OsNovum

OsNovum testing progress

Published on Dec 24, 2020

We have been making good progress with our testing for FDA submission. We have just received our histopathology report that looks at inflammation produced by the bone graft at different time points. We compared a control (no graft) to a cadaver bone graft and our graft. The findings are in, but the final statistical analysis is not yet complete, but it looks very good for our product. For the second component of our FDA submission, we are contracting with a major biomedical testing company to complete the tests that I listed in our previous update. These tests have a 2 month or less turnaround time frame to complete. The third component of our FDA submission is the writing of the FDA submission itself. This is obviously a large, very complex document. We can pay a consultant firm a very large amount of money to produce this document but we there are no consultants with extensive background in this field, so we have developed the skills to do our own FDA submissions in house. The FDA submission is 90% complete at this time. The submission will be complete when the testing is complete so we can merely insert the test results and submit to the FDA. We estimated in our funding proposal that the FDA submission would be ready 6 months after funding. Our first cash draw from Wefunder is January 29. We are arranging to have the tests complete when funding is available so if all goes as planned, we will be 3 months ahead of schedule for the FDA submission. Happy Holidays from all of us at OsNovum.

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