Various JCAHO (Joint Commission on Accreditation of Healthcare Organizations) accredited hospitals are used for collection. We have contracted with AATB accredited companies that have protocols in place, to collect placental tissues during elective C-section deliveries and provide all interviewing, collection and maternal testing.
Yes, all deliveries are tracked to ensure that donated tissue is taken care of upon delivery. Every step is documented from mother’s decision to donate to ﬁnal delivery to recipient. The collection times and processing times are coordinated to reduce the interval time from delivery to processing.
All candidates undergo an interview by a trained nurse to assess physical appearance, behavioral risk (tattoos, travel, sexual activity, etc.), and maternal health history. All donated tissues are accompanied by a maternal blood test which tests for HIV, HTLV, CMV, Hepatitis A and B, Syphilis.
Our Anu RHEO™ Tissue product is the only product that is oﬀered that comes from amniotic membrane. All chorionic membrane is dissected away during the ﬁrst steps of processing. Tissues are tested for bacterial and fungal contamination at the time of collection.
Chain of custody is closely monitored from the time the mother decides to donate until the ﬁnal product is used. The company procures the tissue and carefully labels all containers and paperwork. They package the material and deliver to FedEx where tracking information is obtained and the tissue is carefully followed until it is delivered into Anu Life Sciences staff prior to 10 am the next day. Paperwork follows the tissue through the check-in process, all processing steps, and storage and shipping steps. In addition, all samples are tracked after shipping as well. We are required to track the sample through injection and afterward in case of adverse eﬀects. Anu Life Sciences follows all FDA, AATB, AABB standards, quality system developed with the goal of becoming ISO 13485 compliant, sampling of all processed tissue per USP 71 standards.
Presently we are minimally manipulated and full under FDA 361. We are preparing for potential new guidelines and rules to be issued by the FDA in the foreseeable future. In anticipation of these rule changes, Anu life sciences is compiling data to submit multiple IND applications for a variety of studies utilizing our allografts. We don’t know if the FDA will decide placental allografts need to be classified as a drug. At that point, then we would pursue FDA 351 approval. The FDA may decide that we need to only show safety and efficacy. Somewhere in between those two options will lie the decision of the FDA and we intend to be fully compliant with their decisions.
Under the new, proposed guidelines, our Anu RHEO™ Tissue products are compliant. Our future allograft product might need to undergo some procedural changes to remain compliant. No matter which path the FDA chooses for placental tissue allografts, we are dedicated and determined to collect all objective and subjective data that we can, and insure that the data is compiled and published in a timely manner.Your Content Goes Here
Our partnership clinics will be put into a database where the general public will be able to search for a physician that utilizes Anu RHEO™ allograft membrane. We will also be highlighting various clinics and also being doing local promotions for the doctors. Details will be worked out with you and your account representative.
Current market prices for regenerative medicine procedures range anywhere from $4000 to $30,000 depending on the procedure. Most procedures involving stem cells are utilizing autologous regenerative cells procured through adipose or bone marrow.
The shortened procedural time and more potent product gives the patient a clear advantage over the use of the aged and often ineffective MSC from adipose tissue. Reduces recovery period as the patient does not have to schedule for the adipose or bone marrow removal. Please see key points for more beneﬁts of Anu RHEO™.
Currently our Anu RHEO™ has been specifically developed for orthopedic and surgical applications. We make no claims on the use of the product for diseases or the treatment of diseases. Stem cell therapy is relatively new and any statements regarding the cure of any disease has not been scientiﬁcally proven.