Celleration, Inc.

Celleration^®, Inc. Receives FDA Clearance for Expanded Indication of “Promotes Wound Healing" for the MIST Therapy^® System 5.0 Wound Treatment Device

Eden Prairie, MN, May 24, 2005 - Celleration, Inc. announced today that it has received its second clearance with expanded indications from the U.S. Food and Drug Administration (FDA) for the MIST Therapy System 5.0. The clearance was based in part on the results of its prospective, randomized, double-masked, sham controlled multi-center study in diabetic foot ulcers which resulted in a statistically significant improvement in the incidence of complete wound closure and time to wound closure. The newly cleared indication for use reads,

“The MIST Therapy System produces a low energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellow slough, fibrin, tissue exudates and bacteria.”

Celleration's proprietary non-contact MIST Technology™ can be used on a variety of wounds including, acute, traumatic, chronic and dehisced wounds to promote wound healing.

The use of MIST Therapy is an attractive technology for health care professionals since its use appears to affect multiple aspects of a chronic wound to optimize the wound bed environment thus promoting healing. The treatment takes only minutes; it is easy to use, compact and portable, and comfortable for patients with painful wounds.

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 wound conditions at costs in excess of $25 billion. Chronic wounds are a major concern for the health care system. Chronic wounds are wounds that have failed to proceed through an orderly and timely series of events to produce a durable, structural and cosmetic closure. These non-healing wounds have substantial public health impact each year, including discomfort, loss of mobility, serious morbidity and mortality. There are an estimated 5-7 million complex and chronic wounds in the U.S. Chronic wounds include but are not limited to diabetic ulcers, pressure ulcers, venous stasis ulcers and arterial ulcers. Chronic wounds can take weeks, months, and in some cases, years to heal. 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 payers 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 providing them a true therapeutic tool for the active management of wounds.”

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. 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 it has recently completed a prospective, randomized, double-masked, 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.

For more information on Celleration, Inc. and the MIST Therapy System 5.0 contact Mr. Chris Ernster,
VP of Sales and Marketing 952-224-8700.