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  • The current gold standard for mandible reconstruction is to harvest a microvascular free flap from fibula bone.
  • This requires two surgery sites which significantly extends the total surgery time and requires skilled expertise.
  • Patients will be subjected to donor site morbidity, they require longer hospitalization stay and rehabilitation post-surgery.
  • Risks of complications such as infection and pain arising at the fibula donor site and associated mobility inconvenience are commonplace in this procedure.

 

Market Impact

Overall the maxillofacial implant market is moderately sized but growing due to a larger elderly population and increased incidence of motor vehicle accidents. The target group is patients with segmental mandible defects that require reconstruction which may arise from i) trauma resulting from road traffic, industrial or other accidents, ii) bone tumours along the mandible, iii) inflammatory diseases at the mandible region. This technology will address some of the noted restraints in the field of maxillofacial implants, which include the high costs of the microvascular free flap procedure (surgical procedure will be shortened by 3-8 hours) as well as the extended recovery time (hospitalisation will be shortened from 1-3 weeks to 3 days).

 

Technology Description
  • The solution is medical grade commercially pure titanium system with a novel modular design to repair mandible defects of varying sizes.
  • A modular design allows for reconstruction of variable defect sizes for different patients using standardized pre-fabricated modular components.
  • It is secured in place using mini-screws allowing it to withstand the stress placed upon the jawbone.
  • Dentures can be secured on top on the endoprothesis. Its modular design means that it can to applied to all patients (often the exact size of the defect is only confirmed during the surgery) and can be manufactured in bulk.
  • The endoprosthesis is coated to promote osseointegration, which is critical for healing. The solution is simple and can be easily used by any head or neck/maxillofacial surgeon without the need for highly specialised training.

 

Development Status

Finalised prototype design freeze incorporating computer-aided design modeling of stress distribution. Fabrication in commercially pure Type IV titanium and full mechanical testing. Surface modification for enhanced osteoblast interaction. Testing of the above in a mandible defect model (form, functionality, stability, histologic evaluation)

Current IP position: Provisional patent application filed.

Regulatory Classification: This innovation is classified as Class III under FDA and CE marking; Class C under HSA (Singapore)

 

Future Progress

Upon successful in vivo demonstration of this technology’s safety and efficacy, the technology is ideally placed to be further developed through first-in-man trials.

Seeking IP licensing to SME/MNC operating in maxillofacial implants OR Collaborative technology development with industry partners.

 

A/Prof Goh Bee Tin / National Dental Centre Singapore

 

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