4iBIO concentrates on innovation to solve clinical dilemmas for care givers and improve quality of life for patients. The first product line, ZiNIT, establishes 4iBIO as a leader in joint preservation. Unique designs are provided for major joints and advanced fabrication techniques developed. In the pipeline are innovations in topical toxin development and simplified, user and patient friendly jaw immobilization kits for trauma victims.
The ZiNIT Project
ZiNIT is a disruptive technology. Protected by a US patent (worldwide pending), the ZiNIT prothesis aims to preserve joint tissue. Rather than allowing destructive disease (Osteoarthritis) to destroy a joint and then replace the complete joint, ZiNIT is designed for insertion early in the disease process to halt or delay its progress and encourage natural repair. The prosthesis is custom-made for each individual. It is surgically positioned between the existing, functioning bones and protects them. It is analogous to placing an adhesive bandage (plaster) on a skin wound. The device is designed to protect the underlying tissues while they repair themselves.
A ZiNIT prosthesis is designed to benefit patients earlier in their life and to minimize disability.
The ZiNIT process allows doctors anywhere in the world to transmit patient joint imaging data (eg CT, MRI) via a secured Internet connection. A joint model is generated and the customized prosthesis fabricated. The prosthesis is sterilized and sent to the surgeon via courier in protected packaging overnight. There is currently no competing prosthesis and entry into the field would be very difficult from the standpoints of IP and proprietary manufacturing techniques.
Project Milestones at a Glance:
IP - US Patent granted March, 2010. Worldwide patents pending.
Engineering - Metallurgical assessment for biocompatibility and formability completed. Forming and manufacturing now advanced to semi-automated process with clinically-acceptable product. Durability testing completed.
Clinical Experience - Proof of concept in progress with almost three years of data.
Business Plan – Completed February, 2010
- Complete Integration of Manufacturing Process – in progress.
- Clinical Trials (TMJ) - Formal Health Canada/FDA compliant clinical trials are the next step in preparation for commercialization.
- Animal Trials (other joints) - The technology is applicable to other human and mammalian joints and will require earlier stage research to open new markets. A pilot project for the ZiNIT hip prosthesis in a sheep model is being prepared.
- Pursue Partnerships
- Applying ZiNIT to help emerging technologies: This prosthesis is complementary to engineered tissue solutions that are not hardy enough to withstand the rigours of joint loading and movement.
- Obtaining new methods/materials to improve ZiNIT: Acquiring IP from academic sources developing complementary methods and materials.
- Commercialization partners: Establish marketing and sales partnerships within existing health care structures.
The OA care market is measured in billions and growing at double digit rates. The Health Care and Utilization Project in the US in 2003 estimated hospital costs alone for hip replacement topping $10 billion. The ZiNIT prosthesis is a disruptive innovation that has the potential for changing the way Osteoarthritis is treated. 4iBIO intends to pursue its patented technology to commercialization on several fronts, including selected human joints and the veterinary market.