FDA Pre-Submission complete · 510(k) filing planned for 2027
Patent-pending technology

Iodine that kills bacteria and spares the wound.

IothaFoam™ is an iodine-releasing foam wound dressing designed to clear biofilm while staying compatible with the cells a wound needs to heal.

$28B–$97B
Medicare spending on wounds, every year
8.2M
Medicare patients with a wound or wound infection each year
78%
of chronic wounds carry biofilm — which today's dressings do not clear
$5B → $8.6B
U.S. advanced wound care, 2024 → 2034
Sources: Nussbaum et al., Value in Health 2018 · Malone et al., J Wound Care 2017 · Global Market Insights 2025; Grand View Research 2025.
IothaFoam in 60 seconds

See how it works.

The problem

Hard-to-heal wounds are a biofilm problem.

Clinicians have long had to choose between dressings that fight infection and dressings that let tissue heal. IothaFoam is designed so they don't have to.

Clinician applying a foam dressing in a wound clinic (illustrative)
Silver is losing

Today's default kills planktonic bacteria — and the keratinocytes and fibroblasts that heal — yet is weak against established biofilm. Resistance is now documented.

Iodine works — in a window

Free iodine kills bacteria, biofilm, viruses and fungi. Too little does nothing; too much harms tissue. The trick is holding the wound inside that window.

That window is our design

An open-cell polyurethane foam that releases iodine slowly, for days between changes — not hours. Patent pending: US 2025/0064645 A1.

Exploded view of IothaFoam: breathable film, iodinated open-cell foam, and the wound bed
How it works

Three layers. One job.

A breathable film over an iodinated open-cell foam. The foam's cells hold the iodine and release it steadily into the wound bed — enough to act on biofilm, below the level that harms healing tissue.

Where we are

From prototype to 510(k).

Product status →
DONE
FDA Pre-Submission

Q253783 complete — predicate and test plan agreed. Class II 510(k) pathway.

DONE
Manufactured

Full-size dressings made by a U.S. medical foam converter.

NEXT
510(k) filing

Planned for Q2 2027, after the verification test program.

IN PROGRESS
Defense Health Agency

Responding to the DHA's open solicitation for this device class.

Eric G. LeVeen, MD, FACS
Surgeon-founded

For more than 40 years, Dr. LeVeen had to choose between dressings that fight infection and dressings that let tissue heal. IothaFoam is built so clinicians no longer have to make that choice.

Eric G. LeVeen, MD, FACS · Founder, CEO & Chief Medical Officer
Son of Harry H. LeVeen, MD, inventor of the LeVeen shunt: two generations of surgical invention.

Investing in medtech, or working in wound care or military medicine? Let's talk.

Get in touch
IOTHANE MEDICAL
1515 El Camino Real, Suite D, Palo Alto, CA 94306
CAUTION: IothaFoam™ is an investigational device. It has not been cleared or approved by the U.S. Food and Drug Administration and is not available for sale.
IothaFoam™ is a trademark of IOTHANE Medical, Inc. Patent pending (US 2025/0064645 A1). Content on this site is for general information only and is not medical advice. Images are illustrative.
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