About PalinGen® ProMatrX ACF

Chorion Free, Amniotic Membrane and Amniotic Fluid

An advancement in regenerative medicine utilizing minimally manipulated amniotic tissues, ProMatrX™ ACF is a human liquid allograft comprised of amnion and amniotic fluid to aid in the healing and repair of wounds.

ProMatrX™ ACF contains key growth factors, cytokines, amino acids, carbohydrates, hyaluronic acid, and extracellular matrix (ECM) proteins recognized as intrinsic to the complex wound healing process1. Published studies on the benefits and efficacy of amniotic tissue in wounds date back over 100 years2. Amniotic tissue is a rich source of various biologically active factors involved in tissue regeneration and wound healing with reported anti-inflammatory, anti-bacterial, reepithelialization, and anti-fibrotic properties 3,4. Class II antigen expression is also mitigated in amniotic tissues, minimizing immunogenicity and reducing risk of graft-host reaction5. As a result, amnion-derived allografts make an attractive wound biomaterial. Our proprietary AdvanTek™ Process preserves the original characteristics of the amniotic fluid (US Patent No: 9132156).

Key growth factors found in ProMatrX™ ACF include:

·         Fibroblast Growth Factor (FGF)

·         Epidermal Growth Factor (EGF)

·         Platelet Derived Growth Factor (PDGF) A & B

·         Vascular Endothelial Growth Factor (VEGF)

·         Transforming Growth Factor beta (TGFβ)

Extracellular matrix elements found in ProMatrX™ ACF include:

·         Collagen Types I, III, IV, V and VII

·         Laminin

·         Fibronectin

·         Tissue Inhibitors of Metalloproteinases (TIMPs) Proteoglycans

·         Hyaluronic Acid

ProMatrX™ ACF does not require fetal sacrifice and recovery is performed with maternal consent during elective Cesarean delivery.

ProMatrX™ ACF donor tissue is recovered using one of the safest recovery techniques and sterile equipment to minimize bioburden contamination. Amniotic tissues are procured through a network of qualified and trained recovery partners, following stringent screening and recovery protocols in a highly controlled processing environment. All tissues are processed aseptically.

Donors are prescreened through an intensive and complete medical review and prenatal evaluation. Communicable disease testing is performed by an FDA registered and Clinical Laboratory Improvement Amendments (CLIA) laboratory. Donor blood sample is taken prior to or at the time of recovery and tested for HBsAg, HBcAb, HCVAb, HIV1/2 Ab, HCV NAT, HIV NAT, HBV NAT, RPR/STS, HTLVI/II and WNV. Allografts are subjected to stringent USP testing prior to release.

ProMatrX™ ACF is manufactured and regulated for human homologous allograft use under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

ProMatrX™ ACF is processed and packaged at an FDA registered and American Association of Tissue Banks (AATB) accredited facility in accordance with cGMP standards.

About Amnio Technology:

Amnio Technology, LLC is a global leader in the development and use of amnion-derived technologies. Amnio Technology enhances the gift of human birth tissue donation by developing, processing and distributing innovative allografts that provide regenerative therapies to improve quality of life. Learn more at www.amniotechnology.com.

PRODUCT NOTES"

·         Allografts may be applied topically or implanted based on clinician preference

·         Available in a variety of volumes

·         Easily resorbed in vivo

·         Chorion free

·         May be diluted to any ratio (1:1 recommended)

·         Dilution may be achieved with lidocaine preservative free, Marcaine preservative free, platelet rich plasma and/or normal saline

·         Do not mix with epinephrine, glucose, or glycerol products

·         Flexible storage conditions

·         See package insert for complete Instructions For Use

REFERENCES:

1) Complements and the Wound Healing Cascade: An Updated Review. Hani Sinno andSatya Prakash. Plast Surg Int. 2013; 2013: 146764

2) The Grafting of Preserved Amniotic Membrane toBurned and Ulcerated Surfaces, Substituting Skin Grafts: A Preliminary Report. Maximilian Stern.  JAMA. 1913; 60(13): 973-974

3) Amniotic Fluid: Not Just Fetal Urine Anymore. Mark A Underwood, William M Gilbert, Michael PSherman. Journal of Perinatology. 2005; 25:341-348

4) Growth factors and cytokines in wound healing. Barrientos S, Stojadinovic O, Golinko MS, Brem H,  Tomic-Canic M. Wound Repair Regen. 2008; 16(5): 585-601

5) Immunological characteristics of amniotic epithelium. Hori J, Wang M, Kamiya K, Takahashi H, Sakuragawa N. Cornea. 2006; 25(10): S53-58