4iBIO is a medical device company commercializing Dynamic Implant (DI). DI is a personalized, 3D printed, surgically placed "cap" design that protects and promotes healing in arthritic joints. The DI patent protected design is adaptable for use in all arthritic joints including small (extremities), large (TMJ, hip, knee, shoulder) and veterinary (canine hip) ones. DI is an early disease stage, minimally invasive, non-destructive, reversible treatment option without peers.
The new paradigm for surgical Orthopedic care: protect, don’t replace.
The Arthritis Challenge
Arthritis is classically considered to be a degenerative, progressive and irreversible disease. The current clinical paradigm for the care of arthritic joints relies largely upon the use of medications and reduced activity until the pain and disability are severe enough to warrant joint resurfacing or replacement.
For small joint (extremity) arthritis in humans there are many available surgical procedures and several prosthetic options that all yield compromised results. Reduced functional strength, decreased range of motion and limited longevity are some of the unresolved limitations of current options.
Biologic attempts to replace cartilage in arthritic joints have been unsuccessful and remain experimental due to the avascular, slow healing nature of cartilage and the destructive movement and loading of the joint environment.
These challenges are not insurmountable when using a protective implant solution.
Cartilage and bone are live tissues that are capable of self repair. They only require protection and time.
Designed to function as a protective "cap", DI changes the arthritis paradigm to protection and natural healing rather than destruction and replacement.
DI affords the following advantages:
- Personalized medicine (custom made using 3D printing)
- Early intervention in the arthritic process
- Minimally Invasive Surgery (MIS)
- Rapid recovery and minimal rehabilitation
- Preserve native tissues
- Promote native tissue healing
- Drug eluting option to promote healing
- Reversible procedure
- Replaceable as needed
- Clinical success in early trials
DI will be introduced for the treatment of Arthritis of the CMC Joint of the Thumb initially. Currently, almost 500,000 procedures are provided annually by Doctors for Arthritis of this joint in the US. Clinical options are either temporary or result in limited strength and/or range of motion. This large unmet need is addressed by DI.
Future development for the MTP of the big toe and hip, knee and shoulder will follow. There are over 3 million joint prostheses inserted surgically annually worldwide. The prosthetic market is over $14 billion annually.
Major milestones already completed include:
- Seed funding to date: $500,000 (Founder, 100% ownership)
- IP: 2 US and 1 Australian patents granted with more pending worldwide
- Durability testing in porcine Temporomandibular Joint (TMJ) explants (Gen 1)
- Human TMJ (compassionate use, Gen 1): 9 operated joints, 3 in service over 5 years, ave. service >600 days
- Hip proof of concept trials completed (Gen 1): 3 ovine, 7 canine
- Gen 2 minor modification: easier surgical placement, enhanced durability & retention and drug-eluting option
Significant changes coming soon.
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