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Nexilis augmentation system

Periodic Reporting for period 1 - NAS (Nexilis augmentation system)

Reporting period: 2018-03-01 to 2018-06-30

In Europe, 3.5 million new fragility fractures occur every year resulting in an estimated annual direct cost of €37 billion which will be raise in the next years. Fracture repair is usually done by reinforcing the bone structure with screws and plates. However, osteoporotic bones are very soft and often do not tolerate such surgery. It is required to strength the bone area where the implant will be introduced by scaffolds. Current bone stabilization techniques, based on the application of bone cement, show important drawbacks and risks associated to the surgery procedures which affect both the patient and the health care provider (i.e. excessive heating of the bone cement, bone necrosis, leakage, etc). By developing NAS, Nexilis aims to commercialize the first bioresorbable polymer for bone fixation augmentation system with enhanced bone stabilization performance.
A Feasibility Study focusing on the identification of target markets and technical challenges was prepared, confirming the feasibility of NAS. The technical assessment of NAS and the current state of art - pre-clinical results- confirms the viability to successfully introduce the technology in the market. The risk management plan is set, the IP strategy defined and the regulatory environment as well as the roadmap for certifying the product is clear. The market opportunity is consistent with the identified unmet need –a specific technic for treating fractures in osteoporotic bones-. Upon a moderate scenario, the financial assessment shows attractive margins. Therefore, we decide to go ahead with the next step of the project –clinical study- and apply for SME Instrument Phase 2 funding.
Our initial forecast has established a potential Total Addressable Market above €1.45 billion per year in Europe and US, where over €1 billion belongs to our primary market application: fixation of pedicle screws in spinal application. Based on this, we set a moderate business case with cumulative sales of over 400,000 sleeves and 3,300 ultrasonic devices for the period 2021-2025 (ROI=2.06 Share of Market=6%), creating 20 direct jobs. Economically, NAS reduces costs by -24% per surgery while allowing the use of cheaper standard screws without any need of adjustment, thus improving the health care system. But, among others, it also has no negative side effects, no leakages, no toxicity, thus beneficing the patients.
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