In 2008, an American military contractor working in the Iraqi city of Fallujah came to a trauma unit operated by U.S. Marines complaining of headaches. A few days earlier, the vehicle the contractor was traveling in had hit a bump, knocking his head against the roof. He was seen by Luis Becerra, MD, a neurologist and U.S. Naval Officer with the U.S. Marines deployed during the Iraq War troop surge. The patient appeared normal during his exam and had no other outward symptoms, but Becerra decided to observe him for 24 hours, during which time the man’s condition declined. Becerra believed he was suffering from a potentially lethal brain bleed.
In prior deployments, the doctor would have had to rely solely on his observation of clinical symptoms, such as slurred speech and disorientation, to determine if a patient should be transported to one of the two medical centers in Iraq equipped with a computed tomography (CT or CAT) scan machine that could confirm a head injury. The stakes are high: An expensive helicopter evacuation for a patient who turns out healthy is a waste of precious resources; conversely, waiting too long to treat a head injury could be fatal. On that particular day, a dangerous sandstorm raging across the region also weighed on his decision.
This time, however, Becerra had a new tool in his kit: the Infrascanner 1000, a handheld device developed by a Drexel spin-off that can detect a brain bleed within minutes. After a few passes across the contractor’s scalp, the test returned a positive result, confirming the doctor’s diagnosis and telling him the approximate size and location of intracranial bleeding.
_how It Works
The contractor was quickly air-lifted by helicopter to a hospital in Balad, 50 flight miles to the north, where a CT scan confirmed a bilateral subdural hematoma.
The Infrascanner’s test result probably saved the man’s life, Becerra recalls. “The [evacuation] had to be approved by the three-star general,” he says. “You have to make a really strong case that something needed to be done immediately.”
Back in Philadelphia, the team at Infrascan, the University-based startup that makes the Infrascanner, would draw on this and other early successes to buoy them through a turbulent decade — through a years-long FDA approval process that stalled sales, through the resulting budget crisis that suspended the company’s operations, and through political battles in Washington, D.C., that wreaked collateral damage on its military contracts. All the while, the future of a life-saving new technology hung in the balance.
“In startups, when you have challenge after challenge that you need to overcome, sometimes you think, am I persistent or am I just plain stupid?” says Baruch Ben Dor, founder and CEO of Infrascan. “[But] when you feel that you’re really making an impact, and really helping people, that makes it all worth it.”
As of this year, the company has sold more than 1,000 Infrascanners globally, from Middle East war zones to as far away as the Andes Mountains of South America. With a strong foothold in military and international sales, Infrascan is now planning its expansion into the United States medical market, eyeing ambulances, pediatric emergency rooms and other health care settings where speed, portability and cost matter. In the meantime, Drexel biomedical engineers are constantly improving the Infrascanner, which has evolved from a two-part system to a single device roughly the size of an iPhone, and adding new functions to detect more injuries.
“There is no end to this; there’s so much that can be done eventually,” says Banu Onaral, H. H. Sun Professor of Biomedical and Electrical Engineering at Drexel and chair of the Infrascan board. “We’re introducing not only a breakthrough technology, but also creating a new neurotechnology niche where handheld [devices] will save your brain.”
The technology behind the Infrascanner was originally intended not to save your brain, but to boost your muscles. The idea came from Britton Chance, who won an Olympic gold medal in sailing in the 1950s before joining the University of Pennsylvania as a bio-physicist. Chance, who died in 2010, was one of the first medical scientists to experiment with near-infrared light, which is light that, while invisible to the eye, can penetrate the skull. Chance developed a technology that used different wavelengths of near-infrared light to detect oxygen capacity in muscles. Then, in 1997, Chance and Claudia Robertson, MD, a neurosurgeon at Baylor College of Medicine, completed a study that determined that the technology was also effective in detecting intracranial hematoma, or blood in the skull.
“And, typical to academia, that’s where it stopped,” says Infrascan founder Ben Dor.
At least, that’s where it would have stopped, had Ben Dor been willing to let it go.
Ben Dor is a physicist who had been managing a medical device startup in Israel before he joined Chance’s laboratory in 2002 as a postdoctoral researcher. Whether because of his background in industry or his eight years in Israeli military service, Ben Dor believed that the technology had merit beyond academia. With Chance’s blessing — and the help of some business students — he entered, and won, the University of Pennsylvania’s 2004 Wharton Business Plan Competition, which came with a $20,000 prize. Then, to really get the idea off the ground, he needed a team.
