OsNovum Owners update: FDA testing
The FDA does not have rules to follow when submitting a material for clearance to market a product. The FDA only has guidelines and it is up to the company to convince the FDA that the tests performed on the product are sufficient to determine that product is safe and effective. In addition to no rules, what is accepted will be determined by the attitude of the office who reviews the submission. When you submit to the FDA the officer will reply with a list of deficiencies that need to be resolved. The officer will inform you of the deficiencies in your submission but he will not tell you how to resolve his/her shortcomings. Because the tests are one of the biggest expenses we take a minimalist approach. We only perform those test that we feel are the minimum and then let the officer determine if it is enough to satisfy the questions of safety and effectiveness. We are in the process of completing the following test for our FDA submission:
Cytotoxicity Study using the ISO Elution Method
Cytotoxicity tests are used to determine the lysis (death) of cells, colony formation, inhibition of cell growth, and or other effects on cells caused by medical devices, bio-materials, or their extracts utilizing cell culture techniques
ISO Maximization Sensitization Study- Extract
Sensitization tests are utilized to evaluate the potential of medical devices, bio-materials, or their extracts tissues to cause a sensitizing effect or allergic reaction following exposure.
ISO Systemic Toxicity Study- Extract
Systemic Toxicity tests evaluate the generalized biological effects to organs and tissues following exposure to a medical devices, bio-material, or their extracts. The term systemic implies that the exposure occurs by one route and the toxic substance is carried to distant locations causing an adverse effect.
Genotoxicity Bacterial Reverse Mutation Study
Genotoxicity studies are conducted to detect the risk of gene mutations, change in number or structure of a cell, and chromosomal or DNA damage caused by a medical device, bio-material, or their extracts.
Pyrogen Study Material Mediated
Pyrogen testing is performed to detect pyrogenic or fever responses following exposure to a medical device, bio-material, or their extracts. The pyrogenic response may be due to endotoxin contamination or a “material-mediated” response associated with non-endotoxin materials that can cause a fever response The purpose of this study is to determine if a test solution induces a pyrogenic response following intravenous injection in additional naive subjects after the original test had a equivocal result
Bone Implantation Study
This study is designed to evaluate the histopathological response to the test material. The study is a close representation of actual conditions of placing the material in a bone and watching the immune response. The different time frames are one to two weeks, 6-8 weeks and 6 months for the material to sit in bone. The one to two week time frame is designed to evaluate the immediate response to placing the material. The 6-8 week time period is designed to evaluate the response to the material as it is being resorbed and turned into living bone. The 6 month time frame is designed to see what the bone looks like when all of the material is gone and only bone remains. This study costs around $100,000. However, because SteinerBio is one of the few biotech companies with a vivarium we are able to do this study inhouse at a significant saving. The first phase of the study we performed was to evaluate the product while it was in the process of being converted into bone. However we ran into a problem in that while we were to evaluate the material while it was in the process of converting into bone at 8 weeks we found that the test material was completely resorbed and the bony defect was completely filled with bone. We needed to abandon the study and do the same study at 6 weeks. At this time frame we did have remaining material alongside the newly formed bone. The next study we completed was the 1 to 2 weeks study. Because other resorbable bone graft material takes much longer to form bone and much longer to be completely resorbed they require waiting 6 months. But as I stated that happened with our material at 8 weeks. We are going to submit to the FDA that the 6 month study is not needed because the material was converted into bone at 8 weeks. If they accept this we are done with the bone implantation study. If they do not accept this we would need to complete the 6 months phase of the study. We are going to start the 6 month study hoping they do not require it but if they do we would have that phase of the study nearly done and it will not delay clearance. We will provide updates as we proceed with the testing and FDA submission.