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PRESS RELEASES
FOR IMMEDIATE RELEASE
Celleration®, Inc. Receives FDA Clearance for MIST Therapy® System 5.0
Wound Treatment Device
Eden Prairie, MN, June 25, 2004 - Celleration, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its MIST Therapy System 5.0. The clearance was obtained through the FDA De Novo process, a part of the FDA Modernization Act of 1997 (FDAMA). The Company believes that this clearance may provide potential market advantages. Mist Therapy produces a low intensity ultrasound generated mist; initial claims approved are for wound cleansing and maintenance debridement as well as removal of bacteria, which is paramount to the healing process. This indication allows Celleration's proprietary non-contact MIST Technology™ to be used on a variety of wounds including, acute, traumatic, chronic and dehisced wounds.
Dr. William Ennis at Christ Methodist Hospital, Chicago, IL. commented, "wound healing progresses optimally on a wound bed clean of devitalized tissue and controlled bacteria levels. The use of MIST Therapy is an attractive technology for health care professionals since its use appears to enhance our ability to manage these difficult to heal wounds more effectively".
The wound care market is a very large and a costly component of the United States health care system. Market data estimates that more than 89 million patients are treated annually for all wound conditions at costs in excess of $25 billion.
Kevin Nickels, CEO and President of Celleration comments, "due to an aging population and the rising costs associated with these chronic wounds, many healthcare providers, companies, third party payors and Medicare have increased their focused attention on this problem. For example, one half of all non-traumatic lower limb amputations result from wound complications. We are very pleased to be introducing this new technology to our customers, complementing their efforts to improve the lives of their patients while reducing the overall expenditures required from our healthcare system."
About the Company:
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 ultrasonic sound waves to produce an energized mist of sterile saline in a non-contact fashion. Critical to the Company's strategy is ongoing clinical and scientific research to provide evidence supporting the efficacy of this new technology. The Company's initial focus has been the chronic diabetic foot ulcer market and has recently completed a randomized, sham controlled multi center study in diabetic foot ulcers to pursue additional indications for the MIST Technology.
For more information on Celleration, Inc. and the MIST Therapy System 5.0 contact Mr. Chris Ernster VP of Sales and Marketing 952-974-0490.
Celleration, Inc.
10250 Valley View Road
Suite 137
Eden Prairie, MN 55344
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