Just blocks away on Drexel’s University City campus, Banu Onaral was growing Drexel’s new, interdisciplinary School of Biomedical Engineering, Science and Health Systems, which she helped to establish with a commitment to translate cutting-edge academic research into life-saving technology solutions. She was initially hesitant of Ben Dor’s suggestion of a partnership — as an academic she stayed away from for-profit projects — but her belief in translational research won out.
“This intrigued me,” she says. “I always felt terrible that we had such beautiful solutions as laboratory prototypes sitting on our shelves and never moving forward.”
Ben Dor launched Infrascan in 2005, with his team handling the business side and Drexel serving as its scientific backbone.
The partnership has worked so well — and lasted so long — because it benefits the missions of both Infrascan and Drexel, says Kurtulus Izzetoglu, an associate professor of electrical and biomedical engineering at Drexel and an Infrascan co-founder. Infrascan co-exists with the school’s educational mission as a living case study for biomedical students to see firsthand how to move academic ideas and technology into commercial use. Startups need institutional backing to get grants to fund their work, he says, while universities need startups to push their translational research into the world.
“We created this model to show how academia and industry can work effectively and efficiently,” Izzetoglu says. “We help their survival because they are a startup. They help us on translational research, so our students can learn more about how technology can be developed and moved to the patient side.”
A troubling trend emerged during the Vietnam War: Soldiers who shrugged off seemingly minor head injuries would later succumb, sometimes without any clinical symptoms indicating something was amiss. Only later would autopsies reveal the cause of death was bleeding on the brain. CT scan machines — today’s gold standard in head trauma detection — weren’t widely available until after the war. Even today, the costly and bulky equipment is rare in combat zones.
Ben Dor, whose stint as an Israeli Air Force scientist in the late 1980s and early ’90s leading research and development projects gave him an inside perspective on the military, approached the U.S. military with his technology. In 2005, Infrascan received funding from the Office of Naval Research to spend several years developing its first product, a two-part system including a mobile device and a handheld scanner, called the Infrascanner 1000. Eventually Infrascan would go on to accumulate $10 million in grants from the U.S. Department of Defense over 15 years. Several Philadelphia-area economic development agencies, including BioAdvance, Ben Franklin Technology Partners of Southeastern Pennsylvania and Philadelphia Industrial Development Corp., also provided early funding.
In Iraq, Becerra used the Infrascanner to evaluate some 140 head trauma patients, placing the scanner on eight locations on the head for five to 10 seconds each. When the scan was complete, the mobile device displayed a crude picture of the head with normal regions represented in green and bleeding indicated in red. Even if some measurements needed to be repeated, Becerra knew within five minutes whether a patient had internal bleeding.
During Becerra’s seven-month deployment, three people, including the American contractor who was evacuated during a sandstorm, a U.S. soldier and an Iraqi policeman, received positive Infrascanner results and were sent to medical centers for treatment. “If you are in a place that is remote, it’s always better to have as many tools as possible,” Becerra says. “This is our tool.”
Today, the U.S. military is Infrascan’s biggest single customer. But expanding sales in the United States has proved to be a trickier endeavor for Infrascan. The company expected its device to be approved by the U.S. Food and Drug Administration within three months. Instead, the process took nearly five years.
The delay meant the Infrascanner couldn’t be sold in the United States, nor in the many countries worldwide that won’t sell American medical products without FDA clearance. Potential investments dried up, Infrascan suspended operations and, for several months in 2009, the team went without pay.
“I think we were down to: Plans A, B, C, D and E doesn’t work,” Ben Dor says. “[But] we had a couple of things on the horizon that would help us.”
Drexel offered the team adjunct faculty positions, a timely grant came through and the device was approved for sale in Europe.
“We created this model to show how academia and industry can work effectively and efficiently. We help their survival because they are a startup. They help us on translational research, so our students can learn more about how technology can be developed and moved to the patient side.”
–KURTULUS IZZETOGLU, associate professor of electrical and biomedical engineering at Drexel and an Infrascan co-founder
By the time the Infrascanner 1000 finally received FDA clearance in 2011, the company had already developed its next model. Funded by the U.S. Marines, the Infrascanner 2000 merged its predecessor’s two components into a single, more rugged device.
Yet the challenges for Infrascan continued. As the FDA approved the new device in 2013, the U.S. budget sequestration that year cut the company’s contract with the Marines in half.
Even so, the Infrascan team was boosted by another success story. During an evaluation of the Infrascanner 2000 by U.S. Marines, the device helped save the life of an Afghan boy. The boy’s only clinical symptom was a small cut to the head, but the Infrascanner indicated a brain bleed. The child was evacuated to a hospital for life-saving surgery. “That’s where you feel that…making [the technology] commercial and making it actually reach patients makes the real big difference,” Ben Dor says. “It’s not just a technology. It has a real impact.”
