How a Montgomery County firm’s unusual medical device helped track Joe Biden’s broken foot

After President-elect Joe Biden fractured his right foot in November while playing with one of his German Shepherds, he had to put up with a walking boot for several days. The accident was painful for him, but it provided a bit of useful publicity for the Montgomery County firm whose special medical device was key to checking on his recovery.

On Dec. 12, two weeks after he was hurt in his home near Wilmington, Biden arrived at Pennsylvania Hospital at Eighth and Spruce Streets. There, he stood upright so the device could take a quick CT scan of his foot. That was unusual.

The scan showed he was healing up fine. Doctors conducted the checkup using a $185,000 device made by CurveBeam, the Hatfield-based company that invented the technology.

“Until we came to the market in 2012, CT scans could only be done in a lying down or supine position,” said Arun Singh, 62, CurveBeam’s president and chief executive. “Only plain x-rays could be done in a standing position, but they were limited because they were two-dimensional images of complex three-dimensional objects.”

Getting a three-dimensional picture of the foot while bearing weight is especially important in orthopedics. It allows a surgeon to see what’s happening to a foot when a patient is actually up and standing on it — that is, when it’s under stress, said Daniel Farber, an associate professor of Clinical Orthopaedic Surgery at Penn Medicine.

The machine is more compact than a typical CT scanner and allows easy access for the patient to enter the machine and stand up during the scan.

“The benefit to this technology is several-fold,” Farber said. “It’s super fast, about 60 seconds to see one side and 90 seconds to see both sides. It’s very low-dose radiation, and you can see all the views that you would normally get with a CT scan, but with the relationships between the bones with the pressure on them.”

For example, someone’s flat foot deformity might appear misleadingly normal in an x-ray. But when such a patient stands and put weight on the foot, a truer picture emerges of the alignment of the joints.

Singh’s team invented it out of necessity. After Singh tripped and fell while walking with his wife, his doctor diagnosed a fracture on the bottom of his fibula from an x-ray. But the diagnosis came with some guesswork.

“He said, ‘I think it’s a minor fracture and I think you should wear a boot,’” Singh recalled. “But he could barely see the fascia fracture that was not well-defined and was unclear whether it was displaced.”

Needing to know for sure, Singh went back to Imaging Sciences, a dental imaging company he had cofounded and ultimately sold in 2007 before retiring two years later. He wedged his foot upside down in a dental CT system, scanned the foot and took the images back to his orthopedic surgeon.

“When he saw those images, his jaw just dropped,” Singh recalled. “That’s when a light bulb went off.”

While his physician’s guesswork proved correct, Singh pursued his idea. He went back to work in 2011, putting a team together to create the device. Six months later, they had a prototype and were doing clinical trials in doctors’ offices. By 2012, they had FDA approval.

“We expedited every step of the process because there was an unmet need in the market,” Singh said.

More recently, the company received FDA approval for HiRise, a device that extends the scan to include the knee, hip and pelvis and also covers the hand, wrist and elbow.

So far, the firm has sold more than 135 pedCAT and successor devices, most in the United States, but significant numbers in Australia, China, Europe and South America. He hopes to have thousands, if not tens of thousands, in hospitals and doctor’s offices globally in the next decade.

Singh estimates CurveBeam’s market share at about 90% in the U.S., and 75% worldwide. His competitors include PlanMed Verity and CareStream Onsight.

CurveBeam has 35 full-time employees; Singh hopes it will do about $15 million in sales this year. His products are all made in the U.S., mostly in Pennsylvania.

Farber says the firm deserves to do well.

“It’s our aspirational standard of care,” said Farber. “It is a much more helpful diagnostic study than x-rays. For the equivalent risk of radiation, you get a whole lot more information.”