PalinGen® Flow is a liquid amniotic tissue allograft for the treatment of chronic ulcers in the lower leg and foot. PalinGen® Flow contains growth factors and extracellular matrix proteins, which are naturally found in amniotic tissues, to support wound healing.
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
PalinGen® Flow Development Milestones:
- 2015, FDA begins drafting its Regenerative Medicine Policy Framework
- 2017, Amnio Technology participates in a Type B pre-IND meeting with the FDA, where the detailed manner in which the Organization intends to address the transition of PalinGen® Flow to Regulation under Section 351 of the PHSA was discussed.
- 2017-2019, Amnio Technology completes IND-enabling pre-clinical studies, enhances manufacturing, and plans clinical investigations.
- 2020, Amnio Technology receives authorization to proceed with a Phase 2, multi-site clinical trial from FDA under an IND.
- 2021, Phase 2 clinical trial, PGF-201 begins recruitment and patient enrollment; trial is listed on www.clinicaltrials.gov.
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 During this evaluation period, the FDA actively provided draft Guidance and communication to the Industry, including direct communication with Amnio Technology.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, “Guidance for Industry Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use,” was issued July 2020.
The Final Guidance 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. Regulation under Section 351 of the PHSA requires a pre-market Biologics License Application (BLA). FDA ended the enforcement discretion period with respect to premarket approval requirements for certain HCT/Ps on May 31, 2021.
Amnio Technology’s Commitment to Quality:
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).
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 began clinical trial recruitment in late 2020. Amnio Technology is wholly invested in completing the remaining elements necessary for BLA approval.
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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