UltraMIST® System

Discover gentle healing through non-contact ultrasound wound therapy.

UltraMIST® uses low-frequency acoustic wave therapy to support wound healing by minimizing inflammation and eliminating harmful bacteria from the wound bed. It also stimulates angiogenesis, helping new blood vessels form and deliver oxygen and nutrients. By enhancing blood flow through vasodilation, UltraMIST® promotes faster, healthier tissue regeneration. The UltraMIST® System uses low-frequency ultrasound delivered through a noncontact fluid, such as saline, to accelerate healing at the wound site. Healthcare professionals have trusted this advanced therapy for over ten years, and thousands of patients have benefited from it. Clinical data shows patients experienced up to an 80% reduction in pain over four weeks—four times better than standard care. Additionally, wound closure rates reached 41% with UltraMIST®, compared to just 14.3% using traditional methods.

CONDITIONS UltraMIST® CAN HELP TREAT

Clinically proven to accelerate healing, UltraMIST® Therapy is effective for a variety of chronic and acute wounds, including:

Pressure ulcers
Chronic pressure injuries (DTPI, SDTI)
Venous leg ulcers
Diabetic foot ulcers
Cellulitis
Post-surgical wounds or dehiscence
Heel eschar
Stalled or slow-healing wounds
And other complex wound types

*Exceptions: Cancerous lesions, over-pregnant uterus, over-implanted device

SAFETY CONSIDERATIONS

When Not to Use

UltraMIST® should not be used near electronic implants (like pacemakers), over the heart or chest area in such cases, on the lower back during pregnancy, or over cancerous areas.

Possible Side Effects

Patients may experience mild tingling or redness at the treatment site.

Important Usage Notes

UltraMIST® applicators are for single-patient use only to reduce contamination risks. Do not reuse or re-sterilize applicators. Reuse may lead to infection or diminished effectiveness. The wand should never touch the patient’s skin directly. To prevent burns, avoid contact with the metal tip during operation.

BACKED BY PROVEN CLINICAL RESULTS

UltraMIST® Therapy is supported by strong clinical evidence demonstrating its ability to:

This advanced technology delivers measurable healing benefits for chronic and acute wounds

CLINICAL DATA

Inflammation

When a wound occurs, the body initiates an inflammatory response as part of the healing process. While short-term inflammation supports recovery, prolonged inflammation can delay or halt healing. By reducing chronic inflammation, the wound environment can rebalance—helping the body move forward in the healing cycle.

*Data was compiled utilizing MIST® therapy. UltraMIST® is the successor but maintains the same mechanism of action. For more information, please refer to the UltraMIST® therapy instructions for use. 1. Zhao R, Liang H, Clarke E, Jackson C, Xue M. Inflammation in chronic wounds. Int J Mol Sci. 2016;17(12):2085. 2. Escandon J, Vivas AC, Perez R, Kirsner R, Davis S. A prospective pilot study of ultrasound therapy effectiveness in refractory venous leg ulcers. Int Wound J. 2012;9(5):570-578. 3. Yao M, Hasturk H, Kantarci A, et al. A pilot study evaluating noncontact low-frequency ultrasound and underlying molecular mechanism on diabetic foot ulcers. Int Wound J. 2014;11(6):586-593.

Vasodilation

Healthy blood flow and vessel dilation are essential for effective wound healing.Healthy blood flow and vessel dilation are essential for effective wound healing.

*Data was compiled utilizing MIST® therapy. UltraMIST® is the successor but maintains the same mechanism of action. For more information, please refer to the UltraMIST® therapy instructions for use. 1. Liedl DA, Kavros SJ. The effect of mist ultra-sound transport technology on cutaneous microcirculatory blood flow. Abstract. SAWC, 2001. 2. Honaker J, Forston M. Adjunctive use of noncontact low-frequency ultrasound for treatment of suspected deep tissue injury: a case series. J Wound Ostomy Continence Nurs. 2011;38(4):394-403. 3. Honaker JS, Forston MR, Davis EA, Wiesner MM, Morgan JA. Effects of noncontact low-frequency ultrasound on healing of suspected deep tissue injury: A retrospective analysis. Int Wound J. 2013;10(1):65-72. 4. Thawer HA, Houghton PE. Effects of ultrasound delivered through a mist of saline to wounds in mice with diabetes mellitus. J Wound Care. 2004;13(5):1-6. 5. Yao M, Hasturk H, Kantarci A, et al. A pilot study evaluating noncontact low-frequency ultrasound and underlying molecular mechanism on diabetic foot ulcers. Int Wound J. 2014;11(6):586-593.

Bacteria

Excessive bacterial presence slows the body’s natural wound healing process.

