Amniotic Membranes
Our amniotic membranes come direct from our suppliers and arrive overnight at ambient temperature direct to our providers. The membranes are shelf-stable and are covered by Medicare and most Medicare advantage plans in addition to certain commercial insurances. Our membranes are chorion-free which reduces the chances of maternal antigens (HLA A/B/C/D) causing an allergic reaction or a graft vs. host reaction. Amniotic membrane allografts are proven to be safe and the chances of adverse effects are minimal. Many current grafts currently on the market contain chorion which can be resistant to bio-absorption and can create a wound which is resistant to healing. Our amniotic grafts are proven to greatly reduce the chances of healing resistance and we work with providers to utilize the appropriate graft in a cost-effective manner to treat the condition required, patient by patient. Our grafts are effective for Diabetic Foot Ulcers, Venous Stasis Ulcers, Decubitus ulcers (Stages 1-IV), Burns, & wounds due to trauma, infection, surgery, or cancer. Our grafts require once a week application for a maximum of 12 weeks, limiting tri-weekly dressing changes and greatly reducing the suffering and burnout on patients, healthcare staff, and their caregivers. Our grafts heal patients 98% of the time granted that appropriate wound care is done by a certified wound care specialist with our certified wound care MD's. Providers who utilize our grafts include wound care specialists, plastic surgeons, vascular surgeons, geriatricians, Mohs surgeons, dermatologists, and hyperbaric physicians. We carefully monitor our providers to ensure that they are appropriately documenting wounds and their healing to ensure full compliance with Medicare and all covered entities.
Properties of amniotic membranes
- Mechanical cushioning and support
- Lubrication for movement
- Suppression of inflammation
- Promotes skeletal, muscular, and organ development
- Contain an unique mix of collagen, extracellular matrix proteins, cell adhesion molecules, anti-inflammatory cytokines, and growth factors
Growth Factors
- Fibroblast Growth Factor (FGF)
- Epidermal Growth Factor (EGF)
- Platelet derived Growth Factor (PDGF A&B)
- Vascular Endothelial Growth Factor (VEGF)
- Transforming Growth Factor Beta (TGF-beta)
Properties of amniotic membrane
- Anti-inflammatory
- Anti-bacterial
- Anti-viral
- Anti-microbial
- Anti-fibrotic
- Re-epithelization
- Anti-scarring
- Non-tumorigenic
Physical Scaffold
Amniotic tissue can stimulate the delivery of growth factors, cellular response, collagen and a physical scaffold on which wound repair and regeneration can occur. Amniotic tissue can contribute 10x more mechanical strength and stiffness than membranes which contain chorion or a amnion/chorion composite. Dual layer amniotic membranes may offer up to 20x increased tensile strength vs composite membranes, chorionic membranes, or other collagen matrix substitutes. Our dual layer membranes lead to better absorption of regenerative factors and endothelial growth factors. The amnion layer contains three times as much Collagen Type 1, four times as much Collagen type 3, twice as much Collagen type 4 and 5, and twice as much fibronectin, laminin, and nidogen as opposed to the chorionic layer.
How to apply an amniotic graft by providers
- Surgical debridement must be done to ensure a wound bed free of exudate, debris, and infection.
- This will also ensure vascular access for graft uptake.
- If a wound is addressed and shows positive healing outcomes within the first or second week, this confers an excellent prognosis for the wound to heal in most cases by weeks 6-8.
- For a wound to qualify to receive an amniotic allograft, it must be chronic which is defined as a wound that persists for more than 28 days despite standard of care or conservative therapy.
- After an initial visit by the provider to establish the current status of a chronic wound, insurance is checked, the product is ordered, and then applied by a provider weekly until resolution.
Did you know?
As long as amniotic tissue is:
- Minimally manipulated
- Intended for homologous use
- Not combined with a drug or device
- Has a localized effect
- Is not dependent on metabolic cells for its primary function
It is classified as a Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/Ps) regulated solely under section 361 of the PHS act and 21 CFR part 1271 if it meets all of the following above criteria.
Medicare only allows for 1 application of a HCT/Ps product per patient per year. This is why we believe it is very important for the correct and most cost-effective product to be used. This limits a resistant wound and reduces the suffering of our patients.
During processing
Our amniotic tissue is:
- Cleaned
- Tested for all known bacterial, fungal, and viral pathogens.
- Sourced from mothers after undergoing stringent medical and social history screening.
- All original relevant characteristics of the tissue are not altered.
- Blood components removed
- Sterilized
- Separated from the chorion layer
- Prepared for use as an allograft
- Terminally sterilized in its packaging.
- All processed tissues are tested per US Pharmacopeia Convention guidelines prior to release.
- Our suppliers carry the highest accreditation by the American Association of Tissue Banks (AATB).
