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

Informations projet

PercPad

N° de convention de subvention: 867190

DOI

10.3030/867190

Projet clôturé

Date de signature de la CE 6 Mai 2019

Date de début 1 Mai 2019

Date de fin 31 Août 2019

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

WISE SPA
Italy

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

Période du rapport: 2019-05-01 au 2019-08-31

Résumé du contexte et des objectifs généraux du projet

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.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

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.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

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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