NitricGen developing nitric oxide device to heal chronic wounds

By Kelsey Olson

NitricGen Inc. and its team of experts are developing a product for diabetes patients suffering from chronic foot ulcers. The shoebox­sized eNOGenerator generates nitric oxide from the air in the room and administers a controlled dose of gaseous nitric oxide the wound. Fifteen years of research has shown that nitric oxide is an essential, natural molecule that is necessary in the wound healing process.

Annually, 900,000 patients suffer from diabetic foot ulcer wounds. About 80,000 of these require an amputation, which is roughly 4 percent of diabetics in the US.

“It is a grim market,” said Duncan Bathe, president of NitricGen. “For some reason it (nitric oxide wound healing technology) hasn’t taken off in America; I think because it’s a difficult, long­term project.”

Madison­based NitricGen is taking on the challenge of bringing a nitric oxide healing device to market. NitricGen is planning to market the eNOGenerator to patients who are suffering from chronic foot ulcers, primarily those who have not responded to the previous treatment options.

In the United States, the total cost of both diabetic foot ulcer care and amputations was more than $11 billion in 2001. As a further indicator of where the market is headed, the number of patients in the United States with diabetes in 2010 has more than tripled since 1980, and is expected to double again by 2050.

Indirect competitors have brought treatment devices and procedures to the chronic wound treatment market, however their downfalls include being more expensive, less effective, inconvenient, and time consuming than the eNOGenerator is projected to be.

One of these is the negative pressure wound therapy, and the other is the hyperbaric oxygen treatment. The treatment for negative pressure wound therapy involves wearing bulky equipment for 24 hours per day for 90 days, with low healing rates. The hyperbaric oxygen treatment requires eight weeks of daily 90­minute treatments in a pressurized chamber where the patient breathes 100 percent oxygen, usually with a face mask. This treatment is expensive, time consuming, and may require long­distant travel to a specialized clinic. With only a two­minute daily treatment for three weeks, the eNOGenerator is expected to have improved effectiveness, ease of use and convenience for patients.

With the help of investor funding, NitricGen Inc. is prepared to move development of the eNOGenerator forward, while meeting FDA regulations. NictricGen has completed early clinical trial testing, however Duncan declined to discuss results. NitricGen plans to work with the FDA to agree on what is necessary for device testing and on the procedure for a human clinical trial.

NitricGen hopes to acquire FDA approval by March 2018. From there, the company will launch a sales force and contract a manufacturer for the eNOGenerator. NitricGen plans to have its first full year of sales in 2019, aiming for a positive profit margin after five years.

The management team at NitricGen Inc. has been working together for more than 20 years and has more than 60 years of experience in developing medical technologies, obtaining patent protection and FDA approvals, managing new product introductions, and founding and managing a start­up company to the point of exit through acquisition.

NitricGen presented to potential investors and others during the Wisconsin Early Stage Symposium in November.

— Olson is a student at the University of Wisconsin­Madison majoring in Life Sciences communication.