4iBIO is a medical device company in the early stages of commercializing the ZiNIT implant; the biomimetic, alloplastic meniscus. ZiNIT is a personalized, 3D printed, surgically placed "cap" design that protects and promotes healing in arthritic joints. It is designed to mimic the function of a natural meniscus and is suitable for use in all moving joints including small (extremities), large (TMJ, hip, knee, shoulder) and veterinary (canine hip) ones damaged by arthritis. ZiNIT is an early, minimally invasive, non-destructive, reversible treatment option without peers.
Healthcare IT is a significant component of the disruptive ZiNIT project enabling rapid fabrication and delivery of a customized implant. Secure patient data transfer, CAD/CAM manipulation for 3D printing and logistics are the engines of this disruptive design.
The new paradigm for surgical Orthopedic care: protect, don’t replace.
The ZiNIT Project: 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.
For canine hip arthritis/dysplasia, total joint replacement now exists but it is only considered long after soft tissue atrophy has taken its toll; it is costly and rehabilitation is a major challenge.
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 biomimetic solution.
The ZiNIT Project: The Solution
PROTECT AND REPAIR, Don't replace.
Designed to function as a protective "cap", the ZiNIT implant changes the paradigm to one of natural healing rather than destruction and replacement. ZiNIT 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
The ZiNIT Project: The Market
The personal and societal costs for the treatment and associated disability of arthritis are huge. There are over 3 million joint prostheses inserted surgically annually worldwide, mostly to treat end stage Osteoarthritis (OA). The prosthetic market alone is over $14 billion annually. The ZiNIT project begins with addressing the needs of people who suffer from OA in the small joints of hands and feet as well as the needs of companion animal hips. Advancement to larger joints will follow. ZiNIT is suitable for and holds patent protection for all moving joints in mammals.
The ZiNIT Project: The Milestones
Major milestones already completed include:
- Seed funding to date: $500,000 (personal, 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, Gen1): 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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