Frequently Asked Questions
Signature Biologics is a biotechnology company specializing in the production of placental derived products and a registered tissue bank with the FDA
(FEI: 3014452510).
Perinatal tissue offers a variety of structural tissue constructs; amniotic membrane and umbilical cord. These tissues are immuno camouflaged (lack HLA) to protect the child from the mother’s immune system during gestation. They are also naturally rich in growth factors, cytokines and more.
Our tissue is acquired from licensed third parties whom specialize in tissue acquisition. Once tissue is received the processing, storage, and distribution is all handled within the Signature Biologics Quality Management System.
Signature Cord, Signature Matrix, and Signature APatch products are designed under Section 361 of the Public Health Service Act according to 21 CFR Part 1271.10.
The donor tissue contains live cells and we strive to maintain the integrity of the raw material. This allows preservation of the original tissue structural components and viability.
Signature Biologics follows strict quality control guidelines in donor eligibility, tissue handling, transmittable disease screening, bio-burden reduction and end-to-end traceability. All product is quarantined until third party testing is completed for release and eligibility is approved by our Medical Director.
For more information on our process, please see Our Process page.
Signature Biologics allocates Signature Cord and Signature Matrix product to each vial based on tissue weight (expressed in milligrams). Signature APatch is measured based on total surface area (expressed in centimeters squared). This allows for scientific certainty of tissue quantity present in each vial produced. Please see the Products page for the individual product’s packaged tissue weight or surface area.
Perinatal tissue offers a variety of structural tissue constructs; amniotic membrane and umbilical cord. These tissues are immuno camouflaged (lack HLA) to protect the child from the mother’s immune system during gestation. They are also naturally rich in growth factors, cytokines and more.
Our products are processed under validated aseptic conditions. A statistically significant portion of each lot is tested for sterility by a third party CLIA certified laboratory to ensure absence of any bio-burden. The external container (vial) has been validated to ensure it keeps the sterility of its contents. The vial is then stored in a sterile sealed pouch as a secondary barrier. More information can be found in the package insert.
Orders should be place via emailing an order form to orders@signaturebiologics.com.
The products are shipped overnight on dry ice. Two shipping methods are available today*:
1) FedEx Priority Overnight (10:30 AM Delivery)
2) FedEx First Overnight (08:00 AM Delivery)
*Extra Dry Ice Available Upon Request.
The product should be kept stored at a minimum of -65°C and thawed prior to use. Thawing instructions can be found in the package insert.
Most insurance agents consider this treatment an investigational therapy and are therefore unlikely to cover the costs of the biologics product. Some private insurers are beginning to integrate these offerings into their plans. When considering any medical procedure, patients should always consult their insurance provider to find out what is covered by insurance and what is not. As more research studies become available and demonstrate efficacy, it is expected that more and more insurance carriers will begin to cover the costs associated with structure tissue allografts.
We currently do not offer samples. Please contact Signature Biologics and ask to speak with our Sales Department about evaluating our products within your medical practice for more details.
Please see our Products page for more details.
Our Signature Cord and Signature Matrix products are packed in 1.0 mL, 1.5 mL vials and 2.0 mL (Signature Cord only). Our Signature APatch product is packed in a 15.0 mL wide mouth vial. Please see our Products page for more details.