Periodic Reporting for period 1 - BionicVEST-2 (EUROPEAN DEVELOPMENT OF A FIRST COMMERCIAL BIONIC VESTIBULAR IMPLANT FOR VESTIBULAR DYSFUNCTION - 2)
Período documentado: 2023-09-01 hasta 2024-08-31
The BionicVEST2 project aims to restore balance and prevent falls through vestibular implantation and electrical stimulation of the otolith organ. Worldwide, about 684.000 individuals die from falls each year and 37.3 million falls require medical attention. The medical cost for treating falls in the EU is approximately 25 billion euros each year. This number can be expected to rise as the European population ages. One of the most important causes of falling is vestibular dysfunction. Accordingly, restoration of the vestibular function through neurostimulation has the potential to dramatically reduce falls and may revolutionize the field because it offers a whole new treatment paradigm. The foundation of vestibular dysfunction treatment was laid during the BionicVEST H2020 FET-OPEN project funded by the EU, that ran from 2018 to 2023. The result of this first BionicVEST project was a proof-of-principle treatment in humans using a prototype otolith vestibular implant. It demonstrated that the successful restoration of vestibular function through electrical stimulation of the otolith organ is possible.
To unlock the full commercial potential of this vestibular restorative therapy, the new BionicVEST2 project focuses on the path to commercialization of the vestibular implant. The vestibular implant requires improvements in the neurostimulation electrode technology to achieve its full potential on the market. A clinical trial is required to provide evidence for the safety and efficacy of the therapy. Further, novel diagnostic clinical tools are developed to identify the patients that can benefit from the first-wave of this technology. In-depth market research and an elaborated business case shall confirm that the vestibular implant will bring the long-awaited solution for vestibular disorders and ameliorate the enormous societal impact of this problem.
The key goals of the BionicVEST2 project are: (1) the development of a commercially attractive, hearing-preserving vestibular implant, (2) execute a clinical trial to demonstrate safety and efficacy of the device, (3) further market research and an elaboration of the business case.
To unlock the full commercial potential of this vestibular restorative therapy, the new BionicVEST2 project focuses on the path to commercialization of the vestibular implant. The vestibular implant requires improvements in the neurostimulation electrode technology to achieve its full potential on the market. A clinical trial is required to provide evidence for the safety and efficacy of the therapy. Further, novel diagnostic clinical tools are developed to identify the patients that can benefit from the first-wave of this technology. In-depth market research and an elaborated business case shall confirm that the vestibular implant will bring the long-awaited solution for vestibular disorders and ameliorate the enormous societal impact of this problem.
The key goals of the BionicVEST2 project are: (1) the development of a commercially attractive, hearing-preserving vestibular implant, (2) execute a clinical trial to demonstrate safety and efficacy of the device, (3) further market research and an elaboration of the business case.
The BionicVEST2 project started on 1st of September 2023 and is progressing well. At the end of period and year 1 of the project, its objectives are mostly on track.
A new vestibular implant with an atraumatic neurostimulating electrode array was designed. This vestibular implant reduces any risk of damage to existing hearing and to residual balance function, and is simple and reliable to implant. The anatomical structures of the vestibule have been investigated in detail to determine the constraints for the vestibular electrode design. Unlike the predecessor project BionicVEST, which targeted a small patient group with severe bilateral vestibular issues and severe hearing loss, the new implant aims for a broader market including people without hearing loss. The redesign focuses on hearing preservation and simplified electrode insertion. Together with the design of the device, a novel surgical procedure prioritizing hearing preservation was developed, leveraging advanced cochlear implant and middle ear surgery insights. At the end of period 1, the design of the new implant is complete, design lock achieved, and the technical documentation of the device is being prepared to fulfill the requirements for the clinical trial application. The clinical investigation plan of the BionicVEST2 clinical trial has been designed with input from all consortium partners. It will be a prospective, multicentric, staged feasibility study in adults diagnosed with bilateral vestibulopathy. Its main aim is to evaluate the safety and performance of the second-generation otolith vestibular implant in adults with vestibular dysfunction to mitigate imbalance. In parallel, several patent applications were filed to protect these novel inventions.
Finally, interviews with key stakeholders and customers (ENTs, neurologists and physiotherapists) were conducted to understand market acceptability of the BionicVEST2 vestibular implant.
A new vestibular implant with an atraumatic neurostimulating electrode array was designed. This vestibular implant reduces any risk of damage to existing hearing and to residual balance function, and is simple and reliable to implant. The anatomical structures of the vestibule have been investigated in detail to determine the constraints for the vestibular electrode design. Unlike the predecessor project BionicVEST, which targeted a small patient group with severe bilateral vestibular issues and severe hearing loss, the new implant aims for a broader market including people without hearing loss. The redesign focuses on hearing preservation and simplified electrode insertion. Together with the design of the device, a novel surgical procedure prioritizing hearing preservation was developed, leveraging advanced cochlear implant and middle ear surgery insights. At the end of period 1, the design of the new implant is complete, design lock achieved, and the technical documentation of the device is being prepared to fulfill the requirements for the clinical trial application. The clinical investigation plan of the BionicVEST2 clinical trial has been designed with input from all consortium partners. It will be a prospective, multicentric, staged feasibility study in adults diagnosed with bilateral vestibulopathy. Its main aim is to evaluate the safety and performance of the second-generation otolith vestibular implant in adults with vestibular dysfunction to mitigate imbalance. In parallel, several patent applications were filed to protect these novel inventions.
Finally, interviews with key stakeholders and customers (ENTs, neurologists and physiotherapists) were conducted to understand market acceptability of the BionicVEST2 vestibular implant.
When all documentation for the new BionicVEST2 investigational device is finalized, the clinical trial application can be filed. This is expected to happen in the first half of 2025 in two countries: Spain and Belgium. Further, a screening questionnaire will be developed to identify potential vestibular implant candidates and it will be distributed among general practitioners, patient societies, and ENT doctors.
The business case will detail the economic viability and commercial potential of the vestibular implant. It will examine different commercialization stages, addressing key questions such as target customer segments, market size considering patient pathway complexities, acceptable pricing, and cost of goods sold (COGS) estimates. This analysis will help calculate the expected return on investment (ROI) over time, strengthening the business case. Additionally, a pitch will be created in the last period of the project to secure funding for market access, regulatory approval, and reimbursement. Intellectual property considerations will remain a priority for successful exploitation.
The results of the work will demonstrate the feasibility of a surgically simple, structure-preserving vestibular implant. This translates to a high likelihood of clinical success for a balance and hearing preserving vestibular neurostimulation implant. The impact of this implant will be to protect Europeans and European health systems from the large burden of falls (high costs and high morbidity), and to revolutionize the treatment of balance disorders.
The business case will detail the economic viability and commercial potential of the vestibular implant. It will examine different commercialization stages, addressing key questions such as target customer segments, market size considering patient pathway complexities, acceptable pricing, and cost of goods sold (COGS) estimates. This analysis will help calculate the expected return on investment (ROI) over time, strengthening the business case. Additionally, a pitch will be created in the last period of the project to secure funding for market access, regulatory approval, and reimbursement. Intellectual property considerations will remain a priority for successful exploitation.
The results of the work will demonstrate the feasibility of a surgically simple, structure-preserving vestibular implant. This translates to a high likelihood of clinical success for a balance and hearing preserving vestibular neurostimulation implant. The impact of this implant will be to protect Europeans and European health systems from the large burden of falls (high costs and high morbidity), and to revolutionize the treatment of balance disorders.