Date: Dec 06, 2016 Author: Jeff Buchanan Source: xConomy (
click here to go to the source)
The prospect of undergoing a surgical procedure with the operating room lights dimmed or switched off would probably make a lot of people bristle.
But with some procedures, darkened operating environments make sense because they allow surgical teams to use fluorescent compounds that highlight particular tissues in patients' bodies.
This imaging technique is known as fluorescence image-guided surgery (FIGS). According to the Journal of Clinical Oncology, FIGS allows for more sensitive and specific tumor detection than is possible with other imaging techniques today.
FIGS could become more popular in the coming years as researchers and businesses develop tools that would allow the technique to be used in more types of procedures, including surgeries to remove tumors and cancerous tissue. One of the newer companies in the field is Madison, WI-based OnLume, which is developing a camera system that would allow surgeons to better see residual cancer cells when removing tumors from humans and animals.
As it turns out, patients who undergo FIGS are not really in the dark after all. Before an operation begins, compounds known as fluorophores are given intravenously. The fluorophores act as tags that help surgeons distinguish between healthy tissue and tissue laden with tumor cells while they are operating.
One factor inhibiting the adoption of FIGS is that when patients are given fluorophores, ambient light can interfere with the light emitted by the fluorophores, which are absorbed into tissues in patients' bodies. That makes it harder for surgeons to tell the difference between normal tissue and cancerous tissue, and leaving behind cancerous tissue could lead to metastases or necessitate additional surgeries in the future.
"What we see is that surgeons often need to dim the lights when performing fluorescence-guided procedures," says Adam Uselmann, co-founder and CEO of OnLume. "We think that we have a good solution to the ambient light problem."
Uselmann launched OnLume in March 2015 with four other co-founders, including Rock Mackie, an engineering professor at the University of Wisconsin-Madison who has helped form and grow several successful healthcare-focused businesses over the years. The founding team also includes medical physicists and researchers with expertise in optics and light microscopy.
The company recently received a $300,000 Small Business Innovation Research grant, which was awarded through the National Cancer Institute.
Uselmann says that the inspiration for the device OnLume is seeking to commercialize stemmed from a basic problem: fluorescence microscopy, which involves applying a fluorescent dye to samples, has to be done in dark rooms because researchers are typically looking at very dim light signals.
"The idea behind it was that if you synchronize your detection technology with your lighting, you'd be able to have both the room lit and detect the dim signals," he says. "We started looking at different applications of this technology and then realized that surgery was a really exciting area that could benefit from fluorescence imaging in a well-lit environment."
OnLume's camera system is designed to attach to the end of a boom arm mounted on a cart or stand, Uselmann says, with a monitor showing the surgeon a live video feed of both fluorescent and white-light images.
The FIGS technique has applications for procedures that don't involve cancer patients, such as performing an angiography or reconstructive surgery using a drug called Indocyanine green (ICG), Uselmann says. With these procedures, ICG and other fluorophores cause cells or proteins to emit bright signals and essentially function as contrast agents.
In the case of tumor removal, the signals are typically much dimmer and room lights "become a real issue," he says.
OnLume's plan is to get the device into the hands of veterinary surgeons prior to pursuing a 510(k) clearance from the FDA. The company intends to eventually market its system for use in procedures on humans, but Uselmann says that the regulatory burden is lower with animals, and that selling to veterinary surgeons would allow OnLume to collect user feedback and start bringing in revenue before devoting more attention to the clinical approval process.
Uselmann says that OnLume's device is designed to be compatible to image any fluorophore during surgery. There are some fluorophores that specifically target cancerous cells, but all are currently in clinical trials, he says. Uselmann expects one or more of them to be approved for human use by the time OnLume's device reaches the market.
Jeff Buchanan is the editor of Xconomy Wisconsin. Email: jbuchanan@xconomy.com
