Ask any surgeon what keeps them up the night before a cancer operation, and a lot of them will say the same thing: did I get it all? Removing a tumor is only half the job. Knowing, right there in the operating room, whether any cancer cells were left behind- that’s the part that’s much harder to get right, and it’s where surgical innovation is now focused.
Lumicell is one of the companies working on this problem. It’s a MedTech company built around real-time, fluorescence-guided surgery. Its core idea is fairly simple to state even if it wasn’t simple to build: give surgeons a way to see leftover cancer during breast-conserving surgery, while the patient is still on the table, instead of finding out days to weeks later from a lab report.
Behind this journey are two leaders whose expertise spans both scientific discovery and commercial execution: Marnie Curbow, MBA, MHA, Chief Commercial Officer, and Jorge Ferrer, PhD, Chief Scientific Officer. Together, they have helped guide Lumicell from an ambitious research initiative into a company whose technology is now making its way into operating rooms across leading cancer centers.
With Jorge driving the scientific vision and Marnie leading commercial strategy, Lumicell’s story reflects years of rigorous research, regulatory perseverance, and an unwavering commitment to improving patient outcomes. Their leadership demonstrates that meaningful innovation is not only about developing groundbreaking technology but also about ensuring it can be trusted, adopted, and ultimately make a measurable difference in clinical practice.
Let’s explore the journey, leadership philosophy, and innovation strategy behind Lumicell’s mission to bring greater clarity to surgeons and better outcomes to patients!
From an MIT Spinout to a First-of-Its-Kind Innovation
Lumicell’s journey began as an MIT spinout, built on research out of the Koch Institute in collaboration with Professor Moungi Bawendi’s lab, where Jorge conducted the early R&D on the imaging technology that became the foundation of the company’s platform.
As he explains, “The idea was simple to state and hard to build: give surgeons the ability to see cancer, not just feel for it, while the patient is still on the table.” In breast-conserving surgery, a surgeon removes a tumor while aiming at conserving as much normal tissue as possible, sends it to pathology, and multiple days later some patients learn they need a second operation because the margins weren’t clear. Lumicell set out to close that gap in real time by giving surgeons information they have never had before, while there was still time to act and perform a more complete initial tumor removal to avoid a second operation.
Achieving that vision required years of R&D, clinical development, and evidence generation before the company reached the milestone that transformed its trajectory. In April 2024, the FDA approved LUMISIGHT™ (pegulicianine) and the Lumicell Direct Visualization System, together known as LumiSystem™.
What made the approval especially significant was the regulatory pathway Lumicell chose to pursue. The company simultaneously applied for both a New Drug Application (NDA) for the imaging agent and a Premarket Approval (PMA) for the device, ultimately securing approval for both as part of a combination product. As Jorge notes, it is the kind of regulatory path very few companies choose to take on, and even fewer successfully complete.
For Marnie, however, approval represented the beginning of an entirely new chapter. Since April 2024, Lumicell’s milestones have shifted from asking “can we build this” to “how fast and how well can we bring this to surgeons and patients.” That transition has meant building a commercial organization, expanding sales and clinical support, training surgical teams, and helping hospitals successfully adopt a completely new category of surgical technology.
An important step in accelerating that adoption came when CMS granted transitional pass-through payment status for LUMISIGHT, a milestone that Marnie believes matters enormously for hospitals evaluating new technologies. At the same time, a growing number of cancer centers have begun bringing LumiSystem into their operating rooms, reflecting the company’s transition from years of research into real-world clinical practice.
Like all medical tools, LUMISIGHT™ and LumiSystem™ come with both benefits and risks. The most common side effects with LUMISIGHT™ (pegulicianine) are hypersensitivity and an abnormal color in urine. LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis.
Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use.
For complete product information, visit https://lumisystem.com/.
The Defining Moment Behind the Science
Although Lumicell’s FDA approval stands as one of the company’s most significant achievements, Jorge believes its defining moment occurred years before the regulatory milestone.
During one of Lumicell’s initial clinical trials, he stood alongside Dr. Barbara Smith of Massachusetts General Hospital (MGH) as she used an early version of the system during a lumpectomy. The technology identified an area within the surgical cavity that appeared unremarkable by every conventional measure. Guided by the system, Dr. Smith removed the tissue, and pathology later confirmed that it contained cancer that otherwise would have remained in the patient.
For Jorge, that was the moment the years of research became something tangible.
He recalls, “Everything until then had been promising pre-clinical data and careful hypotheses; in that moment we saw the technology do the one thing we had built it to do, find cancer a surgeon could not otherwise see, while there was still time to act.”
