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How it works

Vertical Integration

Our company model oversees the entire tissue continuum, from Recovering amniotic tissue with our Labor and Delivery partner sites, to Processing and Manufacturing of the allografts, and finally Distribution to Hospital System’s Wound Care Centers and Operating Rooms for patient treatment.

This ensures the quality of clinical healing at a drastically reduced cost, offering more ACCESS to patients.

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intogen
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Pregnant Mother Enrolled in Donation Program

Mother Agrees to Donation and Successfully Completes FDA Donor Screening Assessment

Successful Cesarean Delivery of Healthy Baby in the United States

Recovery of Donated Placental Tissues

Microbiological and Serological Analysis of Donor Tissue

Donor Tissue Processing and Terminal Sterilization

Product Packaged for Shelf Stability

telagen-logo-transparent

Pregnant Mother Enrolled in Donation Program

Mother Agrees to Donation and Successfully Completes FDA Donor Screening Assessment

Successful Cesarean Delivery of Healthy Baby in the United States

Recovery of Donated Placental Tissues

Microbiological and Serological Analysis of Donor Tissue

intogen
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Donor Tissue Processing and Terminal Sterilization

Product Packaged for Shelf Stability

telagen-logo-transparent

Pregnant Mother Enrolled in Donation Program

Mother Agrees to Donation and Successfully Completes FDA Donor Screening Assessment

Successful Cesarean Delivery of Healthy Baby in the United States

Recovery of Donated Placental Tissues

Microbiological and Serological Analysis of Donor Tissue

intogen

Donor Tissue Processing and Terminal Sterilization

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Product Packaged for Shelf Stability

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Amnion Regulation and Science

Amnion is Amnion

Do not be misguided by the “proprietary processing” marketing tactics companies use to claim their tissue products are superior in nature.

All amniotic allografts, no matter the manufacturer/supplier, have the exact same mechanisms for action.

More Details
Amnion Is Amnion

Tissue Processing

Approved Tissue is Sent for Processing

Tissue is Dissected and Prepared for Washing

Tissue is Washed in Reagents

Tissue is Laid Out for Drying

Tissue is Cut and Pouched

Tissue is Sent for Terminal Sterilization

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Tissue is Final Packager for Shelf Stability

Ensuring access to safe, reliable, and affordable wound care therapy through our vertically integrated biotech company, meeting FDA and AATB standards.

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Cross-sectional schematic of placental tissue composition.

 

Used under the Creative Commons License.

Resource: Hitscherich, Pamela & Chnari, Evangelia & Deckwa, Jessa & Long, Marc & Khalpey, Zain. (2022). Human Placental Allograft Membranes: Promising Role in Cardiac Surgery and Repair. Frontiers in Cardiovascular Medicine. 9. 10.3389/fcvm.2022.809960.

Amnion is Amnion

  • All amniotic allografts, no matter the manufacturer/supplier, have the exact same mechanisms for action.
    • All contain the same growth factors, cytokines, and signaling proteins.
    • All amnion allografts fall under the FDA guidelines as a 361 HCT/P.
      • You cannot more than minimally manipulate the tissue.
      • You cannot put anything in or take anything out of the tissue to make it “superior”.
      • For Homologous Use Only.
    • Differing processing formulas do not make the tissue superior to other options.
    • Do not be misguided by the “proprietary” processing marketing tactics companies present to claim their tissue is superior in nature.

361 Regulatory

Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

In 21 CFR 1271.10, the regulations identify the criteria for regulation solely under section 361 of the PHS Act and 21 CFR Part 1271. An HCT/P is regulated solely under section 361 of the PHS Act and 21 CFR Part 1271 if it meets all of the following criteria (21 CFR 1271.10(a)):

  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; and
  4. Either:
    1. 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
    2. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and:
      1. Is for autologous use;
      2. Is for allogeneic use in a first-degree or second-degree blood relative; or
      3. Is for reproductive use.

If an HCT/P does not meet the criteria set out in 21 CFR1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.156 , the HCT/P will be regulated as a drug, device, and/or biological product under the FD&C Act, and/or section 351 of the PHS Act (42 U.S.C. 262), and applicable regulations, including 21 CFR Part 1271, and premarket review will be required.