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ULTRAMIST® TECHNOLOGY

The UltraMIST® System Therapy Developed for Evidence-Based Wound Care,  Perfect for Multiple Aesthetic Applications

Noncontact, Low-Frequency Ultrasound Therapy Has Been Proven to Expedite Healing

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FDA Approved UltraMIST Therapy has been clinically demonstrated to promote healing across a wide range of chronic and acute wounds. This is what makes UltraMist perfect for multiple Aesthetic Applications. The UltraMIST System delivers low-frequency ultrasound to the treatment site without touching the skin using a fluid (such as saline) in a specially designed Applicator producing a low energy ultrasound-generated mist.

 

This Ultrasound Technology Based UltraMist system accelerates healing through cleansing and maintenance debridement by the removal of fibrin, yellow slough, tissue exudates, and bacteria while promoting the production of collagen by compressing and stretching cell membranes. UltraMist also promotes regeneration and vasodilation increasing Oxygen to the cells stimulating the damaged areas and creating Angiogenesis.

 

Low intensity pulsed ultrasound accelerates macrophages that release growth factors including VegF and PGDF or Platelet Derived Growth Factors.  VegF is essential to healthy blood flow and regulation of nutrients to skin and hair follicles. Similar to PRP but “without painful needles,” PGDF or Platelet Derived Growth Factors enhance the removal of damaged tissue by increasing Neutrophil counts. Neutrophils remove bacterial and fungal pathogens through a process known as phagocytosis.

 

UltraMist also lyses the Bacterial Cell Wall on skin surfaces resulting in a reduction of bacteria that can interfere with the healing process.

 

Administered by trained healthcare personnel to thousands of patients for more than a decade and supported by a vast array of clinical evidence, the UltraMIST System’s Ultrasound therapy promotes healing by controlling inflammation and reducing bacteria while increasing angiogenesis. Further, to promote healing, it increases perfusion through vasodilation, ultimately increasing oxygen and nutrients to the tissue.

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How UltraMIST Works

In action, the UltraMIST System mechanically removes barriers and promotes healing in a wide range of wound types. Indications include, but are not limited to, diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical, burn, and deep tissue injuries. It also reduces and removes a wide range of bacteria, including biofilms, while preserving healthy structures.

