After his wife died of breast cancer in 2003, David Lee stepped away from a decades-long career in the semiconductor industry and jumped feet-first into the medtech arena. Fifteen years later, Lee is president and co-founder of a company developing a system that can detect residual cancer cells in real time during surgery.
Lumicell has tested its drug-device combination product in 45 breast cancer patients and, so far, has identified 100% of the cancerous cells that linger behind on the walls of tumor cavities.
Lumicell’s technology could represent a shift in how surgeons determine the success of their tumor-removal procedures, Lee told Medical Design & Outsourcing.
“For the last two or three centuries, [surgeons have] always depended upon pathology to tell them that they succeeded. But they’re only inferring whether it worked. They’re only looking at resected tissue and inferring whether they left tumor behind. Even with the best of our technology at the best of hospitals, it’s still an inference,” he explained.
Lee told us that Lumicell’s technology can serve as a way for surgeons to scavenge for residual cancer cells during a patient’s first surgery, potentially saving them from needing a second operation.
A ‘pan-cancer’ detection agentAfter a patient’s tumor is removed, surgeons using Lumicell’s handheld imaging device can scan the empty cavity to hunt for any remaining cancer cells. Thanks to a proprietary fluorescent optical contrast agent the company developed, any cancerous cells left behind will light up when scanned by Lumicell’s device.
While the surgeon is scanning the patient’s body, Lumicell’s decision-support software displays an image to help guide surgeons to any cancerous tissue.
Those three components — the imaging agent, the handheld device and the decision-support software — combine to create a system that recently-appointed CEO Kelly Londy believes will give them a competitive edge as a platform technology.
“We’re currently in five indications, looking to prove the technology for breast, prostate, colorectal, esophageal and pancreatic cancers,” Londy said. “In the near term, we expect to have FDA approval to move forward with brain and ovarian.”
Lumicell has been able to move between cancer types swiftly, thanks in part to a decision made by Lee and his team when they first developed the Lum015 imaging agent.
“I had two world-class imaging guys back in 2008 and we agreed that we were going to come up with an imaging agent that was pan-cancer in concept,” he explained. “Other approaches and traditional imaging agents require binding to very specific proteins on cells. The problem is that those are very specific to each indication, so they have to create a drug for each.”
Lumicell’s imaging agent is designed to activate in the presence of particular proteases, enzymes that break down proteins. Cancer cells secrete more of these than healthy cells, giving Lumicell researchers something to target.
In some cases, according to Lee, doctors and researchers have helped to push the company to pursue certain indications for the Lumicell system.
“In esophageal cancer, they wanted to know whether we could detect the cancer. It turned out that we could not only detect cancer, we could detect the pre-cancerous condition,” Lee said. “So they’re very enthusiastic.”
Lumicell is pursuing the combination product pathway for its technology with the FDA and expects to file a premarket approval application by the start of 2019.
“In most drug-device combination products, one or the other has already been approved. In our case, neither has been approved. It’s a new drug, a new device and it’s a new methodology, a new standard of care,” Lee said.
From pathology slides to the human body
There’s a financial incentive for hospitals and doctors to adopt Lumicell’s tech, Lee argued. Helping one patient avoid a repeat surgery leaves room in the schedule for a new patient.
But there’s also an argument to be made on behalf of pathologists, according to the company.
“There are six breast cancer pathologists at Mass. General Hospital. There is only one for all of gastrointestinal. They would like nothing better than to take less tissue,” Lee said. “Surgeons don’t want to take the extra time digging around blindly, and pathologists don’t want to take extra time looking at slides that have no tumor.”
Traditionally, pathologists examine slides from a resected tumor, looking for a millimeter-wide margin of cancer-free cells to determine whether a repeat surgery is needed. There is much debate over what constitutes a clear margin. Lumicell’s team is positioning its technology as a way to move the mark of success from a pathologist’s slides into the patient’s body.
“We’re shifting the paradigm from looking at the resected tissue to looking at the cavity in the body, which is really want counts,” Lee said.
Instead of asking surgeons to root around blindly, Lumicell’s technology could help inform them when they’ve removed just enough tissue to rid the patient of cancer, noted longtime medtech design veteran Bill Evans.
“In some cancer-margin detection, particularly in difficult anatomies where there are lots of things going on, you are trying to remove cancers that are intertwined with extremely vital tissues,” said Evans, founder and former innovation SVP at Bridge Design, a Ximedica company. “So you want to remove the minimum tissue possible but yet, at the same time, you want to remove all the margins of the cancer. That’s an area where there’s a lot of interest.”
The technology could also help alleviate the burden of what many surgeons consider the hardest part of their jobs.
“The worst thing that they have to do in their day is go back and tell a patient that they have to do another surgery, that they didn’t get all the cancer,” Londy said.
It isn’t easy to convince surgeons to incorporate a new technology into their procedures, cautioned Dr. Tracey Stokes, a Florida-based plastic surgeon who specializes in breast reconstruction.
“Surgeons are fairly set in their ways. Surgeons are used to being the captain of the ship, and we’re accustomed to getting the results we get by doing the same thing the same way, every time,” Stokes told us. “That being said, there are many surgeons, like myself, who are early adopters of technology. If there’s something that I’m going to use differently in the OR, there has to be a reason that I’m changing from what I’m comfortable with and what I’m used to getting reliable results with. A new technology needs to be innovative, or time-saving or safety-enhancing.”
The Lumicell system was designed to change as a little as possible in a surgeon’s routine, according to Londy. The device feels and responds like an ultrasound probe, which surgeons are already familiar with. And the company’s imaging agent is given to the patient while they’re in the pre-operative room, where they get an IV anyway. It’s not even an additional needle-stick.
“The surgeons don’t have to change much of what they do and the way that it works, it’s like 30 seconds extra in their process, so it’s not a big process change,” Londy explained.
“We are talking about a change to the standard of care, but it’s a dramatic shift that’s actually quite subtle,” Lee added.