Biologic products include a wide range of products such as allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
Q & A On Biologics
What is BioDRestore?
BioDRestore is a novel placental tissue allograft. Placental tissues have been shown clinically and scientifically to support soft tissue repair, reduce inflammation and minimize scar tissue formation. BioDRestore is derived from tissues acquired from living, healthy donors after full term pregnancy and a scheduled Caesarean section. These tissues have been minimally processed and preserved to maintain the natural properties of the placental tissues.
The product is only available through a physician or licensed healthcare provider.
What is an Allograft?
An allograft is tissue from a human donor that is transplanted from one body to another.
BioDRestore is a flowable tissue product that will allow your doctor to apply the product right at the source of injury.
Your physician can determine if your medical condition is appropriate for treatment with BioDRestore and, if so, will advise you as to the number and frequency of recommended treatments based on his or her professional assessment of your condition.
Common injuries treated with placental tissue:
• Repetitive Motion Injuries
• Plantar Fasciitis
• Soft Tissue Injuries
• Muscle Tears
• Inflamed Nerves
Safety and Quality
BioD products are processed in accordance with the standards and regulations set forth by the Food and Drug Administration (FDA) and American Association of Tissue Banks (AATB) for allograft tissue products. Our processes have been developed to preserve the placental tissues’ natural characteristics, including the extracellular matrix, growth factors and inherent cells, and to provide clinically efficacious products.
BioDRestore is derived from living, healthy donors that are prescreened during pregnancy and selected based on our stringent donor suitability criteria. In addition to reviewing pre-natal test results, BioD obtains a comprehensive medical history and behavioral risk assessment from each consenting donor prior to recovery. From aseptic processing to lot release testing of all of our tissues, we are committed to the safety and quality of our products.
Are there risks associated with BioDRestore?
BioDRestore is an allograft that contains tissues from a living, healthy donor. As with the implantation of any human tissue, there is always the possibility of an adverse allergic reaction or transmission of a communicable disease in connection with the use of this product. Over 15,000 allografts distributed by BioD have been used in dental, ocular, orthopedic and wound care applications.
Please review the product insert for additional information about potential adverse reactions and consult your health care provider regarding these risks or any questions you have regarding the use of this product.