About PalinGen® Flow

Chorion Free, Cryopreserved Amniotic Membrane and Fluid Components

An advancement in regenerative medicine utilizing minimally manipulated amniotic tissues, PalinGen® Flow and SportFlow are human allografts comprised of amnion and amniotic fluid components, providing a liquid allograft to aid in the healing and repair of wounds.

PalinGen® Flow and SportFlow contain key growth factors, cytokines, amino acids, carbohydrates, hyaluronic acid, extracellular matrix (ECM) proteins, and cellular components 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 properties3,4. 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.

Key growth factors found in PalinGen® allografts 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 PalinGen® allografts include:

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

· Laminin

· Fibronectin

· Tissue Inhibitors of Metalloproteinases (TIMPs)

· Proteoglycans

· Hyaluronic Acid

PalinGen® Flow and SportFlow may be applied directly to the area of interest by implantation through a 20-23 gauge needle. They are cryopreserved for safe, long-term storage and ease of handling in the clinic or operating room. These products are available in a variety of volumes.

PalinGen® products do not require fetal sacrifice and recovery is performed with maternal consent during elective Cesarean delivery.

PalinGen® Flow and SportFlow 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.

PalinGen® products are manufactured and regulated for human homologous allograft use under 21 CFR Part 1271 and Section 361 of the Public Health Service Act.

PalinGen® tissues are 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

Recommended storage is -80°C ± 15°C until use

See package insert for complete Instructions For Use

REFERENCES:

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

2) The Grafting of Preserved Amniotic Membrane to Burned 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 P Sherman. 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

Uses Documented in Literature

Spinal Surgery – Reduce scarring, and fibrosis. Reduce risk of nerve entrapment. In animal models it has been shown to amplify bone healing.
Neuro Surgery – Treat chronic neuritis, and pain.
Orthopedic Surgery – Augment tendon, fasciae, ligament and capsule repair. Injectable through a 22g needle for use in synovial injuries, injured chondral surfaces, chronic tendinopathies, tendinosis, and chronic fasciosis.
General Surgery – Reduce scar formation and adhesions, augment tissue repair.
Wound Specialists – Excellent intradermal peri wound therapy, provides a healthy anti-microbial, regenerative wound environment. Balances the wound environment, contributing to angiogenesis.
Burn Specialists – Excellent topical wound therapy as anti-microbial, anti-inflammatory and reduce scarring. Can be applied topically or subcutaneously.
Plastic Surgery – Reduce scarring, fibrosis, adhesions, provide a tissue barrier supplement to name a few types of uses in this wide ranging specialty.
Dental Surgery – Post procedure intralesional gum injection to promote tissue regeneration, potential to resolve gum insufficiency.