Biofilm is a dense layer of bacteria protected by a self-made coating that shields it from treatment. Its inactive metabolic state makes it highly resistant to antibiotics, antiseptics, and other antimicrobial solutions—making wound healing significantly more difficult.

*Data was compiled utilizing MIST® therapy. UltraMIST® is the successor, but maintains the same mechanism of action. For more information, please refer to the UltraMIST® therapy instructions for use. 1. Kavros SJ, Schenck EC. Use of noncontact low-frequency ultrasound in the treatment of chronic foot and leg ulcerations: a 51-patient analysis. J Am Podiatr Med Assoc. 2007;97(2):95-101. 2. Serena T, Lee SK, Lam K, Attar P, Meneses P, Ennis W. The impact of noncontact, nonthermal, low-frequency ultrasound on bacterial counts in experimental and chronic wounds. Ostomy Wound Manage. 2009;55(1):22-30. 3. Kavros SJ, Wagner SA, Wennberg PW, Cockerill FR. The effect of ultrasound mist transfer technology on virulent bacterial wound pathogens. Abstract. Presented at SAWC 2002. 4. Seth AK, Mustoe TA, Galiano et al. Noncontact, low-frequency ultrasound is an effective therapy against Pseudomonas aeruginosa-infected biofilm wounds. Wound Repair Regen. 2013;21(2):266-274.

Enhanced Effectiveness of Skin Substitutes with UltraMIST® Therapy

The use of skin substitutes—now referred to as Cellular and/or Tissue-Based Products (CTPs)—is rapidly advancing in wound care. Since these products vary widely by application, preparing the wound bed properly is critical to their success. UltraMIST® Therapy plays a key role by helping improve wound conditions for better acceptance and outcomes. How UltraMIST® Supports CTP Success Noncontact, Low-Frequency Ultrasound Technology UltraMIST® uses gentle ultrasound waves to penetrate below the wound surface, enhancing healing and preparing the site for skin substitute application. Key Wound Conditions and UltraMIST® Benefits

No Infection UltraMIST® reduces bacteria and disrupts biofilm by creating mechanical stress that damages bacterial cells, lowering the risk of infection.
Controlled Inflammation The therapy decreases harmful pro-inflammatory cytokines, helping to restore balance and reduce chronic inflammation in the wound environment.
Improved Blood Flow By boosting vasodilation, UltraMIST® increases oxygen and nutrient delivery to the wound bed, supporting tissue regeneration.
No Active Bleeding UltraMIST® stimulates healing without touching or disturbing the wound, making it ideal for fragile skin and sensitive wounds.
Tissue Clean-Up Dead tissue and slough are naturally broken down and cleared over time, aiding the body’s normal healing process without harsh manual removal.

Preparing Wounds for CTP Placement with UltraMIST®

Patient Profile A 52-year-old woman had a venous leg ulcer that remained unhealed for three months. Initial care involved six weeks of multilayer compression therapy.
Therapy Approach UltraMIST® Therapy was introduced, with six sessions delivered over a two-week span alongside continued compression treatment, followed by the application of Apligraf®.
Result The combination of UltraMIST®, compression wraps, and Apligraf® led to successful wound healing.

Suggested Protocol Apply UltraMIST® Therapy 3 to 6 times before placing any Cellular and/or Tissue-Based Product (CTP) for optimal wound bed preparation. After Treatment Outcomes

ECONOMIC DATA

The UltraMIST® Guide

INTENDED USE/INDICATIONS

The UltraMIST® System delivers low-energy ultrasound-generated mist for advanced wound care. This gentle, non-contact approach cleanses wounds and supports healing by breaking down fibrin, slough, bacteria, and exudates—making it ideal for patients with wounds that are hard to treat through traditional methods. Why Choose UltraMIST®?

CPT Code 97610 – Recognized under Medicare and Managed Medicare across multiple care settings.
Pain-Free and Non-Invasive – Ideal for wounds where traditional debridement causes discomfort.
Versatile – Safely usable over bone, nerves, tendons, and surgical implants.
Mobile-Friendly – Lightweight and easy to transport across healthcare facilities.
Insurance-Friendly – Reimbursable in physician offices, outpatient clinics, and home health environments (POS 11, 12, 22, 32).

Who Benefits Most from UltraMIST®? UltraMIST® is best suited for patients with chronic, non-healing wounds who haven’t shown progress in the past 30 days. This includes:

Wounds showing less than 50% size reduction with standard care.
Individuals experiencing pain during sharp or surgical debridement.
Cases where debridement is contraindicated or delayed due to clinical risk.

