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AN UPDATE FROM AUGUSTINE MEDICAL INC

Augustine Medical Inc. (AMI) designs, manufactures and markets medical device products dedicated to improving the health and well being of its families, friends and global neighbours. AMI’s goal of leadership in the medical device industry will be attained through major innovation and an unparalleled commitment to clinical research. Since its foundation in 1987, the company has supported clinical research to guide its product development, marketing and sales. Outcome studies have been published in peer reviewed medical journals including The New England Journal of Medicine, Lancet, Journal of Wound Care, Wound Repair and Regeneration, JAMA, Journal of Vascular Surgery, Anaesthesiology and numerous others. This is a synopsis of the current research efforts to support Warm-Up^® therapy.

Warm-Up^® temperature control unit

Warm-Up^® wound therapy is a revolutionary concept in wound healing that creates an optimal healing environment. Warm-Up^® therapy utilizes a non-contact wound cover and warming unit to maintain 100% relative humidity and restore both periwound and wound temperatures toward normothermia. The system is based on the fundamental premise that all cellular physiological functions, enzymatic and biochemical reactions, are optimized at normothermia which is defined in the medical literature as 37°±1°C.

Hypothermic wound and periwound tissues inhibit healing. Therefore, optimal wound healing should be achieved by bringing these tissues closer to the normothermia level, since all cellular functions are temperature dependent. The purpose of Warm-Up^® therapy is to restore the wound and periwound tissues towards normothermia, which is believed to be conducive to optimal wound healing.

The product research goal for Warm-Up^® is to initially demonstrate clinical effectiveness in treating chronic and acute wounds. Randomized, prospective, masked (blinded), outcome studies, with a cost effectiveness component, are designed to specifically address each specific wound type. Studies supported by AMI will demonstrate:

• Accelerated rate of healing in direct comparison to the standard of care for the treatment of a specific wound type
• Complete healing of wounds
• Pain relief with the use of Warm-Up^® therapy
• Cost effectiveness
• Patient compliance
• Clinician ease of use
• Improved quality of life for patients
• Clinical reimbursement justification (proof)

In general, it is the policy of AMI to support only research that will be published in peer reviewed journals and presented at national and international meetings. Multi-center and international clinical studies on both pressure and venous ulcers are currently underway.

Luther Kloth, MS, PT, CWS published an article, Effects of a Normothermic Dressing on Pressure Ulcer Healing in Advances in Skin & Wound Care, March /April 2000.

Professor Kloth concluded wounds treated with a radiant heat dressing healed significantly faster than wounds that received only standard care.

Stimulation of fibroblast growth in vitro by intermittent radiant warming was published in Wound Repair and Regeneration, March/April 2000, Vol. 8, Number 2. The authors were Zhidao Xia, MD; Akio Sato, Ph.D.; Margaret A. Hughes, PhD; George W. Cherry, Ph.D.

The purpose of this study was to investigate in vitro the effect of intermittent radiant heating on the growth of human skin fibroblasts using a radiant heat-producing dressing with a designated temperature of 38°C. To determine whether this intermittent warming, following a protocol similar to that used in the clinic, could have a direct effect on the growth of human skin cells in vitro.

After eight days the number of cells in the radiant heat-treated group was 30% higher and the metabolic activity 47% – 90% higher than in the control group. In quiescent fibroblasts that had been maintained for four weeks in a low-serum medium, the warming regime completely prevented the decrease in cell numbers observed in control cells. Their findings suggest that the stimulation of cell proliferation induced by intermittent heating in vitro may indicate a possible mechanism contributing to in vivo effects.