Ortoma Submits Application for CE-mark of Spine Module
Ortoma has submitted a regulatory application for CE-mark of its spine module to be included in the platform Ortoma Treatment Solution (OTS). The spine module is a pre-operative planning solution for spine surgery. The OTS platform is a surgical system that is assisted by AI (Artificial Intelligence) for improved accuracy, efficiency and surgical outcome.
The submission will be reviewed by the Notified Body. Their CE assessment is expected to be completed during the second quarter of 2021. After obtaining the CE-mark, the product will be available for use clinically.
“The development of the advanced spine module for OTS demonstrates how powerful our core technology is. Experienced spine surgeons, including our chairman of the Board of Directors, prof. Gunnar Németh, supported the development team. With OTS Spine we will reach our initial goal to advance pre-operative planning of spine surgery to a higher level of accuracy, efficiency and standard of care” says Linus Byström, CEO of Ortoma.
A CE-marked spine module significantly extends the market potential of OTS. The global spine surgery market is estimated to reach $14.3 billion in 2022 from $10.8 billion in 2017, at a CAGR of 5.8%. Factors driving the growth of the industry include growing incidence of spinal disorders, accessibility of minimally invasive spine surgical techniques, and the increase of Minimally Invasive Spine Surgery in health care centers. The spine module is built on the OTS platform that is assisted by AI, and is designed to address the challenges of the spine surgery market.
Ortoma – Improved Performance
For more information, please contact:
CEO Linus Byström, e-mail: info@ortoma.com
About Ortoma AB (publ)
Ortoma AB develops surgical systems for the planning and positioning of implants in hip, knee and spinal surgery. The purpose of the company's surgical system, Ortoma Treatment Solution™ (OTS) is to enable the surgeon to accurately measure and plan 3D surgery for the placement of a joint implant and during the surgery, to optimally position the implant in the patient. Ortoma’s surgical system is aimed at providing better patient outcomes, fewer complications and less follow-up surgeries - and thus better long-term survival rates for the implant. Another aim is to create a system that can be integrated easily into the processes and routines that are currently used in surgeries, thereby increasing efficiency. Ortoma’s B shares are noted on Spotligh Stock Market. Globally, more than 7.5 million orthopedic procedures are performed each year where OTS could be used in hip, knee and spinal surgery. In Sweden last year around 42,000 surgical procedures were performed involving hip, knee or spinal surgery.