True Minimally Invasive Spinal Fusion System

Projektinformationen

ZygoFix

ID Finanzhilfevereinbarung: 854697

DOI

10.3030/854697

Projekt abgeschlossen

EK-Unterschriftsdatum 28 Januar 2019

Startdatum 1 Februar 2019

Enddatum 31 Mai 2019

Finanziert unter

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Gesamtkosten

€ 71 429,00

EU-Beitrag

€ 50 000,00

Koordiniert durch

ZYGOFIX LTD
Israel

Periodic Reporting for period 1 - ZygoFix (True Minimally Invasive Spinal Fusion System)

Berichtszeitraum: 2019-02-01 bis 2019-05-31

Zusammenfassung vom Kontext und den Gesamtzielen des Projekts

The lumbar spine is the site of many back injuries and conditions, ranging from disc problems to degeneration and spinal arthritis. Current procedures for disorders of the lumbar spine are based on pedicle screw constructs, a costly and highly invasive solution leading frequently to complications and re-operations. Zygofix has developed the zLOCK system, a miniature implant that achieves spinal fusion without screws, in a safer, less invasive and more cost-effective solution. With the market seeking to reduce open spinal fusion procedures, our objective is to improve global healthcare and patient quality of life by providing an innovative solution for minimally invasive posterior stabilization and becoming a leading manufacturer of implanted instrumentation for spinal fusion procedures. The system, covered by one patent granted and two PCT applications, has been successfully validated in pre-clinical studies and a First in Man clinical study. This feasibility study was performed to assess the technical, commercial and financial elements required for a successful commercialization of zLOCK.

Arbeit, die ab Beginn des Projekts bis zum Ende des durch den Bericht erfassten Berichtszeitraums geleistet wurde, und die wichtigsten bis dahin erzielten Ergebnisse

During the Feasibility Study we defined all steps to optimize the zLOCK system, identified manufacturers and designed and established the production and assembly line. We have also defined the clinical trial to be performed for the validation of our product and get the CE mark, needed to reach the market. The second part of the feasibility report present the results of a detailed market study, confirming the adequacy of the commercialization strategy previously defined. Work in this phase included refining our business model and identifying competitors, market barriers and regulations needed for commercialization. Additionally, we present an update of the FTO and IP strategy implemented to protect our innovation. We also performed a detailed forecast for zLOCK to demonstrate the economic viability of the project.

Fortschritte, die über den aktuellen Stand der Technik hinausgehen und voraussichtliche potenzielle Auswirkungen (einschließlich der bis dato erzielten sozioökonomischen Auswirkungen und weiter gefassten gesellschaftlichen Auswirkungen des Projekts)

The zLOCK’s unique construct adjusts its shape during implantation to accommodate the challenging facet anatomy and maintains its strength to resist the joint’s applied load and shear forces. zLOCK utilizes the natural anatomy of the spine, allowing for shorter and less invasive surgery without using pedicle screws and rods. Moreover, zLOCK will have a major social impact by helping increase efficacy in spinal fusion procedures, reducing the associated clinical risks, which will have a positive impact for global healthcare.