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Feasibility assessment of an all‐in‐one nerve repair and regeneration product

Periodic Reporting for period 1 - ULTRANERVE (Feasibility assessment of an all‐in‐one nerve repair and regeneration product)

Reporting period: 2017-06-01 to 2017-09-30

According to the WHO, non-communicable diseases account for 80% of deaths in the European Region. An extensive survey has been led by the European Technology Platform for Nanomedicine (ETPN) in collaboration with EuroNanoMed II, in order to compile the Strategic Research and Innovation Agenda for Nanomedicine 2016-2030. Within this survey, a list of unmet clinical needs has been developed, topped by Cancer and followed by Neurological disorders in second place. Regarding Neurological disorders, one of the specific identified needs is “Regeneration of central/peripheral nerves damage”. This project will directly address this challenge by conducting a feasibility study in order to assess in detail the practical and economic viability of commercialising a new solution for the regeneration of peripheral nerves injuries.

Peripheral Nerve Injuries (PNI) are lesions of the nerves of the head or the extremities. Grand View Research, estimates over 2 million cases of PNI per year in the EU and the USA. These injuries remain incurable, resulting in permanent loss of body function as in paraplegia, leading to disabilities and heavy social burden. The chance to cure PNI based on smart nano-engineered biomaterials will have a major positive impact in heavy and long term burdens on patients and healthcare systems. This is very well in line with the Horizon 2020 orientation towards major social challenges in healthcare, in terms of providing new innovative healthcare interventions at an affordable price so as to sustain a high level of health and well-being in the population. This progress will therefore not only benefit patients, but will also alleviate the pressure on healthcare systems resulting from demographic change. The global Nanomedicine and biomaterials markets are expected to grow rapidly by about 12.5% per year up to the year 2020, reaching over 240 billion € in 2017, according to Bionest Nanomedicine report. To capture the benefit of this growth and to generate and maintain employment, the EU must build a robust SME-based technology supply chain, ready to feed into the product pipelines of the wider healthcare industry in order to face off strong competition from the USA. Europe can thus become a world leader with a strong competitive edge in creating jobs and generating economic wealth in these highly promising biomedical areas.

In this context, Nerve Biomed’s team, a spin-off company of the Polytechnic University of Valencia (Spain) has been leading an R&D initiative in advanced PNI reparation over the past 11 years, in order to develop and further commercialise ULTRANERVE: an easy-to-use medical solution for PNI regeneration, which is going to simplify medical procedures and reduce the average full recovery time, while reducing the average cost of actual repair procedures.

Taking this opportunity, NERVE BIOMED was established in June 2016 on the occasion of the great advances and the good forecasts in the technical and commercial development of the ULTRANERVE technology. After having demonstrated the technical and economic viability of this new solution for the repair of large gap PNI, the company directly addresses the challenge of occupying this free market space. Nerve Biomed intends to complete the development of the technology by applying to SME Instrument phase 2 in order to later approach the commercialisation of ULTRANERVE.
"The market chances that can be exploited to maximise the economic return have been analysed, and a detailed business plan has been developed in order to have the device ready for commercialisation with appropriate business arrangements concluded. Nerve Biomed has begun to keep in contact with a number of pharmaceutical companies with experience in cATMPs and/or in neuroscience.

The work carried out in phase 1 has allowed Nerve Biomed to objectively and rationally uncover the strengths and weaknesses of the ULTRANERVE project, including: potential modifications to adapt the device to new user needs identified, study of scalability of the production process (related to expected sales), identifying the existing opportunities present in the environment and establishing the proper measures to mitigate the effect of potential threats and barriers, establishing a contingency plan.

Regarding the regulatory requirements analysis, Nerve Biomed has decided to work to ensure that ULTRANERVE technology complies with regulation (EC) No 1394/2007 of 13 November 2007 on advanced therapy medicinal products. Taking into account that ULTRANERVE technology will get the market as long as it fully complies regulatory requirements, Nerve Biomed will continue its cooperation with the pharmaceutical company as a partner, working together to provide the regulatory agencies (AEMPS, EMA) with as much as supporting documents as are necessary. This is because Nerve Biomed will continue providing technical advice during technology validation (latter clinical trials), market launch and exploitation during the SME Instrument phase 2.

After analysing the market, competitors as well as the overall economic, political, cultural and technical environment, a list of priority countries among the EU and the USA has been defined. Nerve Biomed has designed its marketing and communication strategies in order to define the best commercial strategy in the targeted countries. Nerve Biomed focusses on the biomaterials products segment. The nerve repair and regeneration market, by biomaterial, is categorized into nerve conduits, nerve wraps, nerve protectors, and nerve connectors. The nerve conduits segment is expected to account for the largest share of the global biomaterials market in 2015. This segment is poised to reach USD 290.45 million by 2020.

Nerve Biomed has already carried out a complete study of industrial property, since it has expert staff in this field. Thus, on the basis of the knowledge protected by patent PCT/ES2015/070909, the necessary measures are currently being carried out for their designation in the target countries of Europe, North America and Asia. In addition, the ""Freedom of operation"" has been periodically validated."
Over the past years, surgical techniques have improved notoriously for PNI repair, although they are far from offering holistic, reliable and economical solutions. Currently, a low percentage of the procedures carried out take place for large gap PNI, as the medical intervention gets more and more complicated with each millimetre of the transection/gap length because of the: i) medical risks associated to the complexity of the procedure, ii) low recovery rates achieved, and iii) high direct (device+procedure) and indirect costs (statutory sick pays, sickness indemnification and sick leaves during convalescence, as well as the subsequent rehabilitation period).

Regarding this, Nerve Biomed’s team has been working since 2005 in the development of ULTRANERVE: a new medical solution for large gap PNI, i) easy-to-use by medical staff, ii) providing high functional recovery rates, at iii) a much lower cost.

According to the Strategic Research and Innovation Agenda for Nanomedicine 2016-2030 of the European Technology Platform for Nanomedicine (ETPN), further introduction of nanomedicines into the research and development pipeline of the healthcare industry is a needed. The extensive survey led by the ETPN has compiled a list of shared unmet clinical needs felt by clinical experts. In the area of Neurological disorders, one of the identified current medical needs is “Regeneration of central/peripheral nerves damage”. ULTRANERVE directly addresses this challenge, by developing a smart nano-engineered bioscaffold that will make a difference in the PNI regeneration market and healthcare systems.

ULTRANERVE brings very positive consequences to the European and global pharmaceutical sector. It is a new, disruptive and unique solution that will revolutionize the treatments of nerve repair and regeneration.