That experience became the foundation for everything that followed. FDA approval, when it came years later, served as the institutional and regulatory validation of what the team had already witnessed in the operating room. In April 2024, LUMISIGHT and the Lumicell Direct Visualization System became the first drug-device combination product in more than a decade to complete the FDA’s rigorous NDA and PMA review processes simultaneously. For Jorge, that achievement was far more than a regulatory distinction; it demonstrated that both the industry and the regulators entrusted with protecting patients had seen sufficient evidence in the pivotal INSITE trial to place confidence in the technology.
For Marnie, the approval also fundamentally changed how Lumicell viewed itself. Before April 2024, it was primarily an R&D story. Since then, the company has become a commercial organization, building a sales and clinical support structure, training surgical teams, and developing sustainable approaches to bringing LumiSystem into hospitals. Every strategic conversation, from territory design to partnership models, now traces back to that single milestone, marking the transition from proving the science to ensuring it reaches the patients it was designed to serve.
Cultivating a Culture That Brings the Light
As Lumicell has grown from a research-driven organization into a commercial MedTech company, its culture has remained anchored in one guiding principle: “The patient is the north star.” For Marnie, every decision ultimately comes back to improving outcomes for patients and giving surgeons greater confidence in the operating room.
That philosophy is embodied in a phrase that has become part of the company’s everyday language: “Bring the Light.” What began as shorthand for what Lumicell owes patients and surgeons during moments that matter has evolved into a standard of accountability across the organization.
As Marnie explains, “It started as shorthand for our commitment to patients and surgeons in moments that matter, when someone is on an operating table, and the people around them need clarity to make the right call.” Internally, it has become the question the team asks itself every day: Did I bring the light today?
In practice, that means choosing clarity over complexity, even when the science is genuinely sophisticated. It means remaining calm under pressure, whether navigating a difficult board discussion or responding to a device question in the middle of a surgical case. Most importantly, it means preparing relentlessly because, as Marnie notes, “Confidence in the operating room is earned long before the procedure begins, not improvised in the moment.”
The same philosophy extends to learning and continuous improvement. Marnie encourages the team to stay curious rather than judgmental, especially when outcomes differ from expectations. A slower adoption curve at a hospital or field feedback that contradicts previous assumptions is treated as valuable information rather than a failure to manage around. Speaking the truth with respect is viewed as a requirement, and insights from Clinical Application Specialists, who spend every week supporting surgeons in operating rooms, are expected to influence training, account support, and even conversations with investors about where the product is headed.
From the scientific side, Jorge believes that culture is reflected through intellectual honesty.
He emphasizes, “Curiosity and rigor are not in tension; the discipline of following the data wherever it leads, even when it complicates a story we would rather tell, is exactly what earns a new technology the right to be in the operating room.”
Building a technology that asks surgeons to trust a signal they have never seen before requires Lumicell to hold its own evidence to a high standard. Being transparent about what the data supports, and equally honest about what it does not yet demonstrate, is essential to earning trust within the medical community.
Marnie also believes collaboration must be structural rather than aspirational. Commercial and clinical teams formally host technology reviews with customers together, while performance management is approached as a tool for growth instead of simply accountability. By serving patients, surgeons, and one another first, Lumicell creates an environment where scientific innovation can successfully translate into clinical practice.
Overcoming the Challenges of Clinical Adoption
Bringing a first-of-its-kind technology into operating rooms requires much more than scientific validation. According to Jorge, Lumicell’s greatest challenge has been changing the very question surgeons ask during surgery.
For decades, the focus has been, “Does the tissue I removed have clean margins?” LumiSystem changes that question to, “Is there cancer still left in the patient?” By providing surgeons with information that would otherwise remain hidden, the technology introduces a new way of thinking about surgical decision-making.
For surgeons who have successfully followed existing standards of care, interpreting this entirely new type of information naturally raises important questions. Jorge explains that answering those questions cannot be accomplished by continuing to use the device alone. It requires years of building the evidence base, which is why Lumicell continues evaluating real-world data and conducting research studies even after receiving FDA approval.
Marnie explains that the paradigm shift also creates practical challenges. Demonstrating success in a controlled clinical trial is fundamentally different from making the technology work consistently across hundreds of operating rooms, each with different workflows, surgical teams, patient characteristics, and varying levels of familiarity with a completely new category of tool.
Changing surgical practice depends on trust driven by clinical data.
To support that transition, Lumicell invested heavily in its Clinical Application Specialist team. Their role is not simply to assist during implementation but to remain alongside surgical teams as they continue adopting the technology. Marnie describes this team as the most visible expression of Lumicell’s culture, since they are the professionals expected to stay calm, clear-headed, and precise inside live operating rooms while always serving the surgeon and patient first.
The company has also developed structured clinical application support programs, making long-term implementation a dedicated part of its operating model rather than a temporary launch initiative.
