I-Flow Corporation, developer of ambulatory drug delivery systems for pain management and infusion therapy, received FDA 510(k) clearance for its oxygen enriched wound dressing. The company set up a wholly-owned subsidiary, AcryMed, to commercialize the product.
With the clearance, I-Flow can commence clinical studies. If all goes as planned, the product will be available in the second half of ‘09.
The oxygen enriched dressing supplies oxygen and better manages moisture. The product is composed of a material that chemically generates and captures oxygen.
“We are excited about this new product, which we believe will drive a paradigm shift toward the use of oxygen enrichment for wound care,” said Donald Earhart, I-Flow’s CEO.
Supplemental oxygen, delivered by hyperbaric chambers, has been shown to accelerate wound healing. I-Flow’s dressing, indicated for topical application to burns, acute and chronic wounds, could be beneficial to patients that do not have access to hyperbaric oxygen.
There are potential marketing synergies with I-Flow’s other offerings. ON-Q, I-Flow’s principal product, delivers local anesthetic continuously to the surgical site. Wound care patients, especially burn patients, suffer enormous pain.