In January 2026, the ARCA+® project entered a decisive stage: we have completed the key technical and regulatory steps that bring us closer to the final goal of bringing the device to market, and we are now awaiting the official responses from INVIMA and the FDA for commercialization.
It has been a long, rigorous, and deeply formative journey. And although we are still in process, we can now say with pride that the foundations are firmly in place.
Progress that gives us confidence
In Colombia, as part of the regulatory process, INVIMA conducted the manufacturing verification visit for ARCA+®, and the manufacturing capacity was approved. This step represents significant validation of our team’s work and of how we build our quality, traceability, and control processes.
In parallel, in the United States, we have also made consistent progress: our suppliers and raw materials have already been approved, strengthening the project’s reliability and the continuity of development. At this point, we are confident that this effort will soon conclude with the best possible news.
If anything has been decisive in getting us here, it has been our team. Their commitment, consistency, and discipline have enabled solid results and allowed us to face each stage with seriousness. Behind every document, review, visit, and requirement, there are hours of work and a shared conviction: to do things right.
What’s next
Today, we are awaiting the final responses from INVIMA and the FDA for commercialization, and we continue to work with the same energy—strengthening processes, ensuring technical coherence, and maintaining the level of quality that this type of development demands.
It has been a demanding journey, and we hope it will soon conclude with the best news.
In the meantime, we keep building—calmly, rigorously, and with pride in everything we have learned.