Another major challenge involved reimbursement and health economics. Because LumiSystem represents a genuinely new category of technology, there was no established pathway through hospital budgeting or CMS coding. Achieving transitional pass-through payment status for LUMISIGHT required sustained regulatory and policy work that, while rarely visible, proved essential in making adoption practical for healthcare institutions.
Staying Ahead by Staying Close to the Evidence
In a rapidly evolving MedTech landscape, Lumicell believes that innovation must remain grounded in evidence rather than assumptions.
Marnie explains that the company stays close to both clinical and commercial data, approaching it with curiosity rather than confirmation. Forecasting and pipeline planning are built directly from what is happening in the field, enabling the organization to identify challenges early and discuss them honestly. Whether it involves slower-than-expected adoption at a particular account or exploring how surgeons incorporate LumiSystem into their decision-making, the focus remains on understanding reality rather than reinforcing optimism.
The company also carefully monitors the competitive landscape while maintaining clarity about what differentiates LumiSystem from other available surgical tools. Existing intraoperative margin assessment technologies evaluate tissue only after it has been removed from the patient. LumiSystem, however, enables surgeons to interrogate live, intact tissue while it is still inside the patient’s body.
For her, this distinction defines an entirely new category in vivo cavity assessment, rather than an incremental improvement on existing ex vivo margin assessment tools. Ensuring both Lumicell’s team and the surgeons they work with understand that difference is part of the company’s broader commitment to “bring the light”.
Looking beyond breast cancer, Lumicell is continuing to explore where real-time fluorescent imaging can make a difference across other surgical applications. For its leadership team, staying ahead means treating the company’s first FDA approval not as a finish line, but as the foundation for the next stage of innovation.
Partnerships That Shape Better Surgical Care
For Lumicell, collaboration has never been something that happens after innovation; it has been fundamental to how the company was built. Partnerships with clinicians, researchers, and healthcare institutions continue to shape the science, the technology, and the way LumiSystem is used in real-world clinical settings.
As Jorge explains, these partnerships are the foundation of everything Lumicell has built. The science began in the Bawendi Lab at MIT, where the early research behind the technology was conducted. Moungi Bawendi, a Nobel laureate in chemistry, is also a co-founder of Lumicell, reflecting the company’s deep scientific roots.
The clinical program was equally collaborative, shaped by some of the country’s most respected breast surgical oncologists, who co-authored Lumicell’s New England Journal of Medicine: Evidence publication demonstrating the effectiveness of the system. As Jorge explains, “We didn’t develop LumiSystem and then look for clinicians to adopt it. We built it with them, from the questions we asked to the endpoints we measured, and that collaboration is why the technology works the way surgeons actually need it to.”
For Marnie, nearly everything Lumicell has learned about making LumiSystem genuinely useful in an operating room has come from clinicians rather than internal discussions. Relationships with breast surgeons, radiation oncologists, pathologists, nurses, allergists and researchers continue to shape the company’s understanding of surgical workflow, what “usable” actually means during a procedure, and where the technology still has room to improve.
Staying curious about that feedback is part of how Lumicell approaches its role as a partner rather than simply a vendor.
The company also relies on these collaborations to continue generating real-world evidence. A post-market registry studying LumiSystem’s performance and clinical utility in everyday practice allows Lumicell to keep learning after approval instead of treating the FDA decision as the end of the process.
These relationships take time to build and depend on trust, particularly because Lumicell is asking surgeons to become early adopters of a genuinely new category of surgical technology. The company strives to earn that trust the same way it expects its own teams to earn trust internally: by showing up prepared, remaining honest when something needs improvement, and always serving the patient and surgeon first.
Balancing Innovation with Real-World Needs
Scientific advancement has little value if it cannot be applied effectively in the operating room. For Marnie, balancing innovation with practical clinical needs requires discipline, not simply adding more capabilities, but deciding which capabilities truly help surgeons.
Lumicell’s R&D team could expand the functionality of LumiSystem, but innovation is guided by a higher standard: whether a new feature genuinely helps a surgeon intraoperatively, not simply because it sounds impressive on a specification sheet. The company continues to apply its philosophy of choosing clarity over complexity by asking a straightforward question: does this make it easier for a surgeon to trust what they’re seeing and act on it quickly, calmly, and correctly?
That is why Clinical Application Specialists have such an influential voice in both product development and commercial strategy. Working directly with surgical teams allows them to understand what functions well, where friction exists, and what improvements would make the greatest difference in practice.
Engagement extends beyond surgeons to patients themselves. Data collected directly from patients (patient-reported outcomes) showed that patients who had tissue removed guided by LumiSystem reported meaningfully lower postoperative cancer worry without compromising breast satisfaction. Those findings are particularly meaningful because they demonstrate that removing additional tissue to achieve a more complete resection did not come at the expense of how the breast looked or felt to the patient after surgery.
