Ponya Therapeutics is registered with the U.S. Food and Drug Administration (FDA) under Section 361 of the Public Health Service Act and 21 CFR Part 1271.
Our operations follow the standards outlined in Current Good Tissue Practice (CGTP) and align with the guidelines of the American Association of Tissue Banks (AATB). We are committed to maintaining the highest levels of safety, consistency, and product integrity throughout every step of our tissue processing workflow.
“(a) An HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:
(1) The HCT/P is minimally manipulated;
(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent;
(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P
(4) Either:
(i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
(ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
(a) Is for autologous use;
(b) Is for allogeneic use in a first-degree or second-degree blood relative; or
(c) Is for reproductive use.”
eCFR :: 21 CFR Part 1271 — Human Cells, Tissues, and Cellular and Tissue-Based Products
According to Title 21,
“Minimal manipulation means:
(1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; and
(2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.”
Our unique procedure ensures that the original relevant characteristics of the tissue remain unaltered while avoiding the isolation of any components found in the tissue. Our highly skilled tissue processing scientists resize and suspend the tissue in a saline solution with cryopreservative, which is authorized by the FDA.
Throughout our manufacturing process, we dissociate the donated umbilical tissue and reduce it to a size that preserves the tissue’s inherent characteristics while maintaining its primary functions.
According to Title 21,
“Homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”
Scientific literature extensively supports Wharton’s jelly’s primary function as providing cushioning and structural support. Within the umbilical cord, Wharton’s jelly effectively cushions, safeguards, and insulates internal structures, such as the vein and arteries, from compression, torsion, and bending. When utilized in soft tissue defects, our product demonstrates these same functions by effectively cushioning and supporting the surrounding tissues.
According to Title 21,
“The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P;”
Luxegen™, our Wharton’s Jelly product, is only combine with saline and an approved cryopreservative, which are both acceptable according to the FDA.
According to Title 21,
“The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P;”
Luxegen™, our Wharton’s Jelly product, is only combine with saline and an approved cryopreservative, which are both acceptable according to the FDA.
Ponya Therapeutics upholds stringent donor acceptance criteria. Our screening process involves utilizing highly sensitive nucleic acid testing (NAT) to detect the presence of Hepatitis B virus (HBV), Hepatitis C virus (HCV), and HIV. We conduct a comprehensive evaluation of potential donors, carefully considering any high-risk behaviors. Our donor eligibility criteria are extensive, encompassing testing for anti-HIV1, anti-HIV2, HBsAg, anti-HBc-total, IgG/IgM, anti-HCV, RPR, syphilis, HTLV I/II, and West Nile Virus. Additionally, our products undergo sterility testing after packaging to ensure adherence to USP<85> standards.
Tissue tracking and traceability is mandated by the FDA, meaning that we must ensure that every tissue we provide to our customers can be traced back to its original donor and all records relevant to the donor.
VRL Laboratories CLIA Expires 9.4.2023
Eurofins Denver FDA Registration Expires 12.31.2023
Ponya Therapeutics, LLC products are intended for homologous use only as defined by FDA regulations. Our products are not intended to diagnose, treat, cure, or prevent any disease or medical condition and are not classified as drug products by the U.S. Food and Drug Administration (FDA). Ponya Therapeutics, LLC does not offer mesenchymal stem cells or Wharton’s Jelly as a cure for any condition, disease, or injury. No statements made on this website or in any related marketing materials have been evaluated or approved by the FDA. The content provided is for educational and informational purposes only and does not constitute medical advice. We do not diagnose or treat any condition via this website, printed materials, or telephone communications. Ponya Therapeutics makes no claims—express or implied—regarding the safety, efficacy, or regulatory status of any specific use or application of our products. It is essential that all healthcare decisions be made in consultation with a licensed physician. We encourage patients and providers to perform their own due diligence when considering the use of our products.
© 2025 Ponya Therapeutics.
