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Biomech Innovations (BMI) is pleased to announce receiving CE marking approval for its 5.0 mm Variable Fixation Locking Screw. Variable Fixation is the novel locking screw technology based on mechanobiology principles. Variable Fixation Locking Screws provide rigid fixation followed by progressive fracture dynamization, when they matter.
Gradually transitioning from one fixation method to the other, they increase the chance to trigger the fracture healing process and promote the formation of larger amount of bone callus.
Dr. Stefano Brianza, Biomech Innovations’ CEO and founder, commented: “Big leaps in bone fracture treatment have been possible thanks to technological advancement promoting healing after the first surgery and thus reducing the complication and co-morbidity rates. Providing surgeons with innovative, evidence based medical devices is our contribution to advancing traumatology and patient care”.
Implanted with existing surgical techniques and instruments, Variable Fixation is virtually compatible with all locking technologies. BMI starts clinical activity with prestigious academic trauma centres and limited launch in selected EU countries in 2020.
Biomech Innovations today announced that its quality management system (QMS) has been certified by Italcert as ISO 13485:2016 compliant. Italcert is a Milan based notified body with remarkable experience in orthopedics.
Compliant to European and US requirements its scope enables Biomech Innovations to execute on development, manufacturing and distribution activities necessary in order to bring safe and effective medical devices to the European market and later to the US and other international markets.
Stefano Brianza, Biomech Innovations’ CEO and founder, said: “The certification of the quality system is a fundamental milestone for Biomech Innovations. We are very proud to develop our Variable Fixation technology fulfilling current international quality requirements.”
Start in 2015 - Incorporation
2015 - Incorporation
We incorporated Biomech Innovations in Nidau, in the center of the Swiss medtech valley.
2016 - Innosuisse project
We have been granted a 1.2 Mio CHF grant from Innosuisse, the Swiss Innovation Agency.
2018-nonclinical concept proof
Out study shown that the Variable FIxation Locking Screws foster the production of more bone tissue!
2019 - Audits and CE marking
to be continued ...