BioGenix grew out of the recognition that regenerative medicine presents hope to patients who suffer from diseases or injuries. Regenerative medicine is expected to play a pivotal role within the healthcare industry. BioGenix has a longstanding reputation for building and maintaining supportive relationships with clinicians.
Realizing the intrinsic value of transparency, BioGenix is committed to consistently share cutting-edge studies about innovative therapies and life science principles that support the natural healing of the body. We are equally committed to providing high-quality allograft products to clinicians all over the world.
Our commitment to excellence serves as the foundation to our core operating ethos culminating in the best safety track record within the industry. BioGenix adheres to stringent guidelines per Current Good Manufacturing Practices (cGMP), Current Good Tissue Practice (cGTP), State Regulations, AATB guidelines, FDA requirements for Human Cells, and Cellular and Tissue-based Products (HCT/P).
This website is intended to inform and educate medical professionals. It is NOT intended for patients. It also does not seek to make claims about the effectiveness of regenerative medicine and its respective therapies in medical treatment.
Regenerative therapies have great potential in helping treat a range of conditions. This site serves to inform medical professionals about regenerative medicine, BioGenix allograft products, and key in vitro, animal model, and clinical research studies that have been carried out to date across medical specialties and health conditions. However, regenerative medicine is an early and evolving field, and clinical studies are still insufficient to determine effectiveness.
While the BioGenix products are produced in an FDA compliant laboratory, it has not been approved by the FDA for treatment effectiveness. The FDA states:
Like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood-forming stem cells) for certain indications.
Patients interested in regenerative therapy in the U.S. are advised to consult a physician about the state of FDA approval for any given product and/or inquire about opportunities to participate in a clinical trial. Patients interested in regenerative therapies outside the U.S. should investigate regulations in the specific country. It is important to be aware that regulations and clinical study requirements vary from country to country.
By clicking yes you confirm that you are a medical professional, understand that the information contained in this website is intended for medical professionals and not for the general public, and have read and understood the disclaimer above.