The first Percutaneous Paddle Lead for Spinal Cord Stimulation (SCS)

Informazioni relative al progetto

PercPad

ID dell’accordo di sovvenzione: 867190

DOI

10.3030/867190

Progetto chiuso

Data della firma CE 6 Maggio 2019

Data di avvio 1 Maggio 2019

Data di completamento 31 Agosto 2019

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

WISE SPA
Italy

Periodic Reporting for period 1 - PercPad (The first Percutaneous Paddle Lead for Spinal Cord Stimulation (SCS))

Periodo di rendicontazione: 2019-05-01 al 2019-08-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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.

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