Year One:
Adapt and expand current dental guided surgery software for spinal use, making it simple and intuitive for Spinal Surgeons to use. Apply for FDA approval for the conversion of current FDA approved dental guided software to spinal surgery. This ensures a streamlined regulatory process and expedites the path to the spinal market.
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Begin machine learning for the AI core for spinal use.
Year Two:
Finalizing FDA approval.
Continuing to refine software workflow so that it can be used easily by others, and be easy for a clinician to make suggestions prior to production.
Adding Key Opinion leaders for marketing and technique development.
Developing Planning Team with AI Technology:
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Revolutionary Spinal Solutions will begin training a core group of surgical treatment planners and a fabrication center for 3D printed surgical guides. Our AI-driven planning system will empower the team to efficiently generate optimized treatment plans and personalized surgical solutions tailored to each patient's unique anatomy and condition. As soon as the planning team and FDA approval are in place, Revolutionary Spinal Solutions will begin monetizing the program by offering guided solutions for orthopedic surgeons.
Engineering and test production will begin for custom 3D printed spinal surgery implantable parts.
Advancing to Patient-Specific Implants: Revolutionary Spinal Solutions will initiate the FDA approval process for patient-specific 3D metal printed spinal implants within the first year. This parallel effort will run alongside the development of the planning team and the implementation of AI-driven planning. We anticipate that obtaining FDA approval for patient-specific implants will take approximately a year or two.
Year Three:
Pivoting to marketing and offering patient-specific 3D metal printed implantable spinal devices, leveraging our guided surgery approach to provide customized solutions for each patient.
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Building out the Key Opinion Leader pool.
Offering technique courses.
For more information and to discuss partnership opportunities, please contact:
info@revolutionaryspinesystems.com