Issue link: https://beckershealthcare.uberflip.com/i/1507099
27 EXECUTIVE BRIEFING 3 EXECUTIVE BRIEFING To date, SST has undertaken four clinical trials and is finding promising results. They began with the Nucleus 181, and Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1) studies. These clinical trials explored the safety and efficacy of implanting the PerQdisc using an anterior or lateral surgical approach, in patients experiencing pain and disability from DDD identified at a single level. This initial data showed the PerQdisc Nucleus Replacement System provided patients with a statistically significant reduction in disability, back and leg pain (when present), as well as reduction in pain medication usage at 6- and 12-months post-op. Additionally, the device has been shown to preserve disc height, maintain RoM, and resistant expulsion. LOPAIN2 began enrollment in July 2022 and is gathering additional long-term safety data (up to 5 years) on the PerQdisc. Patient enrollment is also underway for LOPAIN3, a study exploring the feasibility of implanting the PerQdisc using a minimally-invasive posterolateral approach on patients undergoing concurrent discectomy procedures. SST is paying close attention to the lessons learned over nearly a decade of research on the PerQdisc and has been refining the surgical procedure and patient selection criteria. Mark Novotny states, "Surgical technique and methodical patient selection are critical in achieving positive outcomes in patients undergoing the PerQdisc surgical procedure. As for the surgical process, two vital lessons we have learned are the importance of implant positioning as well as the value of preserving the native anatomy." "Everything is moving in the right direction," says Novotny. "We are in discussion with the FDA to clear the way for a US IDE trial for the PerQdisc." No more settling for fusion "There is no shortage of data indicating that mobility is linked to quality of life, mental health, and longevity," states Javier Duarte, M.D. Hospital Sanatorio Americano, Asunción, Paraguay. Dr. Duarte, who has performed 16 PerQdisc surgical procedures to date, adds, "The PerQdisc device and surgical procedure have been engineered to preserve and work with the patient's native anatomy, the focus being to provide a motion- preserving disc arthroplasty with minimal tissue disruption. The data thus far indicate that this device enables patients to maintain segmental motion. An innovation like the PerQdisc will open the door to mobility for thousands, if not millions of people who are living with constant pain and disability." No more metallic balls wandering into vertebral bodies…or devices that move into surrounding muscle. David Cleveland of PMMA fame would be pleased…the next, next, next generation of his vision has arrived. Spinal Stabilization Technologies, Ltd (SST), an Irish company headquartered in Kilkenny, Ireland, develops novel technologies for treating patients with lumbar discogenic back pain. SST's products and techniques are based on the philosophy that less invasive surgery may be associated with better clinical outcomes and could improve the lives of many patients with limited options for treating their back pain. The company has extensive worldwide intellectual property and is focused on evidence-based medicine. For more information, visit https://www. sstspine.com/