Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces major milestones in preparation of its expected 510(k) approval later this year. EIT Cellular Titanium® is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize bone ingrowth. Due to the availability of Selective Laser Melting (SLM) technology and post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration. This EIT Cellular Titanium® structure has been applied in the complete ALIF, TLIF, PLIF and Cervical implant line, and clinical case studies and retrieval analysis demonstrate extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short time frame.
To prepare for the launch of its innovative cellular titanium interbody devices, EIT has completed 3 major milestones. First, EIT has created a subsidiary and located its US Headquarters in Atlanta, GA. This move demonstrates its commitment to the US marketplace.
The second step EIT has made towards commercialization is by engaging GlobalMed Logistix (GMLx) to support its US distributors and surgeons by providing Warehousing, Supply Chain, Inventory Management and Customer Service. GlobalMed Logistix is a third-party logistics (3PL) company born from a rich 35-year distribution and warehousing history that will help coordinate and efficiently manage EIT’s logistics in the US.
Lastly, to help with Market Knowledge and Access, EIT has engaged Ortho Sales Partners (OSP). The primary areas of service that will be provided by OSP to EIT is Surgeon Access, Distributor Recruitment and Onboarding, Hospital Approvals and National Contracts through Group Purchasing Organizations (GPO) an Integrated Delivery Networks (IDN). Armed with the experience of the top industry talent, OSP leverages its team to help its clients shorten the cycle from launch to revenue.
Guntmar Eisen, Co-Founder and CEO for EIT says “We are very pleased to be partnered with these organizations in advance of our anticipated FDA Approval to help us deliver these innovative implants to US surgeons and patients. Our implants offer a combination of solid and cellular implant architecture to facilitate the rebuilding of natural cortical and cancellous bone structures while maintaining excellent imaging characteristics and we are eager to get started with our commercialization process.”
EIT is the first medical device manufacturer to exclusively focus on spinal implants that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods.
The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. The limited amount of titanium material in the EIT implant ensures uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.
A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to address the various anatomical requirements. Over 10.000 cases have been performed in over 15 markets globally since 2014.