Our Story
For OsNovum, the journey to improving skeletal health actually began in the mouth.
For 15 years, SteinerBio has been developing, perfecting, manufacturing, and marketing a novel synthetic bone grafting material for use in the jawbone to regenerate bone and augment lost bone. What set this material apart from the antiquated methods and materials still being used in clinics is its ability to biologically stimulate a patient’s own bone cells to grow bone, thanks to our patented molecular compound. However, it was a matter of time, principle, and duty that the same novel material we had been using to treat bone loss in the jaw should be applied to treat bone loss in the skeleton.
In 2019, we suspected a cyclic financial crisis had to be near, so we restructured and prepared for the hit. All unnecessary costs were stopped. Research and development staff and projects were halted, except for exploring the skeletal application of our regenerative technology. Debts were paid off. We were lean. We decided that the one area we wanted to move forward at full speed was the FDA clearance for treating osteoporotic bones. However, that move was expensive and did not fit into our financial survival posture. At that point, we decided to break off this R&D program from SteinerBio and officially form OsNovum.
In December 2020 we went live on the public crowdfunding portal Wefunder, which ran through April 2021. In less than 6 months, OsNovum was able to raise over $200,000. This milestone gave OsNovum the fuel needed to go full speed with initiating the 510(k) application required by the FDA, using FDA-cleared SteinerBio technology as the predicate technology on which to base OsNovum clearance. The FDA’s skeletal division has never approved a device that actually stimulates bone growth, so they were in uncharted territory and no one seemed to be able to make a decision. Our original path was to submit the device exactly how our dental bone grafts were classified and regulated because it is the identical material. Yet, the skeletal division says that because our material does not exist in their database (skeletal database) we will first need to go through a submission process that classifies the device. We accomplished this and waiting patiently for their response. To our amazement, even though the material was approved as a bone graft in the maxillofacial division, the skeletal division does not recognize the existence of our products at the FDA because it is a different division.
The FDA finally responded to our Q Submission, which is a list of questions proposed by a company asking for decisions on key issues that need to be answered before a submission to the FDA. The questions were previously raised during our 510(k) submission. However, the FDA officers in charge are not equipped to make final decisions that control the path of the submission, so a formal Q Submission needed to be sent to the FDA for final clarification. The ultimate decision was that because our device is a Class III and since the Skeletal Device division does not recognize maxillofacial devices as part of their division, a 510(k) submission has been ruled out. Since a PMA submission is highly impractical in our position, that leaves us one exception — De Novo requests.
De Novo submissions are for products that are unique, have no submission history, and are classified as moderate risk. We fit the requirement very nicely. Shortly after receiving our Q submission response from the FDA, we received a call from a former FDA principal involved with our original submissions who informed us they have left the FDA, are now working as a consultant, and want to assist in our submission. We have contracted with this person’s consulting firm to pursue our De Novo application. To have this person on our side is monumental.
We raised the funds to complete the required tests and sent a 510(k) application to execute that process to the end. The result was not what we wanted, but we did stay on budget and completed what we budgeted for. At this point, we will need to raise additional funds to pay consulting fees and application fees. Both of these items will cost approximately $50,000. The FDA fee for submission of a De Novo device is approximately $30,000 alone. The consulting fees are for putting together a submission outlining how our device is moderate risk requesting clearance to submit a De Novo application. If approved, we will not require human clinical trails, but possibly more laboratory testing. The FDA never gives something without demanding something in return.
We are now going back to Wefunder for a second round of financing. Startup companies fail when they run out of money. When we set up this company, it was designed to never allow that to happen. We have no employee salaries. We have no rent or utilities or ongoing costs. This allows us to have a zero cash burn rate and never be in a position of running out of money. Money is only spent on budgeted projects. The company was designed in this manner because we are committed to bring OsNovum to market no matter what path that takes, and our path has just gotten a lot clearer.
As always, no matter how much is raised, OsNovum is moving forward at full speed.
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PROUD MEMBER OF:
Tissue Engineering and Regenerative Medicine International Society (TERMIS)
American Society for Bone and Mineral Research (ASBMR)