"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."
