Spine fixation surgery is among the most painful surgical procedures performed today. Patients routinely receive high-dose opioids to manage postoperative pain, despite well-documented side effects including nausea, sedation, confusion, and respiratory depression, and a 18% risk of opioid dependence after surgery. Meanwhile, up to 80% of patients still experience insufficient pain relief in the first few days, which is linked to the development of chronic postsurgical pain, which currently affects one in five patients. Unlike hip and knee replacement, where hospital stay has halved over the past two decades, spine fixation patients still spend more than four days in hospital on average. No approved implantable or sustained-release local analgesic product existed for this indication.
BR-003 (Bupi-Ring) is a ring-shaped hydrogel designed to be co-implanted with spine fixation screws during surgery. It delivers an approved and well-established local pain blocker called bupivacaine directly at the surgical site for more than 72 hours, which is nine times longer than conventional injections. As such, it provides ultra-sustained non-opioid local pain relief without altering the surgical workflow, after which the hydrogel biodegrades in the body. The underlying technology is a viscoelastic, ultra-pure modified gelatin developed entirely in-house, protected by a broad patent portfolio with granted patents in the EU, US, and China.
The OPERAS project, supported by the EIC Accelerator with blended finance of €2.5 million grant and €13 million equity, was designed to advance BR-003 from preclinical proof-of-concept to clinical and commercial readiness for late-stage development. The project ran for 36 months (April 2023 – March 2026) and was structured around three objectives: conducting a Phase Ib clinical trial to demonstrate first-in-human safety; developing a comprehensive market access strategy; and managing the project including IP portfolio maintenance and regulatory preparation.
