Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - REBOOT (Toolbox of multipotent bioactive composite implants for the full functional regeneration ofbones after a trauma)
Teaser
Noraker is a leader in the development of bioactive medical devices towards bone regeneration. The company owns a unique know-how in the processing of composite implants made of 45S5 bioactive glass, a revolutionary biomaterial that triggers osteostimulation, a biological...
Summary
Noraker is a leader in the development of bioactive medical devices towards bone regeneration. The company owns a unique know-how in the processing of composite implants made of 45S5 bioactive glass, a revolutionary biomaterial that triggers osteostimulation, a biological phenomenon which guarantees a fast and complete restoration of the patient’s bone capital.
This is a major advantage as compared to conventional implant, which often requires a 2nd surgical intervention to be removed because of side effects, leaving a critical sized gap to be treated with a bone graft.
To this day, Noraker has combined an absorbable polymer with 45S5 bioactive glass in one single bioactive composite fixation implant for the knee, named LockActiv.
The ambition of Noraker is go much farther and design implants to regenerate the full skeleton. This requires developing a “universal†bioactive composite formulation (= the main technical goal of the SMEI Phase 1 project).
Regarding the impact of the project:
- The ageing of the European population boosts market opportunities for regenerative medicine products and increases cost pressures on healthcare providers. It is not enough anymore for an implant to be bioresorbable in bone trauma. The demand for full bone regeneration products is now strongly expressed by surgeons, hospitals and specialized distributors. Therefore, NORAKER’s bone regeneration REBOOT toolbox is expected to raise major attention from the market.
- The REBOOT implants will stand ahead of the competition. There will be no equivalent offer and the biocomposite toolbox will challenge the products of the biggest players in the market .
- NORAKER will use a single multipotent bioactive composite formulation, shaped in different implant designs. This opens an opportunity to access the market faster: only one product will have to follow the entire validation process as requested by the new regulation on medical devices. The other biocomposite implant designs will benefit from the precedence on the market.
Work performed
This report explains the different steps, which NORAKER took to validate a “universal†recipe mixing a new combination of bioactive glass with absorbable polymer:
• Select commercially available critical implants design which are representative of a large scale of bone and ligament fixation indication
• Define the required performances and criteria of selection for NORAKER’s first toolbox implants from the competitive designs
• Study the effect of the sterilization on the mechanical, biological and degradation properties of the composite with a selected set of composition
• Select the final composition
• Design and inject prototype implant
• Validate the high potential of the new bioactive composite implants by a cohort of specialized surgeons.
This recipe will then enable Noraker to design and produce any type of bone regeneration implant: from shoulders to toes.
The report also develops NORAKER’s business plan towards the global commercialization of a wide range of REBOOT bioactive composite implants in a unique toolbox for the surgeons. The business analysis was comprised of the following steps:
• Disease overview
• Market characterization
• Competitor analysis
• Market opportunity for REBOOT implants
• Business plan, including a business model canvas analysis, channels and customers relationships and a P&L and financial tables
Final results
The conclusions of the technical feasibility study led to the definition of the best candidate, a multipotent material that will be used for all the future implants of the toolbox. The power of having ONE material usable for a various applicated sites and indications is a significant optimization of the required biocompatible tests. Assessment of biocompatibility is a big challenge to take up for innovating medical material. It requires long and expensive campaign testing. One the other hand, the conclusions of the business analysis led to accurate and ambitious business targets for each of the segments, with specific P&L and financial projections.
Website & more info
More info: http://www.noraker.com.