IothaFoam™
A moist, iodine-releasing foam dressing designed to clear biofilm while staying compatible with healing tissue. Already manufactured in full size by a U.S. medical foam converter.
Used like any foam dressing.
No new workflow for nurses and wound care teams: open the pouch, cut to size, apply.
Made in Ohio. Seven steps, one of them chemistry.
Everything except the iodine bath is standard medical-foam converting — so scale means more batches and a second shift, not new capital equipment.
- 01FoamOpen-cell medical polyurethane
- 02Pre-wetPrepared for uptake
- 03IodinateThe only chemistry step
- 04DryControlled, to spec
- 05LaminateBreathable film
- 06Cut25 × 25 cm
- 07PouchSealed moist, labelled
510(k). FDA has already reviewed the test plan.
Class II wound dressing · Pre-Submission Q253783 complete · predicate and test plan agreed. No clinical trial required for clearance.
The dressing is the first product. The chemistry is the company.
Manufactured; heading into the 510(k) test program.
Additional sizes and shapes on the same foam after first clearance.
A sustained-iodine Foley catheter on the same science; patent in progress. About 560,000 catheter-associated urinary tract infections occur each year in the U.S.
Designed for spray-on skin and cell-therapy workflows, where silver sulfadiazine is already excluded.