ABOUT ORTOMA
Controllable Treatment Solutions With Cutting Edge Technology
Orthopaedic surgical procedures involve several challenging steps and many technical components. Ortoma’s goal is to improve patients’ lives by developing efficient, innovative products to support surgeons so they can provide the best possible outcome for their patients while keeping them in control of the entire process.
HISTORY
As a True Pioneer
The connection between art, science, and medicine exists since the beginning of time and curiosity is its driving force. Ortoma believes that improving medical science comes with using cutting-edge technology. That philosophy is what inspired Ortoma to develop products to improve the patient’s quality of life. We focus on developing technology solutions for orthopaedics procedures. In 2011, Ortoma initiated the development of a 3D pre-operative planning platform for orthopaedics procedures with hip replacement surgery as the first priority.
2002
Ortoma begins researching
2011
Starts developing Ortoma Treatment Solution for hip replacement surgery
2013
Ortoma receives EU grant
2014
Ortoma´s quality management system is ISO 13485 certified and Ortoma goes public on Aktietorget
2015
CE mark for Ortoma Hip Plan™
2016
CE mark for Ortoma Hip Guide™ and Ortoma Treatment Solution™ for hip replacement surgery is used clinically
2018
OTS™ for hip replacement surgery obtains FDA clearance. Ortoma signs an agreement with Depuy International to access implant templates
2019
Artificial intelligence improves Ortoma Treatment Solutions™. Ortoma signs an agreement with Zimmer gmbh to access implant templates
2020
Hip module adapted for market introduction with reusable instruments and disposables. spine module under development; knee module foundation is achieved and ready for final development
2021
OTS™ Spine Plan CE marked and FDA 510(k) application submitted. OTS™ Hip Plan regulatory application in Japan submitted
Management
Linus Byström
CEO
- Chief Intellectual Property Officer of Ortoma between 2012 to 2017
- IP Lawyer
- Previously managed the IP department of Nobel BioCare
- Holds an M.Sc. in electrical engineering at Lund University of Technology and a graduate of European Patent Litigation from the Université Robert Schuman (Strasbourg III)
Dr. Andreas Pettersson
Product Manager
- Ph.D in Medical Science at Karolinska Institutet 2011,
- Served as Medical Imaging Manager, at Nobel Biocare.
- Has published several peer-reviewed scientific articles about the accuracy of 3D planning implants and guided surgery
Prof. Tommy Hansson
Chief Medical Officer
- Professor emeritus in Orthopedics at the University of Gothenburg
- Spine Surgeon, holds a M.D. and Ph.D. from University of Gothenburg
- Internationally renowned for his contribution in spine surgery and biomechanics
- Has published almost 200 articles in international peer reviewed medical journals and 30 books
Board of directors
Yvonne Mårtensson
Chairman
- Independent board member
- Other assignments include board member of Xvivo Perfusion AB, Boule Diagnostics AB, Uniogen OY
- Holds an M.Sc. in Industrial Economics at Linköpings Tekniska Högskola
Prof. Tommy Hansson
Board member and Chief Medical Officer
- Professor emeritus in Orthopedics at the University of Gothenburg
- Spine Surgeon, holds a M.D. and Ph.D. from University of Gothenburg
- Internationally renowned for his contribution in spine surgery and biomechanics
- Has published almost 200 articles in international peer reviewed medical journals and 30 books
Roy Forslund
Board Member
- Has a vast experience of developing companies that operate in industries where innovative business models and new technology can contribute to influencing operations to achieve great success
- Principal owner of Infotech Väst AB, which conducts active development of technology-intensive companies with AI capabilities
Matts Andersson
Boardmember
- Dr. Matts Andersson is the innovator and founder of Ortoma
- Well known and acknowledged for his achievements as a pioneer in digitizing dentistry
- Built systems including surgical navigation for dental applications that was sold to a Danaher company
- Adj. Professor at Chalmers University of Technology, Gothenburg, Sweden
Jonny Nordqvist
Board Member
- Independent investor and owner of family office EQ Care AB
- Founder and CEO of educational group Baggium AB
Peter Möller
Board member
- Independent investor and owner of family office Peroso AB
- Serial entrepreneur, has founded several business within the financial, construction, and engineering industries
FDA CLEARED, CE CERTIFIED & PMDA CERTIFIED
The Ortoma Treatment Solution™ is Cleared
Ortoma Treatment Solution (OTS™) for hip replacement surgery, including OTS™ Hip Plan and OTS™ Hip Guide, is CE marked and FDA 510(k) cleared. OTS™ Hip Plan and OTS™ Hip Guide are PMDA certified.
Ortoma Treatment Solution (OTS™) for spine surgery, including OTS™ Spine Plan, is CE marked, and FDA 510(k) application submitted.
ISO 13485 CERTIFIED
Quality Management System for Medical Devices
Perhaps more than any other product, medical devices’ quality directly impacts their effectiveness and the patient, users, and other people’s safety. Therefore, most national regulatory bodies require medical device manufacturers and suppliers to have an internal quality management system that is independently verified and audited.
Ortoma´s Quality Management System is ISO 13485 certified. The standard specifies requirements for a quality management system of a medical device manufacturer and includes specific requirements concerning e.g. development, production, marketing, distribution, and sale of medical devices. ISO 13485 is similar in scope and intent to ISO 9001 and includes additional requirements specific to medical devices.
Ortoma´s quality management system is also audited and certified as part of the CE certification of Ortoma´s products and is in compliance with applicable requirements in the U.S. 21 CFR820 (QSR) concerning quality management system.