Every advancement, Marnie believes, should translate into tangible patient benefits, fewer repeat surgeries, more complete resections, less time under anaesthesia, and less fear after leaving the operating room. If a new capability cannot be clearly connected to outcomes like these, the company believes it should ask harder questions before moving forward and remain willing to accept feedback from the people closest to patient care.
Advice for Emerging MedTech Leaders
Reflecting on Lumicell’s journey, Marnie believes one of the most important lessons for emerging MedTech companies is not to let scientific progress outpace commercial and regulatory preparation.
Approval is a major milestone, but it is only the beginning. Organizations must also ensure hospitals can adopt the technology, reimbursement pathways exist, and clinical support infrastructure is in place to enable long-term success. Companies that begin building those foundations well before approval are better positioned to move quickly once regulatory clearance is achieved.
She also encourages leaders to invest in the people closest to customers earlier than may seem comfortable. Clinical support teams and field specialists often provide the most valuable insight into whether a technology truly works in everyday practice, provided they operate within a culture where honest feedback is welcomed rather than discouraged.
At the heart of every decision, however, she believes leaders must remain connected to the reason the company was founded. As she says, “The companies that stay impactful are the ones where leadership keeps translating the numbers back into what they mean for an actual person on an operating table, and keeps asking, even on the hard days, whether they brought the light.”
Looking Ahead: Expanding the Possibilities of Surgical Innovation
Looking ahead, Lumicell’s immediate priority is disciplined commercial growth, bringing LumiSystem into more operating rooms in a way that is sustainable for hospitals, surgeons, and the company itself. Marnie explains that this means continuing to invest in the clinical support infrastructure that makes adoption successful while remaining honest about where the data shows progress and where additional work is still needed.
Over the longer term, she sees opportunities for real-time fluorescence-guided surgery well beyond breast cancer. The underlying principle that surgeons should be able to see both what they are removing and what they are leaving behind while a patient is still on the operating table has the potential to reshape surgical decision-making across multiple cancer types. Further research and regulatory oversight are needed to bring additional indications to market.
Her hope is that Lumicell becomes an example for future MedTech innovators: proof that a genuinely novel drug-device combination can successfully navigate the FDA’s most rigorous regulatory pathways while building a sustainable commercial organization that remains true to its mission of “bringing the light.”
From the scientific perspective, Jorge is equally optimistic about what lies ahead. The core idea behind LumiSystem is not specific to breast surgery. The same approach could help surgeons visualize disease in other cancers where identifying residual tumor or detecting disease earlier during surgery can significantly improve patient outcomes.
He is also energized by the opportunities artificial intelligence presents. Because LumiSystem is fundamentally built around capturing and interpreting images in real time, AI has the potential to sharpen the detection of previously hidden signals while accelerating future development.
As Jorge explains, “Breast-conserving surgery is where we proved the science works, but the larger mission, amplified by these tools, is to give surgeons across many kinds of cancer the ability to know what they are leaving behind while they can still do something about it.”
That vision continues to guide Lumicell’s journey. From its beginnings as an MIT spinout to achieving one of the FDA’s most demanding drug-device approvals, the company has remained committed to combining scientific rigor, clinical collaboration, and commercial execution in service of better patient care. Guided by evidence, strengthened through partnership, and united by a culture of “Bring the Light,” Marnie Curbow and Jorge Ferrer are helping redefine what is possible in surgical oncology, ensuring that innovation is measured not simply by technological achievement, but by the confidence it gives surgeons and the lives it improves.
Important Safety Information
What is LUMISIGHT (pegulicianine) and Lumicell DVS?
LUMISIGHT (pegulicianine) is an optical imaging agent, and Lumicell DVS is a fluorescence imaging device. LUMISIGHT and Lumicell DVS, in combination, are used in adults with breast cancer to help detect any remaining cancerous tissue at the surgical site following removal of the primary specimen during a lumpectomy procedure.
What is the most important information to know about LUMISIGHT?
Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Tell your doctor if you have any history of hypersensitivity reactions to pegulicianine or to contrast media or products containing polyethylene glycol (PEG). Your healthcare provider should have emergency resuscitation drugs, equipment, and trained personnel available during the use of LUMISIGHT. Healthcare providers should monitor all patients for hypersensitivity reactions and, if one is suspected, immediately discontinue the injection and initiate appropriate therapy.
The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
What additional important information should I know about LUMISIGHT and Lumicell DVS?
- Adjunctive Use: Lumicell DVS is for use as part of the lumpectomy procedure and is not a replacement for the standard of care lumpectomy procedure and pathology.
- Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in noncancerous tissue.
- Interference from Dyes Used for Sentinel Lymph Node Mapping: Your healthcare provider should avoid use of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
- Other Risks: Using the Lumicell DVS handheld probe may cause tissue damage or infection.
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, visit: www.LumiSystem.com.
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