The amniotic tissues used in Surgilogix allografts are donated by consenting, healthy women between the ages of 18 – 45 who have just delivered a full-term, healthy baby through elective Cesarean section. A careful medical and social history is collected in advance to ensure donor mothers meet all eligibility requirements. Donor blood samples are collected and thoroughly screened for communicable diseases.

COLLECTION

Placental tissues are collected at several facilities around the country, following strict guidelines and consistent with industry best practices. At the time of Cesarean delivery (also known as C-section), the baby is delivered and the placenta and amniotic fluid, which are typically discarded, are saved. There is no harm to the new born baby or mother. All tissues are then tested to ensure viability and safety.

PROCESSING

The collected placental tissues (amniotic membrane and amniotic fluid) are processed to the highest standards in a state-of-the-art American Association of Tissue Banks (AATB) accredited facility. Our process maintains the original characteristics of the amniotic tissue including its cellular components, growth factors, and collagen, and keeps the extracellular matrix intact. This specialized technique results in a graft that maintains the original healing characteristics and protective barrier properties of the amniotic tissue. All processed tissues are tested per USP guidelines prior to release.

Its unique make-up:

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  Includes cytokines, amino acids, carbohydrates, hyaluronic acid, and cellular components.¹

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  Contains key growth factors and extracellular matrix proteins.¹

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  Offers anti-inflammatory, anti-bacterial, re-epithelialization, and anti-fibrotic properties.^2,3

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  Has published studies on its benefits and efficacy in woundcare dating back over 100 years.⁴

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  Mitigates the expression of class II antigens, minimizing immunogenicity and reducing the risk of adverse reaction.⁵

Amniotic tissue is known to contain the following extracellular matrix elements:

• Collagen Types, I, III, IV, V and VII
• Laminin
• Tissue Inhibitors of Metalloproteinases (TIMPs)
• Fibronectin
• Proteoglycans
• Hyaluronic Acid

Regenerative amniotic tissue allografts have been used successfully in wound care to cover and aid in healing a variety of wound types both topically and in vivo, including:

• Incision wounds made during open, laproscopic or DiVinci System® surgical procedures
• Trauma wounds caused by an accident or repeated use
• Hard to heal or chronic wounds, like diabetic ulcers

Safe Tissue Handling

• Procurement is done by qualified partners following stringent protocols.
• Donors are pre-screened through an intensive medical review and prenatal examination.
• Communicable disease testing is performed by an FDA-registered, CLIA laboratory.
• Allografts are subjected to stringent USP testing prior to release.

Patient Reaction

• Class II antigen expression is mitigated in amniotic tissue minimizing immunogenicity and reducing the risk of graft versus host reaction.⁵
• Unlike other amniotic tissue allografts on the market, Surgilogix allografts do not contain chorion, further reducing the risk of an adverse reaction.
• Amniotic tissue has been used in wound care for over 100 years.
• There have been no reported adverse reactions to Surgilogix allografts.

Our focus on the true science behind amniotic tissue and allograft technologies has allowed us to produce superior products.

• Chorion Removal – Research has shown that chorion contains
  maternal antigens that may trigger an immune reaction. To improve safety, we remove the chorion from all amniotic tissues used in SurgiLogix allografts. Over 55,000 patients have been treated with these chorion-free allografts and with no known adverse events.
• Processing Technique – Our scientists have spent countless hours refining our processing technique in order to maintain the viability and concentration of the key healing properties found in amniotic tissue.