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H2020

ACE Report Summary

Project ID: 684546

Periodic Reporting for period 1 - ACE (ANNULUS CLOSURE EXPANDABLE DEVICE BASED ON SHAPE-MEMORY MATERIALS AND MEDICAL TEXTILES: SCALE-UP TO PRODUCTION, TESTING AND DEMONSTRATION.)

Reporting period: 2015-10-01 to 2016-09-30

Summary of the context and overall objectives of the project

Low Back Pain is a major social and economic problem affecting 80% of the total European population at some point of their life. It is estimated that Low Back Pain leads to direct and indirect costs reaching almost 0.1% of the EU’s Gross Domestic Product.

Lumbar Disc Herniation is one of the recurrent causes of Low Back Pain. The lumbar disc is made of two structures: a gel-like core (Nucleus Pulposus) and a ring of collagen fibres (Annulus Fibrosus) surrounding it. Lumbar discs act as shock absorbers for the spine. Disc herniation occurs when the annulus fibres break and the nucleus pulposus bursts out of the disc, thus pressing the nerves and tissues behind it causing back pain.

The gold standard treatment for disc herniation is Discectomy: eliminating the herniated nucleus pulposus through an incision in the annulus. Discectomy is often performed with minimally invasive surgery, which is when the whole procedure is done through a small incision in the skin.

The main drawback of the discectomy procedure is that the hole created in the wall of the annulus fibrosus is left open, thus there is a risk of re-herniation through this hole. Indeed, one year after the surgery, an average of 10% of patients are re-operated due to re-herniation. This entails an important socioeconomic burden: patients suffer the consequences of a complex and risky second surgery, long-term relapse of back pain and reduced quality of life, while insurance companies and Public Administrations have to assume the costs associated to reinterventions and recurrent sick leaves.

The objective of the ACE project is to broaden NEOS’ product portfolio by launching its first Spinal Product, an Annulus Closure Device. The ACE product will cover the unmet clinical need of managing disc re-herniation, by combining the latest advances in materials and manufacturing technologies into a mechanical solution that provides a permanent, strong and flexible barrier against re-herniation

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

In October 2016, the ACE is entering its Regulatory approval phase. Design and industrialisation are almost finished, and most technical tasks are centred on testing and documenting its Regulatory Approval Strategy. Market feedback is being obtained by performing demonstration activities with key stake-holders.

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)

Sales from this product will multiply NEOS’ turnover between 2019 and 2022. It will also position NEOS in a very strategic segment of the Spinal Implants Market: Non-Fusion Spinal Implants (900-1400 M€, CAGR 10-18%), consolidating its visibility as a manufacturer of innovative implants.

The ACE will add value to Patients, Surgeons and Payers by offering a cost-effective, permanent solution to low back pain. NEOS will be the first European company to launch an Annulus Closure Device, which will address many European challenges: the socio-economic impact of low back pain (Health Costs, sick leaves, productivity loss), European industrial leadership in the high added-value Medical Devices sector, and bridging the gap between research and the market.

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