Student-Developed Product Designed to Reduce Tracheal Injuries

An idea hatched by a South Carolina high school student has grown into a business start-up aimed at producing a medical device that’s designed to reduce tracheal injuries in intubated patients.

That student, Shrihan Ganesh Babu, is now a rising junior at the University of South Carolina studying biochemistry and entrepreneurship.

And his company, CuffWay, won the 2025 InnoVision Award, which honors South Carolina businesses and individuals for innovation and technology advancement.

The device works by managing the pressure on the trachea from endotracheal tubes – which keep the airway open during surgery and prolonged intubation – thereby reducing the risk of injury, he said.

Nationwide, intubations are performed about 15 million times in operating rooms and 650,000 times outside of the OR, including 346,000 times in the ER, according to the Cleveland Clinic.

Babu estimates that there are millions of injuries from these tubes each year, ranging from a simple sore throat and hoarseness to damage that requires surgery and a narrowing of the trachea, called tracheal stenosis.

“Currently, when patients are intubated, they may have unsafe pressures against the trachea,” said Babu, founder and CEO of CuffWay. “This is automated and dynamic, managing pressures and modulating them so they’re safe for each patient.”

The idea makes a lot of sense, said Dr. Yandong Jiang, chair of the American Society of Anesthesiologists Ad Hoc Committee on Airway Management.

Tracheal injuries can happen when the air pressure in the endotracheal tube cuff is too high, particularly in patients who require prolonged intubation and mechanical ventilation, such as those in the ICU, he said.

About 1 percent to 2 percent of these ICU patients can suffer clinically significant tracheal stenosis, which may require surgery, he said, adding that incidence and severity of injuries depends on how long mechanical ventilation is used.

Other injuries wind up being treated by ENTs, and may not be seen by the clinicians who initially inserted the breathing tube, said Jiang, a professor of anesthesiology at the University of Texas Health Science Center at Houston.

“You put the tube in but once the patient goes home, you may not know what happens,” he said, “but they go see the ENT.”  

Continuous air pressure monitoring of the tube cuff could alert clinicians to excessive pressure, allowing them to take corrective action, and potentially help reduce tube-related injuries, he said, although neither he nor the ASA provide any kind of endorsement.

“We do not know the exact cuff-pressure cutoff that best maintains tube function while avoiding impairment of blood flow to the tracheal wall,” he said. “Hopefully, this could reduce cuff-related complications.”

Still in the early stages, Babu said the company has raised more than $100,000 so far and is raising additional funds for the next round of development.

And he’s testing the device on pig tracheas as well as scheduling more clinical demonstrations. 

He’s applied for a patent and hopes to get FDA approval by 2028 with an eye on having the product on the market that same year.

The Elgin, South Carolina, native was attending high school when he took a class to become an EMT. 

“I got my EMT certification in high school and started working,” the 20-year-old explains. “That’s where I was first exposed to intubation and the risks.”

Based on his experiences with EMS, he wrote a research paper for school and the idea for the device grew out of that research, he said.

“In EMS, injuries aren’t too big of an issue,” he said. “But I learned more about it and said I think we can do better than this.”

About the size of a cell phone, the unit, which is made of plastic, is used outside the body and is reusable with a disposable tube, he said.

This year, CuffWay was awarded a $25,000 grant from the South Carolina Research Authority to pursue development of the device.

The organization helps start-ups through mentorship, business advice and other expertise in addition to funding, said Javon Jones, a senior SCRA investment associate for the Midlands.

The SCRA has just over 200 members who are involved in advanced manufacturing, energy, scalable software, and life sciences, he said.

“We sit at the intersection of entrepreneurship, academia, and industry to build scalable businesses that create high-paying jobs and more economic opportunity for South Carolina,” Jones said. “Along with member benefits, we help them prepare for investment opportunities.”

Typically, he said, start-ups initially get a $25,000 grant which accelerates to $50,000 to help them scale-up. It’s partially funded through a statewide tax credit program, he said.

The SCRA also recently launched innovation hubs around the state, Jones said. These are clusters of entrepreneurial support organizations designed to impact the state’s economy. One begun in Rock Hill with Winthrop University will be replicated in Aiken, Charleston, Columbia, Florence, and Greenville, he said.    

“We want people to have places in their own regions where they can get help,” he said. “That includes mentorship programs, technical workshops, pitch competitions, and putting partnerships together with economic development organizations.”

The SCRA funding helped Babu build out his prototype and develop a strong advisory team.

“Shrihan has done a great job of building a network in Columbia,” Jones said.

“I had no idea what to do at first,” Babu said. “But I connected with Javon very early, and the biggest thing he was stressing was (an advisory) team, and talking to all those people helped me put together a game plan.”

The company has since become a member of the SCRA as well.

Incorporated in Delaware, CuffWay has team members in Georgia and New York as well as South Carolina who are in the medical-technical start-up space, Babu said. These include Chief Operating Officer Jordan Lisnow, Chief Product Officer Dr. Lawrence Boyd, and Chief Technology Officer Ashwith Jay.

Winning the InnoVision Award came as a complete surprise, Babu said, adding, “That was an insane experience. I didn’t expect to win.”

He also credits the support of his family for his success.

“My parents are always encouraging me, always helping me,” he said.

Upon graduation, Babu plans to work full time on CuffWay.

“FDA approval is the biggest hurdle,” he said. “But I hope to have a product on the market in 2028 – the same year I graduate.”