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  • steber.kir
    Participant
    Post count: 8

    Dr. Corenman,

    In your opinion, what is the outlook of bio-engineered lumbar disc replacements? Are there some already in clinical trials in humans?

    Thanks in advance for any and all information!
    Kira Steber

    Donald Corenman, MD, DC
    Moderator
    Post count: 8455

    That’s an interesting topic. I have patented a biological disc that is in early research stages.

    Dr. Corenman

    steber.kir
    Participant
    Post count: 8

    How many stages are there in the research and trial phases of such patented inventions? What is the expected timeline of the stages, and how/where could I keep up-to-date on the status of the research and trials?

    Kira

    Donald Corenman, MD, DC
    Moderator
    Post count: 8455

    Depends if you have to get FDA approval thru the 510K process or not. My implant is tissue transfer like an ACL transplant so no 510K needed. If phase 1-III trials needed, that means millions of dollars and years of research. You can apply for a license based upon “prior art” and get a variance decision.

    Dr. Corenman

    steber.kir
    Participant
    Post count: 8

    How many years do you anticipate the research will take?

    I’ve asked a few practicing neurosurgeons with whom I’ve had consultations about the bio-engineering advancements being made for lumbar discs and not a one of them has indicated they are aware of such advancements under way. What is the best resource for me to stay current on the topic?

    Donald Corenman, MD, DC
    Moderator
    Post count: 8455

    There are many biologically developed disc replacements under consideration but i can’t give you direct communication pathways. If I have developmental success of my disc, I will announce that on this website.

    Dr. Corenman

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