At the 2026 Stanford Symposium on Optical Surgical Navigation, two consecutive presentations offered a compelling contrast in how companies are navigating the path to clinical adoption in fluorescence-guided surgery.
Brian Schlossberg, VP, New Business Strategy and Innovation at Lumicell presented the perspective of a company that has already completed the journey. Lumicell made the deliberate decision to develop both a fluorescent imaging agent and a dedicated imaging system, navigating the full regulatory and commercialization pathway.
Connor Barth Cofounder & CEO of Trace Biosciences offered a different vantage point. Trace is earlier in its development, working to define its strategy before committing to a specific path. Dr. Barth shared how his team is studying the landscape, learning from prior efforts, and attempting to chart a course forward.
There are many contrast agents under development, and each team is exploring the regulatory landscape because the field does a one-size-fits all got-to market strategy. Companies rely on case studies, partial guidance, and shared experience to navigate a complex and evolving system.
Here, I’ll present some of the topics covered by Dr. Barth, and a later post will contrast this with the Lumicell strategy.
Fluorescence-guided surgery introduces a different kind of intervention, compared to theaupetic pharmaceuticals. These imaging agents are designed to be used once, during a critical moment, to improve surgical decision-making and potentially enable curative resection. This stands in contrast to many therapies that are administered repeatedly over time, and the current system is largely optimised for these longitudinal treatment models.
These imaging agents must also be used with a device and interpreted by a surgeon. This added complexity introduces a structural disconnect in the regulatory pathway:
The FDA approves the drug, often through CDER
The clinical use depends on an imaging device, regulated through CDRH
After FDA approval, developers face a second challenge: ensuring the technology can be financially supported in clinical use. In practice, this means:
There is often no native CPT code for these use cases
Separate reimbursement pathways must be pursued after approval
The imaging agent is frequently absorbed into the surgical bundle
Surgeons take on additional cognitive and technical workload without direct compensation
One of the clearest signals from Dr. Barth’s analysis is that reimbursement remains one of the primary barriers to adoption.
ICG, which is widely used for perfusion imaging, is available under $100 per vial. In contrast, new targeted optical imaging agents typically cost $1,000 to $5,000 per patient. While these agents have the potential to improve surgical outcomes and reduce downstream costs, the current reimbursement structure does not consistently reward that value.
Most procedures involving these agents fall under bundled payment models, including:
DRGs (Diagnosis-Related Groups) for inpatient procedures
APCs (Ambulatory Payment Classifications) for outpatient care
In these models, the cost of the imaging agent is often absorbed into the overall procedure payment. The result is margin erosion at the hospital level, even when the technology improves care.
This creates a barrier to adoption. Without reimbursement alignment, adoption can stall, even when clinical benefit is well supported.
Several temporary reimbursement pathways exist, but they are often insufficient for long-term adoption. These mechanisms are intended to support new technologies, but they are often temporary or constrained.
For inpatient use, NTAP (New Technology Add-On Payment) can provide additional reimbursement. However:
It is limited to cases exceeding cost thresholds
Payments are capped and time-limited, typically to three years
It does not fully eliminate financial risk for hospitals
For outpatient settings, New Technology APCs can provide similar temporary support, but early adoption of these agents is often concentrated in inpatient surgical workflows, where APC pathways are less relevant.
Developers may also pursue:
J-codes for drug reimbursement
ICD-10 codes to define procedures or indications
However, these pathways are not guaranteed. As seen in the GLEOLAN, attempts to secure a J-code were unsuccessful because the agent is used intraoperatively.
Dr. Barth highlighted CYTALUXⓇ as a key example of how companies have navigated these challenges.
One of the notable aspects of On Target’s strategy was its focus on clinically meaningful endpoints, such as completeness of resection and detection of residual disease. Rather than positioning the technology purely as an imaging improvement, it was framed in terms of outcomes that matter to both clinicians and payers.
This reinforces an important lesson. Imaging performance alone is not sufficient. Technologies must demonstrate how they influence decisions and improve outcomes within the clinical workflow. This type of framing is exactly what emerging companies like Trace are considering early in development.
Hospitals primarily evaluate new technologies based on:
Reimbursement opportunities
Impact on operating room efficiency
Ability to enhance clinical offerings and remain competitive
There are also indirect considerations:
Reduction in complications and readmissions
Lower malpractice risk
Shorter length of stay
These factors are increasingly relevant in value-based care programs, where a portion of Medicare reimbursement is tied to outcomes, safety, and efficiency.
The entire field benefits when companies like Trace discuss these challenges. Insight beyond the academic and scientific advances are needed to define a viable long-term commercialization strategy. On Target chose to focus on clinical outcomes for specific indications and relied on imaging device companies to apply for separate 510(k) clearance. Lumicell took a vertically integrated approach through a PMA pathway to develop both the drug and device.
Trace is still evaluating its path and is learning from those that came before them. Should it partner with an existing imaging platform? Develop its own imaging system? Align with a specific reimbursement pathway from the outset?
In parallel, Trace is also pursuing a novel direction by developing imaging agents to highlight nerves. This expands beyond a field that has been largely focused on cancer resection.
These are not purely technical decisions. They are strategic choices shaped by regulatory structure, clinical workflow, and reimbursement constraints.
At this stage, companies are navigating with:
Case studies
Regulatory guidance that continues to evolve
Informal knowledge shared across the field
It is a process of charting a course with incomplete information, where each new entrant builds on the experiences of those who came before.
One of the most encouraging aspects of this field is the willingness to share lessons learned. From regulatory engagement strategies to clinical trial design and reimbursement approaches, there is a growing body of collective knowledge. This openness has the potential to accelerate translation across the entire ecosystem.
At QUEL Imaging, we see this firsthand. Working across both device and drug development efforts, we encounter many of the same challenges described by Dr. Barth. The need for alignment between imaging systems, probes, and clinical workflows is clear.
As the field continues to mature, collaboration and shared experience will be essential. No single company is solving these challenges in isolation.
Fluorescence-guided surgery is advancing rapidly, with strong clinical promise and increasing technical sophistication. The remaining challenge is not only scientific, but structural.
For these technologies to reach broader adoption, there must be better alignment across:
Regulatory pathways
Reimbursement models
Clinical workflow integration
Companies like On Target and Lumicell have demonstrated that it is possible to navigate this path successfully. Trace and many others are now working to refine the path forward.
In the absence of a complete map, progress depends on shared knowledge and collaboration. At QUEL Imaging, we’re focused on helping teams move from R&D through regulatory approval and into clinical adoption more efficiently. If you’re facing challenges along this path, we’d welcome the opportunity to connect and explore how we can support your efforts.