Swissmedic, Switzerland’s medical regulatory authority, has announced an important update regarding NexoBrid®. On November 22, 2025, Swissmedic extended the therapeutic indication of this product, marking a key milestone for clinical, quality, and regulatory teams managing advanced wound-care strategies.
What changed?
NexoBrid®, known for its enzymatic debridement of severe burns, has received approval for an expanded therapeutic indication. This extension reflects new scientific evaluations on its efficacy and safety across additional patient profiles or clinical uses.
The move aligns with strict standards for medical device regulations, ensuring that professionals can leverage its benefits for broader treatment scopes.
Who is affected?
This update directly impacts clinicians specializing in burn treatment as well as quality assurance teams tasked with the compliance of wound-management devices. Regulatory affairs professionals should also note changes to required documentation for marketing or clinical adoption.
Clinical impact
The therapeutic extension highlights NexoBrid®’s performance within carefully monitored settings. Its active component, bromelain-based extract, achieves faster and more precise burn debridement compared to traditional methods. These advancements contribute to improved patient outcomes while reducing the dependence on surgical intervention in eligible cases.
Safety remains a cornerstone of this decision, supported by scientific data confirming controlled adverse events during trials.
Healthcare providers should acquaint themselves with updated usage guidelines and integrate them into clinical practice workflows responsibly.
FAQ
Q1: What is NexoBrid®?
A1: NexoBrid® is a wound-care product designed for enzymatic burn debridement, utilizing bromelain extract.
Q2: Why was the indication extended?
A2: The therapeutic scope expansion followed data demonstrating safe and effective outcomes in broader patient scenarios.
Conclusion
Swissmedic’s decision represents progress for patients who require advanced enzymatic burn treatment. Clinicians and regulatory professionals should prioritize understanding the updated guidelines and implications for hospital adoption.
Disclaimer
This post is for professional informational purposes only and does not constitute legal or regulatory advice.
Swissmedic announcement
For full information about the Swissmedic announcement, see the link below.