catalyst AC™ grafts act as a surgical barrier to reduce or inhibit post-surgical scarring and post-surgical fibrosis produced in sizes up to 48 square cm . The grafts also reduce inflammation at the surgical site.

Catalyst AC™ allografts are available for immediate commercialization or allografts can be developed & supplied under a third-party label with the buyer’s commercial name & specific branding.

Processing & Regulatory Standards

All Catalyst amnion-derived allografts are:

  • processed in ISO Class 5 environments

  • regulated by the FDA under 21 CFR 1271

  • produced by a manufacturer registered with the US FDA as a Human Cells Tissues and Cellular and Tissue-based Products establishment (HCT/P) (regulated under section 361 of the Public Health Service Act and Part 1271)

 

Documented Clinical Benefits of the Use of Amniotic Tissue

  • Immune-privileged

  • Anti-inflammatory: Amniotic tissue has been shown to exert an anti-inflammatory effect by inhibiting the inflammatory cascade. Specifically, it has been shown to inhibit cytokines such as tumor necrosis factor- alpha in the presence of dendritic cells, as well as inhibiting transforming growth factor-beta, interleukin-8, and fibroblast proliferation.

  • Anti-adhesive/antifibrotic

  • Antimicrobial: Amniotic tissue produces β-defensins, which is a major group of antimicrobial peptides that are expressed by epithelial cells and form an integral part of the immune system. They protect epithelial surfaces from microbial colonization.

  • High concentration of growth factors important for healing: Amniotic tissue is comprised of an extracellular matrix, which acts as a natural scaffold for cellular attachment and structural support for cells as well as collagen types I, III, IV, V, and VI, hyaluronic acid, and a host of growth factors.

  • Effective stem cell recruitment

  • Analgesic

 

 

Amniotic membrane has biocompatibility, low immunogenicity, adequate mechanical properties (permeability, stability, elasticity, flexibility, resorbability), good cell adhesion, and easy delivery of biomodulatory agents such as growth factors and genetic materials.

Contact us for assistance with reimbursement related to the use of Catalyst AC™ grafts including appropriate CPT and HCPCS codes.

References

  1. Castellanos, G., Bernabé‐García, A., García Insausti, C. et al. The Use of Amniotic Membrane in the Management of Complex Chronic Wounds. Wound Healing, Oct 2016, DOI: 10.5772/64491.

  2. John A. Hovanesian, MD, FACS. Take advantage of amniotic membrane. Ophthalmology Management, Volume: 23, Issue: September 2019, page(s): 28, 31, 32.

  3. Kogan, S., Sood, A., Granick, M.S. Amniotic Membrane Adjuncts and Clinical Applications in Wound Healing: A Review of the Literature. Wounds. 2018; 30(6) 168-173.

  4. Lei, Jennifer PhD, Priddy, Lauren B. PhD; Lim, Jeremy J. PhD; Koob, T. J. PhD. Dehydrated Human Amnion/Chorion Membrane (dHACM) Allografts as a Therapy for Orthopedic Tissue Repair, Techniques in Orthopaedics: September 2017 - Volume 32 - Issue 3 - p 149-157.

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