SALT LAKE CITY — A Utah biotechnology company says it has developed a device designed to make blood transfusions safer and more effective for recipients while also giving donated blood a longer shelf life.
Nu-Med Plus, headquartered in Salt Lake City, has applied for a patent for a product it has developed which pre-treats stored blood with nitric oxide, revitalizing its durability and further protecting patients from the risk of transfusion complications such as heart failure, hypoxia and infection.
"What this product does is (it) basically reinvigorates the blood so you could have oxygenation at the same level as if you had fresh blood," said Tom Tait, co-inventor of the delivery device and vice president of scientific advancement at Nu-Med Plus. "It can extend that range of what that blood can do for you as it gets older."
Tait said nitric oxide occurs naturally in a person's blood when it is inside their body, but gradually dissipates over time in donated blood. Because of that, for some patients "what happens is you get a lack of oxygen" in the blood used in the transfusion, he said. Federal regulations do not permit blood that has sat unused for more than 42 days to be used in a transfusion.
With donated blood that is specially infused with nitric oxide, Tait said, the idea is that "they get greater oxygenation, (which) prevents the hypoxia — the lack of oxygen that occurs during transfusions."
"It would certainly be an additional safety factor," he said.
Tait said he is confident the patent application, first announced in November, will be successful.
"Typically it takes about 18 to 24 months. … We expect it to go through," he said.
Jeff Robins, CEO of Nu-Med Plus, said the device's success would have "huge" implications for clinical blood donations long term. But more immediately, he said, it would be employed "for research use."
Before filing what is called a new drug application with the Food and Drug Administration and eventually putting it on the market, Tait said, the device will need to be clinically tested as "a safety check (which) shows the efficacy of the product," as well as demonstrates its safety.
Nu-Med Plus said in a release it "will now seek enrollment in further studies to investigate (the device's) efficacy."
Robins said he expects when the product is eventually put to use to improve the quality of blood used by transfusion patients, it could be especially helpful in making international blood donation more realistic in a larger number of scenarios.
Currently, Robins said, because of blood's short shelf life, there are "shipping constraints" making it difficult for an American to donate blood to a patient in Africa, for example.
"By the time it gets there (it may) not have the components that you really want," he said.
In fact, many people in third-world countries currently use blood donations which "go past the usage date" recommended, Robins said, and he believes the new technology could help them to not have to resort to that by lengthening the amount of time in which they are efficacious.
Additionally, the device could have implications for the roughly 300,000 patients in the United States who receive at least one donated blood unit that has sat in storage for more than 30 days, relatively close to the federal time limit for unused blood, Robins said. Close to 5 million Americans are estimated to need blood transfusions annually, according to the National Heart, Lung and Blood Institute.
While Nu-Med Plus expects its device to lengthen the viability of donated blood, Robins said the more precise question — "how long of a timeframe can you extend it (for)" — remains.
Although in some circumstances the technology could benefit people recovering from acute injuries, improving the quality of the donated blood by keeping nitric oxide levels high is likely to be of most benefit to people with compromised immune systems and chronic conditions who especially need the donated blood to perform well, Tait said.
"That's where the product really starts to shine," he said.
Tait said he envisions a future for the device in which "you could put it theoretically right next to the patient and 'nitroxylate' the blood right as it goes into the patient."
Robins said it is also possible the company could eventually produce a "diffusion device that could be operable" at the hand of any physician, though such a product would be "second generation."
The product is also intended to allow nitric oxide to be "diffused in … at any time (during) the storage" if needed, according to Robins.
Tait said the product took about a year to develop until the company concluded it was ready for a patent application.
"(The challenges) were all surmountable, which is a good thing," Tait said. "It turned out to be a great product. That's even better."
Nu-Med Plus, founded in 2011, specializes in research into nitric oxide's potential "therapeutic use," and delivery systems for it, the company explained in a recent release.
"Inhaled nitric oxide has already been proven to stabilize blood pressure, open airways, fight infections and blood clots, combat aging and treat erectile dysfunction," says the release.