Cervi-LOK™ test results
21 October 2020
TruSpine Technologies plc (AQSE: TSP), the medical device company focused in the spinal (vertebral) stabilisation market, announces an update to the market following additional independent biomechanical testing of the Company’s product Cervi-LOK™. The Cervi-LOK demonstrated excellent results in testing performed in the laboratory of Professor Vijay Goel, at the University of Toledo, internationally considered one of the foremost experts in spinal biomechanics. The testing was performed using a validated computer generated model widely recognised in the medical device community.
Cervi-LOK™ is a stabilisation device which is applied to the posterior cervical spine, eliminating the serious risks and damage to the bony anatomy caused by the traditional screw-based fixation systems, as well as making the surgical procedure faster, easier, and more predictable in outcome.
In order to secure FDA clearance, the device must demonstrate biomechanical properties that are at least equivalent to the traditional screw-based systems. This includes testing to evaluate pull-out strength, cycle testing/ fatigue (already completed), and fixation performance expressed in reduction of Range of Motion.
During Range of Motion testing, Cervi-LOK™ demonstrated an average reduction of over 90%, which compares very favourably to the average reduction in the Range of Motion exhibited by screw-based fixation systems, which typically range between 80-84%. In addition, the Cervi-LOK™ has a significantly reduced biomechanical effect on adjacent healthy vertebrae, thereby maintaining the fixation purely in the damaged anatomy.
These tests will be subject to further validation through additional mechanical testing and cadaver studies as part of the FDA submission process. Cervi-LOK™ is expected to complete its FDA submission during Q4 2020.
FDA clearance is expected in Q1 2021, following which initial commercial production, marketing and early adopter surgical training will commence.
Ian Roberts, CEO, commented: “We are encouraged by the Range of Motion test results obtained by Professor Vijay Goel and his team. This follows on from previous mechanical and cadaver test work and is further evidence of the superior potential performance of the Cervi-LOK™, the Company’s first minimally invasive spinal stabilisation device. We look forward to updating the market with additional progress.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 ("MAR").
The Directors of the Company take responsibility for this announcement.
|TruSpine Technologies Plc||Tel: +44 (0)20 3638 5025|
|Ian Roberts, CEO|
|Cairn Financial Advisers LLP (AQSE Corporate Adviser)||Tel: +44 (0)20 7213 0880|
|Liam Murray / Ludovico Lazzaretti|
|WH Ireland (Broker)||Tel: +44 (0)20 7220 1666|
|Walbrook PR (Financial PR & IR)||Tel: +44 (0) 20 7933 7870 or +44 (0) 7876 741 001|
|Anna Dunphy||[email protected]|