Middleton’s NitricGen offers new hope for diabetics

It’s one of those “oh, wow” statistics that at first glance seems all but impossible to believe. Each year, diabetes sufferers endure more amputations than did all American soldiers in every major conflict since the start of the Civil War.

While there’s some evidence that diabetes patients’ prospects are slightly improving in this respect, the toll is nevertheless sobering: Year after year, about 80,000 Americans receive lower-extremity amputations as a result of foot ulcers.

That’s a number that Duncan Bathe would like to see go down – preferably sooner rather than later.

 “… there would be blue babies, and you would give them nitric oxide and they would turn pink right in front of your eyes.” – Duncan Bathe, president, NitricGen

As president of Middleton’s NitricGen, Inc., Bathe is pouring his heart and soul into the problem, and people are beginning to take notice. Count among them the folks at the Wisconsin Economic Development Corp., which recently certified NitricGen for its Qualified New Business Venture tax credits program – a statewide initiative that makes investors in qualifying companies eligible for a 25% tax credit on the amount they invest in the businesses.

While NitricGen is still an early stage company that has yet to launch a product, its eNO Generator could ultimately prove revolutionary in the treatment of foot ulcers, potentially saving many patients from experiencing the sheer trauma of amputation. The concept is simple, and relies on one of the most abundant resources our planet has to offer: air.

The device is designed to break down oxygen and nitrogen in room air and transform it into nitric oxide, which has been shown to be effective in the treatment of chronic wounds.

Science on their side

Sounds easy enough, but the problem lies in finding an efficient way to do it. In the past century, two major breakthroughs helped put the science at the precipice. In the early 20th century, two German chemists, Fritz Haber and Carl Bosch, proved it was possible to produce ammonia on an industrial scale by combining atmospheric nitrogen and hydrogen. Both scientists won Nobel Prizes for their work, and showed that similar processes that rely on sourcing the gases naturally present in the atmosphere are possible. Then, in 1998, three researchers, Robert Furchgott, Louis J. Ignarro, and Ferid Murad, won Nobel Prizes for discovering that nitric oxide is an important signaling molecule in the cardiovascular system.

 

It was when nitric oxide first started showing promise as a drug that Bathe became interested in its enormous potential.

“I worked on nitric oxide when drug development began back in 1993,” said Bathe. “So the generation of nitric oxide is not unknown. The hard part is you have to make [the device that generates it] into something that is an acceptable size and power, so I guess the novelty that we’ve brought to the table is the ability to take this concept and make it into something that’s the size of a small shoebox.”

Room for improvement

The pressing need for a new way to treat diabetic foot ulcers is no secret to diabetics, their loved ones, or the medical community. According to Bathe, current therapies used to treat ulcers are only about 43% effective – and are more than a little disruptive to patients’ lives.

“Standard care is called moist wound dressing,” said Bathe. “So they basically use dressings and clean up the ulcers and dress them. Sometimes they put them into special boots that take the pressure off the ulcer. Diabetes starts shutting down your peripheral extremities, and there’s a loss of that peripheral blood flow. The nerves start dying off, they lose the capillaries – they may have a cut and not even know they have a cut – the cut gets infected, and they start getting this ulceration. It’s a spiraling process.

“The next level up, which is a third adjunct therapy, would be vacuum therapy, which is where they basically put a special bandage on the wound area and put a vacuum on it, and that’s weeks of walking around with a vacuum pump on you, 24 hours a day.”

It remains to be seen whether NitricGen’s eNO Generator turns out to be a miracle solution and a new standard for care, but Bathe and his partners are extremely encouraged by the potential nitric oxide holds.

“We’re all very fortunate that we started with nitric oxide when it was first used on newborn babies,” said Bathe. “You could actually look and there would be blue babies, and you would give them nitric oxide and they would turn pink right in front of your eyes. … And that is a fantastic feeling to be part of that. So from a rewards standpoint, it’s hugely rewarding that you can continue to make a difference in other people’s lives. Most of us, engineers, don’t really impact people’s lives normally, but we have the opportunity now where we can actually make a huge impact on people’s quality of life if this works.”

A marathon, not a sprint

Before they can make a dent in diabetes patients’ suffering, however, Bathe and company have plenty of hurdles to clear.

“There are several challenges,” said Bathe. “One is you want to make it into a medical device. It’s a huge challenge by itself because of regulation. It’s just the nature of the business. If you’re going into the medical business, that’s what you do. And then obviously, the other one is how do you do it efficiently? How do you make it so it can be used simply and efficiently, that it can be used by somebody at home and isn’t too big and heavy to be carried around?”

 

Bathe says he thinks his team has worked out many of the technological kinks, but that huge regulatory wall still needs to be scaled.

“We’ve taken our technology and we’ve gotten it down to a point where we think it’s useful and works,” said Bathe. “The next phase through that is we have to bring that technology up to the point where it can be used on humans, and it has to go through a suite of medical safety standards, risk measurements, risk control methods, and everything else. So all these are requirements to get a device approved with the FDA. And unfortunately, that’s a long process.”

Finding the requisite funding is also a challenge. First, the device has to go through a full-phase clinical trial, which requires time and money.

“There’s a lot of indicators out there that say it should work, but like every new business, there’s an unknown risk there,” said Bathe. “And so at some point you have to convince investors that it’s a reasonable risk, and that’s what the preclinical work does for you.”

State recognition

Obviously, qualifying for the state’s QNBV program could be a big leg up for NitricGen when it comes to attracting investment, but it’s notable that this is not the company’s first waltz. Earlier this year, the company was one of 12 finalists in the Wisconsin Governor’s Business Plan Contest.

“It was an interesting experience,” said Bathe. “They get you to meet a lot of new people. I think the biggest benefit out of that was you got to meet people who were involved in business as well. You also get to rub shoulders a bit with potential investors.”

From an emotional standpoint, it was also nice to know the company was on the right track business-wise, said Bathe.

“It obviously felt good that we had something that people believed in. It wasn’t just from a technology standpoint, it was that we had a business proposition that was viable.”

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