Madison-based medical imaging device startup OnLume has received FDA clearance to bring its fluorescence-guided surgery system to market.
The cart-based imaging technology uses fluorescence imaging to monitor blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, reconstructive and micro-surgeries.
The device is used in conjunction with indocyanine green dye to help surgeons quickly identify regions of poor blood flow, which can prevent serious and costly complications—such as tissue death—following a surgical procedure.
“Fluorescence-guided surgery is an intraoperative imaging modality that will revolutionize how surgery is performed by providing visualization of what is in the surgical field at the time of the operation,” says Christie Lin, a senior scientist at OnLume. “This complements pre-operative imaging, such as CT scans or MRIs, which are used to plan the surgical approach by providing interoperative imaging to give real-time feedback, which supports the core of surgery.”
The 510(k) clearance from the FDA is an important step for the young startup. The company is now free to market its clinical imaging system as safe and effective for the approved surgical applications, just five years after a group of researchers launched the company from the Biomedical Engineering Lab at the University of Wisconsin-Madison.
Prior to OnLume’s imaging technology, fluorescence-guided surgeries had to be conducted in a darkened operating room, says Adam Uselmann, CEO and a company co-founder.
“We developed a way to do it in well-lit medical rooms,” he said. “When we began looking for applications for this idea, surgery was a very compelling application. We wanted [surgeons] to see signals in real-time.”
Over the next few years, the researchers worked to develop a business plan and secured a $300,000 grant from the National Cancer Institute (part of the National Institutes of Health) to build out the technology. The company also won second place in the Life Sciences category in the Wisconsin Governor’s Business Plan Contest.
“That was a great source of feedback and jumping-off point for developing and understanding the commercial viability of the technology,” Uselmann says. “The [NIH] grant was an important piece of technical validation.”
With a few endorsements under their belt, the team began animal imaging trials and worked to improve the sensitivity of the prototype to appeal to both surgeons and researchers in the field, says Daniel Seemuth, a lead engineer.
The team at OnLume says its medical imaging system, which projects fluorescence images on a video screen so surgeons can confidently spot blood flow and tissue profusions at the surgical site, is just the beginning. As new fluorescence agents emerge and gain FDA approvals, their hope is to apply the imaging technology to help surgeons target cancer tissue or nerve cells—without waiting for a pre- or post-surgical scan.
"The [NIH] grant was an important piece of technical validation."
“In the future, we envision color-coded surgery, where each of these anatomical features are different colors [and] are singled out,” Seemuth says.
To date, OnLume has raised more than $1.8 million through investors and is in the midst of its Series A funding round as it looks to launch its product nationwide in the coming months.
“Our whole team is very passionate about bringing this tech into the clinic and ushering in a new era of surgical guidance that gives surgeons what was otherwise experience and guesswork in evaluating the state of the surgical field,” Uselmann said. “We’re very focused on bringing this into the clinic—and into the hands of surgeons.”
