At the 2026 Stanford Symposium on Optical Surgical Navigation, Brian Schlossberg, VP of Innovation at Lumicell, shared a detailed and candid overview of the development and commercialization of their fluorescence-guided surgery platform. This talk highlighted not only the path to approval, but the broader structural challenges that can limit adoption if companies do not plan ahead.
One of the most important unmet needs in surgical oncology is intraoperative margin assessment during breast-conserving surgery. Incomplete resections often lead to follow-up procedures, which increases both patient burden and healthcare costs.
Lumicell’s approach, described as “Inject, Detect, Resect,” is designed to address this gap. Their system (LumiSystem™) combines:
LUMISIGHT™ is administered intravenously 2 to 6 hours prior to imaging. This allows surgeons to visualize residual cancer directly within the surgical cavity. The goal is straightforward: detect and remove residual disease in a single procedure.
The development timeline for Lumicell’s platform highlights the complexity of drug-device combinations:
Beyond the timeline itself, several key lessons emerged. A key takeaway from Dr. Schlossberg’s discussion was the importance of early and sustained engagement with the FDA. Aligning on endpoints that reflect both diagnostic performance and clinical utility is critical.
Most of the regulatory burden was driven by the imaging agent component, even though the system is used by the surgeon as a device. This dual-path approval, with CDER for the imaging agent and CDRH for the device, adds complexity that many developers underestimate.
A central lesson from Lumicell’s experience was the importance of defining the indication early and designing everything around it.
For Lumicell, this meant aligning clinical trials, system design, and workflow integration around a specific surgical use case. Their primary endpoints included:
At first glance, the sensitivity may seem low. However, performance must be evaluated against the current standard of care. The surgeon images the lumpectomy cavity after they’ve completed their standard of care procedure and done their best to remove the disease. A sensitivity of 49% means roughly half of the residual cancer that would otherwise have been left behind is detected in real time, in approximately seven minutes of intraoperative imaging — disease that otherwise might only have been identified at a second surgery or not at all. In this setting, even incremental improvements in resection completeness can have meaningful clinical impact.
Successful deployment depends not just on the technology, but on operational execution. It requires:
The system is not inherently difficult for surgeons to use. The challenge is ensuring everything is ready when the surgeon needs it. Operational readiness plays a major role in adoption.
Drug-device combination technologies require coordinated reimbursement for both hospitals and providers. Hospitals need appropriate payment pathways for the imaging agent and associated facility costs, and providers must integrate the technology within surgical workflow and operative resource constraints. Sustainable adoption depends on reimbursement pathways that fit the technology into existing surgical workflows — clinical evidence alone does not drive uptake when the economic structure does not support it.
Lumicell recognized early that successful commercialization would require alignment across several reimbursement mechanisms and therefore pursued multiple reimbursement pathways concurrently with the clinical and regulatory program.
This strategy highlights a broader issue: U.S. reimbursement is built for therapies used repeatedly over time, with defined payment pathways. Intraoperative fluorescence imaging is different — a single-use agent used once during surgery to inform decisions in real time. No existing category was designed for that shape, so commercialization requires building coding, coverage, payment, and provider economics in parallel with the clinical and regulatory program. The path is engineered, not accessed.
Lumicell’s approach stands out because they developed the imaging agent, device, and software as a unified system.
In many cases, there is a disconnect between:
These groups are often developed and operated separately and are regulated by different parts of the FDA on different timelines. All of this creates friction. Lumicell’s integrated approach stands in contrast to this typical fragmentation.
A device company cannot wait for an imaging agent to be approved before starting development. This forces early partnerships or, as in the case of Lumicell, pushes imaging agent developers to build their own systems. Both approaches carry different types of risk.
Draft FDA guidance on combination products has started to address these challenges. Industry feedback, including input from QUEL Imaging, has emphasized the need for more coordinated pathways. For now, developers still have to navigate parallel processes that are not fully aligned.
A key constraint in development is the need to lock the device design early. Once clinical trials begin, changes to the system, especially software, can trigger additional regulatory requirements.
This creates a tradeoff between:
It also raises a broader question. As more general-purpose imaging systems become available, will future imaging agents rely on existing platforms, or will custom systems remain necessary for optimal performance?
Lumicell’s journey highlights both the promise and the structural complexity of fluorescence-guided surgery. Their success demonstrates that an integrated approach can work. At the same time, it highlights the structural challenges that still exist.
For the field to grow, better alignment is needed across:
At QUEL Imaging, we see this as a key opportunity. Bridging the gap between imaging agent developers and imaging system designers will be essential to advancing the field and improving surgical outcomes. If you’re navigating similar challenges in fluorescence-guided surgery, we’d be glad to connect. At QUEL Imaging, we work with teams across imaging agent and device development to support validation, training, and clinical translation.
What is LUMISIGHT (pegulicianine) and Lumicell DVS?
What is the most important information to know about LUMISIGHT?
What additional important information should I know about LUMISIGHT and Lumicell DVS?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information www.LumiSystem.com.