PalinGen® Flow is an amniotic tissue allograft containing cellular components, cytokines, growth factors and extracellular matrix proteins that are naturally found in amniotic tissues.
Key growth factors found in amniotic tissue 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 amniotic tissue allografts include:
- Collagen Types I, III, IV, V and VII
- Tissue Inhibitors of Metalloproteinases (TIMPs)
- Hyaluronic Acid
Amnio Technology, established in 2013, has processed and distributed Products in a manner which has met, or exceeded, the Quality and Regulatory expectations of the Food and Drug Administration’s (FDA) requirements as detailed in Current Good Tissue Practices (cGTP) defined in 21 CFR 1271. Further, all Amnio Technology Products are processed and manufactured within an FDA Registered Facility which is also Certified by the American Association of Tissue Banks (AATB); resulting in Amnio Technology Products being marketed and distributed as cellular and tissue-based products (HCT/P) Regulated solely under Section 361 of the Public Health Service Act (PHSA).
The FDA began an initiative in 2015 to further evaluate Products manufactured and distributed under 21 CFR 1271 and Section 361 of the PHSA. During this evaluation period, the FDA actively provided draft Guidance and communication to the Industry, including direct communication with Amnio Technology. Final Guidance was issued in November 2017 and updated in July 2020: Guidance for Industry, “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use.”
The final issuance of the Guidance for Industry confirmed that Amnio Technology’s PalinGen® Membrane and Hydromembrane Product Lines would continue to be regulated solely under Section 361 of the PHSA; however, Amnio Technology’s liquid Product Lines would be Regulated under Section 351 of the PHSA in the future. Regulation under Section 351 of the PHSA requires the submission of an investigational New Drug Application (IND), Clinical Trials to supplement existing Clinical Case Studies and approval of a Biologics License Application (BLA). In the July 2020 update to its Guidance for Industry, FDA communicated that the agency intended to exercise enforcement discretion with respect to the IND and premarket approval requirements for certain HCT/Ps through May 2021.
In order to ensure continued compliance with FDA Guidance and Section 351 of the PHSA, Amnio Technology participated in a Type B pre-IND meeting with the FDA, where the detailed manner in which the Organization intends to address the transition of Product Lines to Regulation under Section 351 of the PHSA was discussed. In October 2020, Amnio Technology received authorization to proceed with a Phase 2, multi-site clinical trial from FDA under an IND.
Amnio Technology is committed to Compliance, Quality and fosters a culture of Continuous Improvement. We have further demonstrated this commitment by making a substantial investment in the construction of new Facilities/Clean Room Suites, Closed Aseptic Isolator Technology, and Automated Processing Equipment. Amnio Technology holds a commercial IND for our PalinGen® Flow product and will begin clinical trial recruitment in late 2020. Amnio Technology is wholly invested in completing the remaining elements necessary for BLA approval.
Contact us for any questions regarding reimbursement.
Donor tissue is recovered using one of the safest recovery techniques and sterile equipment to minimize any bioburden contamination. Amniotic tissues are procured through a network of qualified and trained recovery partners, following stringent screening and recovery protocols. All tissues are processed aseptically in a highly controlled processing environment.
Communicable disease testing is performed by an FDA registered and Clinical Laboratory Improvement Amendments (CLIA) certified 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, WNV, and HTLV I/II. Allografts are subjected to stringent USP testing prior to release.
1) Complements and the Wound Healing Cascade: An Updated Review. Hani Sinno and Satya 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