No, none of the currently marketed birth tissue derived therapies are approved by the Food and Drug Administration (FDA) to treat any specific condition. However, they are regulated by the FDA under 21 CFR 1271, as well as section 361 of the Public Health Services Act.
Surgenex® has contracted with a FDA registered and AATB accredited tissue recovery organization that acquires all birth tissues domestically from healthy mothers having pre-scheduled cesarean section deliveries. Each donor is pre-screened for medical and social history, and their blood is serologically tested to ensure the absence of relevant communicable diseases and disease agents, and any associated risk factors.
Surgenex® products are rigorously tested to ensure safety and quality. Every lot is sampled and tested for sterility and endotoxin levels prior to release for distribution. We at Surgenex® pride ourselves on exceeding regulatory standards by performing additional infectious disease testing not required by the FDA. SurForce® has been administered in over 24,000 injections with no adverse reactions reported. In addition, birth tissues naturally have unique immunological properties that typically do not trigger immune rejection.
Although many patients immediately experience the associated benefits of SurForce®, including a dramatic decrease in pain, some patients may feel a slight increase in discomfort. This is due to an anticipated mild inflammatory response, which may last 24 to 48 hours. On some occasions, patients have reported a self-limiting feeling of general malaise, which gradually subsides 24 hours after treatment.
In addition, the application and use of any allograft tissue may potentially have negative outcomes. Occurrence of complications at the site of application may transpire post-treatment, without early warning signs. These may include but are not limited to: 1) transmission of communicable diseases, known or unknown; 2) transmission of infectious disease agents; and 3) immune rejection of, and/or allergic reaction to the allograft. Any adverse reactions potentially attributable to the allograft must be reported promptly to Surgenex.
Although Surgenex® has taken great measure to ensure the safety of our allograft products, current technologies cannot preclude the transmission of certain diseases, known or unknown. Therefore, Surgenex® can make no claims concerning the biological properties and absolute safety of allograft tissue.
The FDA has identified intra-articular, intra-dermal, and subcutaneous injections to be low-risk and currently under enforcement discretion. Systemic administration, intravenous or intra-ocular injection, aerosol inhalation, or administration into the central nervous system (CNS) are considered high-risk, due to known post-treatment complications, and must never be attempted or performed with Surgenex products.
Caution must be taken when administering these tissue allografts to immunocompromised individuals, such as patients suffering from HIV or other immunocompromised conditions. Surgenex allografts must not be injected in the area of, or into patients with, active infections, nor patients that have conditions that could cause substantial risk to their health while using these products.
Patients should be cancer free and not receiving chemo or radiation therapy. Oncologist approval and clearance for treatment is recommended prior to treatment. Surgenex® injectable allografts may be considered an option 14 days after receiving a final chemotherapy treatment. Surgenex® injectable allografts should not be used concomitantly with radiation therapy.
The Surgenex® Medical Director recommends waiting a minimum of 14 days after termination of any steroid therapy before receiving treatment with Surgenex® injectable allografts. However, if a steroid is injected into the same joint, the patient should wait 2 to 3 months before receiving Surgenex injectable allografts. If additional application of steroids is necessary after receiving an injectable allograft, it is recommended to wait 6 weeks after treatment before receiving another steroid injection into the same joint.
Skin infiltration with local anesthetic prior to the application of Surgenex® injectable allografts is common practice and has yielded no negative effects. Because Surgenex® injectable allograft products have not been tested in conjunction with anesthetics, it is recommended that Surgenex® injectable products and local anesthetics not be mixed within the same syringe. Also, refrain from injecting any local anesthetics into the articular joint space or area of treatment.
Surgenex® injectable allograft products have not been tested in combination with any other products or therapy methods and it is not recommended to use Surgenex® injectables in conjunction with other products.
Recipients of Surgenex® injectable allografts typically walk out of the treatment center unassisted after injection. The application site should be rested and light, easy movement is advised. The patient should restrict their activity to tasks of average, daily living for the first 3 days. Caution should be taken to resuming any activity involving the treated area. The patient should avoid repetitive, loaded exercise, such as stair steppers, running or weight lifting involving the treated area for the first 4 weeks. Strenuous activity should only be resumed under the direction of the treating heath care provider.