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Nu-Med Plus tweaks NO delivery system pre-FDA 510(k) submission

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Nu-Med-PlusNu-Med Plus said today it is making tweaks to its delivery system prior to applying for FDA 510(k) submission.

The Salt Lake City, Utah-company said it is incorporating its newly developed nitric oxide generation and delivery system into its existing hospital delivery model in hopes of speeding up approval.

Nu-Med Plus said the next-generation system “takes advantage of room temperature operation and easier handling.”

“It was a straight forward task to change the delivery system in our Hospital model over to our new proprietary Nitric Oxide generator. We believe that this will simplify the 510k submission and speed up the approval of this product,” CEO Jeff Robins said in prepared remarks.

Last December, Nu-Med Plus said it received interim funding to accelerate the completion of its inhaled nitric oxide clinical device designed for congenital pulmonary hypoplasia and neonatal hypoxia therapy.

Nu-Med Plus said research is being undertaken to explore other uses for the device and applications that require vasodilation and increased delivery of oxygen to diseased and injured tissue.

The company said its small, multi-dose in-development INO clinical device is being designed to be able to deliver high-purity inhaled nitric oxide in single-dose treatments for therapeutic uses.

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