RHEO™ FLOWABLE ALLOGRAFT

RHEO™ is a flowable perinatal tissue allograft. It’s derived from human placental tissue and amniotic fluid, then cryopreserved to maintain the viability. RHEO™ retains the biologic functionality that ensures symmetrical development, growth, and repair of the soft tissue by acting as a biologic matrix for use in points of localized inflammation1.

The placental Extracellular Matrix (ECM) modulates correct cellular reconstruction rather than scar tissue formation. This ECM includes growth factors, fibronectin, laminin, hyaluronic acid, proteoglycans, and other proteins. Anti-inflammatory and anti-fibrotic proteins in placental ECMs reduce inflammation, fibrous tissue growth, and potential scar tissue formation as they downregulate TGF-B, suppress pro-inflammatory cytokines, and inhibit MMPs and fibroblast formation1.

RHEO™ IS NON-IMMUNOGENIC2-4

Placental tissues possess little risk of foreign body reaction in the patient, which can lead to fibrosis and graft failure. They perform a similar role during pregnancy, preventing a response between baby and mother. Placental tissue contains components that help to create a healthy environment by potentially reducing bacteria counts in the wound. Its antibacterial effects have been demonstrated against a wide range of bacteria.

FOUNDATION FOR
REGENERATION

Placental ECMs contain Collagens I, III, IV, V, VI, VII, and fibrous proteins that provide a structural scaffold to support migration. Fibronectin, integrins, laminin, and hyaluronan also play a key role in proliferation, differentiation and adherence to the scaffold.

TISSUE DONORS

Healthy women 18-35 years old, undergo an extensive clinical risk assessment of their medical and social histories as well as blood and tissue testing to determine eligibility to donate. The placental tissue can be accepted for donation after a healthy baby is delivered via elective Caesarian section.

RELEASE APPROVAL

Once donor tissue is collected it is processed utilizing a proprietary process within the regulations of FDA 21CFR part 1271/PHS 361. Release criteria includes extensive bioburden testing to ensure safety as well as quality protocols and review:

 

VEGF: 36.6± 3.2 pg per 1-mil

bFGF: 802± 34 pg per 1-mil

PDGF-BB: 38.7± 2.8 pg per 1-ml

IL-1ra: 13,015± 58 pg 1-mil

RHEO™ is a pure product, carefully prepared for maximum effect and safety. No adverse events have been reported during its years of research, development and use. Placental allografts have an exemplary safety record, making RHEO™ a reliable option.

1 Olczyk P, Mencner Ł, Komosinska-Vassev K. The role of the extracellular matrix components in cutaneous wound healing. Biomed Res Int. 2014;2014:747584. doi:10.1155/2014/747584
The immunology of successful pregnancy. Veenstra van Nieuwenhoven AL, Heineman MJ, Faas MM. Hum Reprod Update. 2003;9:347–357.
Immunogenicity of human amniotic membrane in experimental xenotransplantation. Kubo M, Sonoda Y, Muramatsu R, Usui M. Invest Ophthalmol Vis Sci. 2001;42:1539–1546.
Immunological characteristics of amniotic epithelium. Hori J, Wang M, Kamiya K, Takahashi H, Sakuragawa N. Cornea. 2006;25:0–58.