Sometimes the newest medical innovations find their inspiration from old technology. Wilmington startup GO2’s inspiration came from an old-fashioned sewing machine.

GO2 has developed a device whose pumping action improves blood flow in patients. The concept came from a Wilmington physical therapist who was working with a patient troubled by mobility problems. GO2 CEO Jim Hundley Jr. said the physical therapist was trying to find a way to help the patient while the patient remained seated. He thought of an old-fashioned sewing machine powered by a foot pedal.

“He actually used an old sewing machine,” Hundley said. “The patient moved his feet up and down. After using it, he was able to get up and move around.”

The physical therapist worked with an industrial designer to develop a device. He also connected with Hundley’s father, Dr. Jim Hundley Sr., a retired orthopedic surgeon, for medical perspective. The Hundleys licensed the technology from the physical therapist and formed GO2. Roughly two years later, GO2 now has marketing clearance from the Food and Drug Administration, startup funding and a startup competition win in hand as the company brings its new product to market.

There’s more behind the science of the device than simple foot movement. When a person walks, each squeeze of the calf muscles sends blood up the leg and back toward the heart, explained Hundley, who brings to GO2 a background in medical sales and marketing. This pumping action of the calf is sometimes called the “the second heart” and it inspired to the device’s name – CV2, or cardiovascular 2. The “2” refers to the second heart. The device resembles a small box topped by a big pedal. A user pushes down on the device with both feet, flexing the calves. The CV2 pushes the feet back up. GO2 calls this motion “treadling.”

There are already existing technologies available to patients to address circulation problems in the feet or legs. In hospitals, the standard of care is a sequential compression device – a boot or sleeve pumped with  air to compress the legs. But Hundley said that these devices are hot and cumbersome. Electrical stimulation is another option to promote circulation, though that can also be uncomfortable. A lower-tech option is compression hosiery, which can be hard to put on.

Patent for Methodology

The CV2 is protected by a methodology patent. It is considered a medical device and has clearance from the Food and Drug Administration, which has deemed the device equivalent to an exercise bike or treadmill. Hundley says the advantage of treadling is that the motion improves blood flow in a non-fatiguing way. Treadling for 15 minutes, he adds, is the equivalent of walking a mile and a half.

GO2 has done clinical studies to document physiological effects of using CV2. Tests show the device increases venous blood flow up to 300 percent and arterial blood flow up to 900 percent. The company has published two studies documenting the findings. GO2 also conducted an edema (swelling) study and Hundley said that in each and every case the patient had a reduction in pain and swelling. Patients who might need the CV2 include the elderly, the obese, people who have peripheral arterial disease, restless leg syndrome, night cramps or edema in their lower extremities.

GO2 is starting to gain recognition for the CV2. The company was announced last week as one of three winning companies in a contest to find new technologies to treat the aging population. The competition was sponsored by non-profit senior housing and services organization Ecumen and MOJO Minnesota, a group supporting entrepreneurship and innovation. As one of the winners, GO2 will work with Ecumen on a six-month study to gain information to help commercial expansion of the device. MOJO will work with the company to strengthen its business strategy and execution.

Looking for Grants

GO2, which operates from the University of North Carolina Wilmington’s Center for Innovation, has just three employees and Hundley said the company has no immediate plans to add more choosing instead to outsource as much work as possible. CV2 manufacturing is done in China, though Hundley said he explored options for domestic production of the product. GO2 is funded primarily by investments from friends and family.

Last year, the company was awarded a $75,000 loan from Innovation Fund North Carolina, a program that supports North Carolina startups. The company is currently seeking $350,000 from angel investors, which would be used for sales and marketing and additional inventory. The CV2, which is not yet reimbursed by health insurers, sells for $299 from GO2’s website though Hundley said the company is also building relationships with distributors that could sell the device through channels such as independent pharmacies.

In the meantime, GO2 is also pursuing grant funding to support additional clinical studies. The company plans to apply for a $225,000 National Institutes of Health SBIR grant this spring to study the device’s role in addressing diabetes complications. Hundley said some users have reported that the CV2 helped heal leg ulcers. But the the company is holding off on making any claims because it doesn’t yet have clinical data. GO2 plans to pursue clinical data in various indications, which Hundley hopes will win FDA clearance for more applications of the device. That clinical data will also be key for demonstrating CV2’s value to health insurers.

“The more indications we get, the more likely we are to have this reimbursed at some point,” Hundley said.