Regina-Orthopedic-New-Device

MIST Therapy by Celleration

MIST Therapy® is a painless, noncontact, low-frequency ultrasound delivered through a saline mist to the wound bed. Unlike most wound therapies that are limited to treating the wound surface, the gentle sound waves of MIST Therapy stimulate the cells within and below the wound bed to accelerate the normal healing process.

The result of these gentle sound waves pushing against the tissue include:

Removal of Barriers to Healing

  • Reduces a wide-range of bacteria
  • Disrupts biofilm
  • Reduces sustained inflammation
  • Reduces MMP-9

Stimulates Cells to Promote Healing

  • Increased blood flow through vasodilation
  • Increased angiogenesis
  • Early release of growth factors
  • Increased collagen deposition

MIST Therapy System

The MIST Therapy® System includes several components:

  • Ultrasound Generator and Transducer – the generator produces the energy needed to create the sound waves that are delivered to the wound bed from the transducer tip.  The transducer is the “wand” attached to the system that is held near the wound to the deliver the gentle sound waves without direct contact.  The metal tip of the transducer vibrates over 40,000 times a second to create the gentle, low-frequency sound waves.

12

  • Applicator– the applicator is attached over the transducer and dispenses the saline which is the conduit for delivering the sound waves to the wound bed.  The applicator and saline are “single use only” and should be discarded after the treatment session is completed to reduce risk of contamination and infection.

 

23

45

Celleration provides you two options when selecting an applicator for use with the MIST Therapy System.  The MIST Therapy kit provides a 100ml bottle of sterile saline in the kit.

MIST 360o provides a new applicator design with increased flexibility to access even the most difficult to reach wounds while allowing larger wounds to be treated more easily.   The MIST 360o design replaces the saline bottle and holder of the applicator with tubing that is attached to a 0.9% normal saline IV bag.   The features of MIST 360o include

  • Improved access to difficult to treat locations
  • Enhance wound visualization during treatment
  • Minimize repositioning of your patients
  • Treat larger wounds without stopping to refill saline
  • Lighter transducer designed to minimize user fatigue

456

UltraMIST® System

The UltraMIST System is Celleration’s next generation MIST System which combines the efficacy of MIST Therapy with the today’s latest technology advancements.

  • Treatment wand – the hand-held treatment wand is positioned near the wound to the deliver the gentle sound waves without direct contact.  The ultrasound tip vibrates over 40,000 times a second to create the gentle, low-frequency sound waves.

treatment-wand31-300x168

 

 

  • Applicator – the applicator is attached over the transducer and dispenses the saline which is the conduit for delivering the sound waves to the wound bed.  The applicator and saline are “single use only” and should be discarded after the treatment session is completed to reduce risk of contamination and infection.

applicator-6-300x175

  • Ultrasound Generator – the generator produces the energy required by the treatment wand.  It has a built in pump that provides a consistent delivery of saline while the ultrasound is being delivered.

generator-3-300x200

Cell Stimulation

The mechanical stress placed on the cell membrane by the MIST Therapy® ultrasound waves has been shown to have several affects.

  • Cell Stimulation – Cells treated with MIST Therapy demonstrated stimulation by the increase of ERK(extracellular regulated kinase) and JNK (c-Jun N-terminal kinase) and the ERK/JNK ratio, which regulates cell proliferation and cell survival mechanisms. (2)
  •  Growth Factors – Fibroblasts stimulated by MIST Therapy show earlier release of two growth factors needed for wound healing; KGF (Keratinocyte Growth Factor) and TGF-b1  (Transforming Growth Factor).(2)

KGF specifically promotes the proliferation and migration of keratinocytes

TGF-b1 stimulates the regeneration of soft tissue and the production and deposition of collagen by fibroblasts

Growth-Factors-300x165

  •  Collagen Deposition – Increased deposition of blood vessels and a stronger, more natural collagen in granulation tissue was seen in the MIST Therapy treated tissue.

Collagen-Graphic

Reduces Inflammation

The mechanical stress placed on the cell membrane by the MIST Therapy® ultrasound waves has been shown to have several affects.

  • Reduces inflammation – Study data indicates that MIST Therapy significantly down-regulates inflammatory responses of THP-1 cells.  The mechanism of inhibition involves diminished activation of p38 MAPK signaling pathway

Inflammatory-Marker1-300x168

Since excess inflammation is a characteristic feature of chronic wounds, the anti-inflammatory effects of MIST may contribute to improved healing.

