UltraMIST® System

When a wound forms, the body triggers an inflammatory response as part of the natural healing cycle. While short-term inflammation aids recovery, prolonged or chronic inflammation can disrupt progress and stall wound closure. By reducing persistent inflammation, UltraMIST® helps restore balance in the wound environment, allowing the healing process to advance effectively.

Proper blood flow and vessel dilation are vital for wound repair. UltraMIST® promotes vasodilation, improving circulation and ensuring that oxygen and nutrients are delivered to the wound bed to support faster tissue regeneration.

An excessive bacterial load can significantly slow the body’s natural healing process. Biofilm—a dense layer of bacteria shielded by a self-produced protective coating—further complicates treatment. Because biofilm bacteria remain in an inactive metabolic state, they resist antibiotics, antiseptics, and most antimicrobial agents, making wounds harder to heal. UltraMIST® disrupts biofilm and reduces bacterial presence, creating a healthier wound environment.

Cellular and/or Tissue-Based Products (CTPs), commonly known as skin substitutes, are an important advancement in wound care. However, their effectiveness depends on proper wound bed preparation. UltraMIST® supports this process by conditioning the wound bed and improving acceptance of CTPs for better long-term outcomes.

• Intended Use/Indications

  The UltraMIST® System delivers low-energy ultrasound-generated mist as a safe, non-contact solution for advanced wound care. This innovative therapy cleanses and prepares wounds by breaking down fibrin, slough, bacteria, and exudates, making it especially effective for chronic or difficult-to-heal wounds that have not responded to traditional methods.

• Why Choose Ultramist®?

  • CPT Code 97610 – Recognized by Medicare and Managed Medicare across multiple care environments.
  • Non-Invasive and Pain-Free – An excellent option when sharp or surgical debridement causes discomfort.
  • Highly Versatile – Safe for use over bone, nerves, tendons, and surgical implants.
  • Mobile and Lightweight – Easily transportable for use across different care settings.
  • Insurance-Friendly – Reimbursable in physician offices, outpatient clinics, and home health environments (POS 11, 12, 22, 32).

• Who Benefits Most From Ultramist®?

  UltraMIST® is particularly effective for patients with chronic, non-healing wounds who show little improvement with standard care. Best suited for:

  • Wounds with less than 50% reduction in size after 30 days of conventional therapy.
  • Patients who experience pain during sharp or surgical debridement.
  • Cases where debridement is contraindicated or delayed due to medical risks.

• Clinically Proven Performance

  Since its U.S. launch in 2004, UltraMIST® has been extensively validated in clinical research, including:

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

• Optimal results are typically achieved with 2–3 sessions per week, leading to:

  • Significant reductions in biofilm and bacterial load
  • Lower levels of inflammation
  • Improved blood flow and oxygenation through vasodilation

• Therapy Indications

  UltraMIST® is a low-frequency, non-thermal, non-contact ultrasound therapy (CPT code 97610) approved for use in the treatment of chronic wounds, burns, venous leg ulcers, diabetic foot ulcers, and pressure injuries.

  It may qualify for insurance reimbursement when medically necessary, particularly for patients who:

  • Cannot undergo sharp or excisional debridement
  • Show little or no progress after 30 days of conventional wound care

• Coding And Billing Guidelines

  • CPT 97610 should be billed once per day per treatment session.
  • Documentation must include wound evaluation and a record of ongoing care.
  • Classified by CMS as a “sometimes therapy” code, allowing qualified professionals to provide the service outside a certified therapy plan of care (POC).
  • In hospital outpatient settings, it may be billed without therapy modifiers.
  • When performed under a certified therapy plan by a therapist, proper therapy modifiers are typically required for reimbursement through the Medicare Physician Fee Schedule (MPFS).

• Important Billing Tips

  • Always confirm documentation and billing requirements with your Medicare Administrative Contractor (MAC) or the patient’s insurance provider.
  • Final reimbursement depends on the patient’s plan, policy details, and service setting.
  • Medicare rates are updated annually under the RBRVS fee schedules, but coverage may vary.

• Disclaimer

  This information is provided for general guidance only and should not be interpreted as legal or billing advice. Providers are responsible for accurate coding based on the patient’s condition, procedures performed, and payor guidelines. Coverage is not guaranteed and may change based on updates from CMS or private insurers. Always consult official sources for the most up-to-date requirements.

• References

  • 2025 American Medical Association Current Procedural Terminology (CPT).
  • Centers for Medicare and Medicaid Services (CMS) – 2025 Medicare Physician Fee Schedule (MPFS) Addenda.
  • CMS – 2025 Medicare Outpatient Prospective Payment System (OPPS) Fee Schedule Addenda.
  • CMS – 2025 Medicare Claims Processing Manual.

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Chronic wounds are injuries that do not heal within the expected timeframe, often lasting for weeks, months, or even years. These persistent wounds may lead to:

• Continuous pain
• Increased risk of infection
• Accumulation of dead tissue
• Slowed or stalled healing response

Non-healing wounds may develop due to several underlying issues, including:

• Poor blood circulation
• Diabetes-related complications
• Prolonged or excessive pressure on the skin
• Nutritional deficiencies
• Bacterial infection or high microbial load
• Ongoing inflammation

UltraMIST® Therapy is a non-invasive wound care treatment that uses low-frequency ultrasound delivered through a fine saline mist. This gentle, contact-free technology penetrates deep into the wound tissue to stimulate healing and accelerate recovery.

UltraMIST® supports wound healing by:

• Stimulating cellular activity to re-activate stalled healing
• Breaking down bacteria and biofilm that delay recovery
• Delivering a pain-free, contact-free treatment for patient comfort

UltraMIST® is clinically effective for managing a variety of acute and chronic wounds, including:

• Venous leg ulcers
• Pressure ulcers (bedsores)
• Diabetic foot ulcers
• Deep tissue injuries
• Post-surgical wounds

Each UltraMIST® treatment typically lasts 3 to 20 minutes, depending on wound size and severity. It can be performed as a standalone therapy or combined with other advanced wound care treatments for optimal results.

UltraMIST® is generally safe and well-tolerated. Some patients may experience mild tingling or temporary redness at the treatment site, which usually resolves quickly.