Healthcare Industry News:   diabetic foot ulcer 

Devices Wound Care

 News Release - October 28, 2008

Study Shows Celleration's MIST Therapy(R) Expedites Wound Healing

Chronic Lower-Extremity Wounds Heal Faster When MIST Therapy(R) System Is Combined with Conventional Wound Care

EDEN PRAIRIE, Minn.--(HSMN NewsFeed)--New research shows Celleration’s MIST Therapy System results in faster healing when combined with conventional wound care. The study also revealed an increased rate of complete wound closure.

The MIST Therapy System, developed and marketed by Celleration, is an innovative device that uses low-frequency ultrasound energy to stimulate the healing of wounds. The study, authored by Steven J. Kavros, DPM, and colleagues at the Mayo Clinic Gonda Vascular Wound Healing Center, was published in the September 2008 issue of Advances in Skin and Wound Care.

In this retrospective study of chronic lower-extremity wounds, the authors compared the wound healing of 163 patients who had received MIST Therapy in addition to standard of care (SOC) with 47 patients who had received SOC alone. In the study, the patients receiving MIST Therapy received treatments three times per week for 90 days or until healed.

During the 6-month study period, 53 percent of the wounds treated with MIST Therapy and SOC healed compared to only 32 percent of wounds treated with SOC alone (P = 0.009). In addition, the study showed wound volume decreased 26 percent more in the MIST group in comparison to the SOC group. Furthermore, statistical analysis of the rate of wound healing showed that MIST-treated wounds healed at a faster rate than wounds treated with SOC alone.

“Ultimately, our goal as clinicians is to heal wounds as quickly as possible, thereby minimizing the opportunity for infection or complications that hinder the healing process,” explains Dr. Kavros. “The findings from this study confirm and bolster the evidence from smaller prospective studies showing the benefit of combining MIST Therapy with SOC to expedite healing of chronic lower-extremity wounds.”

“This study further confirms patients experience faster healing with MIST Therapy,” said Kevin Nickels, president and CEO of Celleration. “It also supports our commitment to providing trusted medical devices that are backed by clinical and scientific data.”

Source: Kavros SJ, Liedl DA, Boon AJ, et al. Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. Adv Skin Wound Care. 2008; 21:416-23.

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About Celleration, Inc.

Celleration, Inc., a privately held medical device company, was founded in 1999 to develop and commercialize its therapeutic ultrasound platform. The patented MIST Technology utilizes low-intensity ultrasonic sound waves to produce an energized mist of sterile saline in a non-contact fashion. The MIST Therapy® System is a painless, non-contact ultrasound device used to promote wound healing through cellular stimulation while removing bacteria, allowing clinicians to heal wounds faster. Critical to the Company’s strategy is on-going clinical and scientific research to provide evidence supporting the efficacy of this new technology. The Company’s initial focus has been on the chronic diabetic foot ulcer market. It recently completed a prospective, randomized, double-blind, sham-controlled multi-center study in diabetic foot ulcers, which resulted in a statistically significant improvement in the rate of wound closure and time to wound closure.

Source: Celleration

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