Periodic Reporting for period 1 - PercPad (The first Percutaneous Paddle Lead for Spinal Cord Stimulation (SCS)) Reporting period: 2019-05-01 to 2019-08-31 Summary of the context and overall objectives of the project The Percutaneous Spinal Cord Stimulation Paddle Lead (SCS ExpertTM) proposed by WISE is a foldable lead fit for minimally invasive percutaneous implantation, which can be achieved by neurosurgeons and anesthetists. PercPad addresses a key market need within the segment of the growing neuromodulation market (to reach $2.36 Billion by 2022). The goal of this feasibility study was to assess the viability of PercPad from a technical, regulatory, commercial and financial perspective. Our study shows that PercPad is a solid project that will generate important benefits for our company. Within a 5-year period after the launch, WISE expects cumulative revenues of over €38 Million, with a payback period of less than 5 years. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far First, we analyzed the technical features of our prototype and determined several improvements needed to ensure an effective stimulation of the spinal cord, while guaranteeing a minimally invasive surgery for the implantation. This include studying the introducer design and MRI compatibility. Moreover, we designed a development plan complying with all regulatory policies for EU and US for Class III devices. Secondly, we carefully analyzed our market with its trends and barriers, including a detailed PESTLE analysis to guide our B2B business model and value chain. We developed a detailed exploitation and dissemination plan in 3-stages, assuming strong indirect sales to maximize our impact in transforming the SCS market, where currently less than 1% of the patients needing a SCS therapy are in fact receiving it. Finally, we performed a financial analysis demonstrating that the PercPad project is economically feasible and profitable with an expected 5y ROI of ~3.7. 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) Chronic pain is the first cause of disability in Europe. By bringing SCS ExpertTM to the market, we aim for a transformation improving the offer of SCS devices for chronic pain treatment. Since SCS ExpertTM can be easily implanted through a minimally invasive surgery, it will reduce the probability of complications in the patients, improving their quality of life. We have identified a promising market opportunity, as the global neuromodulation market is projected to attain a value of $6.5 Billion in 2022 by rising at a CAGR of 12.5% from 2017, and our target segment is expected to cover over 1/3 of such market worth. Altogether, this represents a very promising scenario for the deployment of SCS ExpertTM and we envisage a country entry SOM of 1,6% reaching a 15% after 5 years. wise.png