Reduced Bacteria and Bioburden

A critical benefit of MIST Therapy when treating nonhealing wounds is its ability to reduce the amount of bacteria within and below the wound bed.  Bacterial cells are more rigid and susceptible to micromechanical stress. When treated with MIST Therapy, many bacterial membranes will fracture and the cell will die.

breakdown_bacteria

MIST Therapy has been shown to reduce a wide range of bacteria, including MRSA, VRE and pseudomonas.

Micro-Bacteria-Effect2-e1267569710265

A prospective, multi-center single arm study used biopsies to demonstrate the amount of bacteria within the wound bed and MIST Therapy’s impact on the bacterial count after two weeks of treatment (6 sessions).

  • Eleven (11) patients with Stage 3 pressure ulcers from three wound care centers were enrolled
  • Each participant received a biopsy at enrollment and after two weeks of 3x/wk MIST treatments
  • All participants needed to have greater than >105 bacterial count, show no signs of infection and be free-from antibiotics to be included in the study.

Macro-Bacteria-Effect-graphic

Of the 12 types of bacteria seen on initial evaluation, all but one showed a significant reduction.  Overall mean bacterial burden was reduced 50% from 4 x 107 to 2 x 107after 2 weeks of MIST Therapy treatments.

50% Reduction in Bacteria

bacterial-reduction

Increased Blood Flow

The vasodilatation effect is a well-documented benefit of ultrasound. Dilation of the capillaries surrounding the wound bed increases circulation to the site, thereby enhancing healing on a macro level.

Flowmetery2-600x242

The resulting stress placed on the capillaries leads to the stimulation of new capillaries on a micro level.

Angiogenesis-Graphic

 

Clinical Evidence

 

Few technologies can demonstrate the depth of clinical data supporting its efficacy like MIST Therapy®.  The results show MIST Therapy accelerates wound healing in even the most difficult types of wounds with patients having multiple comorbidities.

Clinical-Data-Pyramid-01-13-15

Over 2,000 patients have been included in MIST Therapy clinical studies. This growing body of data includes; one (1) Meta-analysis, four (5) Prospective, Double-Blinded Randomized-Control Studies, two (2) Prospective Studies, six (6) Retrospective Studies, two (2) Observational Studies, over thirty (30) other articles (i.e. case series) and over one hundred (100) Posters.

Few wound care technologies have the clinical evidence to support a meta-analysis.  In the meta-analysis using only MIST Therapy ultrasound clinical data, eight (8) peer-reviewed studies with consistent designs for treatment and control wound groups were pooled to review the effects of MIST Therapy.  The authors concluded that “MIST Therapy demonstrates consistency of reduction in wound area, volume, pain and healing times across a wide range of wounds.”

 


Intellectual Property

Notice is hereby provided by way of this Virtual Patent Mark per 35 U.S.C. § 287(a) that the Celleration Inc. products or portions thereof listed below are covered under one or more patents in the United States or elsewhere. Additional patents may be pending in the United States or elsewhere.

Last updated: June 28, 2013

Wound Care
MIST® Therapy System, MIST® Therapy Applicator, and MIST® 360° Applicator

In the United States:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following United States Patents: 6,478,754; 6,533,803; 6,569,099; 6,601,581; 6,663,554; 6,761,729; 6,960,173; 7,914,470; 8,235,919.
MIST® Therapy Applicator and MIST® 360° Applicator or portions thereof are protected by one or more of the following United States Patents: 6,964,647; 7,713,218; 7,785,277

In Countries other than the United States:
Patents marked as “EPXXXXXX” denote a European Patent number. Inclusion of this number in a specific country list provides that the EP patent post grant is validated in that country.
In France:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following French Patents: EP1355696; EP1322275
In Germany:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following German Patents: EP1355696; EP1322275
In United Kingdom:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following United Kingdom Patents: EP1355696; EP1322275
In Canada:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following Canadian Patents: CA2463600; CA2521117
In China:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following Chinese Patents: CN1466445
In India:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following Indian Patents: IN207058; IN228689
In Japan:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following Japanese Patents: JP4164582
In Singapore:
MIST® Therapy System method and device or portions thereof are protected by one or more of the following Singapore Patents: SG95385

 

 

Leave a Reply

Your email address will not be published. Required fields are marked *