SentryX is thrilled to announce the first clinical results for BR-003, its lead implantable anesthetic designed for spine fixation surgery. In an open-label study in two hospitals in Switzerland and the Netherlands, 11 patients were treated with BR-003 during elective spine fixation procedures. Afterwards, they were closely monitored to assess safety. Efficacy was explored by comparing pain and opioid use to recent observational data from the same hospitals, where patients underwent similar procedures but without BR-003.

No safety concerns arose for BR-003 in the first six weeks after surgery. No serious adverse events were attributed to BR-003, and systemic bupivacaine levels remained ten times below known safety limits. In the first three days after surgery, patients with BR-003 required 52% less opioids and reported 36% lower pain scores than patients without BR-003. Discharge criteria for pain and opioids were reached after one day. Patient-reported satisfaction with pain treatments in the first three days was 9.1/10.

Dr. Ruth Geuze, orthopedic surgeon and the principal investigator at the Dutch hospital, noted: “Remarkably, patients with BR-003 had a good first night of sleep and were able to start moving around on the first day after surgery, which are key elements of ‘enhanced recovery after surgery’ programs.”

Pain management after surgery has a tremendous impact on patients’ health and well-being in the short and long term, scientific evidence shows. Currently, over 1 million spine fixation surgeries take place each year in Europe and the US, a number which is expected to double in the next 10 years. After surgery, patients remain in the hospital for 3.7 days, on average. Readmission rates, the risk of chronic postsurgical pain, and the risk of opioid addiction all strongly relate to pain and opioid use in the first few days. Safer, better pain treatments are urgently needed to ensure that these procedures remain accessible and affordable in the coming decade.

"For certain patients with severe back problems, spine fixation surgery can restore mobility and substantially improve quality of life”, says dr. JJ Verlaan, UMC Utrecht orthopedic surgeon and co-founder of SentryX. “However, the intense pain and opioid-related side-effects after surgery put a major strain on patients and our healthcare system as well. In five years from now, we want to have a product available that can help millions of patients facing acute pain after spine surgery. With our first clinical results, we are confident that we are on the right track.”

The Phase Ib study is still ongoing and monitored by a data safety monitoring board until all patients have been followed for 1 year. The results above may change after final data verification. BR-003 is still in development and is only available in a clinical trial setting. The SentryX team wants to thank the patients and hospital staff for their participation, as well as the many others whose efforts and contributions were invaluable to the success of the first clinical study. The next step will be a multi-center, Phase III, double-blind, randomized controlled trial to confirm the findings and assess the impact of BR-003 opioid use, pain, and early recovery after spine fixation surgery.