Periodic Reporting for period 2 - DISC care (DISC care™ , the Hernia Blocking System to prevent Lumbar Disc Re-Herniation)
Berichtszeitraum: 2022-01-01 bis 2023-04-30
Lumbar disc herniation occurs when the intervertebral disc breaks and its nucleus bursts out pressing the nerves. It causes extreme back and leg pain, numbness and disability. To relieve the pain, a surgical intervention (discectomy) is usually performed, consisting of removing the herniated material. Disc herniation was the most frequent cause of spine surgery for working-age patients and in 2019. 1,3M lumbar discectomies were performed WW. Although discectomy may work in some cases, at least 51% of procedures have a high risk of re-herniation through the same disc defect, requiring a costly and complex re-operation. To avoid re-herniation, some surgeons remove a larger amount of nucleus, making it unlikely to re-herniate, but compromising the disc functionality and causing chronic back pain.
NEOS Surgery has developed the DISC care™ Hernia Blocking System, an implantable strong barrier that prevents re-herniation while allowing surgeons to remove the minimum disc tissue. After completing several years of development and pre-clinical testing, with the current project NEOS wanted to overcome the final barriers for its market launch:
- clinical trial
- complete product range
- CE-marking under the new EU MDR
Thanks to the project, the first generation of the DISC care™ Hernia Blocking System has successfully complete a 30-patient Clinical trial, proving its safety and performance.
NEOS Surgery has developed the DISC care™ Hernia Blocking System, an implantable strong barrier that prevents re-herniation while allowing surgeons to remove the minimum disc tissue. After completing several years of development and pre-clinical testing, with the current project NEOS wanted to overcome the final barriers for its market launch:
- clinical trial
- complete product range
- CE-marking under the new EU MDR
Thanks to the project, the first generation of the DISC care™ Hernia Blocking System has successfully complete a 30-patient Clinical trial, proving its safety and performance.
The safety and performance of the DISC Care™ has been proven through the completion of a set of pre-clinical tests and the ACE Clinical Trial ( Safety and Performance of a Hernia Blocking System - Full Text View - ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04188236?term=neos+surgery&draw=2&rank=4(öffnet in neuem Fenster)).
Several demonstration activities were performed to train surgeons and show the product. The clinical results have been shared with the medical committee. Through many press releases, website and linked-in publications, newsletters, attendance to congresses, etc... the project results have been disseminated and communicated.
Several demonstration activities were performed to train surgeons and show the product. The clinical results have been shared with the medical committee. Through many press releases, website and linked-in publications, newsletters, attendance to congresses, etc... the project results have been disseminated and communicated.
The DISC care™ will enter a “Blue Ocean” market segment (estimated at 1.500M€ at least), being the first Hernia Blocking device from a European company and the second worldwide.
The DISC careTM will contribute to reduce re-herniation direct and indirect costs associated to second surgeries, sick-leaves and back-pain. Moreover, it will impact the EU high tech industry and contribute to the creation of high-qualification jobs.
The DISC careTM will contribute to reduce re-herniation direct and indirect costs associated to second surgeries, sick-leaves and back-pain. Moreover, it will impact the EU high tech industry and contribute to the creation of high-qualification jobs.