FDA Gives Clearance to Second MEDIHONEY Wound Dressing

Derma Sciences Receives Second FDA 510K Clearance and Adds to Their MEDIHONEY Wound & Burn Dressings with Active Leptospermum Honey Line
Medical News Today, 11/16/2007

Derma Sciences (OTCBB: DSCI), a manufacturer and marketer of advanced wound care products, announced that the FDA has given 510K clearance to the company's second dressing in the MEDIHONEY line. This dressing is indicated for use on wounds with light to moderate exudate, and - based on its hydrocolloidal properties - forms a gel when it comes into contact with wound fluid to assist in promoting a moist environment conducive to healing. Hydrocolloids are the most commonly used advanced wound care dressings, as most chronic wounds fall into the category of light to moderate exudate. In 2007 it is estimated that over $150 million in hydrocolloids will be sold in the US alone. The first MEDIHONEY dressing from Derma Sciences, cleared for use by the FDA in July 2007, is in an alginate base and is indicated for wounds with moderate to heavy levels of exudate.

The new dressings, both in adhesive and non-adhesive versions, have been shown to lower the pH level of wounds. This is significant in that much recent attention has been focused on the effect of pH modulation in wounds, and the research suggests that lowering the pH of a wound helps to create a more optimal environment for wound healing. When wound pH is lowered, it has been shown that protease modulation and increased oxygen diffusion take place, both beneficial to hard-to-heal wounds.

Additionally, the dressings - due to their high levels of glucose and other sugars - have been shown to promote a strong osmotic effect. This osmotic effect, drawing fluid from surrounding tissues, helps to constantly bathe wounds in lymph fluid, which assists in the removal of necrotic tissue, slough, and debris from the wound bed…