PalinGen® InovoFlo is a human allograft comprised of amniotic fluid components intended for homologous use to supplement tissue for protection, cushioning and lubrication.

 

Amniotic fluid functions as a supportive cushion to the fetus and provides a protective environment including rich sources of nutrients, cytokines and growth factors that are required for fetal development and maturation¹. Amnio Technology’s proprietary process preserves the original relevant characteristics of the amniotic fluid.

Amniotic fluid possesses anti-inflammatory, anti-microbial and regenerative properties that make it attractive for use in clinical applications².

Components in PalinGen® InovōFlo include:

  • Fibroblast Growth Factor (FGF)
  • Epidermal Growth Factor (EGF)
  • Platelet Derived Growth Factor (PDGF)
  • Vascular Endothelial Growth Factor (VEGF)
  • Transforming Growth Factor beta (TGF-β)
  • Hyaluronic Acid (HA)
  • Interleukin-1 Receptor Antagonist (IL-1Ra)
  • Tissue Inhibitor of Metalloproteinases 1 (TIMP-1)
  • Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)

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 During this evaluation period, the FDA actively provided draft Guidance and communication to the Industry, including direct communication with Amnio Technology.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: 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 Family 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 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. 

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 has entered into the investigational New Drug process, to be quickly followed by clinical trial recruitment and completing the remaining elements necessary for BLA approval.

Contact us for any questions regarding reimbursement.

Safety
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.

References
1) Collection and characterization of amniotic fluid from scheduled C-section deliveries. Jan Pierce, Pam Jacobson, Eric Benedetti, et al. Cell Tissue Bank. 2016; 17: 413-425
2) Amniotic Fluid: Not Just Fetal Urine Anymore. Mark A Underwood, William M Gilbert, Michael P Sherman. Journal of Perinatology. 2005; 25: 341-348

 

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