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Innovative biocompatible game changing material for medical implants in trauma

Periodic Reporting for period 1 - MP-ORIF (Innovative biocompatible game changing material for medical implants in trauma)

Reporting period: 2016-06-01 to 2016-09-30

Orthopaedic fractures are a common daily acute health issue. A significant increase of bone fracture cases is expected in the coming years as a result of:
- population aging and increased life expectancy with osteoporosis being the most common cause of fractures due to bone mass reduction and increased bone fragility,
- more active lifestyle,
- obesity increasing rates,
- road traffic accidents (RTAs) and sport injuries.
In order to fix the fractured bones different fixation implants, internal and external trauma fixation devices are used. The internal trauma fixation devices are more widely used, having the 87.7 % of the overall trauma fixation devices market share in 2014. Standard metal internal fixators mostly need to be removed after the fracture has healed. This needs open surgery under full anaesthesia, which is both costly and potentially dangerous.
Within the MP-ORIF project we will introduce to the market a new game changing Open Reduction Internal Fixation (ORIF) implant made of MP-1TM, called MP-ORIF. This new polyimide material will substitute the currently used metal orthopaedic implants used in trauma surgery. We therefore predict that MP-ORIF will become the gold standard for directly-insert bone fixation in trauma. The final product of the MP-ORIF project will be a kit ready to use for small femoral nail implant. Using the kit we will be able to change the trauma paradigm in terms of patient outcome (shorter hospitalization time, lower incidence of re-interventions and repeated surgeries, lower number of X-rays needed and a biocompatible material with no pain sensation for the patient due to metal expansion in warm climate conditions), less demanding surgical procedure, reduction of trauma surgical costs. This will have a strong impact on the society by granting access for high quality trauma care.
We have defined and achieved all three objectives in Phase 1 implementation:
- TECHNICAL OBJECTIVE: A) To design a near-net-shape compression molding for mass production of MP-1TM articles. A feasibility test of compression molding of a net-shaped disk was done where the overall chemistry, fabrication, physical properties, quality control, direct forming, preparation and molding were assessed. The results show that molding was a success at the first attempt. During the near-net shape molding study we also determined B) the functional properties and specifications for the optimization of the implant in order to reach the highest performance in the market. C) The patentability search showed we have freedom to operate for MP-ORIF
- COMMERCIAL OBJECTIVE: A) we designed the protocol to perform the clinical trials and data management system for the clinical validation and is included in the feasibility study report. B) we finalized the contractual agreements with the mass manufacturing company for the implant (goal of production price 300€/unit) which is included in the FS report. C) we involved the Orthopedics and Traumatology Association EFFORT for dissemination of project results. We will submit an abstract to be selected for several types of presentations at the 18th EFORT Vienna Congress in May/June 2017. D) we identified international distributors to help us entering the EU and US markets as planned in the FS report
- FINANCIAL OBJECTIVE: we evaluated the total investment requirement for MP-ORIF which is 1.517.410 €. The budget breakdown in included in the FS report. B) The cost/benefit analysis and C) business plan for the 5 years are included in the FS report. We will achieve the ROI of MP-ORIF is 3,62; payback time (i.e. the amount of time it takes to recoup the funds invested in MP-ORIF) of 2,4 years and the break-even point (the number of units needed to recoup the funds invested in MP-ORIF) is 2500 MP-ORIF units sold. The revenue after 5th commercialization year is 8,9 million €.
Progress beyond the state-of-the-art:
- MATERIAL: we will optimize the functional properties (easier insertion of the screws), use the near-net-shape compression molding and save 30 % of the material. By using MP-ORIF the location of the screws will not need to be visualized as nails will be made of MP-1TM instead of metal thus eliminating the need for repeating X-ray imaging
- CARE: Surgery time will be dramatically reduced (from 1h15min to 30min). There will be no need for additional corrective surgeries which would increase the cost of healthcare, personnel, time and equipment. The implant will be easy to use for less trained medical stuff in developing countries
POST-OPERATIVE CARE: no inflammation due to drilling as all the debris are inert, healing time is short, measured in days, the patient will not feel pain due to temperature change since MP-1TM has very low heat conductivity and a significant reduction of post-operative scaring
MP-ORIF will have a significant impact on various levels:
- Market/clients (hospitals, healthcare providers, doctors): shorter surgery time and higher success rate than current surgeries (no need for additional corrective surgeries). This represents a lower overall cost for the hospital and healthcare providers on one side as well as a better reputation and increased visibility for the hospitals and the doctors on the other side. Trauma surgeries can thus be offered by small and medium hospitals and private clinics. The cost per intervention and the cost associated to the necessary training of an orthopaedic surgeon will be reduced
- End-user (patients): shorter post-operation recovery time as patients are more active earlier, with greatly reduced scarring. The patient quality of life will be significantly improved by the drastic elimination of lifelong adverse effects experienced after surgery.
- Company: an increase in MMATECH’s revenue in the first 5 years after launch of selling MP-ORIF.
- Stakeholders: The reduced need for repetitive X-ray imaging, decrease in number of control visits, shorter hospitalization, no need for additional surgeries, and the necessary analgesics prescription will lower the public healthcare costs
- Society: developing economies may gain access to high quality trauma care otherwise impossible. Women will be the major beneficiaries of MP-ORIF project given that approximately 80% of the world populations affected by osteoporosis, osteoarthritis and bone injuries are women over 50.