Our Story
For OsNovum, the journey to improving skeletal health actually began in the mouth.
A proven leader in bone regenerative technology, SteinerBio began research to introduce its existing regenerative technology for the treatment of failing bones in 2016. While the regenerative material was successfully FDA-cleared for use in the jaws, a separate clearance was required for the material’s use in the skeleton. The journey for clearance has been ongoing ever since and has taken form of SteinerBio’s sister company, OsNovum.
We began our 510(k) application, using FDA-cleared SteinerBio regenerative 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 will not recognize non-skeletal materials as predicate technology for skeletal use. The FDA’s 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.
At this point, we will need to raise the funds to pay consulting fees and application fees. The FDA fee for submission of a De Novo device is approximately $30,000 alone. Our raise must also cover the consultants, who will assist us in putting together a submission that adequately outlines how our device is moderate risk in the request for De Novo clearance 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.
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)