January 2023 - Green Light for SentryX's First Clinical Trial
SentryX is happy to announce the formal approval of its first clinical trial. The Phase Ib study will investigate an innovative local pain treatment specifically designed for spine fixation surgery. The trial is centered around safety in humans and may also provide an early indication of efficacy. After promising preclinical results, this approval marks SentryX’s entrance into the clinical stage. The study will commence in the second quarter of 2023, in the Netherlands and Switzerland, and the first results are expected six months later.
There is a troubling lack of safe and effective pain treatments after major surgery. Every year, more than 25 million people undergo musculoskeletal procedures to maintain mobility and quality of life. As the population ages, this number is only expected to grow. To keep musculoskeletal surgery accessible and affordable, there is an increasing focus on innovative surgical techniques enabling enhanced recovery after surgery. However, the intense pain that patients experience in the first few days after surgery remains a major bottleneck, especially since opioids are still the dominant pain treatment. Opioids provide insufficient pain relief in up to 80% of patients and routinely cause side-effects such as nausea, obstipation, or dizziness. Severe side-effects occur in 13,6% of patients, resulting in longer hospital stays, higher costs, and increased readmission rates. Even today, patients generally remain in the hospital for several days, mostly because of pain and opioid-related side-effects. For this problem, SentryX believes it can realize a radical change. Through sustained, non-opioid pain relief after major surgery, its goal is to enhance recovery, improve outcomes, free up scarce hospital capacity, and save costs.
SentryX was founded late 2017 to realize improved pain control after major surgery. One of its founders, a spine surgeon from the University Medical Center Utrecht, has long witnessed the downsides of existing pain treatments like so many of his colleagues. Rather than administering opioids, which act on the central nervous system, he began looking for a way to block pain locally. Local anesthetics are widely used in dentistry, as epidural anesthesia, and in many other indications. They are well-known for their comparative safety, efficacy, and consistency when compared to opioids. In major surgery, however, local anesthetics are scarcely used because they work for only 6-8 hours and can be difficult to inject consistently near the relevant nerves and pain receptors. Together with the UMC Utrecht, SentryX has found a way to circumvent these limitations using revolutionary local drug delivery technology. Their first solution is specifically designed for spine fixation surgery and could clear the way for many other applications to follow.