Survey of Cervi-LOK™
27 May 2021
TruSpine Technologies plc, (AQSE: TSP) the medical device company focused on the development of its proprietary, pioneering "screwless," spinal (vertebral) stabilisation system, announces that its cornerstone Cervi-LOK™ device has completed Round II testing.
Round II testing consisted of a cadaver study which was conducted at the Upstate Medical School in Syracuse, New York, and was performed by two highly experienced surgeons who are also members of TruSpine's medical advisory board: Dr. Mark Smith / Neurosurgeon (tested on May 6) and Dr. William Lavelle / Orthopaedic spine surgeon (tested on May 7). Also in attendance was Nathan Erickson, the Lead Engineer from TruSpine's engineering partner, LincoTek, Inc., as well as Professor Frank Boehm, TruSpine's Chief Technical Consultant.
The objectives of the cadaver study included evaluating the usability of the instruments to implant the system, as well ease of insertion, grasp of the vertebrae and strength of the implant system. T he surgeons conducted their study independent of one another, further enhancing the validity of the evaluation. The procedures were recorded on video, and pending editing, this should be available for general viewing on the TruSpine website in due course.
A stabilisation from the C2 to C5 vertebrae was achieved, on average in less than 15 minutes; in one instance, a unilateral stabilisation was achieved in 14 minutes from the time of the initial skin incision until the time of complete insertion of the implant, which is an exceptional outcome relative to current technologies as detailed below, even for a highly skilled surgeon.
No X-Rays were required, no injury to the bone was noted, and - as further confirmation of the benefits of the system, there was no possibility of injury to vascular or neurologic structures. This is in contrast to current technology, which can take 30 to 45 minutes or longer, requires significant intraoperative X-Rays, and can be complicated by injuries to critical blood vessels, nerves or even the spinal cord.
Dr. Smith was particularly impressed with the versatility and flexibility of the device and Dr. Lavelle thought that the system was excellent, noting some additional indications beyond those originally stated.
The overall view of both participating surgeons was that the system was extremely effective, efficient and has a great deal of appeal to practicing surgeons, with ease and convenience and avoidance of injury to critical structures. In addition, the Cervi-LOK ™ system was highly praised for its flexibility and versatility and it was mutually agreed that the potential for commercial success was high.
Ian Roberts, CEO of TruSpine Technologies plc, commented: "We are delighted to receive this compelling feedback on the Cervi-LOK™ system by highly experienced surgeons. Both surgeons involved are extensively trained in their field, and gave invaluable insights into the product performance.
"We have concluded that Cervi-LOK™ offers other advantages previously not considered, including as a rescue technique for failed lateral mass screws, or as a topping off procedure for deformity constructs. Both surgeons universally agreed that the convenience and low risk nature of the system make it a very attractive alternative to the current screw technologies. This evidence is very advantageous to us as we progress towards FDA application and clearances."
Truspine Technologies Plc
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Ian Roberts, CEO
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