Clinically Proven Performance Since its U.S. market launch in 2004, UltraMIST® Therapy has been validated through robust clinical research, including:

3 Meta-analyses
8 Randomized controlled trials
3 Prospective studies
4 Retrospective reviews
4 Observational analyses

Best results are seen when used 2–3 times per week, showing:

A significant reduction in biofilm and bacteria
Lower inflammation levels
Improved blood flow and oxygenation via vasodilation

The UltraMIST® Reimbursement Guide

Therapy Indications UltraMIST® is a low-frequency, nonthermal, and non-contact ultrasound therapy (CPT code 97610) used to support healing in wounds, burns, and ulcers—including venous leg ulcers and diabetic foot ulcers. It may be eligible for insurance reimbursement when deemed medically necessary. Best suited for patients who:

Cannot undergo sharp or excisional debridement and have not responded to conventional methods.
Show little or no healing progress after 30 days of standard wound care.

Note: CPT 97610 reimbursement is influenced by RVUs (Relative Value Units), a key part of Medicare’s Resource-Based Relative Value Scale (RBRVS). Medicare rates are determined using updated annual fee schedules, but final payment varies depending on the patient’s insurance plan, policy details, and how the service is delivered. For accurate billing and reimbursement information, healthcare providers should always check directly with the patient’s insurance carrier. Coding and Billing Guidelines CPT 97610 should be billed once per day for each treatment session. Proper documentation is essential and must include wound evaluations and ongoing care instructions. The Centers for Medicare and Medicaid Services (CMS) classifies CPT 97610 as a “sometimes therapy” code. This means that qualified healthcare professionals can administer the service outside of a certified therapy plan of care (POC). For hospital outpatient settings, it can often be billed without therapy modifiers. However, if performed under a certified therapy plan by a therapist, appropriate therapy modifiers are typically required for reimbursement through the Medicare Physician Fee Schedule (MPFS). Billing Tip: Always confirm documentation and billing guidelines with your Medicare Administrative Contractor (MAC) or the patient’s insurance provider to ensure compliance with current requirements. Disclaimer: This information is for general guidance only and should not be interpreted as legal or medical billing advice. Providers are responsible for accurately coding services based on the patient’s condition, procedures, and payor guidelines. Medicare policies and fee schedules may change, and coverage is not guaranteed. Always consult official sources or your Medicare contractor for up-to-date requirements. This information is based on CMS updates as of February 2025 and may be subject to change. References:

2025 American Medical Association Current Procedural Terminology (CPT). CPT is a registered trademark of the AMA. The AMA assumes no liability for data contained or not contained herein.
Centers for Medicare and Medicaid Services. 2025 Medicare Physician Fee Schedule (MPFS) Addenda.
Centers for Medicare and Medicaid Services. 2025 Medicare Outpatient Prospective Payment System (OPPS) Fee Schedule Addenda.
for Medicare and Medicaid Services. 2025 Medicare Claims Processing Manual.

PATIENT MARKETING

UltraMIST® MOA Video

FREQUENTLY ASKED QUESTIONS

What Are Chronic Wounds?

Chronic wounds are injuries that fail to heal within a typical timeframe—lasting weeks, months, or even years. These wounds can result in:

Ongoing pain
Infection
Presence of dead tissue
Slower healing response

What Causes Chronic Wounds?

Non-healing wounds may be triggered by:

Poor circulation
Diabetes
Excessive pressure
Nutritional deficiencies
Infections or high bacterial load
Inflammation

What Is UltraMIST® Therapy?

UltraMIST® is a non-invasive wound care therapy that uses low-energy ultrasound delivered through a fine saline mist. It reaches deep into the wound tissue to accelerate healing—without direct contact.

How Does UltraMIST® Work?

UltraMIST® uses ultrasound waves to:

Re-activate stalled healing by stimulating cells
Break down bacteria that may delay recovery
Deliver pain-free treatment since there is no physical contact with the wound

What Types of Wounds Can UltraMIST® Treat?

UltraMIST® is effective for many chronic and acute wounds, including:

Venous leg ulcers
Pressure ulcers
Diabetic foot ulcers
Deep tissue injuries
Surgical wounds

How Long Does UltraMIST® Therapy Take?

Each treatment session lasts between 3 to 20 minutes, depending on the wound size. UltraMIST® can be used as a standalone treatment or combined with other clinical wound care therapies.

Are There Any Side Effects?

UltraMIST® is generally well-tolerated. However, some patients may experience mild tingling or redness at the treatment site.

Is UltraMIST® Safe for Everyone?

Patients with pacemakers, metal implants, or who are pregnant should speak with a healthcare provider before receiving treatment.

Is UltraMIST® Therapy Painful?

UltraMIST® Therapy is a non-contact, painless solution, ensuring comfort throughout the healing process.