Key Benefits of UltraMIST Therapy

  • Increased Perfusion and Arteriogenesis​ Aid Healing
    PACE® treatment leads to an increase in blood perfusion. As the PACE® shockwaves penetrate the microcirculatory system, there is an immediate change in local blood flow in the treated area. Li et al. determined that local blood perfusion increased from two to eight hours after treatment due to the vasodilation (increasing diameter) of preexisting vessels.1 Research performed at the Cleveland Clinic using Doppler readings to measure blood flow in treated tissue showed an increase in blood perfusion and vessel density 24 hours after treatment.2 This increase in perfusion is important since ischemia is often associated with impaired healing.3
  • Bacterial Biofilms Disruption Allows Antibiotics to Penetrate
    Antibiotic-resistant bacterial colonies often produce biofilms. A biofilm is a defense mechanism that creates a physical protective barrier against antibiotic treatment. Wanner et al. concluded that shockwave treatment can break up physical biofilm barriers and allow antibiotics access to entrenched bacteria so bacterial colonies may be eradicated.4 SANUWAVE® conducted bench testing to assess the effect of shockwaves on Staphylococcus aureus (Gram-positive bacterium) and Pseudomonas aeruginosa (Gram-negative bacterium) biofilms, which showed that shockwaves removed completely the viable bacterial biofilms from the shockwave exposed surfaces.
  • Inflammatory Response​ Leads to Cell Proliferation
    An immediate inflammatory response is apparent after PACE® treatment. Researchers at the Cleveland Clinic reported a decrease in rolling and sticking leukocytes (white blood cells) and an increase in transmigrating leukocytes moving through the vessel wall and into the treatment area.5 Increasing leukocyte activation assists in the inflammatory phase of wound healing by triggering the release of pro-angiogenic factors. After shockwave treatment, wounds move much faster through the inflammatory phase6 when compared to the normal inflammatory process.7
  • Altered Cytokine and Chemokine Expression Promotes Healing
    Studies show that the early pro-angiogenic and pro-inflammatory responses to PACE® treatment are accompanied by significantly increased expression of both CD31 and angiogenesis pathway-specific genes, including ELR-CXC chemokines (CXCL1, CXCL2, CXCL5), CC chemokines (CCL2, CCL3, CCL4), cytokines (IL-1B, IL-6, G-CSF, VEGF-A), matrix metalloproteinases (MMP3, MMP9, MMP13), hypoxia-inducible factors (HIF-1a), and vascular remodeling kinase (Mst1) as early as six hours and up to seven days post-treatment.2,6,7 This may be evidence of an immediate and long-term angiogenic effect and of a jump start of inflammatory healing response that moves chronic wounds to a normal healing cascade of events. Further, PACE® treatment significantly decreased neutrophil and macrophage (white blood cell) infiltration into the wound, attenuating both CC- and CXC-chemokines at the wound margin.6 This may indicate a change from a chronic, nonhealing wound to a natural healing state. Shockwave treatment was found to decrease the rate of apoptosis (programmed cell death) to normal levels. Wang et al. reported a statistically significant decrease in TUNEL (indicator of apoptosis) after PACE treatment.8
  • Mechanical Forces Upregulate Growth Factors
    At a cellular level, PACE® treatment applies mechanical forces to individual cells in the treated tissue. The cells respond to these mechanical forces through cellular expression: Pro-angiogenic and cellular proliferation factors such as endothelial nitric oxide synthase (eNOS), vascular endothelial growth factor (VEGF), von Willebrand factor (vWF), proliferating cell nuclear antigen (PCNA), epidermal growth factors (EGF), and others are upregulated. These factors start a cascade of cellular activities that cause an increase in cellular proliferation and tissue regeneration and have been shown to persist for up to 12 weeks.9
  • Outperforms Topical Vascular Endothelial Growth Factor (VEGF) in Angiogenesis
    The pro-angiogenic factors released in response to PACE® treatment lead to new blood vessel formation resulting in the creation of new capillary networks in the treated tissue. Vascular endothelial growth factor (VEGF) is related to the growth of new blood vessels that allow prefusion improvement in a wound and periwound region. Wang et al. reported an increase in VEGF after PACE® treatment.8 Davis et al. reported that by Day 7, shockwave treatment created a greater number of blood vessels versus untreated controls.7 Another series of studies compared the effects of shockwave treatment with a direct gene therapy and VEGF application in ischemic tissue.10-12 The shockwave treatment actually outperformed direct topical VEGF application in these studies.
  • Granulation Stimulation Factor Increases
    Cellular proliferation is one of the most noticeable stages of wound healing: Cells divide and cover the wound surface to close the wound. This process begins with a granulation tissue phase that builds vascularized tissue in the wound defect. Proliferating cell nuclear antigen (PCNA) is a factor related to cellular replication and repair machinery indicating that this stage of wound healing is progressing. Wang et al. reported a statistically significant increase in average PCNA levels after PACE treatment.8 This finding indicates that PACE treatment may accelerate wound granulation. Stojadinovic et al. reported marked granulation tissue development on post-treatment Day 4.7 Saggini et al. reported that the percent of granulation tissue increased significantly in the wounds of patients after being treated with shockwaves. 13
  • Wound Closure and Re-Epithelialization Accelerate
    Results of a recent Phase III clinical trial strongly suggest that the dermaPACE® System has an effect in the stabilization, size reduction and, with time, complete re-epithelialization of chronic wounds, specifically diabetic foot ulcers. Clinically significant re-epithelialization of greater than 90% was demonstrated to have statistical significance at 12 weeks in favor of PACE®-treated wounds (51/107, 47.7%) compared with sham-control wounds (31/99, 31%) (p=0.016). Furthermore, of the wounds that achieved at least 90% wound area reduction at 12 weeks, the median reduction in area exceeded 99%. Overall, PACE-treated wounds were twice as likely to achieve 90% to 100% wound closure compared with sham-control subjects within 12 weeks of the initial PACE procedure. Further, by 12 weeks, the reduction in target ulcer area in PACE subjects was on average 48.6% compared with an average of only 10.7% in subjects randomized to sham-control (p=0.015).14

References

  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 as an effective therapy against Pseudomonas aeruginosa-infected biofilm wounds. Wound Repair Regen. 2013;21(2):266-274.

  5. Liedl DA, Kavros SJ. The effect of mist ultra-sound transport technology on cutaneous microcirculatory blood flow. Abstract. SAWC, 2001.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

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