The Next Generation of Amniotic Tissue for Chronic Wound Care

THERION PRODUCT

Therion is a dehydrated and terminally sterilized allograft wound covering derived from human placental membrane. Unlike other amniotic membranes on the market, the proprietary ChAmPion process removes the maternal-derived decidua cells, leaving the amnion and chorion layers in their native configuration. By maintaining the native configuration, higher levels of bioactive compounds are retained compared to a market leading dehydrated human amnion/chorion membrane (DACM).

Chorion has similar bioactives as amnion and is also immune privileged.1,2 By keeping the chorion, the membrane contains more bioactives than amnion alone and provides additional matrix to alleviate the impact of endogenous wound protease activity.3

Therion is safe, effective, and when compared to similar allografts, has excellent handling characteristics. When applied, Therion is:

  • Thin and semi-transparent
  • Conformal and displays excellent adherence
  • Strong and compact yet flexible and less brittle than comparable allograft products

BIOLOGICAL COMPOSITION

Chronic wounds suffer from an amalgamation of prolonged inflammation and a lack of endogenous tissue inhibitors of metalloproteinases (TIMPs), growth factors, and cytokines. The deleterious imbalance of positive wound healing factors versus negative remodeling moieties prevents the migration of healthy cells into the wound and the synthesis and deposition of extracellular matrix (ECM) components.

Benchtop testing shows that a select group of important bioactives are maintained at high levels in the finished products.1

TIMP-1: Tissue Inhibitor of Metalloproteinases 1, HA: Hyaluronic Acid, HGF: Hepatocyte Growth Factor, bFGF: Basic Fibroblast Growth Factor

Therion: three donors assayed in triplicate. Market leading DACM: one donor assayed in triplicate.

THE ChAmPion PROCESS

The ChAmPion Process transforms human placental membranes obtained from consented Caesarean sections into a dehydrated chorioamniotic allograft. The proprietary and validated ChAmPion process maintains the native configuration of the amnion and chorion layers throughout the process to preserve interstitial constituents, such as hyaluronan, that are lost if membranes are separated. The removal of the non-immune privileged maternal decidua cells is performed to enhance the physical and biological uniformity of the tissue. The resultant membranes are then processed utilizing benign processing solutions, with no detergents, to maintain the integrity of the amniotic epithelium and biological composition.

After liquid phase processing, the chorioamniotic membranes are subjected to a proprietary compacting and dehydration process that yields allografts with dense, uniform, and flexible physical properties coupled with extremely favorable handling characteristics. Sidedness is generated during the drying process without loss of material so that the amnion and chorion surfaces can be easily distinguished. The dehydration process yields allografts with low moisture content, which is maintained during packaging to ensure stability at room temperature storage.1

Rehydration of a ChAmPion processed allograft delivers a flat and easy to handle membrane that conforms to any surface.

Native Placental Membrane
Histology (H&E)

 


ChAmPion Processed
Chorioamniotic Membrane
Histology (H&E)

CLINICALLY PROVEN IN A MULTICENTER PROSPECTIVE STUDY

Therion was evaluated for safety and efficacy as a wound cover for chronic diabetic foot ulcers (DFUs).11 In a multicenter prospective study, eligible patients received up to 11 weekly wound cover applications. A total of 63 patients and 64 ulcers were enrolled. Mean baseline DFU area was 3.8cm2. After 12 weeks a total of 19 (40%) DFU’s had closed. Results varied by size category, small (≤2cm2) 57%, medium (>2-4cm2) 33%, and large (>4-25cm2) 10%. Of those DFU’s that closed, the average closure time was 6.5 weeks.

Conclusion: Known risk factors for healing, including DFU size, location and duration, affected the outcomes. However, the results are in line with the literature and support the use of Therion in chronic and complex wounds.

MEDICARE REIMBURSEMENT

Treatment must be based on medical necessity, be consistent with medical standards of care for wound care, and be coded based on documentation of services in the patient record. Coverage cannot be guaranteed. For Therion, the facility or practitioner will code the product, per sq.cm. placed on the wound using the HCPCS code the invoice pricing should be referenced on the claim form. In the hospital outpatient or ambulatory surgery center setting, Therion will be packaged into the High Cost APC for skin substitutes. Therion may be reimbursed by Medicare contractors based on either invoice price, wholesale acquisition cost, or CMS ASP when applied in the physician office setting. Private insurer coverage and payment will vary.12

ORDERING INFORMATION

TO ORDER THERION

Therion References:

  1. Data on file.
  2. Bailo, et al. (2004). “Engraftment potential of human amnion and chorion cells derived from term placenta.” Transplantation, 78(10): 1439-48.
  3. Gould, et al. (2016). “Topical collagen-based biomaterials for chronic wounds: rational and clinical application” Advances in Wound Care, 5(1): 19-31.
  4. Muller, et al. (2008). “Matrix metalloproteinases and diabetic foot ulcers: the ratio of MMP-1 to TIMP-1 is a predictor of wound healing.” Diabetic Medicine, 25(4): 419-26.
  5. Rayahin, et al. (2015). “High and low molecular weight hyaluronic acid differentially influence macrophage activation.” ACS Biomaterials Science and Engineering, 1: 481-93.
  6. Gao, et al. (2009). Hyaluronan oligosaccharides promote excisional wound healing through enhanced angiogenesis. Matrix Biology, 29: 107-16.
  7. Matsumoto, et al. (1991). “Marked stimulation of growth and motility of human keratinocytes by hepatocyte growth factor.” Experimental Cell Research, 196(1): 114-20.
  8. Toyoda, et al. (2001). “Overexpression of hepatocyte growth factor/scatter factor promotes vascularization and granulation tissue formation in vivo.” FEBS Letters, 509(1): 95-100.
  9. Barrientos, et al. (2008). “Growth factors and cytokines in wound healing.” Wound Repair and Regeneration, 16(5): 585-601.
  10. Gomez-Lopez, et al. (2014). “Immune cells in term and preterm labor.” Cellular and Molecular Immunology, 11: 571-81.
  11. Pacaccio, et al. (2018). “Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study.” Journal of Wound Care, 27(7):S28-S37.
  12. Individual Medicare Contractors, other public payers, and commercial insurers may have additional billing instructions. Please follow any instructions provided by the individual payer. The billing provider is responsible for correct coding and billing. This information is provided as a guide; Misonix accepts no responsibility for incorrect coding or billing on the part of the provider.

Therion was previously known as NeoPatch®. NeoPatch is a registered trademark of CryoLife, Inc.