The Infrascanner was deployed to Afghanistan for military use, but its impact on the Afghan boy highlights another avenue the company was pursuing: the potential for the device to make in-roads in poor and rural regions worldwide, where its portability and dramatically lower cost over CT equipment give it an advantage. Some developing countries have fewer CT scan machines than a single U.S. medical center, Ben Dor notes, and that lack of access to head trauma diagnosis and treatment means more disability and death.
Andres Rubiano, MD, a neurosurgeon in Colombia specializing in trauma, believes the Infrascanner could serve as a powerful health care tool in areas with few medical resources. Rubiano, who this summer expects to publish the results of his study on the accuracy of the Infrascanner on 150 patients in Colombia, is now using the device to determine whether head trauma patients in rural Guatemala need surgery.
“There are going to be settings where the device will make a lot of difference: low-resource settings, maybe military settings, also some sport-related injury areas,” says Rubiano.
The Infrascan team has no illusions about its chances of replacing CT scans as the gold standard of care for brain injuries in the United States, where some 70 million CT scans are performed each year.
Instead, the company frames its device as a way to prevent unnecessary radiation exposure in the United States. A typical head CT scan exposes a patient to about two millisieverts of radiation, which, while on the lower end of radiation doses from CT scans, can still elevate lifetime cancer risk. The radiation produced by the Infrascanner, by contrast, is comparable to that of a TV remote control.
Radiation exposure is especially worrying for children. One study found that patients who had two to three CT scans in childhood tripled their lifetime risk of developing brain tumors. Many countries worldwide already use the Infrascanner in pediatric settings, Ben Dor says, and the company is preparing a submission to the FDA for clearance for pediatric use in the United States, as well.
Infrascan has begun studies at several U.S. hospitals. One research project is expected to expand to a multi-center study at 10 of the top trauma research centers in the world. This will focus on the Infrascanner technology in monitoring neurointensive care and emergency department patients. These patients, Ben Dor says, would otherwise be exposed to repeated CT scans as doctors decide if, and when, their condition worsens enough to require surgery. The Infrascanner could also serve patients under the influence of drugs or alcohol, he says, who are frequent candidates for head CT scans because their symptoms mimic those of head traumas.
Once proven in hospitals, the company wants to see the Infrascanner deployed in ambulances. The device is simple to operate with just two hours of training. Ben Dor says that the device would let emergency workers immediately assess whether a head injury patient could be treated at a local hospital or must be transferred to a trauma center.
“This is futuristic stuff, science-fiction-type stuff, but it’s feasible and full of promise for brain health and performance.”
–BANU ONARAL, H. H. Sun Professor of Biomedical Engineering and Electrical Engineering at
The long, and often bumpy, road for Infrascan highlights the challenge of introducing the established health care community to an entirely new type of medical device, says Hasan Ayaz, an associate professor of electrical and biomedical engineering and an Infrascan co-founder. “It’s not only developing your engineering technique, but it’s also communicating to all stakeholders, understanding the process, placing it into the right spot,” he says. “When you develop a completely new, novel technology… that’s another kind of soul searching, another aspect of the translation.”
As Ben Dor and the Infrascan team explore niches for their technology, Drexel engineers are continuously updating the device. The latest breakthrough came in 2018, when the U.S. Army asked for a miniaturized version. The smaller, smarter and more efficient Infrascanner 2500 was approved by the FDA last year. It’s about the size of an iPhone, weighs less than half a pound and works on four AA batteries.
Also on the horizon: a multi-function Infrascanner that will use the same near-infrared technology to detect about a dozen different data points, from the dangerous (cerebral edema, or swelling of the brain) to the interesting (muscle fitness — the very thing for which Chance intended to use the technology decades ago).
Infrascanner represents just the beginning of the potential advances the Drexel team can make in how health care is delivered throughout the world, Onaral says.
“The non-fancy side,” she says, “is that we can shine this light and see if you are bleeding in the brain.” The fancy side? That’s functional near-infrared spectroscopy, she says, which involves using the same light to study cognition and watch the brain in motion as it learns. This technology uses the same blood oxygenation information the Infrascanner collects in order to study attention and brain activation. The applications, Izzetoglu adds, could range from monitoring student learning to helping NASA understand cognitive load.
The journey is a long one, Onaral says. “Other neurotechnologies we’re working on make people think that we are talking science fiction. No, come to our lab, let’s monitor your brain activity,” she invites. “This is futuristic stuff, science-fiction-type stuff, but it’s feasible and full of promise for brain health and performance.”