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BriScrew Report Summary

Project ID: 763129

Periodic Reporting for period 1 - BriScrew (BioResorbable Ostheosynthesis Implant)

Reporting period: 2017-03-01 to 2017-06-30

Summary of the context and overall objectives of the project

Bone fractures are extremely common in the EU. Osteosynthesis implants are usually made of titanium or steel and need to be removed by a second operation if they trigger side effects (pain, necrosis). Moreover, if the procedure is done in children, the implant always gets removed to avoid disturbance in the growing skeleton. This carries an important economic and emotional burden. To overcome this problem, new materials are being investigated that should: i) be degradable and reabsorbed by the human body, ii) present mechanical strength to re-align and stabilize fractures, and iii) be composed by elements compatible with human body. So far, biodegradable implants made by either synthetic polymers or magnesium have been developed and approved for human applications. However, they usually contain REE that may interfere with human health, accumulate in tissues and trigger unexpected infections and allergic reactions. The safety of bioresorbable implants has not been fully demonstrated and, as a result, they have not been approved for children.
BRI.TECH has developed a revolutionary implant for treating bone fractures, BRI.SCREW, made of a unique material, BRI.MAG, meeting all the conditions needed by a biodegradable material for human applications. Through a patented process of producing our Magnesium alloy, we have obtained a material that: i) is formed only by natural biological components (Mg, Ca and Zn), ii) does not accumulate in bone and any other tissues, iii) presents excellent mechanical properties supporting physiological bone healing, and iv) slowly degrades in a tailored fashion.
We have performed a feasibility study to confirm the viability of BRI.SCREW: i) technically we optimised the manufacturing process, defined implant characteristics and designed a clinical trial, ii) commercially we studied the orthopaedic market, performed FTO analysis and update our IPR strategy, and iii) financially, we updated our sales plan and confirmed project profitability.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Over the last 4 months of the Feasibility study we have assessed the technical, commercial and financial viability of BRI.SCREW project. The work done and the results found are summarized below:
- Technical Feasibility: i) Design the alloying and extrusion process: we have optimized the process to stimulate the formation of only favorable intermetallic particles and decrease magnesium corrosion. We have optimized the final composition of the alloy to tailor the degradation rate of the implant, reaching an excellent ratio of Mg, Ca and Zn for slow degradation, ii) Determine the functional properties of the implant: we have defined the properties that BRI.SCREW should present for supporting excellent bone healing in humans, especially in children, and how to achieve those characteristics during production and manufacturing and finally, iii) Define the protocol of a randomized multi-center clinical trial: we have designed a multi-centre clinical trial to validate the superiority of BRI.SCREW compared with titanium implants in fractures in children.
- Commercial Viability: i) Explore the possibilities to get certification needed for commercialization of health care products: we have confirmed the ISO13485 and CE marking needed for medical devices and we have updated our plan accordingly, ii) Search for providers of ultra-pure magnesium and extrusion process, manufactures and providers for cleaning, sterilizing and packaging: we have identified several companies for these actions, and iii) Identify international distributors: we have obtained interest of collaboration from Hofer Medical, distributor of medical devices in Austria and Germany, our first target markets.
- Financial feasibility and Business plan: i) Validate financial and growth strategy, and business model: we have confirmed the cost and price of BRI.SCREW, and prepare a 5 years financial forecast to assess the profitability of the project. We have also updated our exploitation and promotion strategy to be able to reach that financial forecast, ii) Competitors, barriers and opportunities analysis: we have updated our main competitors (both for non degradable and degradable implants) and studied the barriers and opportunities for our company using tools like the Porter analysis and SWOT analysis, iii) Target markets and in-depth market study: we have conducted an in-depth analysis of the trauma, orthopedic and osteosynthesis markets, where BRI.SCREW will be introduced. We have quantified the market and calculated the impact of our product: up to €600 million on second surgeries could be saved in osteosynthesis treatments using BRI.SCREW. We have also studied the trends, segments and drivers of the market in order to update our business plan, and the barriers and restrains of the market to update our management plan.
- Establish alliances: i) Determine the need of a partner: we have studied the possibility of partnering with another SME to carry out BRI.SCREW project and concluded that BRI.TECH team hold the necessary experience and knowledge to successfully complete the entire Phase 2 of BRI.SCREW.
- Risk assessment, contingency plan and IPR protection: i) Identify risks and develop a contingency plan: we have identified technical and operation risks that could affect the completion of the project, and drafted the corresponding mitigation plan, and ii) IPR protection: we have defined the IPR landscape for BRI.TECH and performed a FTO to secure our right for commercialization. BRI.SCREW is well protected by two patents and is not in conflict with other existing IP.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Titanium and steel osteosynthesis implants are widely used and accepted. However they trigger deleterious side effects such as osteolysis, infections and even necrosis. The appearance of these situations makes necessary to remove the implant through a second surgical intervention. The situation is even worse for children, where removal of the titanium/steel implants is always mandatory due to safety reasons. Bioresorbable implants arise as the proper solution to avoid the second operation that carries along important economic and societal burden. There are several biodegradable implants available at the moment, but they either contain potentially toxic elements (like REE or Yttrium) that could interfere with the healing process, or they degrade too slow or too fast for supporting optimal healing. As a result none of them have been approved for treating children bone fractures.
To answer this need we have developed BRI.SCREW, a biodegradable osteosyntheis implant made only of natural elements (magnesium, calcium and zinc), especially tailored for children bone fractures. Compared with other solutions available at the market, our product presents the following advantages: i) tailored biodegradation that can be controlled via proportion of its components, ii) no deleterious and toxic side effects and no foreign body reaction, as the only components of the implant are natural elements found in human body, and iii) no need to remove the implant through a second operation.
BRI.SCREW launching at the market will bring important economic and societal impacts:
- Economic impact: no need for a second operation to remove the implant, no treatment due to infections and allergic reactions, less hospitalization time, less absence from school and/or work. Regarding children second operation (mandatory for titanium implants), ~€600 million can be saved by using BRI.SCREW implants in the EU. This is an important cost saving for health systems and insurance bodies.
- Societal impact: the second operation to remove the implant is a painful and stressful intervention not only for children, but for the parents too. It carries an emotional stress that will be avoided using biodegradable BRI.SCREW. Both patients and doctors will be benefited by the use of our biodegradable implants.
BRI.TECH is a young SME but its members have a vast and long experience on orthopedic treatments for treating fractures. Dr. Weinberg, CEO and founder of the company, has devoted most of her scientific and clinical career to improve the current treatments and quality of life of children affected by bone fractures. BRI.SCREW is the culmination of her vision and her efforts. Our team is highly skilled and passionate, and we are convinced that we have the expertise and know-how to bring BRI.SCREW from its actual development stage up to the market phase.

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